cyrilzakka/clinical-trials huggingface dataset:
Study of TOP1630 for Dry Eye Syndrome

In subjects with Dry Eye Syndrome (DES):

The primary objective of this study is to confirm the efficacy of TOP1630 0.1% Ophthalmic Solution TID OU compared to placebo treatment at Day 29 on pre-specified sign and symptom endpoints in subjects with moderate to severe DES.

This study is designed to assess the efficacy and safety of TOP1630 ophthalmic solution in subjects with Dry Eye Syndrome (DES).

Eligible subjects will be randomized double masked to either TOP1630 or placebo for a duration of 28 days' treatment.

Eligibility Criteria:
Inclusion Criteria:

* Be at least 18 years of age;
* Provide written informed consent;
* Have a reported history of dry eye;
* Have a history of use of eye drops for dry eye symptoms;

Symptoms of dry eye syndrome including:

* Ocular discomfort
* Conjunctival redness
* Tear film break up time
* Schirmer test score

Signs of dry eye syndrome including:

* Conjunctival staining score

Exclusion Criteria:

* Have any clinically significant slit lamp findings at entry visit ;
* Be diagnosed with an ongoing ocular infection;
* Have any significant ocular lesion that could interfere with assessment of safety or efficacy or prevent study conduct in the opinion of the PI;
* Have any planned ocular and/or lid surgeries over the study period;
* Have an uncontrolled systemic disease;
* Be a woman who is pregnant, nursing or planning a pregnancy;
* Be a woman of childbearing potential who is not using an acceptable means of birth control;
* Have a known allergy and/or sensitivity to the test article or its components;
* Have a condition or be in a situation which the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study
A Safety, Tolerability, and Efficacy Study of VX-264 in Participants With Type 1 Diabetes

The purpose of the study is to evaluate the safety, tolerability, and efficacy of VX-264 in participants with type 1 diabetes (T1D).


Eligibility Criteria:
Key Inclusion Criteria:

* Clinical history of T1D with greater than or equal to (\>=) 5 years duration
* Participant is on a stable diabetic treatment
* Consistent use of continuous glucose monitoring (CGM) for at least 4 weeks before Screening and willingness to use CGM for the duration of the study

Key Exclusion Criteria:

* Prior islet cell transplant, organ transplant, or cell therapy

Other protocol defined Inclusion/Exclusion criteria may apply.
Transcranial Bright Light Therapy in Seasonal Affective Disorder (SAD)

Bright light therapy (BLT) has been found to be effective in treatment of seasonal affective disorder (SAD). The mechanism of action of conventional BLT in the treatment of SAD is under debate. Recently, transcranial bright light (TBL) via ear canals has been proved to modulate the neural networks of the human brain and improve cognitive performance in healthy subjects. Moreover, TBL has been found to alleviate symptoms of SAD in open trial. In this case the investigators will study the effect of transcranial bright light treatment via ear canals on depressive and anxiety symptoms in patients suffering from SAD in randomized controlled double-blind study design.


Eligibility Criteria:
Inclusion Criteria:

* patient has (according to the Diagnostic and Statistical Manual of Mental Disorders, fourth edition, text revision \[DSM-IV-TR\]) a Major depression, recurrent episode, seasonal pattern
* Structured Interview Guide for the Hamilton Depression Rating Scale - Seasonal Affective Disorder Version Self Rating Version (SIGH-SAD-SR) score ≥ 16
* patient is over 18 years and under 66 years
* patient can read and understand the subject information sheet
* patient has signed the informed consent form
* patient is not pregnant

Exclusion Criteria:

* patient has a lifetime psychotic disorder
* patient has a bipolar disorder
* patient has alcohol or some other substance use dependence or misuse
* patient has some unstable somatic disorder
* patient uses some psychotropic agencies
* patient is, in the opinion of the investigator, unsuitable for any reason
* patient is a member of the site personnel or their immediate families
* patient has administered bright light therapy via ear canals during the current episode
A Study of Baricitinib (LY3009104) in Participants From 1 Year to Less Than 18 Years Old With Systemic Juvenile Idiopathic Arthritis (sJIA)

The reason for this study is to see if the study drug baricitinib is safe and effective in participants from 1 year to less than 18 years old with systemic juvenile idiopathic arthritis (sJIA). Participants are assigned to 1 of 2 cohorts. In cohort 1, participants will receive baricitinib or tocilizumab reference. In cohort 2, participants will receive baricitinib.


Eligibility Criteria:
Inclusion Criteria:

* Participants must have a diagnosis of systemic Juvenile Idiopathic Arthritis (sJIA) as defined by International League of Associations for Rheumatology (ILAR) criteria with onset before the age of 16 years
* Participants must have at least 2 active joints at screening and baseline
* Cohort 1 (IL-6 inhibitor therapy naive): Participants who are at least 1 year and less than 18 years of age, except in countries that restrict use of tocilizumab in participants less than 2 years of age
* Cohort 2 (open-label baricitinib): Participants who are at least 1 year and less than 18 years of age

Exclusion Criteria:

* Participants must not have polyarticular JIA (positive or negative for rheumatoid factor), extended oligoarticular JIA, enthesitis-related JIA, or juvenile psoriatic arthritis
* Participants must not have persistent oligoarticular arthritis as defined by the ILAR criteria
* Participants must not have a history or presence of any autoimmune inflammatory condition other than JIA
* Participants must not have active anterior uveitis or are receiving concurrent treatment for anterior uveitis
* Participants must not have active fibromyalgia or other chronic pain conditions that, in the investigator's opinion, would make it difficult to appropriately assess disease activity for the purposes of this study
* Participants must not have biologic features of Macrophage Activation Syndrome (MAS) over the past 12 weeks
* Participants must not have a current or recent (\<4 weeks prior to baseline) clinically serious infection
* Participants must not have a positive test for hepatitis B virus
* Participants must not have evidence of active tuberculosis (TB) or untreated latent TB
Efficacy and Safety Evaluating Study of CT-P6 in Her2 Positive Early Breast Cancer

This study will determine whether CT-P6 and Herceptin are equivalent in patients with early-stage breast cancer undergoing neoadjuvant chemotherapy. Our hypothesis is that the pathologic complete response rate will be equivalent in patients treated with neoadjuvant CT-P6 or Herceptin. Patients will receive 8 cycles of neoadjuvant systemic therapy and up to 10 cycles of therapy in the adjuvant setting.


Eligibility Criteria:
Inclusion Criteria:

* Patient who has histologically confirmed and newly diagnosed breast cancer
* Patient who has clinical stage I, II, or IIIa operable breast cancer according to AJCC (American Joint Committee on Cancer) Breast Cancer Staging 7th edition
* Patient who has HER2-positive status confirmed locally, defined as 3+ score by IHC (immuno-histochemistry).

Exclusion Criteria:

* Patient who has bilateral breast cancer
* Patient who has received prior treatment for breast cancer, including chemotherapy, biologic therapy, hormone therapy, immunotherapy, radiation or surgery, including any prior therapy with anthracyclines.
Closed Loop DBS Implanted RC+S Study

This study involves patients who are already planning to have deep brain stimulation (DBS) surgery to treat the symptoms of severe Parkinson's Disease (PD). The study has two goals:

1. to evaluate the effectiveness of implanting DBS electrodes in the two most common locations for DBS (subthalamic nucleus (STN), and globus pallidus interna (GPi)), instead of just one electrode, on each side of the brain; and
2. to develop an adaptive DBS system using brain signals measured from these two electrodes.

The purpose of this study is a small, first in man, clinical feasibility trial for patients with severe Parkinson's Disease (PD), who are already clinically eligible for deep brain stimulation (DBS) with two goals:

1. to compare efficacy from two common sites of DBS (subthalamic nucleus (STN), and globus pallidus interna (GPi)) through the implantation of dual DBS electrodes on each side of the brain; and
2. to develop a closed loop DBS system using evoked and spontaneous potentials derived from these two electrodes.

The study will involve bilateral dual DBS electrode placement in clinically standard locations (ie, STN and GPi) unilaterally or (more often) bilaterally, the placement of the RC+S Medtronic research implantable pulse generator (IPG), and a commitment to return for both extensive postoperative programming and testing to define clinical efficacy and separate research days to develop the closed loop approach. In addition, patients will undergo intraoperative research using temporary percutaneous extensions to the DBS electrode(s) and DBS lead cannula after implantation to confirm the electrode location and to identify what the signals will look like during later chronic recordings through the research IPG.

The research RC+S IPG includes both ordinary DBS stimulation as well as a recording system that simultaneously measures the DBS local evoked potential (DLEP) and/or local field potential (LFP) responses from either the same or a second DBS electrode.

Eligibility Criteria:
Inclusion Criteria:

* able to give informed consent
* diagnosed with Parkinson's Disease and is considered a surgical candidate for DBS
* has medication-related side effects from levodopa (i.e., dyskinesias, on-off fluctuations)
* has off-on improvement with levodopa of at least 30%
* is available for follow-up visits for length of study

Exclusion Criteria:

* is not safe surgical candidate for DBS
* has severe neurological injury or disease other than Parkinson's Disease
* has condition requiring repeated MRI scans
* has untreated, clinically significant depression
* has an electrical or electromagnetic implant
* had a prior thalamotomy or surgical ablation procedure
* has dementia interfering with ability to comply with study requirements or give informed consent
* abuses drugs or alcohol
* has a history of seizures
* has any metallic implants
* is pregnant
Promoting Resilience in Stress Management (PRISM) and Clinical-focused Narrative (CFN) Pilot in Adults With Primary Mitochondrial Disease (PMD).

The goal of this study is to find the best way to help people with primary mitochondrial disease deal with the stress of their condition, and to help these people be better able to "bounce back," or be resilient. In order to do this, the investigators are going to test two interventions (an intervention means that it aims to change something): Promoting Resilience in Stress Management (PRISM) and clinical-focused narrative (CFN) intervention.

The investigators are going to test two interventions in this pilot study. The first is called Promoting Resilience in Stress Management (PRISM). The second is called clinical-focused narrative (CFN) intervention. These interventions involve talking with the researcher about several specific topics.

Participants will join six virtual study visits. They will be assigned to the PRISM group or the CFN group. During the first study visit, participants will learn about the study and will fill out consent forms if they want to participate. In the next four visits, participants will receive one of the study interventions (PRISM or CFN). Some interventions will be supported with a digital app for participants to track progress and review what was talked about in the intervention. The sixth virtual study visit will be a discussion group that happens a couple months after participants finish the intervention.

Participants will also be sent several surveys to complete. One set of surveys is sent just once after the participant enrolls in the study. Another set of surveys is sent after the participant enrolls and again after the participant finishes the interventions.

The study team will review participants' medical records to confirm they have primary mitochondrial disease and to review the genetic diagnosis. If participants do not have copies of their own medical records or if the study team does not already have access to them, the study team will ask participants to sign a release form to obtain a copy of the medical records and/or genetic testing report.

Eligibility Criteria:
Inclusion Criteria:

1. Males or females at least 18 years old
2. Capable of giving consent, or there is a legally authorized representative capable of giving consent on the subject behalf and if appropriate, assent.
3. Able to speak and read English
4. Able to participate in Web- and App-based interventions
5. Confirmed molecular diagnosis of primary mitochondrial disease

Exclusion Criteria:

1. Suspected but no molecular diagnosis primary mitochondrial disease
The Efficacy of Surgical Treatment After Neoadjuvant Chemotherapy Plus Intraperitoneal Immunotherapy Versus Chemotherapy Alone for Patients With Positive Wash Cytology Gastric Cancer

The purpose of this study is to determine whether intraperitoneal immunotherapy (with interleykin-2 - human cytokine reaction activator) with systemic chemotherapy will be more effective than systemic chemotherapy alone in patients with gastric cancer and verified free cancer cells in abdominal cavity in improving the long term outcomes and overall survival of further surgical treatment.


Eligibility Criteria:
Inclusion Criteria:

* ECOG 0-2
* Histologically proven gastric cancer T2-3 N+, T4a with any N (0,+) with free cancer cells in the abdominal cavity and no macroscopic canceromathosis and no other distant metastases (TNM classification 7th edition)
* Histological forms: gastric adenocarcinoma and signet ring cancer
* Blood characteristics (creatinine \<150 mg/l, total bilirubin \< 50 mkmol/l, neutrophils \< 1500/mkl, hemoglobin \>90 g/l, thrombocytes \> 100000/mkl)

Exclusion Criteria:

* Clinically apparent distant metastasis (besides free cancer cells)
* Synchronic or metachronic malignant tumors
* Previous systemic or surgical or combined therapy for gastric cancer
* Complications of gastric cancer (obstruction 0-1 GOOSS scale and/or gastric bleeding)
* Adhesions in abdominal cavity
* Gastrooesophageal junction cancer or gastric cancer with spreading on oesophagus.
Children's Activity and Nutrition III

To track blood pressure from childhood through adolescence.

BACKGROUND:

Children's Activity and Nutrition III was originally part of the Institute-initiated Studies of Children's Activity and Nutrition (SCAN), first funded in 1985. Children's Activity and Nutrition III was renewed in 1992 as a stand-alone project with a focus on assessment of the development of hemodynamic mechanisms responsible for blood pressure (BP) control within the context of ethnicity and family history of early myocardial infarction (MI), defined as having a parent or grandparent with an MI at less than 55 years of age and a family history.

Blacks have a higher mortality rate through middle adulthood than whites from coronary heart disease (CHD), the leading causes of death in the United States. Blacks have been found to exhibit greater cardiovascular (CV) response to stress (i.e., reactivity), a potential risk factor for CHD, as have individuals with a family history. . Although CHD has its pathobiologic origins in childhood, little longitudinal reactivity research has been conducted in youth, especially from childhood through late adolescence.

DESIGN NARRATIVE:

The study followed a multiethnic sample of 250 13 to 14 year olds for an additional 5 years to determine: 1) whether blood pressure (BP) reactivity during childhood predicted changes in resting BP, left ventricular mass and concentric remodeling, carotid artery wall elasticity and endothelial dependent arterial dilation up to 11 years later after controlling for other expected predictors (i.e., age, gender, ethnicity, resting BP, adiposity, ambulatory BP); 2) the influence of ethnicity, family history and a select group of moderator variables (i.e., environmental stress, anger and John Henryism coping styles, aerobic fitness on youth's cardiovascular (CV) reactivity; and 3) the stability of CV reactivity and a 24- hour ambulatory BP from childhood through late adolescence. The long- term objectives were to provide a better understanding of the development of CV reactivity in youth and its influence upon early pathobiologic markers of coronary heart disease prior to overt manifestation of disease.

Eligibility Criteria:
No eligibility criteria
A Long-Term Treatment Study of ACH-0144471 in Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH)

The purpose of this study is to evaluate the long-term safety and efficacy of ACH-0144471 in participants with paroxysmal nocturnal hemoglobinuria (PNH) who have demonstrated clinical benefit from ACH-0144471 in Study ACH471-100. This study is designed to include up to 12 participants.


Eligibility Criteria:
Inclusion Criteria:

* Study designed to include up to 12 participants who completed treatment in Study ACH471-100 and demonstrated clinical benefit from ACH-0144471 with no significant safety or tolerability concerns.
* Negative pregnancy test for females prior to dosing and throughout the study.

Exclusion Criteria:

* Have developed any clinically relevant co-morbidities while participating in Study ACH471-100 that would make the participant inappropriate for the continuation of treatment with ACH-0144471, in the opinion of the Investigator.
* Have developed any clinically significant laboratory abnormalities while participating in Study ACH471-100 that, in the opinion of the Investigator, would make the participant inappropriate for the study or put the participant at undue risk.
* Females who are pregnant, nursing, or planning to become pregnant during the study or within 90 days of study drug administration or participants with a female partner who is pregnant, nursing, or planning to become pregnant during the study or within 90 days of study drug administration.
Histological Outcome of the Use of Different Biomaterials for Fresh Socket Regeneration. A Split-mouth Design

Purpose: The aim of this study was to analyze the quality of bone regeneration in fresh sockets using four different materials and at different times points.

Materials and Methods: A split-mouth clinical trial was designed to evaluate the histological and histomorphometrical characteristics of fresh sockets from 30 patients. One socket per patient will healed spontaneously (control) and, at least, one fresh socket, will be grafted with platelet-rich growth factor (PRGF), PRGF+autologous bone, autologous bone or PRGF+demineralized freeze dried bone allograft (DFDBA). The day of the implant placement, biopsies will be taken at different time points divided into three assessment groups: short duration (2-4 months), intermediate duration (5-6 months) and long duration (7-12 months). The histologic findings will be assessed to quantify the trabeculae pattern, the degree of mineralization and the quality of bone regeneration.


Eligibility Criteria:
Inclusion Criteria:

* Patients in need of at least one bilateral tooth extraction due to one or more of the following causes:

  * periodontal disease,
  * vertical fracture
  * included teeth.
* Patients seeking dental implant to replace their missing teeth.
* All sockets should have intact or partially conserved buccal wall according to Elian´s classification (Type I, II).

Exclusion Criteria:

* Patients under 18 years old.
* Patients with a severely untreated periodontal disease.
* Smokers of more than 15 cigarettes a day.
* patients suffering from any systemic disease requiring pharmacological treatment.
* Patients whose socket´s buccal wall is totally missing after tooth extraction
Effects of Desoximetasone Spray 0.25% in Patients With Moderate to Severe Plaque Psoriasis

The objective of this study is to demonstrate that desoximetasone 0.25% topical spray is effective for the treatment of patients with moderate to severe plaque psoriasis.


Eligibility Criteria:
Inclusion Criteria:

* Male or non-pregnant, non-lactating female 18 years of age or older.
* Have a definite clinical diagnosis of stable plaque psoriasis involving ≥ 10% of the body surface area (BSA).
* Have a combined total lesion severity score (TLSS) of ≥ 7 for the Target Lesion.
* Have a plaque elevation score ≥ 3 of (moderate) for the Target Lesion.
* The Target Lesion must have an area of at least 5 cm².
* Have a Physicians Global Assessment (PGA) score of 3 (moderate) or 4 (severe) at baseline for the overall disease severity.

Exclusion Criteria:

* Patient has current diagnosis of other types of psoriasis other than stable plaque psoriasis (i.e. acute, guttate, erythrodermic, exfoliative or pustular psoriasis) or has psoriasis of any kind of the face or scalp that will require active treatment during the study. Nonprescription antipsoriatic shampoos will be allowed during the study when applied solely to the scalp.
* Patient has a history of psoriasis that has been unresponsive to topical corticosteroid therapy.
* In the Investigator's opinion, the patient has other dermatological conditions, such as atopic or contact dermatitis, that may interfere with the clinical assessments of the signs and symptoms of psoriasis.
* Patient has a history of allergy or sensitivity to corticosteroids or history of any drug hypersensitivity or intolerance which, in the opinion of the Investigator, would compromise the safety of the patient or the results of the study.
* Patient has been treated within 12 weeks (or five half lives, whichever is less) prior to the first dose of study drug with any biological therapies for psoriasis.
* Patient has received any systemic steroids within 4 weeks of the first dose of the study drug. The use of inhaled or intranasal corticosteroids is acceptable as long as usage has been stable for at least 2 weeks prior to the first dose of study drug and will be continued during the study.
* Patients who have used any topical antipsoriatic agents of any kind or any topical corticosteroids for any reason within 2 weeks prior to first use of study drug. Nonprescription antipsoriatic shampoos used only on the scalp will be allowed during the study.
* Receipt of any drug as part of a research study within 30 days prior to first dosing.