cyrilzakka/clinical-trials huggingface dataset:
Short and Optimal Duration of Dual Antiplatelet Therapy Study

The purpose of this study is to evaluate safety of reduction of thienopyridine treatment period to 3 months after implantation of Cobalt-Chromium everolimus-eluting Stents.

"Thienopyridine antiplatelet agents have markedly inhibited incidence of stent thrombosis, when they were combined with aspirin for 1 month after implantation of bare-metal stent (BMS). On the other hand, combination of aspirin with thienopyridine (dual antiplatelet therapy: DAPT) for more than 1 year after drug-eluting stent (DES) implantation is frequently used to prevent very late stent thrombosis in the current clinical practice. In the RESET study, which was carried out in clinical practice in Japan, DAPT was performed for at least 1 year in 90% of the patients. However, there has been no report showing that long-term thienopyridine treatment for at least 1 year reduces incidence of serious cardiovascular events, and large-scale observational studies or small-scale randomized comparative studies have demonstrated that thienopyridine treatment for 6 months or for at least 12 months does not reduce incidence of serious cardiovascular events. These results suggest that the optimal duration of DAPT after DES implantation may be shorter than 6 months.

With respect to Everolimus-eluting stent (EES), which is the most widely used DES in Japan, it has been associated with significantly lower incidence of early or late stent thrombosis compared with the first-generation DES and with BMS in large-scale observational study and randomized comparative studies and their meta-analyses.

Considering that long-term DAPT obviously increases hemorrhagic complications compared to Aspirin monotherapy, it is desirable to reduce the duration of DAPT as far as possible, if long-term DAPT is not effective in inhibiting the incidence of serious cardiovascular events. Moreover, long-term DAPT enormously increases medical expenses. In this study, we planned an exploratory multicenter study to evaluate incidences of cardiovascular events and bleeding events at 12 months after stent implantation using an EES (XIENCE Prime™), which is associated with low risk of stent thrombosis, when thienopyridine therapy is discontinued at 3 months after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients who received PCI using everolimus-eluting cobalt-chromium stents

Exclusion Criteria:

* Patients who had been implanted drug-eluting stents other than everolimus-eluting cobalt-chromium stents
Prospective Evaluation of Facial Cosmetic Procedures

A prospective, trial to quantitatively and qualitatively compare the dermal fillers for the treatment of age related aesthetic changes.

Dermal fillers have been approved for the treatment of age related aesthetic changes, including facial volume loss, and attenuation of the static and dynamic rhytid. Despite widespread use of volumizing fillers there is little data quantifying the subjective benefit of these minimally invasive treatments from the patient perspective. Furthermore, there is little data comparing the subjective benefit with true objective volumetric results. Such data will provide much needed information for patient counselling and treatment optimization for patient perceived outcomes.

This study is to determine the patient reported outcomes of three different dermal fillers and establish the volumetric changes over 90 days. Screening will be performed during the patient's office visit. Approximately 100 patients will be enrolled. Patients will participate up to 90 days (Day 1, 14 days, 28 days, and 90 days).

Eligibility Criteria:
Inclusion Criteria:

* Female patients 40 - 65 years of age

Exclusion Criteria:

* Male patients
* Prior surgical facial rejuvenation procedures
* Facelift
* Neck lift
* Blepharoplasty
* Facial fat grafting
* Prior minimally invasive rejuvenation procedure ≤ 12 months
* Known contraindications to devices or drugs used in this study
* Facial paralysis
* Congenital facial asymmetry
* Pregnant women
* Patient actively taking blood thinners
Efficacy, Safety and Tolerability of SPD485 in Children Aged 6-12 Diagnosed With ADHD

This study will assess the efficacy, duration of effect, tolerability and safety of 4- and 6- hour wear times of SPD485 in 6-12 year old subjects diagnosed with ADHD.

Attention-Deficit/Hyperactivity Disorder (ADHD) is a psychiatric disorder characterized by 3 main symptoms: inattention, hyperactivity and impulsivity. This study will assess the efficacy, duration of effect, tolerability and safety of 4- and 6- hour wear times of SPD485 in 6-12 year old subjects diagnosed with ADHD.

Eligibility Criteria:
Inclusion Criteria:

* Subjects have primary diagnosis of ADHD
* Females of childbearing potential must have a negative serum beta Human Chorionic Gonadotropin (HCG) pregnancy test
* Subject has an IQ score of \>_ 80
* Subject is able to complete as least the Basic Test of the PERMP assessment

Exclusion Criteria:

* Subject has a comorbid psychiatric diagnosis such as Axis II disorders or severe Axis I disorders
* Subject is taking Strattera(r)
* Subject has a recent history of suspected substance abuse or dependence disorder
Enhanced TB Screening to Determine the Prevalence and Incidence of TB in Patients With HIV

This study will examine an enhanced protocol to systematically screen a cohort of 400 new HIV clinic enrollees for prevalence and 1-year incidence of tuberculosis (TB).

Zambia is a high burden country for both HIV and TB infection and HIV clinic enrollees are a high-risk group for active TB. Current Zambian Ministry of Health screening protocols are symptom-based even though active case-finding studies in HIV-infected populations have shown that symptoms are not always predictive of active TB. As a result, there may be a significant amount of un-diagnosed TB among HIV-infected Zambians even in the context of accessing HIV care. This study will examine an enhanced protocol to systematically screen a cohort of 400 new HIV clinic enrollees for prevalence and 1-year incidence of TB using symptoms, light and fluorescence microscopy, chest radiography and TB culture of sputum and extra-pulmonary fluids (when indicated). In addition, the sensitivity, specificity and cost-effectiveness of each diagnostic tool will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Persons with HIV/AIDS, 16 years of age or older, who are enrolling at the Kalingalinga ART clinic and are able and willing to provide informed consent
* Antiretroviral therapy-naïve except for short-course therapy through prevention of mother-to-child-transmission programs
* Not have taken any TB treatment in the past 3 months
* Willing to provide locator information and allow study staff to contact by phone or visit them at home if required

Exclusion Criteria:

* Any condition, including active drug or alcohol use, which in the opinion of the investigators, would interfere with adherence to study requirements
Double Rewire Versus Double Kissing Crush Stenting Technique in Left Main Bifurcation Lesions

The DR vs DK trial is designed to elucidate the benefits of Double Rewire crush technique (DR-Crush) over Double Kissing Crush (DK-Crush) technique in patients with Unprotected Left Main Bifurcation lesions (ULMb).

DR vs DK is a multicentre, randomized, prospective, non-inferiority clinical trial designed to evaluate the efficacy and safety of DR crush over DK crush for patients with ULMb. More than 12 tertiary centres from Spain will participate including patients. Subjects with Medina 1,1,1 ULMb will be randomized in a 1:1 fashion to DR or DK crush. In order to avoid bias, the Sirolimus coronary stent will be used in all patients (UltimasterTM TanseiTM). The use of Intracoronary imaging techniques are recommended. The primary endpoint is target lesion failure (TLF) including target vessel myocardial infarction, cardiac death and TLR. Other endpoints address individual event of primary end-point, and target vessel revascularization. The safety objective is the ST. Recruitment began in January 2022 and will be completed in January 2024; 180 patients will be randomized.

Eligibility Criteria:
Inclusion Criteria:

* Patients between 18-90 years of age.
* Patients who gave written informed consent for participation in the trial.
* Lesions are eligible for percutaneous coronary intervention (PCI).
* Patient has stable/unstable angina or myocardial infarction (MI): all-comers.
* ULMb (Medina 1,1,1) with/without left main ostial/shaft lesions. Downstream lesions in LAD or LCX could be covered by two stents. Severe calcification needing rotational atherectomy, orbital atherectomy or Laser are included.
* Diameter stenosis in LAD/LM and LCX ≥ 50% by visual estimation or minimal luminal area by IVUS in LM ≤6 mm2.

Exclusion Criteria:

* Restenotic lesions.
* Patient was allergic to the study stent or protocol-required concomitant medications.
* Patient is intolerable to dual anti-platelet therapy.
* Patient has any other serious medical illness that may reduce life expectancy to \<12 months.
* Patient is a woman who is pregnant or nursing.
* Patient has a planned procedure that may cause non-compliance with the protocol or confound data interpretation.
* Patient is participating in another clinical trial.
* Patients in shock.
Antibiotic Safety (SCAMP)

The main purpose of this study is evaluate whether it is safe or not to use various combination of antibiotics (ampicillin, metronidazole, clindamycin, piperacillin-tazobactam, gentamicin) in treating infants with complicated intra-abdominal infections

The most commonly used antibiotics in infants with complicated intra-abdominal infections are not labeled for use in this population because safety and efficacy data are lacking. This study will provide the safety information required for labeling. In addition, the pharmacokinetics(PK) and effectiveness data will also be collected during this study.

Eligibility Criteria:
Inclusion Criteria:

1. Informed consent obtained from parent(s) or legal guardian(s) (Groups 1-5)
2. ≤33 weeks gestation at birth (Groups 1-3, 5)
3. ≥34 weeks gestation at birth (Groups 4 and 5)
4. PNA \<121 days (Groups 1-5)
5. Sufficient venous access to permit administration of study drug (intravenous \[IV\]) (Groups 1-5)
6. Presenting physical, radiological, and/or bacteriological findings of a complicated intra-abdominal infection within 48 hours prior to randomization/first study drug dose (Groups 1-4)\*\*. Complicated intra-abdominal infections include secondary peritonitis, NEC grade II or higher by Bell's criteria, Hirschsprung's disease with perforation, spontaneous intestinal perforation, meconium ileus with perforation, bowel obstruction with perforation, gastroschisis with necrosis and/or perforation, omphalocele with necrosis and/or perforation, neonatal appendicitis, intestinal pneumatosis or portal venous gas, free peritoneal air on abdominal radiographic examination, or abdominal abscess.
7. Suspected or confirmed infection for which the study drug may provide therapeutic benefit and planned CSF collection per standard of care (Group 5).

Exclusion Criteria\*

1. History of anaphylaxis in response to study drugs (Groups 1-5)
2. Serum creatinine \>2 mg/dL within 48 hours on measurement prior to and closest to randomization /first study drug dose (Groups 1- 5)\*\*
3. Known ALT \>250 U/L or AST \>500 U/L on measurement closest to the time of randomization or first study drug dose (Groups 1-5)\*\*
4. Any condition that, in the judgment of the investigator, precludes participation because it could affect participant safety (Groups 1-5)

   * Do not apply for Group 5 participants receiving drug per standard of care

     * Criteria must be satisfied by randomization (randomized Groups 1-3) or first study drug dose (non-randomized Groups 1-3, Group 4 and Group 5), whichever comes first.
Stereotactic Radiation Therapy in Treating Patients With Brain Metastases

RATIONALE: Stereotactic radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue.

PURPOSE: This phase II trial is study how well stereotactic radiation therapy works in treating patients with brain metastases

OBJECTIVES:

Primary

* To determine the neurological death rate following the initiation of conformal stereotactic radiotherapy in patients with 1-3 brain metastases.

Secondary

* To determine the overall survival rate at 6 months.
* To determine the progression-free survival rate or brain metastases recurrence rate at 6 months.
* To determine the time to neurological death, time to systemic death, and Karnofsky decay time.
* To determine the frequency and severity of adverse events associated with conformal stereotactic radiotherapy.

OUTLINE: Patients undergo conformal stereotactic radiotherapy over 5 days to an area including 3 mm around the metastases or the surgical cavity. Patients may receive additional radiotherapy if symptomatic metastases emerge at different sites.

After completion of study treatment, patients are followed up at 1 and 2 months and then every 3 months thereafter.

Eligibility Criteria:
Inclusion Criteria:

* Histology-confirmed cancer with 1 to 3 symptomatic brain metastases imaged by MRI/CT scans.
* Have cancer not originating in central nervous system (CNS)
* Karnofsky score of at least 60
* Given written consent
* At least 18 years of age

Exclusion Criteria:

* Prior whole brain radiotherapy or prior focal radiotherapy of the metastasis/es considered for this trial.
* Certain radiosensitive primary tumors such as small cell lung cancer, germ cell tumors, lymphoma, leukemia or multiple myeloma.
Effectiveness of CFTR Modulators According to Co-therapy

Unless CFTR modulators are highly effective, the introduction of CFTR (Cystic fibrosis transmembrane conductance regulator) modulators could lead to concomitant reduction or discontinuation of respiratory co-therapies in real-life. Such reduction/discontinuation of respiratory co-therapies could lead to an overall decrease of the effectiveness of CF care.

MODUCO study aims: 1) to compare the clinical effectiveness on lung function and pulmonary exacerbation of CFTR modulator during the year of initiation, according to level of co-therapy among CF patients; 2) to describe the nature and level of respiratory co-therapies (azithromycin, RhDNase, inhaled antibiotics) in the year before the initiation of CFTR modulator; 3) to describe the changes in respiratory co-therapies during the first and the second year following the initiation of CFTR modulator and compare between the two CFTR modulators; 4) to describe adherence to CFTR modulator during the first and the second year following its initiation; 5) to study the association between the nature of respiratory co-therapies and adherence to CFTR modulator during the first and the second year following its initiation.

A national population-based comparative effectiveness study will be conducted, based on retrospective analysis of clinical and prescription data of the French CF registry linked with the French national health data system (SNDS).


Eligibility Criteria:
Inclusion Criteria:

* - CF patients aged 6 years and more,
* Treated at least 6 months by ivacaftor or lumacaftor/ivacaftor or elexacaftor/tezacaftor/ivacaftor,
* Included in the French CF registry,
* For whom probabilistic matching with the SNDS database has succeeded.

Exclusion Criteria:

* none
Cognitive Recovery After Electroconvulsive Therapy and General Anesthesia

This study is geared toward characterizing the recovery of brain activity and cognitive function following treatments of electroconvulsive therapy and ketamine general anesthesia.

Seizures are often associated with loss of consciousness, possibly through effects on sub-cortical arousal systems, disruption of cortical-subcortical interactions, and ultimately through depressed neocortical function. Furthermore, people are often confused in the post-ictal state even when consciousness returns after a seizure. Disrupted cognitive function during the postictal phase has not been fully characterized but presents short and long-term implications. Many experience an acute disorder of attention, consciousness, and cognition, referred to as delirium. Memory deficits are also common. The neurobiology for these phenomena are incomplete and challenging to test, as seizures are typically sporadic and vary in intensity and character. In contrast, the setting of electroconvulsive therapy (ECT) provides the opportunity to study the reconstitution of consciousness and cognition following seizures in an elective and predictable context.

There is no standard agent used to induce general anesthesia during ECT. Ketamine is receiving greater attention as an infusion for treating depression and for its potential benefits on improving ECT efficacy and expediting cognitive recovery. Further data are needed to determine whether ketamine may improve recovery of cognitive function relative to etomidate, a commonly used anesthetic for general anesthesia during ECT.

The investigators will evaluate the cognition function and electroencephalographic patterns that accompany the recovery from ECT and general anesthesia. Twenty patients with refractory depression will be randomized in this interventional single-blinded randomized crossover trial. Each patient will complete seven study visits. The first visit will be conducted during the dose-charge titration ECT treatment with etomidate anesthesia. After this session, patients will be randomized to three sessions each week for two weeks (six treatments total). Over the first week patients will be randomized in order for three treatment arms: (1) etomidate general anesthesia and ECT, (2) ketamine general anesthesia and ECT, and (3) ketamine alone. Patients will be blinded to the treatment arm for each session. Baseline and post-treatment measurements of cognition and ECT will be acquired on each of the six treatment sessions.

Patients that agree will have a MRI.

Eligibility Criteria:
Inclusion Criteria:

* Treatment resistant depression requiring outpatient ECT
* Planned right unilateral ECT stimulation
* English speaking
* Able to provide written informed consent

Exclusion Criteria:

* Known brain lesion or neurological illness that causes cognitive impairment
* Schizophrenia
* Schizoaffective disorder
* Blindness or deafness or motor impediments that may impair performance for cognitive testing battery
* Inadequate ECT seizure duration with etomidate
The Stress Response in Laparoscopic Colorectal Surgery and Its Role in the Development of the Enhanced Recovery Program.

Keyhole bowel surgery provides the patient with an improved outcome following surgery in comparison to more traditional surgery requiring a large cut. In order to further improve outcomes there are several variables that must be controlled before, during and after the operation. These variables are the correct pain relief, accurate control and measurement of the fluid that is given during the operation and the subsequent mobility following surgery. Previous research has already identified that an enhanced recovery program (careful control and structure to the patients journey) will reduce the length of stay and complications after an operation. Currently an integral part of the enhanced recovery program requires the use of an epidural (a thin tube in the spine) to provide continuous pain relief for up to 48 hours. Through research previously undertaken at the MATTU the investigators have shown that an epidural can lead to an increase in the length of stay and a delay in the return to normal bowel function. A reason for the use of an epidural is to suppress the stress response.

The investigators aim to recruit patients from outpatient clinic undergoing keyhole bowel surgery in one unit and randomize them to receive one of two different pain relief methods after the operation. Patients will follow the same care as standard patients but their pain relief will differ between two already well established modalities. They will also receive different intravenous fluids. Blood will also be drawn at various intervals immediately after the operation for future analysis. The trial will be funded by the MATTU and will run for approximately 18 months. This trial will enable us to establish the stress response in the four groups and correlate it to the patient's outcome with an aim to refining the enhanced recovery program.


Eligibility Criteria:
Inclusion Criteria:

* Colonic or rectal resection procedure.

Exclusion Criteria:

* Stoma formation (previous research at the MATTU has shown that the formation of a stoma significantly affects the quality of life to the degree that there is no difference between open and laparoscopic surgery)

  * Conversion to a traditional open operation (removes the elements of keyhole surgery)
  * Contraindication to spinal anaesthesia: abnormal clotting, skin infection over or near the back, presence of neurological disorders or anatomical abnormalities of the vertebral column. (For patient safety)
  * Contraindication to the use of oesophageal Doppler: oesophageal disease, recent oesophageal surgery or upper airway surgery, moderate to severe aortic valve disease and any condition that causes bleeding problems. (For patient safety)
  * Diagnosis of diabetes mellitus (will confound the stress response analysis)
  * Treatment with exogenous steroids in the proceeding 3 months (will confound the stress response analysis)
A Study of Rapastinel as Adjunctive Therapy in Major Depressive Disorder (RAP-MD-03)

This study will evaluate the efficacy, safety, and tolerability of rapastinel 450 milligrams (mg) compared to placebo adjunctive to antidepressant therapy (ADT) in patients with major depressive disorder (MDD) who have a partial response to ADT.


Eligibility Criteria:
Inclusion Criteria:

* Meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for MDD
* Current major depressive episode of at least 8 weeks and not exceeding 18 months in duration at Visit 1
* Have no more than partial response (\< 50% improvement) to ongoing treatment with a protocol-allowed antidepressant
* If female of childbearing potential, have a negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test.

Exclusion Criteria:

* DSM-5-based diagnosis of any disorder other than MDD that was the primary focus of treatment within 6 months before Visit 1
* Lifetime history of meeting DSM-5 criteria for:

  1. Schizophrenia spectrum or other psychotic disorder
  2. Bipolar or related disorder
  3. Major neurocognitive disorder
  4. Neurodevelopmental disorder of greater than mild severity or of a severity that impacts the participant's ability to consent, follow study directions, or otherwise safely participate in the study
  5. Dissociative disorder
  6. Posttraumatic stress disorder
  7. MDD with psychotic features
* Significant suicide risk, as judged by the Investigator.
Efficacy and Safety of Therapy With Tri-Luma® Cream in Sequence With Glycolic Acid Peels for Melasma

To determine the effectiveness and safety of sequential therapy with of Tri-Luma® Cream and a series of Glycolic Acid peels in treatment of moderate to severe melasma.

To determine the efficacy and safety of sequential therapy with Fluocinolone acetonide 0.01%, Hydroquinone 4% and Tretinoin 0.05%, and a series of Glycolic Acid peels in the treatment of moderate to severe melasma.

Eligibility Criteria:
Inclusion Criteria:

* Subjects diagnosed with moderate to severe melasma

Exclusion Criteria:

* Subjects under treatment for a dermatologic condition, which may interfere with the safe evaluation of the study combination (e.g. eczema, psoriasis, severe sun-damage, dermatitis)
* Subjects with a diagnosis of skin cancer (BCE, SCC, Melanoma) in the areas to be treated