cyrilzakka/clinical-trials huggingface dataset:
Study to Assess the Efficacy and Safety of Simtuzumab (GS-6624) in Adults With Idiopathic Pulmonary Fibrosis (IPF)

The primary objectives of this study are to determine the effect of simtuzumab (GS-6624) on progression-free survival (PFS) as determined by either a categorical decline in forced vital capacity (FVC) or all-cause mortality, in all participants enrolled or in a subset of participants who are classified as lysyl oxidase-like-2 (LOXL2) high based on a prespecified level in serum at baseline.


Eligibility Criteria:
Key Inclusion Criteria:

* Male or female subjects from 45 to 85 years of age
* Definite IPF within 3 years prior to screening
* Be able to walk at least 50 meters

Key Exclusion Criteria:

* Significant diseases other than IPF
* Obstructive lung disease
* Aortic aneurysm greater than or equal to 3.5 cm in diameter
* Treatment with immunosuppressive, cytotoxic, or antifibrotic drugs \< 28 days prior to randomization are not permitted.

  * N-acetylcysteine is permitted provided the individual has been on a stable dose for \> 4 weeks prior to screening
  * Concomitant use of pirfenidone or nintedanib must be in accordance with the approved prescribing instructions in the country where the site is located
* Individuals actively listed for lung transplant are excluded. However individuals at transplant centers with long waiting times (greater than 1 year) may be permitted to enter the study after discussion with Medical Monitor.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
A Phase IIIB/IV Study to Compare the Efficacy of Vancomycin Therapy to Extended Duration of Fidaxomicin Therapy in the Clinical Cure of Clostridium Difficile Infection (CDI) in an Older Population

The main objective of the study is to evaluate whether the extended duration fidaxomicin therapy is superior to the standard vancomycin therapy in sustained clinical cure of CDI at 30 days after end of treatment (Day 40 or Day 55).


Eligibility Criteria:
Inclusion Criteria:

* CDI is confirmed by clinical symptoms (either \> 3 unformed bowel movements or ≥ 200ml of unformed stool (for subjects having rectal collection devices)) in the 24 hours prior to randomization and CDI test confirmed positive for presence of C. difficile toxin A or B in stool within 48 hr prior to randomization.
* Subject agrees not to participate in another interventional study whilst participating in this study.

Exclusion Criteria:

* Subject is taking or requiring to be treated with prohibited medications
* Subject has received more than one day of dosing of any therapy for CDI within the last 48 hours
* Subject has experienced more than 2 previous episodes of CDI in the 3 months prior to study enrolment
* Subject is unable to swallow oral study medication.
* Subject has a current diagnosis of toxic megacolon.
* Subject is not willing to adhere to the provisions of treatment and observation specified in the protocol.
* Subject has been randomized into this study previously, has taken any investigational drug within 28 days or 5 half lives, whichever is longer, prior to enrollment, or is currently participating in another clinical study which may influence the assessment of efficacy and/or safety endpoints of this study, in the opinion of the Sponsor.
* Subject has previously participated in a CDI vaccine study
* Subject has hypersensitivity to fidaxomicin, vancomycin or any of its components.
Noninvasive Brain Stimulation in Mild Cognitive Impairment and Dementia

The research objective of this study is to examine the efficacy of HD-tDCS to the preSMA/DACC region and its influence on verbal episodic memory in patients with MCI or dementia after 10 sessions of HD-tDCS. There will be three treatment arms: two active HD-tDCS (1 mA or 2 mA) and a sham group. A verbal episodic memory task will be completed at baseline, immediately following the last HD-tDCS session, and a 2-month follow-up.

This is a pilot study being done to attempt to improve verbal episodic memory in persons with mild cognitive impairment (MCI) and dementia. Although the hippocampus is a brain structure most often associated with early deficits in MCI and dementia, the pre-supplemental motor area (preSMA) and dorsal anterior cingulate cortex (DACC) have been shown to play a role in verbal episodic memory for such patients. The purpose of this study is to examine the efficacy of high-definition transcranial direct current stimulation (HD-tDCS) to the preSMA/DACC region and its influence on verbal episodic memory in patients with MCI and dementia. Entraining the preSMA/DACC circuit with 10 sessions at one of two levels of HD-tDCS will allow the researchers to investigate whether neuromodulation may be used to improve verbal episodic memory. Participants will receive 10 sessions at one of two levels of active stimulation (1 mA or 2 mA anodal HD-tDCS targeting preSMA/DACC for 20 min) or sham across 2 weeks. The device is used to deliver high definition transcranial direct current stimulation to targeted regions. A verbal episodic memory task will be completed at baseline, immediately following the last HD-tDCS session, and a 2-month follow-up. The investigators plan to recruit English-speaking participants aged 50 years and older with MCI and dementia. Participants will be randomized into HD-tDCS conditions.

Eligibility Criteria:
Inclusion Criteria:

1. Age 50 and older
2. Fluent in English
3. Active diagnosis of MCI or dementia

Exclusion Criteria:

1. Substance use disorder
2. Has metal fragments in head
3. Taking medications that may interact with the HD-tDCS effect (i.e., amphetamines, L-dopa, carbamazepine, sulpiride, pergolide, lorazepam, dextromethorphan, D-cycloserine, flunarizine, or ropinirole)
Buccal Mucosa Healing Trial With Tissue Matrix Placement

Prior studies have been performed to understand the optimal way to minimize the morbidity rate of buccal mucosa. While some studies have reported primary closure to be inferior to healing by secondary intention, this appears to be true for large defects greater than 2 cm in width. For small defects for which the wound can be closed without tension, the most recent study has shown improved pain outcomes in the immediate post-operative setting, although no difference is seen long term whether or not the wound was primarily closed. However, for larger defects, standard practice is to allow delayed healing by secondary intention.

The use of Alloderm graft placement for donor site coverage was first described in Armenakas' group. Alloderm is an acellular dermal lattice from human allograft skin. The only study to report the use of Alloderm failed to find a significant improvement in patient outcomes; however, very small defects were included in this study and the control group underwent primary closure, which has been shown to be inferior for large defects. Importantly, no increase in post-operative pain was noted, although there was some increased swelling reported. From experience, patients with moderate and large (\>2 cm width) defects following buccal mucosa harvest benefit from Alloderm placement with decreased post-operative pain, more rapid resumption of normal diet and mouth function with no associated increase in morbidity of the procedure. This study aims to determine whether this is a reliable improvement in technique.

This study will clarify how the cheek heals after the buccal mucosa is removed during reconstructive surgery. Subjects will be randomized to either receive tissue collagen matrix or no stitches after the surgery. Subjects will be evaluated up to six months to determine if the outcomes of the tissue matrix graft are better for the subject.


Eligibility Criteria:
Inclusion Criteria:

* \>18 years of age
* Male
* Patients with clinically necessary buccal mucosal graft \>2 cm
* Patients who are able to present for pre-operative and post-operative evaluations
* Patients who are able to comprehend and read English

Exclusion Criteria:

* History of oral cancer
* Severe cognitive impairments
* Unwilling or unable to follow procedures in protocol
* Contraindicated to participate for any reason
Feasibility Study for Improving the Relevance of Diagnostic Proposals for an Artificial Intelligence Software in the Elderly Population.

The ageing of the population is accompanied by the problem of chronic pathologies and sometimes heavy dependence, requiring admission to Nursing Homes (NHs). Approximately 660,000 people currently live in NHs in France. One out of 3 NHs does not have a coordinating doctor, even though the law requires it, and access to care in these NHs is very unequal nationally and especially in the Limousin and Dordogne regions. Some Hospices may find themselves in a situation where there is no coordinating doctor and difficult access to General Practitioners (GPs) visiting a large area.

This inequality of access to care results in a difference in care that can go as far as a loss of opportunity for residents who are immediately transferred to the emergency department (ED) with a risk of iatrogeny or delirium once in the ED or a risk of inappropriate hospitalization.

Residents are hospitalized:

* when the latter could have been avoided because the health care team, not knowing what attitude to adopt, prioritized hospitalization
* Late because the resident waited for the attending physician to come, which resulted in a worsening of symptoms.

The arrival of Artificial Intelligence (AI) is an opportunity to find new models of care organization that can mitigate medical desertification but also develop advanced practices in gerontology. For example, nurses will be able to intervene at a first level for early detection, better triage and early management of certain pathologies.

The "MEDVIR society" AI, developed by a French company, is a medical decision support system with Artificial Intelligence and offers pre-diagnosis based on the information collected (medical and surgical history, concomitant treatments and symptoms). MEDVIR is a diagnostic aid tool and does not replace the doctor who remains at the end of the chain, the final decision-maker.

Before research is conducted to integrate this technology into routine care, it is important to validate the diagnostic relevance of AI in the elderly, as it has been validated in the general population.

This pilot feasibility study will then enable us to methodologically dimension a future project to evaluate the efficiency of this new care system in the management of elderly patients in medical deserts in France.


Eligibility Criteria:
Inclusion Criteria:

* Patient aged 65 or over
* Patient living in one of the two NHs tests
* Patient with a functional complaint or abnormal symptoms involving the call of a physician
* Patient or his legal representative who has not expressed his opposition to the collection of his medical and personal data
* Patient affiliated to social security

Exclusion Criteria:

* End-of-life patient
* Patient with a clear vital emergency according to the physician
* Chronic aphasic patient
Effects of Analgesia Nociception Index (ANI)-Guided Analgesia on Postoperative Bowel Function.

Investigators will examaine the effects of Analgesia Nociception Index (ANI)-guided analgesia on postoperative bowel function recovery in laparoscopic colorectal surgery. This is a prospective randomized-controlled study.

Investigators will randomly divide the patients into two groups. In ANI group, remifentanil infusion rate during anesthesia will be adjusted according to ANI monitoring. In Control group, remifentanil infusion rate during anesthesia will be adjusted according to the conventional method of blood pressure and heart rate monitroing. And Investigators will evalualte the bowel function recovery in both groups after surgery, and compare between the two groups.


Eligibility Criteria:
Inclusion Criteria:

* Patients over 19 years who undergo laparoscopic colorectal surgery for colorectal cancer at Gangnam Severance Hospital, Seoul, South Korea.

Exclusion Criteria:

* Emergency surgery
* Patients with history of open abdominal surgery
* Patients with arrhythmia
* Patients with pacemaker insertion
* Patients with history of heart transplantation
* Patients taking medications that may affect ANI (antimuscarinics, alpha-agonists, beta blockers)
* Patients with chronic opioid medication.
* Cognitive impairment
* Unable to read consent form (eg illiterate, foreigner, etc.)
Evaluation Of The Effect Of SGLT-2 Inhibitors On Atrial Fibrillation Recurrence In Diabetic Patients

Consecutive DCCV was performed until to achieve 120 patients in SR (60 DM patients who used SGLT-2 inhibitors and 60 DM patients who did not use SGLT-2 inhibitors). Patients defined as SGLT-2 inhibitor user group and control group. The two groups were monitored for AF recurrence on the first day, then at one, three, and six months after CV.


Eligibility Criteria:
Inclusion Criteria:

* patients \> 18 years and \< 90 years, a patient diagnosed with DM who underwent electrical cardioversion due to AF and was restored to sinus rhythm

Exclusion Criteria:

* patient who are not suitable for anticoagulant use, have thyroid dysfunction, glomerular filtration rate ≤ 25 ml/min/1.73 m², patients whose sinus rhythm cannot be achieved with electrical cardioversion, malignancy patients, patients with acute or chronic inflammatory disease, patients with peripheral artery disease, patients with pacemakers, patients with advanced valve stenosis or insufficiency, patients who have had coronary bypass surgery, patients with percutaneous or surgical bioprosthesis or metallic valve surgery.
Prospective Randomized Trial of Fruits or Nuts Eaten Between Regular Meals in Healthy Subjects

Recruitment of 28 subjects that will be randomized to consume fruit or nuts as snacks between regular meals for two months. Laboratory tests for cardiovascular risk factors, metabolic rate, liver steatosis and physical activity are investigated ahead of start of the study and at the end of the trial period och two months. Participants will be allowed to buy fruits or nuts on their own but to keep track (diaries) of the amount consumed. They will be reimbursed for the costs of the snacks.


Eligibility Criteria:
Inclusion Criteria:

* healthy subjects

Exclusion Criteria:

* significant diseases that can affect outcomes, mental disorders that can affect participation.
LearningRx Cognitive Training for ADHD

The purpose of this investigation is to conduct a series of case studies on the impact of LearningRx cognitive training on cognitive skills, brain structure, and daily functioning for participants with ADHD.

Using a multiple baseline design across cases with start point randomization, the proposed study will examine the outcomes from LearningRx one-on-one cognitive training across domains on standardized measures used to monitor treatment effectiveness for ADHD.

Eligibility Criteria:
Inclusion Criteria:

* Age 15-22 previously diagnosed with ADHD
* High school students or college students with a prior diagnosis of ADHD living in the greater Colorado Springs area

Exclusion Criteria:

* No braces, metal implants, or claustrophobia that would contraindicate magnetic resonance imaging
Interleukin-2 in Treating Patients With Metastatic Kidney Cancer

RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill cancer cells. It is not yet known which regimen of interleukin-2 is most effective for kidney cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of different regimens of interleukin-2 in treating patients who have metastatic kidney cancer.

OBJECTIVES: I. Determine the response rate and overall survival of patients with metastatic renal cell carcinoma treated with either low-dose or high-dose intravenous interleukin-2 (IL-2) or subcutaneous IL-2. II. Compare the toxic effects of these 3 regimens in this patient population.

OUTLINE: This is a randomized study. Patients are stratified according to presence of renal tumor (yes vs no). Patients are randomized to one of three treatment arms. Arm I: Patients receive low dose interleukin-2 (IL-2) IV every 8 hours for up to 15 doses. Treatment repeats in 7-10 days for one complete course. Arm II: Patients receive high dose IL-2 IV every 8 hours for up to 15 doses. Treatment repeats in 7-10 days for one complete course. Arm III: Patients receive IL-2 subcutaneously daily 5 days a week for 6 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease receive an additional complete course of therapy.

PROJECTED ACCRUAL: A total of 400 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically proven, metastatic renal cell carcinoma with measurable disease No more than 25% of liver replaced with tumor No CNS involvement or major nerve compression allowed

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: More than 3 months Hematopoietic: Not specified Hepatic: Bilirubin less than 2.0 mg/dL AST and ALT no greater than 3 times normal Renal: Creatinine less than 1.6 mg/dL Cardiovascular: Normal EKG Normal thallium stress test (required of patients 50 years of age and older or as clinically indicated) Pulmonary: FEV1 and VC greater than 65% of predicted (pulmonary function screening required of patients with significant smoking history or suspicion of pulmonary disease) Other: No second malignancy, except: Basal cell skin cancer Carcinoma in situ of the cervix No significant psychiatric disease that would preclude consent or treatment No systemic infection No coagulation disorders or bleeding Not pregnant HIV negative

PRIOR CONCURRENT THERAPY: No prior therapy within 28 days Biologic therapy: No prior interleukin-2 Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified Other: No concurrent steroids
Parent Intervention to Improve Child Sleep

In this study, the investigators pilot tested a parenting intervention to improve young children's sleep in families with low income. Families were randomized to an intervention or wait-list control group. The investigators hypothesized the intervention would be feasible and acceptable to enrolled families.

This pilot study tested a parenting intervention to improve young children's sleep in families with low income using a randomized controlled trial (RCT) design. Parents were randomized to the intervention or wait-list control group. Intervention content was delivered in virtual sessions with a parent and interventionist. The primary aim was to examine intervention feasibility (e.g., recruitment, retention, acceptability) with a secondary goal of preliminary efficacy on intervention changes in child sleep patterns to inform a future large-scale RCT. Exploratory evidence was collected on changes in children's health behaviors (e.g., diet, screen time), and social-emotional health (e.g., behavior problems) as indicators for potential spillover effects on these domains.

Eligibility Criteria:
Inclusion Criteria:

* Parents or primary caregivers 18 years of age or older
* Have a child 2-4 years of age
* Child's 24-hour sleep duration does not meet established recommendations based on child age
* English speaking
* Annual household income \<= 200% of the Federal Poverty Line or receive assistance benefits (e.g., SNAP, WIC)
* Computer or phone access for video calls

Exclusion Criteria:

* Parent or child has a medical condition that impairs their ability to participate
* Child has a clinical sleep disorder
* Child takes medication that significantly impacts their sleep
Validation Study of a Patch-based PSG System

This study is a study that qualifies as "other clinical investigation" under Art. 82 MDR and §47 Abs. 3 MPDG with a CE-marked device that aims to demonstrate that the physiological signals from the Onera STS system are substantially equivalent to physiological systems recorded by traditional PSG systems. Furthermore, the study aims to identify the proportion of users who can successfully perform an overnight Onera STS study in an unsupervised home setting. The Onera STS will be used within its approved indication, and the study participants will not be subjected to additional invasive or burdensome procedures.


Eligibility Criteria:
Inclusion Criteria:

* 18 years and older
* Either referral for a suspected sleep disorder requiring a sleep diagnostic study, or,
* An already diagnosed sleep disorder requiring a planned follow-up PSG.

Exclusion Criteria:

* Inability to provide informed consent
* History of allergic reactions to adhesives or hydrogels or a family history of adhesive skin allergies
* Severe skin condition at sites of patch administration such as wounds, burns or on any damaged skin
* Has an implanted cardiac stimulator or diaphragmatic pacer
* Has an anatomical abnormality that, in the opinion of the Principal Investigator, makes the subject ineligible for inclusion
* Will be exposed to high-frequency surgical equipment, near strong magnetic fields or with devices such as MRIs, external cardiac stimulators during their use of the Onera device
Plastic Stent Within a Lumen-Apposing Stent for Malignant Biliary Obstruction

There are doubts concerning the possible benefits derived from the insertion of double-pigtail plastic stents (DPS) within the lumen-apposing metal stents (LAMS) in the EUS-guided transmural biliary drainage (BD). The aims was to evaluate the safety of LAMS with and without a coaxial DPS in EUS-BD for the palliative management in malignant biliary obstruction.


Eligibility Criteria:
Inclusion Criteria:

* Consecutive unresectable/inoperable biliopancreatic cases with distal biliary obstruction who underwent EUS-BD after failed ERCP cannulation or inaccessible papilla

Exclusion Criteria:

* Borderline cancer cases
* Others type of biliary stents
* Severe coagulopathy or thrombocytopenia.
Retrospective Collection of Effectiveness and Safety Data From Patients Treated With Liraglutide or DPP-4 Inhibitor in Primary Care in Europe

This study is conducted in Europe. The aim of this study is to demonstrate the clinical effectiveness and safety of liraglutide and dipeptidyl peptidase-4 (DPP-4) inhibitor therapy in routine primary care in Europe.


Eligibility Criteria:
Inclusion Criteria:

* Patients treated with liraglutide or DPP-4 inhibitors, according to license in respective participating country with data available for 12 (+/- 2) months

Exclusion Criteria:

* Patients treated with liraglutide or DPP-4 inhibitors, outside of license in respective participating country