cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy on Phase III Study on 300 IR SLIT to Patients Suffering From Grass Pollen Rhinoconjunctivitis

The purpose of this study is to evaluate the efficacy and safety of sublingual tablets of grass pollen allergen extract when initiated 2 months before the grass pollen season compared with placebo for reduction of rhinoconjunctivitis symptoms and rescue medication usage.

To assess the efficacy of sublingual tablets of grass pollen allergen extract when initiated 2 months before the grass pollen season on:

- The Average Adjusted Symptom Score (AASS).

To document the safety of the treatment.

Eligibility Criteria:
Inclusion criteria:

1. Male or female outpatients aged 12 to 65 years (inclusive).
2. Patients with grass pollen-related allergic rhinoconjunctivitis for at least the last two grass pollen seasons.
3. Positive SPT
4. RRTSS during the previous pollen season of greater than or equal to 12 out of a possible 18.

Exclusion Criteria:

1. Positive SPT to any other seasonal allergens present during the grass pollen season
2. Patients with clinically significant confounding symptoms of allergy to other allergens
3. Significant symptomatic perennial allergy due to an allergen to which the patient is regularly exposed.
4. Patients with moderate or severe persistent asthma (Global Initiative for Asthma \[GINA\] 3 or 4).
Effectiveness of a Barbershop-Based Program to Improve High Blood Pressure Control and Awareness in Black Men

Black men in the United States have a greater risk of developing high blood pressure than men of any other ethnic or racial group. The purpose of this study is to evaluate the effectiveness of a high blood pressure detection and medical referral program conducted by barbers in predominantly Black barbershops at increasing awareness and lowering blood pressure levels among their Black male customers.

High blood pressure affects approximately 35% of Black men in the United States. This may be due to the fact that Black men frequently have an unusually high number of risk factors for high blood pressure, including diabetes, high stress levels, and increased salt intake and sensitivity. While high blood pressure can often be controlled through diet, lifestyle changes, or medication, it is a chronic asymptomatic medical condition for which individuals should remain under the care of a regular medical provider. A predominantly Black barbershop may be an optimum and receptive setting for an intervention that focuses on improving the detection and treatment of high blood pressure among Black men. In this study, barbers, deemed as influential peers, will be trained to continually monitor their customers' blood pressure, deliver health messages designed to change risk perception and ideas about healthcare utilization, and provide social support for changes in healthcare-seeking behavior and blood pressure levels. The purpose of this study is to evaluate the effectiveness of a barbershop-based intervention at increasing blood pressure awareness and lowering blood pressure levels among Black male customers. With over 18,000 Black barbershops in the United States, the results from this study may be extremely influential in improving the diagnosis and treatment of high blood pressure in Black men.

This study will enroll Black men who are regular customers at a participating barbershop. Each barbershop will be randomly assigned to either a 10-month intervention group or a control group. Nurses will train the intervention group barbers to measure blood pressure and deliver health messages related to blood pressure control during each customer's visit. Before and after the intervention, study researchers will interview barbers and customers over an 8-week period to collect information on blood pressure control. A 12-month follow-up visit will include assessments of blood pressure levels, customer recognition of elevated blood pressure levels, and the number of customers receiving regular medical care.

Eligibility Criteria:
Inclusion Criteria:

* African American
* Regular customer at one of the participating barbershops

Exclusion Criteria:

* Does not speak English
Biopsychological Intervention in Chronic Fatigue Syndrome - a Pilot Study

This is a pilot study of a biopsychological intervention program for adolescent chronic fatigue syndrome. The program is related to cognitive behavioral therapy, which has been proven beneficial in this disorders, but includes other mental techniques, such as emotional control and metacognitive elaboration.

The aim of this pilot study is to explore a) patients' experiences and b) possible positive effects on symptoms. We hypothesise that the intervention will be regarded feasible by the patients, and that fatigue score will improve during the intervention period.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of chronic fatigue syndrome
* Significant school absenteeism
* Above 12 years of age and below 18 years of age

Exclusion Criteria:

* Other diseases or life events that might explain chronic fatigue
* Bed-ridden
Nitrous Oxide for the Treatment of Major Depressive Disorder

The investigators are conducting a randomized controlled trial to evaluate the antidepressant effects of nitrous oxide in people with Major Depressive Disorder (MDD). MDD is a global medical condition that causes significant health and economic burden. Recent studies have shown that a single dose of ketamine, an NMDA-antagonist, has fast and long lasting anti-depressant effect. Nitrous oxide, another NMDA-antagonist, is widely used for anesthesia and analgesia, safer to administer and has fewer side effects than ketamine.

A randomized controlled crossover feasibility study showed significant reduction in depressive symptoms at 2 and 24 hours after a single 1-hour treatment session of inhaled nitrous oxide compared with placebo. Nitrous oxide is inexpensive and can be safely administered by any trained clinician. If found to be efficacious, it could be used to provide rapid anti-depressant effect whilst the benefit of traditional anti-depressants has its delayed effect. Another potential application could be in acutely suicidal patients.

This investigated-initiated phase 2b trial will enable confirmation and extension of the findings from the feasibility study, and identify the optimal dose and regimen in a broader population of those with MDD. Participants will be randomized to receive a weekly 1-hour inhalational sessions of either nitrous oxide or placebo (oxygen-air mixture) for 4 weeks, and the nitrous group will be further randomly assigned to a dose of 50% nitrous oxide or 25% nitrous oxide. Depression severity will be assessed by a blinded observer pre-treatment and at weekly intervals during and for 4 weeks after treatment using the Hamilton Depression Rating Scale.


Eligibility Criteria:
Inclusion Criteria:

1. Adult (≥18 years, both sexes), with DSM-IV-TR criteria for MDD without psychosis, as determined using a structured clinical interview \[Mini International Neuropsychiatric Interview\]
2. MDD, as defined by a pretreatment score \>18 on the HDRS-21 scale

Exclusion Criteria:

1. A history of bipolar disorder, schizophrenia, schizoaffective disorder, obsessive-compulsive disorder, panic disorder, or documented Axis II diagnoses; active suicidal intention, as determined by clinical interview
2. Active or recent (\<12 months) substance abuse or dependence; excluding nicotine
3. Administration of NMDA-antagonists (e.g., ketamine) in previous 3 months
4. Ongoing treatment with ECT
5. Presence of acute medical illness that could interfere with study participation, including significant pulmonary disease
6. Pregnancy or breastfeeding
7. Any contraindications to the use of nitrous oxide (e.g., pneumothorax, middle ear occlusion, elevated intracranial pressure, chronic cobalamin or folate deficiency unless treated with folic acid or vitamin B12).
Analyzing Childhood Recall Antigens in Patients With Pancreatic Cancer

The investigator is developing an immune therapy against pancreatic cancer. Immune cells, known as "T cells with tumor killing capacity", are involved in this immune therapy. In mice with pancreatic cance there is evidence that one tetanus toxoid (TT) vaccination (that patients receive from childhood) combined with Gemcitabine activates these killer T cells. (Gemcitabine improves T cell responses) These killer T cells are able to destroy tumor cells uploaded with TT protein (such studies are planned in future clinical trials). The goal of this study is to test whether one TT vaccination combined with Gemcitabine treatment activates the same T cells in pancreatic cancer patients.

Treating PDAC patients with gemcitabine and one TT booster Gemcitabine will be delivered as is standard of care. However, doses may be modified by the treating physician based on patient tolerance. Patients diagnosed with PDAC will be treated with Gemcitabine and boosted once with the human childhood vaccine to TT by Dr. Chuy as outlined in Fig 2. Gemcitabine will be administered on days 1, 8, 15 every 28 days, and one booster with the human TT childhood vaccine will be administered on day 8 (there must be 2 hrs between the TT booster and the Gemcitabine treatment). Blood will be drawn just before each Gemcitabine treatment, except on day 8 at least 2 hrs will be needed between the blood draw and Gemcitabine treatment because the TT booster needs to be given just after the blood draw but 2 hrs before the Gemcitabine treatment (Fig 2). Three tubes of 10 mls each with heparinized blood will be needed for the isolation of peripheral blood mononuclear cells (PBMC). Two tubes will be used to analyze the T cells and one tube for analyzing the MDSC. The memory T cells and MDSC will be analyzed in the laboratory of Dr. Gravekamp.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically or cytologically confirmed adenocarcinoma of the pancreas
2. Patients is a candidate for gemcitabine chemotherapy (adjuvant, metastatic, locally advanced, borderline resectable settings all permitted)
3. Patients at least 18 years of age
4. ECOG performance status 0-2
5. Consent to donate 12 tubes of peripheral blood of 10 mL each
6. Adequate organ function as defined as -neutrophil count ≥ 1200 -platelets ≥ 75,000 -hemoglobin ≥ 8.0 -bilirubin ≤ 2.0 -creatinine ≤2.0 or calculated GFR ≥ 30
7. Ability to understand and willingness to sign a written informed consent document
8. Prior chemotherapy permitted, as long as 60 days have lapsed since last dose. Prior radiation therapy permitted, as long as 28 days lapsed since last treatment.
9. Patients may receive other concurrent chemotherapy, immunotherapy, or radiotherapy

Exclusion Criteria:

1. Patients never been immunized with tetanus toxoid (TT). Patients with a history of adverse reaction to tetanus vaccine (with the exception of self-limited fever or local tissue reaction
2. Patients may not be receiving any investigational agents
3. Pregnant women
4. Patients with HIV
Safety, Tolerability, and Pharmacokinetic Evaluations of CKR-051 After Transdermal Administration in Healthy Male Subjects

This study will evaluate the safety, tolerability, and pharmacokinetics (PK) of CKR-051 in healthy participants.

This study aiming to develop an agent for skin regeneration; potential treatments include acute and chronic wounds (c.f. Diabetic foot ulcers).


Eligibility Criteria:
Key Inclusion Criteria:

* Age 19 years to 60 years (Healthy male)
* Body weight 55 kg to 90 kg and BMI 19 kg/m\^2 to 29 kg/m\^2
* Do not have skin disease or skin damage (including scars or tattoos) or excessive body hair at the drug application site
* Must be suitable by a subject by medical evaluation including physical examination, laboratory tests, questionnaire, etc.

Key Exclusion Criteria:

* History of clinically significant hepatobiliary, kidney, nervous, immune, respiratory, digestive, endocrine, blood/tumor, cardiovascular, urinary, mental, dermatological diseases, etc.
* With tattoos, dermatitis, pigmentation, dermatitis, etc., or damaged skin at the site of clinical trial drug administration
* Drug hypersensitivity reactions and history (Aspirin, antibiotics, etc.)
* History of drug abuse and positive urine screening test
* eGFR (CKD-EPI) \< 60 mL/min/1.73m\^2
* AST/ALT \> 1.5 UNL
* Alcohol \> 21 units/week
* Smoker
* Eating food containing a grapefruit
* Caffeine \> 5 units/day
A Phase Ib Study of Primary Efficacy and Safety of IBI321 Monotherapy or Combination Therapy in Patients With Advanced Solid Tumors

This is open-label, multicenter, Phase Ib study is designed to evaluate the Primary Efficacy and Safety of IBI321 Monotherapy or Combination Therapy in participants with advanced solid tumors.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects able to give voluntary informed consent, understand the study and are willing to follow and complete all the test procedures.
2. Male or female subjects ≥18 years and ≤75 years.
3. At least one measurable lesion per RECIST version 1.1
4. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤1
5. Life expectancy of ≥ 12 weeks.
6. Adequate hematologic and end organ function

Exclusion Criteria:

1. Failure to recover from adverse events from the most recent anti-tumor treatments
2. Acute or chronic hepatitis B, hepatitis C or human immunodeficiency virus (HIV) infection.
3. Subjects with CNS metastasis unless they are asymptomatic or adequately treated with radiotherapy and/or surgery and subjects are neurologically stable with minimal residual symptoms/signs.
4. Any other serious underlying medical (e.g., uncontrolled hypertension, active uncontrolled infection, active gastric ulcer,uncontrolled seizures, cerebrovascular incidents, gastrointestinal bleeding, severe signs and symptoms of coagulation and clotting disorders, other serious cardiac conditions not listed in exclusion criteria), psychiatric, psychological, familial or geographical condition that, in the judgment of the investigator, may interfere with the planned staging, treatment and follow-up, affect patient compliance or place the patient at high risk from treatment-related complications.
5. Pregnancy, lactation, breastfeeding.
6. Previous exposure to any anti-TIGIT antibody, or recombinant protein.
Genotype and Susceptibility to COVID-19

COVID-19 is a viral disease induced by infection with the novel SARS-CoV-2 coronavirus. Infection arises from the inhalation of viral particles spread by an infected individual. The main virus entry pathways are the nose and mouth mucous membranes, particularly rich in ACE2 receptors, that are used by the virus to enter cells and begin its replication.

Not all individuals who contract the virus fall ill, and most of those who do (about 70-80%) experience mild symptoms (fever, cough, headache, muscle aches, loss of taste and smell). If the immune system is unable to rapidly fight the virus back, the latter can attack the lungs, affeting oxygen absorption inside the alveoli and lead to pneumonia. This more severe form is observed in 20% of patients and can develop into even more serious complications requiring intensive care, with a high mortality rate. In severe cases (about 5%), the disease spreads to the entire body reaching the cardiovascular system and brain, with the risk of heart attacks, encephalitis and stroke, but it can also affect the liver, kidney and bowel.

Reasons why some subjects develop a highly severe disease while others have little or no symptoms at all still remain unclear. Many researchers are trying to find an answer by investigating the human genome, and the Mario Negri laboratories are also working in this direction.

The general hypothesis underlying this research project is that inter-individual genetic variations can explain the different responses to viral infection in a population, and that COVID-19 severity is, therefore, genetically determined in each infected subject.


Eligibility Criteria:
Inclusion Criteria:

- Age \> 18 years

Exclusion Criteria:

None
Synechie Afrer Rhinosug. Proc. 2024

Analyze the factors influencing the development of intranasal adhesions (synechiae), with particular emphasis on the use of nasal septal separators, and to suggest a solution to reduce this complication in the future.

Analyze of the medical documentation. It was not an experimental examination.


Eligibility Criteria:
Inclusion Criteria:

* septo or septoconchoplasty

Exclusion Criteria:

* incompleted documentation
Modulation of Cortical Brain Activity During Attentional Control

The goal of this study is to determine whether an open-loop sham neurofeedback system can effectively modulate EEG alpha rhythms, which are associated with attentional control. The main questions it aims to answer are:

Does positive sham neurofeedback lead to a decrease in relative EEG alpha power compared to a control condition without feedback?

Researchers will compare the effects of positive and negative sham-neurofeedback conditions to a control condition without feedback to assess the system's impact on alpha rhythm modulation. Participants will:

Experience three conditions (positive sham-neurofeedback, negative sham-neurofeedback, and no feedback) within a virtual reality environment.

Undergo EEG recordings to measure changes in alpha power as a marker of attentional resource allocation.

Provide written informed consent and complete the study following ethical guidelines.

This study seeks to explore the potential of open-loop feedback systems to enhance attentional control by modulating alpha rhythm.

Attention is a vital cognitive process that enables selective focus on behaviourally relevant information. A perceived lack of attentional control has been linked to mental disorders such as depression and anxiety, often manifesting through maladaptive coping strategies like rumination. As a trainable cognitive skill, attentional control can be enhanced through learning processes, particularly when reinforced by positive feedback within a classical operant conditioning framework. EEG studies have demonstrated that decreases in alpha rhythm power are associated with increased attentional resource allocation. While neurofeedback systems, especially those targeting alpha rhythms, typically rely on closed-loop modulation during attentional tasks, the impact of open-loop feedback on EEG alpha modulation remains unexplored. This study aims to determine whether an open-loop feedback system can effectively modulate EEG alpha rhythms, as a marker correlate of attentional control. The investigators propose a within-subject experiment where participants will experience positive and negative sham neurofeedback conditions, as well as a control condition with no feedback, all within a virtual reality environment. The investigators hypothesize that relative EEG alpha power will decrease in the positive sham neurofeedback condition compared to the control condition, reflecting a meaningful increase in attentional resource allocation.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged between 18 and 60 years.
* Normal or corrected vision.
* Ability to provide written informed consent.

Exclusion Criteria:

* Diagnosed with photosensitive epilepsy.
* Significant hearing loss or diagnosed hearing impairment.
* Current psychiatric illness or disorder.
* History of migraines or chronic headaches.
* History of substance or alcohol abuse.
* Currently pregnant.
* Discomfort with using a virtual reality headset, assessed during a pilot session.
Influenza Vaccine Randomized Educational Trial: Adult

Influenza vaccine is recommended as routine care for all individuals who are at least 6 months of age and older. Recently, questions about vaccine safety and concerns for side effects have increased, contributing to both influenza vaccine hesitancy and refusal. In an effort to educate patients, public health entities and physicians give informational handouts in various forms.

However, recent publications have found that pro-vaccine messages can have paradoxical effects on vaccine intentions, therefore further studies on vaccine related public health communication is needed. The purpose of this study is to compare the effectiveness of pro-vaccine messages of local data, pro-vaccine messages of national data, and no educational message on patient's receipt of the influenza vaccine. These results will help to understand the relationship between patient education and the intent to vaccinate and receipt of the influenza vaccine as well as to optimize educational information given to patients regarding the influenza vaccine.


Eligibility Criteria:
Inclusion Criteria:

* visit to study site at time of intervention

Exclusion Criteria:

* prior receipt of influenza vaccine that season
Exopulse Mollii Suit and Fibromyalgia

Fibromyalgia is a debilitating pain condition that is characterized by the chronic occurrence of pain affecting the musculoskeletal system, a sensitivity to pressure stimuli, and a low threshold to noxious stimuli. The topography of pain is widespread, although it could be more pronounced in some bodily regions. Besides pain, patients suffer from a wide range of symptoms, including fatigue, anxiety and depression manifestations, and altered quality of life. Facing these debilitating symptoms, the available therapeutic strategies for treating pain and associated manifestations are usually faced with limited efficacy and numerous side effects. For these reasons, non-invasive stimulation techniques, namely transcutaneous stimulation by means of Exopulse Mollii suit, might be of help in this context.

The investigators designed a randomized sham controlled double-blind trial to demonstrate the improvement of pain, quality of life, fatigue and mood in adult patients with fibromyalgia following a 2-week intervention of "active" versus "sham" Exopulse Mollii suit. A 2-week washout period should be enough to prevent a potential carry over effect. After this phase (phase 1), a second open label phase (phase 2) will be proposed for patients to understand the effects of Exopulse Mollii suit employed for 4 weeks (7 sessions per week) on the studied outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged between 18 and 75 years, with a definite diagnosis of fibromyalgia according to the American College of Rheumatology (ACR) 2010 criteria, set for at least one month
* Patients should be French speakers, able to understand verbal instructions, and affiliated to the national health insurance

Exclusion Criteria:

* Patient with VAS \< 4
* Patient included in another research protocol during the study period
* Patient unable to undergo medical monitor for the study purposes due to geographical or social reasons
* Patient with contraindication to wearing Exopulse Mollii suit (e.g., cardiac stimulator, a ventriculoperitoneal shunt, intrathecal baclofen pump, pregnancy, and/or body mass index above 35 kg/m2)
* Patient with other somatic or psychiatric diagnoses other than anxiety and depression (e.g., arrhythmias, uncontrolled epilepsy, other diseases causing osteoarticular and muscular pain)
* Any change in the pharmacological therapy in the last three months
* Introduction of a medical device other than Exopulse Mollii suit during the study period
* Patient under juridical protection (" mesure de protection judiciare : tutelle, curatelle, sauvegarde de justice ")
Mindful Movement and Breathing to Improve Outcomes of Gynecologic Surgery

The purpose of this clinical trial is to understand if women undergoing surgery for a suspected gynecologic malignancy are interested in participating in a Mindful Movement and Breathing program and what the effects of this program are on women and the surgery-related symptoms they experience. Mindful Movement and Breathing programs may be effective for easing distress, post-surgical pain, and other symptoms of surgical procedures.


Eligibility Criteria:
Inclusion Criteria:

* Signed protocol specific informed consent
* 18 years of age or older
* Scheduled for a major abdominal gynecological surgery to remove a mass that is suspected to be malignant

Exclusion Criteria:

* Unable to read or understand English
* Cognitively impaired and/or cannot complete interviews as judged by the referring physician, nurse, or study staff