cyrilzakka/clinical-trials huggingface dataset:
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IONIS-MAPTRx in Patients With Mild Alzheimer's Disease

The purpose of this study was to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of IONIS-MAPTRx in patients with Mild Alzheimer's Disease.

This was a randomized, double-blind, placebo-controlled study in 46 participants, followed by an Open-Label Extension. This study consisted of two parts:

Part 1: a randomized, double-blind, placebo-controlled multiple ascending dose period in participants with Mild Alzheimer's Disease, followed by Part 2: the open-label, long-term extension period.

Eligibility Criteria:
Inclusion Criteria for Part 1:

* Males or females aged 50-74 years, inclusive, at the time of informed consent
* Diagnosed with mild Alzheimers disease, including CSF biomarkers consistent with this diagnosis
* Body Mass Index BMI ≥ 18 and ≤ 35 kg/m2 and total body weight \> 50 kg (110 lbs)
* Able and willing to meet all study requirements, including toleration for MRI scans, blood draws and lumbar punctures, travel to Study Center and participation in all procedures and measurements at study visits
* Have a trial partner who is reliable, competent and at least 18 years of age, is willing to accompany the patient to select trial visits and to be available to the Study Center by phone if needed
* Reside within 4 hours travel of the Study Center

Exclusion Criteria for Part 1:

* Treatment with another Study Drug, biological agent, or device within one-month of Screening or 5 half-lives of investigational agent, whichever is longer
* Clinically significant medical condition which would make the patient unsuitable for inclusion or could interfere with the patient participating in or completing the study
* Use of a disallowed CNS-active or antipsychotic medication within 4 weeks prior to Screening punctures

Inclusion Criteria for Part 2:

* Must have completed the Treatment Evaluation and Post-Treatment Periods in Part 1

Exclusion Criteria for Part 2 (only applicable to participants in Cohorts A and B, as participants from Cohorts C and D will seamlessly transition to Part 2):

* Treatment with another Study Drug, biological agent, or device within one-month of Screening or 5 half-lives of investigational agent, whichever is longer
* Clinically significant medical condition which would make the patient unsuitable for inclusion or could interfere with the patient participating in or completing the study
* Use of a disallowed CNS-active or antipsychotic medication within 4 weeks prior to Screening punctures
Dexmedetomidine Versus Magnesium Sulfate Infusion During Spinal Anesthesia

The aim of this work is to compare the hemodynamic and analgesic properties of Dexmedetomidine and Magnesium sulphate infusion in lower abdominal surgery.

Dexmedetomidine is a relatively new alpha 2 adrenergic receptor agonist with a higher α2/α1 selectivity ratio of 1620:1 that provides analgesic and anesthetic effects . Dexmedetomidine has various clinical uses in anesthesia such as sedation, and prolongation of the duration of postoperative analgesia when used as an adjuvant through intrathecal, epidural, or intravenous routes.

Magnesium sulphate is another commonly used drug in anesthesia. Magnesium sulphate suppresses nociceptive impulses through inhibition of voltage-gated calcium channels and through antagonism of the N-methyl D-aspartate (NMDA) receptors.

Although both drugs were reported to prolong the duration of spinal anesthesia, no studies to the best of our knowledge had compared the analgesic and hemodynamic profile of both drugs when used as intravenously during spinal anesthesia.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients aged between 18 and 65 years.
* Scheduled for lower abdominal surgery.

Exclusion Criteria:

* Systolic blood pressure less than 100 mmHg
* Coagulation disorders
* History of heart failure
* Mitral or Aortic stenosis
Influence of Pancreatic Transection With CUSA on Postoperative Pancreatic Fistula Incidence (PANCUT)

Objective: To compare the outcomes after elective pancreatic resections using cavitron ultrasonic surgical aspirator (CUSA) and selective closure of small blood vessels and branch pancreatic ducts versus surgical scalpel or stapler for the transection of pancreatic tissue.

Study design: A randomized controlled, single centre trial.

Study population: Two groups of 80 patients (160 in total) scheduled for elective open pancreaticoduodenectomy (PD) for any indication.

Intervention: Transection of pancreatic tissue with CUSA.

Control: Standard transection of pancreatic tissue with surgical scalpel (in PD) or stapler (in DP)

Rationale: Postoperative pancreatic fistula (POPF) is one of the major causes of morbidity and mortality after pancreatic resections. There is no predominant surgical technique of pancreatic stump closure in distal pancreatectomy (DP) or formation of pancreaticojejunostomy in pancreaticoduodenectomy (PD) proven to prevent/lower POPF incidence. Cavitron ultrasonic surgical aspirator (CUSA) selectively removes tissue parenchyma, evading blood vessels and pancreatic ducts which could consequently be selectively ligated. Such technique could anull pancreatic juice drainage from branch ducts and provide better (skeletonised) view of the main duct to from an anastomosis (or to ligate it in DP) and thus lower the incidence of POPF formation.

Objective: To compare transection of pancreatic tissue with CUSA and selective closure of small blood vessels and branch pancreatic ducts with transection with surgical scalpel or stapler in elective pancreatic resections regarding the incidence of POPF.

Study design: A randomized controlled, single centre trial. The study protocol was designed according to the SPIRIT guidelines.

Study population: Two groups of 80 patients (160 in total) scheduled for elective open pancreaticoduodenectomy (PD) for any indication.

Intervention: Transection of pancreatic tissue with CUSA.

Control: Standard transection of pancreatic tissue with surgical scalpel (in PD).

Main study parameters/endpoints: Primary outcome is the incidence of POPF. Main secondary outcomes are intraoperative outcomes (such as blood loss and operative time), postoperative outcomes (such as complications, time to functional recovery and hospital stay).

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years or more
* Patients capable of understanding the provided information about the study
* Patients with signed informed consent
* Planned elective pancreaticoduodenectomy for any indication

Exclusion Criteria:

* Patients aged less than 18
* Patient incapable of understanding the provided information about the study
* Pregnancy
* Previous surgical procedures on pancreas
* Immunosuppressive therapy
* Preoperative radiotherapy
Study of Difluprednate Ophthalmic Emulsion in the Treatment of Uveitis

The purpose of this phase 3 confirmatory study is to determine if difluprednate ophthalmic emulsion is effective in the treatment of treatment of uveitis.

The objective of this phase 3 study is to assess the efficacy and safety of 0.05% difluprednate ophthalmic emulsion (DFBA) in patients with endogenous anterior uveitis, in comparison with 0.1% betamethasone sodium phosphate ophthalmic solution (BP).

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with endogenous anterior uveitis or panuveitis
* Patients with 10 - 49 anterior chamber cells within one field of the anterior chamber as observed by slit lamp microscopy (criterion for rating of signs 2 or 3)
* Patients aged ‰1425 years (on the day of obtaining informed consent) who were able to accurately express their own symptoms
* Patients provided written informed consent prior to initiation of the study

Exclusion Criteria:

* Patients who did not meet all of the above inclusion criteria
* Patients received systemic administration of any corticosteroid or immunosuppressive drug within the past 1 week prior to instillation of the investigational product
* Patients received topical injection of any corticosteroid in eyes prior to instillation of the investigational product (Solution formulation: within the past 1 week, depot: within the past 2 weeks)
* Patients received systemic administration of any non-steroidal anti-inflammatory drug or antiphlogistic enzyme within the past 3 days prior to instillation of the investigational product
* Patients received instillation of any corticosteroid, non-steroidal anti-inflammatory drug or antiphlogistic enzyme within 12 hours prior to instillation of the investigational product
* Patients with glaucoma or ocular hypertension
* Patients with corneal abrasion or ulcer
* Patients with any confirmed or suspected viral, bacterial or fungal keratoconjunctival disease
* Patients with allergy to similar drugs such as other corticosteroids
* Patients requiring use of contact lens during the study period
* Women who are or might be pregnant, or lactating women
* Patients participating in another clinical study within the past 3 months before initiation of the present study
Detection of Area of Ischemia in Patients With Subacute Stroke Via a Hybrid EEG-fNIRS Brain-computer Interface

The purpose of this research study is to determine whether a combined electroencephalography (EEG) and functional near infrared spectroscopy (fNIRS) recording is able to detect changes in brain activity and blood flow after stroke.


Eligibility Criteria:
Inclusion Criteria:

* All patients with a subacute ischemic stroke with symptom onset within 8 weeks
* Must have a measurable deficit on the National Institute of Health Stroke Scale (NIHSS)
* Able to give and sign informed consent

Exclusion Criteria:

* Aphasia
* Underlying dementia
* Any chronic neurological disorder
* Malignancy
* Non-ambulatory (ambulation with assistance will be included)
* Modified Rankin Score (mRS) \> 3
The Effect of Fertility Health Awareness Strategies on Fertility Knowledge and Childbearing in Young Married Couples

Singapore, like many developed countries, is experiencing low birth rates, which is coupled with increasing age at first marriage and birth. In addition, demand for assisted reproduction technology treatments has increased over the years. Fertility awareness surveys have consistently shown that public awareness of age-related fertility decline and the limitations of fertility treatments is generally low, and this may lead to couples not optimising their fertility potential to achieve their family aspirations. This trial aims to study the effect of fertility health screening and fertility awareness tools on knowledge, attitudes and practice around childbearing among young Singaporean married couples.


Eligibility Criteria:
Inclusion Criteria:

* Married couple
* Both partners should be Singapore Citizens or Permanent Residents
* Female partner is 25 - 34 years old at time of recruitment
* Both partners agreeable and able to complete study procedures

Exclusion Criteria:

* Already have children, including from previous marriages
* Pregnant
* Currently undergoing or had previously went for any fertility evaluation and/or treatments
* Self-reported history of previous ectopic pregnancy in the female partner
* At least 1 partner unable to complete a self-administered questionnaire in English
40 Week Trial to Study the Safety of Asenapine When Added to Lithium or Valproate in the Treatment of Bipolar Disorder (A7501009)(P05786)

The primary objective of this trial was to characterize the long-term (up to 40 weeks) safety and tolerability of asenapine in bipolar I disorder subjects who had not completely responded to continuing treatment with lithium or valproic acid (VPA) for the treatment of an acute manic or mixed episodes upon enrollment into the 12-week lead-in trial, A7501008 (NCT00145470). The safety comparison was between the group receiving lithium or VPA and placebo against the group receiving lithium or VPA and asenapine, with the caveat that all subjects may have received benzodiazepine and/or antidepressant rescue medication as needed.


Eligibility Criteria:
Inclusion Criteria:

* Have bipolar I disorder (current episode manic or mixed), be treated with lithium or valproic acid, and have completed the a 12-week lead-in trial

Exclusion Criteria:

* Have an unstable medical condition or clinically significant laboratory abnormality.
* Have a primary diagnosis other than bipolar I disorder.
MicroRNA Expression and Function in Cutaneous Malignant Melanoma

Spectrophotometric intracutaneous analysis (SIAscopy) is a new technique for imaging pigmented skin lesions and for diagnosing melanoma and non-melanoma skin cancer. The SIAscope is a portable system comprising of a laptop computer connected to a small handheld skin probe equipped with a light source. The skin lesion is interrogated with light of different wavelengths and the reflection spectra analysed by proprietary algorithms showing distribution, position and quantity of melanin, blood and collagen within the papillary dermis (the SIAgraphs). Earlier studies generated promising results and documented \>80% specificity and sensitivity of SIAscopy for melanoma diagnosis. It has been suggested that this technique could be used for the initial screening and selection of pigmented lesion for excision. In this work we addressed the usefulness of SIAscopy for the clinical diagnosis of pigmented malignant melanoma in a prospective, blinded design.


Eligibility Criteria:
Inclusion Criteria:

* Pigmented lesion

Exclusion Criteria:

* No pigmented lesion
A Phase 3 Trial of MM120 for Major Depressive Disorder (Emerge)

A Phase 3 Double-blind, Placebo-controlled Study (Part A) with an Open-label Extension (Part B) Evaluating MM120 Compared to Placebo in Major Depressive Disorder - Emerge

The study will enroll approximately 140 adult men and women aged 18 to 74 years, inclusive with a Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) confirmed primary diagnosis of MDD,a minimum MADRS total score of at least 26 and a CGI-S score of at least 4 at Screening and Baseline without clinically relevant medical or psychiatric history.

The study consists of a 12-week randomized, double-blind, single-dose administration period evaluating MM120 versus placebo, followed by a 40-week extension phase with the opportunity for open-label treatment. During this phase, participants will be monitored and evaluated for potential treatment with MM120 based on pre-specified safety and symptom severity criteria.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of MDD per DSM-5
2. Male or female aged 18 to 74
3. Currently experiencing a major depressive episode (MDE) of ≥8 weeks and ≤24 months duration
4. MADRS Total Score ≥26
5. CGI-S Score ≥4

Exclusion Criteria:

1. Certain psychiatric disorders (other than major depressive disorder)
2. First degree relative with or lifetime history of a psychotic disorder or bipolar disorder
3. Current diagnosis of alcohol or substance use disorder (excluding nicotine and caffeine
4. Any clinically significant unstable illness
A Multicenter, Real-world Study of Adebrelimab in the Treatment of Extensive Stage Small Cell Lung Cancer

This study collected data on patients with extensive stage small cell lung cancer treated with Adebrelimab to investigate its safety and efficacy


Eligibility Criteria:
Inclusion Criteria:

1. Sign informed consent and join the study voluntarily;
2. Patients diagnosed with extensive small cell lung cancer;
3. Age ≥18 years old;
4. Have at least one measurable lesion (according to RECIST 1.1);
5. The investigators judged that adebrelimab treatment was acceptable;
6. Contraception: Patients should agree that it must be used during the study period and within 6 months after the study ends Effective contraception;

Exclusion Criteria:

1. Allergic to adebrelimab and its excipients;
2. Patients who have also received other immune drugs or therapies;
3. Patients who are participating in other interventional studies;
4. patients with other malignant tumors;
5. Pregnant or lactating women;
6. The investigator considers that the patient is not suitable to participate in any other conditions of the study.
PLUG Dementia Trial and MRI PLUG Dementia Sub-Study

PLUG Dementia Trial:

Patients will be screened at Intermountain Medical Center and at Intermountain affiliated anticoagulation clinics in the Salt Lake City region. Patients with atrial fibrillation that undergo a standard of care, clinically approved, left atrial appendage closure will be considered for study. All patients will be followed for 24 months, and will be assessed at the 3-, 6-, 12-, 18- and 24-months post-left atrial appendage closure as well as other visits deemed necessary for clinical care. All subjects will undergo protocol-specified laboratory tests and will complete 6 standard, validated questionnaires at each follow-up visit, except at the 3-month visit when only one questionnaire will be administered. A subset of patients (n=20), will receive a cranial MRI at baseline and 24-month visit.

MRI PLUG Dementia Sub-Study:

In addition to the above, 20 of the 60 subjects who are selected for participation in this sub-study will receive a cranial MRI at baseline and at the 2-year (24 months) follow-up visit.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female \>65 years of age
2. Atrial fibrillation documented by electrocardiogram, ambulatory event monitor, or telemetry within 6 months of enrollment
3. Moderate risk of thromboembolism based upon a CHADS2 score or CHADS2 Vasc score of ≥2.
4. Recipient of a left atrial appendage closure device within 3 months of enrollment (within 6 months, for patients considered for the MRI PLUG Dementia Sub-Study)
5. Have the ability to complete a mini-mental status evaluation
6. Have the ability to independently comprehend and complete a quality of life and dementia questionnaires.
7. Ability to provide informed consent for study participation
8. Willing and able to comply with the prescribed follow-up tests and schedule of evaluations.

Exclusion Criteria:

1. Have a history of any form of dementia
2. Have a life expectancy less than 24 months
3. Are unable to comply with the follow-up schedule
4. An upper age limit not to be used if participation inclusion criteria are met.
5. Participation in any other clinical trials involving an investigational or marketed drug within 30 days prior to entry in this study;
6. Other conditions that in the opinion of the Principal Investigator may increase risk to the subject and/or compromise the quality of the clinical trial
7. The Principal Investigator(s) determine(s) that the subject is not eligible for participation in this research study.

In addition to the above exclusion criteria, patients considered for the MRI PLUG Dementia Sub-Study will be excluded if the patient -

1. Does not receive a left atrial appendage closure device
2. Has contraindication towards the MRI scan (presence of a nonconditional cardiac implantable device, a history of metallic implants, shrapnel, neurosurgical clip placement)
3. Has conditional cardiac MRI cardiac implantable device, joint replacements, coronary stents, ASD/PFO closure devices, sternal wires or most prosthetic heart valves
4. Has severe renal dysfunction, defined as a creatinine clearance \<15 mL/min (documented within the last 3 months)
KinetiGait- Analysis of Depth Camera to Assist Gait Analysis for Unilateral Transtibial/Transfemoral Amputees

This is a feasibility study about implementing and using the KinetiGait gait analysis system in clinical practice to enhance the rehabilitation of service members with lower limb disfunction. There will be questionnaires completed by participants and surveys completed by both participant and provider.

We propose a feasibility study about implementing and using the KinetiGait gait analysis system in clinical practice to enhance the rehabilitation of service members with lower limb dysfunction. Up to 100 subjects will be consented, with the expectation that 80% (e.g., n=80) will complete the study with a complete dataset. Baseline sessions will consist of 7 minutes of walking at a self-selected speed between 0.7 and 1.3 m/s, after which participants will take the PLUS-M 12 Item Short Form and PROMIS-29 questionnaires, as well as a short survey. Participants will complete the questionnaires again at 1 month and 3 month. Providers who observed/operated the KinetiGait system will also take a short survey on ease of use and satisfaction.

Eligibility Criteria:
Inclusion Criteria:

* Unilateral transfemoral or transtibial amputee
* Fitted by a prosthetist at a Military Treatment Facility
* K2-K4 Medicare Functional Classification Levels
* DEERS-eligible.
* For providers: MHS provider

Exclusion Criteria:

* K0-K1 Medicare Functional Classification Levels
* Physically unstable or requires an ambulatory device
* Pregnant women
Motor and Premotor Cortex Stimulation for Treatment of Secondary Focal Dystonia With Striato Palliadal Lesion : Evaluation of Safety and Effectiveness

Dystonia is a neurological movement disorder in which sustained muscle contractions cause twisting and repetitive movements or abnormal postures. This disease is very heterogeneous and can have many causes. Current treatments (drugs, pallidal stimulation) improve primary generalized dystonias; however they are ineffective for focal dystonias following brain damage.

Cortex stimulation is a present and effective technique used in the treatment of chronic pain and could represent an interesting strategy to treat focal dystonias. This is the aim of the present study.

Pilot study included 6 centres (Clermont-Ferrand, Bordeaux, Paris, Créteil, Lyon and Grenoble)

Study progress :

* 3 months to 1 month before chirurgical intervention : selection of patient that could be included in the protocol.
* 15 days to 8 days before chirurgical intervention : inclusion visit.
* Operating phase : under anaesthesia, implantation of the neurostimulator and its components, and adjustment of stimulation parameters.
* 1 month after chirurgical intervention : checking that all is fine (detection of undesirable events)
* 2 months to 5 months after chirurgical intervention: randomization (double blind): the stimulator is put on position On or OFF
* 5 months after chirurgical intervention : Stimulators of all patients are stopped for one month whatever the group they belong.
* 6 months to 9 months after chirurgical intervention: Stimulatiors are put on position On or OFF (cross over with the first period).
* 9 months to 13 months after chirurgical intervention: Stimulators of all patients are started for four months whatever the group they belong.
* 13 months after chirurgical intervention : study end

Eligibility Criteria:
Inclusion Criteria:

* Age : \>18 years and \< 65 years
* Evolution time of dystonia \> 1 year
* Clinical stability of dystonia = 1 year
* Secondary dystonia due to a focal lesion (vascular or anoxic) of central grey nuclei
* Inefficiency of others treatments (anticholinergic, benzodiazepine, neuroleptique, botulinum toxin, etc.)
* Stability of treatment \>3 months
* Agreement of patients
* Affiliation to social security

Exclusion Criteria:

* Significant heart vascular disease; significant respiratory, metabolic, renal or hepatic diseases
* Significant clinical and biological anomalies
* Disease or treatment in favour in bleeding
* Sever cognitive disorders
* Psychiatric evolutionary pathology
* Counter-indication during inclusion examination
* Chirurgical counter-indication
* Pregnant women ou women who nurse
* Person who participate to an other study