cyrilzakka/clinical-trials huggingface dataset:
TIL Cells for the Treatment of the Advanced Solid Tumors Patients

This study is to investigate the safety and efficacy of tumor infiltrating lymphocyte (TILs) therapy in patients with Advanced malignant solid tumors. TILs are expanded from tumor resections or biopsies, and after ex vivo stimulation, activation and extensive expansion, are reinfused to patients after non-myeloablative lymphocyte-depleting preparative regimen.

This is a single-center, open-label, Phase I clinical study of TILs for the treatment of the recurrent/metastatic solid tumors patients who had failed standard therapy.

TILs are expanded from tumor resections or biopsies, and after ex vivo stimulation, activation and extensive expansion, are reinfused to patients after non-myeloablative lymphocyte-depleting preparative regimen.

The primary purpose of this study is to evaluate the safety and tolerability of TILs in patients with recurrent/metastatic solid tumors.

The second purpose of this study is to preliminarily explore the effectiveness of TILs in patients with recurrent/metastatic solid tumors.

Eligibility:

Adults aging 18-75 who were failed to standard treatment or have no standard treatment with recurrent/metastatic solid tumors.

Eligibility Criteria:
Inclusion Criteria:

1. Have the willingness to communicate with investigator, be able to understand and follow the trail requirements, and voluntarily to participate in the trail;
2. 18 \~ 75 years;
3. The expected survival period is at least 3 months;
4. ECOG score of 0-1;
5. There is at least one lesion that can be operated or biopsied for the preparation of TIL;
6. According to RECIST 1.1 standard, there is at least one measurable target lesion for efficacy evaluation;
7. Patients with recurrent or metastatic solid tumors confirmed by histopathology;
8. Subjects who failed standard treatment in the past or have no standard treatment currently tor who are judged by the investigator to be unsuitable for current standard treatment for other reasons, and the objective imaging assessment is disease progression

Exclusion Criteria:

1. Female subjects who are pregnant or breastfeeding, or have a positive blood pregnancy test at baseline ;
2. Subjects who have had severe allergic reactions to any drug or its components in this trial in the past;
3. Subjects who have received any investigational drug within 28 days before the infusion of TIL cells, or participated in another clinical study at the same time;
4. Subjects who have other known history of malignant tumors in the past 5 years, except for localized tumors that have been cured, including in situ cervical carcinoma, basal cell carcinoma of the skin, and in situ prostate carcinoma;
5. Patients who have received adoptive cell therapy in the past;
6. According to the judgment of the investigator, the condition of the subject is not suitable for this trial.
"Core Stabilization Exercises in Hearing Impaired Children"

In this study the investigators will examine the effects of core stabilization exercises on respiratory muscle strength, respiratory functions and postural control in hearing-impaired children.

Hearing organs develop together with the vestibular system and work with close cooperation. Because of this close neuro-anatomic relationship; cochlear, semicircular canal, or both may cause damage to the vestibular dysfunction, resulting in imbalance. Sensory impairment in children with hearing loss may lead to decreased muscle strength and respiratory function with balance and coordination disorders. Core stabilization is provided anatomically with abdominal muscles at the front, spinal and gluteal muscles at the back, diaphragm at the top and pelvic floor and hip muscles at the bottom. Core stabilization training is a training to increase the strength, endurance and neuromuscular control of the aforementioned muscles.

When the literature is checked, the invetigators find that postural control is being evaluated in children with hearing impairment, but there are few studies evaluating respiratory functions. However, they did not encounter a study in which respiratory muscle strength was assessed in these children. In this study the investigators will examine the effects of core stabilization exercises on respiratory muscle strength, respiratory functions and postural control in hearing-impaired children.

Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 7-16
* Clinically diagnosed sensorineural hearing loss
* Prelingual hearing loss
* No neurological and orthopedic problems
* Absence of syndrome or disease that may lead to mental disorder, impaired development and impaired vision
* Not participating in any core stabilization, strengthening and balance program in the past six months
* No medication to affect respiratory functions in the past 3 months
* Parental permission for participation of child in the study

Exclusion Criteria:

* Intellectual disability for participating to the evaluation and training program
* Presence of chronic respiratory disease
* Not to join the training for more than 3 days
Comparative Pharmacokinetics and Pharmacodynamics of Synthetic Nicotine

In a crossover study, experienced electronic cigarette users will vape 3 different forms of nicotine: natural (derived from tobacco), synthetic, or a 50:50 mixture of both natural and synthetic. The investigators will compare nicotine metabolism, cardiovascular effects, patterns of self-administration, and participants' feelings of craving/withdrawal and enjoyment.


Eligibility Criteria:
Inclusion Criteria:

* Healthy on the basis of medical history and limited physical examination.
* Current regular user of E-Cigarettes (≥ 15 days in the past 30 days)

Exclusion Criteria:

* • Medications

  * Use of medications that are inducers of nicotine metabolizing enzyme CYP2A6 (Example: rifampicin, carbamazepine, phenobarbital, and other anticonvulsant drugs).
  * Use of sympatholytic medications for cardiovascular conditions including hypertension (Example: beta and alpha-blockers).
  * Concurrent use of nicotine-containing medications (Example: nicotine patch, lozenge, gum).
  * Any stimulant medications (example: Adderall) generally given for ADHD treatment.

    • Pregnancy
  * Pregnancy (self-reported and urine pregnancy test)
  * Breastfeeding (determined by self-report)
  * Women of childbearing potential must be using an acceptable method of contraception

    * Inability to read and write in English
    * A known propylene glycol/vegetable glycerin allergy
    * Uncomfortable with getting blood drawn
Helping People to Exercise Regularly

This study tests two different incentive mechanisms to induce members of a particular urban senior center to attend more exercise classes. Coupons for future use are given to participants who attend an exercise class and will be redeemable within either a one week or three month time period, depending on which experimental group the participant is assigned to. Frequency of exercise class attendance at the end of 2 months will be the primary outcome.


Eligibility Criteria:
Inclusion Criteria:

* Age 55 years or older
* Member of the Philadelphia Senior Center

Exclusion Criteria:

* None
Influence of Neuromuscular Block on Mask Ventilation

Difficult mask ventilation might lead to a life-threatening situation, if endotracheal intubation is also impossible and neuromuscular blocking agents (NMBA) inhibit spontaneous ventilation. However, controversies exist if NMBA improve or impede face mask ventilation. Therefore, the effect of NMBAs on mask ventilation is assessed in patients with predictors for difficult face mask ventilation.


Eligibility Criteria:
Inclusion Criteria:

* Patients with risk factors for difficult face mask ventilation
* Patients scheduled for general anaesthesia with endotracheal intubation

Exclusion Criteria:

* Increased Risk for pulmonary aspiration
* scheduled for awake fiberoptic intubation
* pregnancy
Oxytocin and Affect Processing in Posttraumatic Stress Disorder

The investigators will use multiple methods (including Oxytocin intranasal inhalation, neuroimaging, behavioral measures, peripheral hormone measurements) to examine how individuals' behavior, cognition, and brain function is impacted by the neuro-hormone Oxytocin. Specifically, the investigators plan to evaluate the influence of Oxytocin administration on affective processing in non-trauma exposed and trauma-exposed adults (both with and without posttraumatic stress disorder, PTSD).

The investigators will use multiple methods (including Oxytocin intranasal inhalation, neuroimaging, behavioral measures, peripheral hormone measurements) to examine how individuals' behavior, cognition, and brain function is impacted by the neuro-hormone Oxytocin. Specifically, the investigators plan to evaluate the influence of Oxytocin administration on affective processing in non-trauma exposed and trauma-exposed adults (both with and without posttraumatic stress disorder, PTSD). The investigators expect oxytocin (compared to placebo) to positively influence affect processing in healthy subjects, as well as among those diagnosed with PTSD. Given current literature, the investigators expect oxytocin to elevate the processing\\perception of positive-related stimuli, and reduce the salience of aversive or un-pleasant cues. The investigators expect oxytocin to impact participants' brain function as measured with functional magnetic resonance imaging (fMRI) while visually processing social and affect-related stimuli, rendering brain function and affective processing to be "more typical" or "adaptive" compared to placebo. Oxytocin's effect on human repertoire is not necessarily direct, but can interact with the individual's socioemotional characteristics, early life environment, and psychiatric symptoms. Therefore, the investigators will incorporate measures that capture the various dimensions that likely shape the effect of oxytocin.

Eligibility Criteria:
Inclusion Criteria:

* Adults: age 18-55
* Be in good medical health
* Be cooperative with testing
* English is a language spoken in the family
* PTSD as diagnosed by a certified clinician or the research team for PTSD group.

Exclusion Criteria:

* Moderate or severe acute or chronic medical illnesses (e.g.cardiac disease, diabetes, epilepsy, influenza).
* History of hypertension with baseline blood pressure above 160 mm Hg (systolic) over 100 mm Hg (diastolic).
* history of syncope and/or baseline blood pressure below 100 mm Hg (systolic).
* weight \>300lb
* The use of some psychotropic medications will not be allowed. Females taking contraceptive hormones will not be able to participate in the study.
* Currently breast feeding or pregnant
* For MRI ONLY: Any metal or electromagnetic implants
* For MRI ONLY: Significant hearing loss or other severe sensory impairment
* A fragile health status.
* For MRI ONLY: A history of seizures or current use of anticonvulsants
* Healthy adult controls (HC):
* Be free of both neurological and psychiatric disorders (current and past) on the basis of self-report
* Be free of psychiatric disorders
Cancer Screening Smoking Cessation AND Respiratory Assessment

The CASSANDRA project (Cancer Screening, Smoking Cessation, AND Respiratory Assessment) is a project led by SEPAR whose main coordinators are Dr. Luis Seijo, a pulmonologist at the Clínica Universitaria de Navarra, and Dr. Juan Carlos Trujillo-Reyes, a thoracic surgeon at the Hospital de la Santa Creu I Sant Pau and Coordinator of the Thoracic Oncology Area, in addition to the collaboration of a large number of professionals with expertise in lung cancer screening.

Despite its proven efficacy, Spain does not yet have a unified lung cancer screening protocol. The aim of the CASSANDRA project is to initiate a national screening program that can join forces with existing smoking cessation programs in Spain, which have proven to be insufficient in reducing the number of people affected by lung cancer.

CASSANDRA aims to analyze the feasibility of implementing a lung cancer screening program in Spain implemented in the public health system and carry out a cost-effectiveness analysis

CASSANDRA aims to be the first lung cancer screening pilot project in Spain. A project to assess the feasibility of implementation as well as to look for models that allow a better selection of the cases to be screened.

Eligibility Criteria:
Inclusion Criteria:

* Age 50-75 years active smoker with cumulative dose of \>20 packets/year
* Age 50-75 years ex-smoker less than 15 years old with cumulative dose of \> 20 packets/year

Exclusion Criteria:

* Pre-existing or new-onset comorbidities that, in the opinion of the coordinator, prevent surgical resection if lung cancer is found on low dose computed tomography (LDCT) scan, for example, severe chronic obstructive pulmonary disease (COPD) with forced expiratory volume at one second (FEV1) \< 30%.
* Inability to sign the informed consent or collaborate with the CT scan.
* Performing a chest CT for any reason in the previous year or planned CT for any reason in the next 3 months.
* Subjects with a history of any cancer (except non-melanoma skin cancer) in the 5 years prior to inclusion in the screening program.
Determining Highest Dose Administration of TC-5214 and Evaluating Effect on the Electrical Activity in the Heart

This is a two part study. Part A will determine the maximum tolerated dose of TC-5214 administered to healthy male subjects in single ascending oral doses. This part of the study will define the highest dose of TC-5214 to be administered in Part B. Part B of this study will investigate the effect of TC-5214 on the electrical activity of the heart following single oral administration. The study will be carried out healthy male subjects in a four period crossover study with TC-5214 compared to placebo and oral moxifloxacin as a positive control. The safety, tolerability and pharmacokinetics of TC-5214 will also be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male 18 to 50 years old inclusive with suitable veins for cannulation or repeated venipuncture
* Have a body mass index (BMI) between 19 and 30 kg/m2 inclusive and weigh at least 50 kg
* Male subjects should be willing to use a double barrier method of contraception (condom with spermicide) from the first dose of investigational product until 3 months after the last dose of investigational product
* Be able to understand and comply with the requirements of the study as judged by the investigator

Exclusion Criteria:

* History of any clinically significant medical, neurologic or psychiatric disease or disorder which, in the opinion of the Investigator and Sponsor may either put the subject at risk because of participation in the study, or influence the results of the subject's ability to participate in the study
* History or presence of gastrointestinal (including irritable bowel disease), hepatic, or renal disease or other condition known to interfere with the absorption, distribution, metabolism, or excretion of study drug. Subjects with a history of surgery on the gastrointestinal tract (not including appendectomy or cholecystectomy) should also be excluded
* History of seizure activity, including febrile seizures
* Prolonged QTcF \>450 ms or shortened QTcF \<340 ms, or family history of Long QT Syndrome
* Use of concomitant medications that prolong QT/QTc interval
Mobility Protocol Adapted for Advanced Visually Impaired Subjects

Retinitis Pigmentosa is characterized by a progressive disappearance of photoreceptors, responsible for a progressive and severe loss of vision.

People Retinitis Pigmentosa therefore encounter a large number of difficulties in daily life, specifically for:

* Visual research
* Visuo-motor coordination in tasks requiring fine motor control
* Visuo-motor coordination in mobility tasks

This study aims to assess the difficulties in the daily life of subjects with Retinitis Pigmentosa at a very advanced stage unsing, quaify of life questionnaires, simplified locomotion tasks in real situation and a posture task.

They are proposing a new test adapted and carried out in real situations, in binocular and monocular vision, making it possible to finely assess locomotion especially for "very low vision" patients.

This test will also ultimately make it possible to better evaluate the effectivements, that is to say to observe and quantify objectively by a score the performance progression obtained for locomotion tasks related to the visual recovery generated by the treatment.

This is monocentric study and the total duration of the study is 48 months. The duration of participation for each research subject is 3 months and maximum 4 visits. This is research involving the human type of non-invasive interventional research, with minimal risks and constraints.

This exploratory study will be conducted on a group of patients with Retinitis Pigmentosa at a very advanced stage.

There will be an inclusion visit including a visual assessment and an ophthalmological consultation. Two experimental visits with tests carried out in a real environment including a locomotion and a posture tasks. An end-of-study visit within a maximum of 1 month following the second experimental visit.

Eligibility Criteria:
Inclusion Criteria:

* Retinitis Pigmentosa, non-syndromic, the diagnosis of which has been confirmed by an ophtmalmologist
* ETDRS visual acuity less than 2/10 (\>+0.7 logMAR; \<20/100 Snellen)
* Doesn't participate in clinical research that may interfere with this study
* Sufficient knowledge of the French language to ensure a perfect understanding of the tasks to be performed and the instructions received
* Consent to the study signed after information by the investigator
* Health insurance affiliation

Exclusion Criteria:

* Pregnant women
* Inability to give personal consent
* Cataract surgery in the 3 months preceding inclusion
* Amblyopia
* Inability to comply with the instructions for carrying out the study tasks or to complete the study visits
* MMSE score without visual item ≤ 20/25
* Drug treatment which can lead to motor, visual or cognitive disorders (PSA, neuroleptics,etc.) or which may interfere with the study's evaluations
Effect of Controlled Adverse Environment (CAE) on Tear Film Stability

The purpose of this study is to evaluate the effect of the controlled adverse environment (CAE) on Mean Break-Up Area in subjects diagnosed with Dry Eye Syndrome.

Single-Center, Pilot, controlled adverse environment (CAE) Study.

This is a single-center, one visit, pilot, CAE study. Dry Eye Subjects (N=30) who qualify will undergo tear film video recording, fluorescein staining, and break up time before CAE exposure and after CAE exposure.

All subjects will undergo baseline dry eye assessments including fluorescein staining, breakup time, conjunctival redness and tear film video recording. Subjects who qualify will then undergo CAE exposure for 90 minutes. At the end of CAE exposure subjects will undergo dry eye assessments again.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age \& either sex, any race
* Willing and able to follow all instructions
* Positive history of dry eye disease
* Use or desire to use drops for dry eye within the past 6 months

Exclusion Criteria:

* Have planned surgery during trial period
* Female currently pregnant, planning a pregnancy or lactating
* Use of disallowed medications
* Have ocular infections, or ocular conditions that could affect study parameters
* Have used an investigational drug or device within 30 days of start of study
* Female that is currently pregnant, planning a pregnancy or lactating
Phase II Clinical Trial of OPS-2071 in the Treatment of Irritable Bowel Syndrome of Diarrhea Type

This is a A Multicenter, Randomized, Double-blind, Placebo-controlled, Clinical Trial to Evaluate the Efficacy and Safety of Different Doses of OPS-2071 in the Treatment of Irritable Bowel Syndrome of Diarrhea type (IBS-D).The trial is mainly divided into three periods: screening period, treatment period and follow-up period.

Screening period:

After signing the Informed Consent Form, subjects entered a 14-day screening period to evaluate inclusion/exclusion criteria and collect demographic information, medical history, etc. Subject's previous medication should be eluted and concomitant medications should be prohibited.

Treatment period:

After the screening period, subjects who meet the inclusion criteria and do not meet the exclusion criteria will be randomly assigned (1:1:1:1) to four treatment groups to receive a 2-week treatment period. Weekly follow-up and relevant examinations will be performed.

Follow-up period:

The safety follow-up visit will be conducted by telephone on Day14 (+2) after the last dose.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects who are able to fully understand and willing to comply with the trial procedures, and voluntarily participate in the trial and sign the Informed Consent Form;
2. Subjects aged 18 to 65 years at the time of ICF signing;
3. Subjects who meet Rome IV diagnostic criteria for IBS-D;
4. The following criteria should be met during the screening period:

Exclusion Criteria:

1. Subjects who have gastrointestinal alarm symptoms within 14 days before screening, such as hematochezia, positive fecal occult blood test, anemia, abdominal mass, ascites, fever, unexplained body mass loss, and nocturnal diarrhea;
2. Subjects with previously confirmed diagnosis of digestive organic diseases, such as inflammatory bowel disease, intestinal tuberculosis, intestinal polyps (except for polyps ≤ 0. 3 cm or polypectomy time ≥ 15 days), intestinal diverticulum, intestinal tumor, etc., or patients still complicated with peptic ulcer and infectious diarrhea;
3. Subjects with previously confirmed diagnosis of diseases affecting digestive system function, such as uncontrolled hyperthyroidism or hypothyroidism, chronic renal failure, autoimmune diseases, diabetes, and neurological (such as anorexia nervosa) or serious psychiatric system diseases (such as major depression or severe anxiety);
4. Subjects with previously confirmed diagnosis of diseases with symptoms similar to IBS, such as eosinophilic enteritis, microscopic colitis (including collagenous colitis and lymphocytic colitis), lactose intolerance, malabsorption syndrome, etc.;
5. Subjects with previously confirmed diagnosis of non-intestinal digestive diseases, such as tuberculous peritonitis, gallstones, cirrhosis, chronic pancreatitis, etc.;