cyrilzakka/clinical-trials huggingface dataset:
Nitrogen Bubble Detection After Simulated Dives in Divers With PFO and After PFO Closure

The aim of this study is to determine whether catheter-based closure of patent foramen ovale is effective in preventing paradoxical embolization of nitrogen bubbles after simulated dives.

The aim of this study is to determine whether catheter-based closure of patent foramen ovale (PFO) is effective in preventing paradoxical embolization of nitrogen bubbles after simulated dives.

Ultrasonographic detection of venous and arterial nitrogen bubbles will be performed in divers after surfacing from simulated dives in hyperbaric chambers. Divers will be observed after two different dive profiles - Dive A (dive to 18 m for 80 min bottom time) and dive B (dive to 50 m for 20 min bottom time), both performed according to US Navy Air decompression procedure 1996. For both dives two groups will be compared: Divers with PFO and divers after previous catheter-based closure of PFO.

The study will be observational. Sonographic detection of bubbles will be performed after simulated dives that are part of a training program of the divers. Two different dives, previously documented to generate significant amount of venous nitrogen bubbles, were chosen.

The primary end-point will be a positive transcranial doppler test (defined as one or more bubbles detected either during native breathing or after Valsalva maneuver).

Inclusion criteria are: 1) previously diagnosed PFO or a PFO that has been occluded by a catheter-based procedure, 2) signed informed consent

Exclusion criteria: 1) another dive performed in the preceding 24 hours, 2) another previously diagnosed right-to-left shunt, 3) disagreement to be included in the study

This study will be single-center.

Eligibility Criteria:
Inclusion Criteria:

1. previously diagnosed PFO or a PFO that has been occluded by a catheter-based procedure
2. signed informed consent

Exclusion criteria:

1. another dive performed in the preceding 24 hours
2. another previously diagnosed right-to-left shunt
3. disagreement to be included in the study
The Study on the Mechanism of Radiotherapy-elicited Immune Response

Radiotherapy plays an important role in multidisciplinary treatment of esophageal cancer. Data from many laboratories indicate that local radiation produces systemic, immune-mediated anti¬tumour and, potentially, antimetastatic effects. Additionally, the combination of local radiotherapy and immune-modulation can augment local tumour control and cause distant (abscopal) antitumour effects through increased tumour-antigen release and antigen-presenting cell (APC) cross-presentation, improved dendritic-cell (DC) function, and enhanced T cell priming. The generation of an effective antitumor immune response requires the presentation of tumor antigens to naïve CD8+ cells in tumor-draining lymph nodes (TDLN) . Tumor-draining lymph nodes, however, are often subject to the immunosuppressive activity of tumor-derived factors, such as cytokines and other bioactive molecules from tumor cells and their associated leukocytes in the primary tumor site that contribute to the overriding of effective rejection mechanisms. Thus, in TDLN a T cell tolerance rather than a T cell activation often occurs, thereby preventing immune attack and facilitating local tumor progression.

In this study, the investigators collect clinical and biological evidence to interpret the impact of radiotherapy on tumor regression and immunity, and identify key molecular features and immune landscape patterns to characterize patients sensitive/resistant to radiotherapy; and define the dynamic changes occurring in TME and lymph node after radiotherapy.

Eligibility Criteria:
Inclusion Criteria:

1. new diagnosis locoregional esophageal cancer;
2. pathologic diagnosis is squamous carcinoma;
3. Patients had received either neoadjuvant or definitive radiotherapy
4. tumor and lymph node tissue can be collected and can be conducted with single cell RNA (scRNA)-sequencing and other sequencings.

Exclusion Criteria:

1. Pregnant or lactating women.
2. Unable or rejection to receive radiotherapy or unable to comply with study requirements or follow-up schedule.
3. Inability to provide informed consent.
The SNORES Randomized Clinical Trial

Randomized clinical trial among women with polycystic ovary syndrome (PCOS) who present for fertility treatment to evaluate the impact of screening for obstructive sleep apnea.

The investigators' goal is to perform a randomized clinical trial among women with PCOS who present for infertility treatment. Our primary outcome is to determine if screening women with PCOS, and treating those with confirmed sleep apnea, will lead to more ovulatory cycles. Our sub-aims are to describe the rate of OSA and sleep symptoms in patients with PCOS, to see if current sleep questionnaires correlate to a diagnostic sleep study, to describe the correlation between OSA and biomarkers of glucose homeostasis in women with PCOS, to investigate health related quality of life between the groups, to compare perinatal outcomes between the groups, and to evaluate the composition of breastmilk among women who choose to breastfeed.

Eligibility Criteria:
Inclusion Criteria

* Females 18 - 50 years old.
* Receiving care from an Obstetrician / gynecologist or a Reproductive endocrinology infertility specialist
* Polycystic ovarian syndrome defined by the modified Rotterdam criteria
* Able to speak and understand as well as give informed consent in English

Exclusion Criteria

* Late onset congenital adrenal hyperplasia
* Cushings disease
* Androgen-secreting tumors
* Previous diagnosis of obstructive sleep apnea
* Current use of over the counter or prescribed sleep medications.

  * Examples of medications that exclude a patient from this study include but are not limited to Unisom, Ambien or Lunesta.
  * Patients who are taking non-prescribed herbal medications for sleep will not be excluded from the study. Examples of these include but are not limited to melatonin, chamomile, or valerian.
* Untreated thyroid disease
* Prolactin excess
* Patients with the following medical conditions will be excluded from the study as portable sleep apnea monitors are not indicated in patients with severe pulmonary disease, neuromuscular disease, or congestive heart failure.
Effect of Ranibizumab on Malignant Conjunctival Neoplasia

The purpose of this study is to test the safety and tolerability of subconjunctival injection of ranibizumab in the treatment of malignant conjunctival neoplasia using the incidence and severity of adverse events.

Our secondary objective is to assess the efficacy of ranibizumab treatment on malignant conjunctival neoplasia by evaluating tumor destruction or reduction as documented by slit-lamp photography and ultrasonographic imaging and the regression of blood vessels.

Ranibizumab is a recently approved vascular endothelial growth factor (VEGF) inhibitor shown to be effective in treating exudative macular degeneration. Its analog, Avastin has also been employed to treat macular edema, proliferative diabetic retinopathy and wet age related macular degeneration. Ranibizumab binds to and inhibits vascular endothelial growth factor A (VEGF-A), which has been shown to cause neovascularization and leakage in models of ocular angiogenesis. Binding to VEGF-A prevents ranibizumab's interaction with VEGFR-1 and -2 receptors on the surface of endothelial cells, thereby reducing proliferation, vascular leakage, and angiogenesis.

Given that conjunctival tumors require the formation of new blood vessels to supply the proliferating cells, we propose a study to evaluate the effect of subconjunctival ranibizumab as a primary intervention in patients with conjunctival tumors.

Eligibility Criteria:
Inclusion Criteria:

* Ability to provide written informed consent and comply with study assessments for the full duration of the study
* Age \> 21 years
* Tumors whose treatment with standard therapy would cause significant visual morbidity
* Diagnosis of biopsy proven malignant conjunctival neoplasia and are
* Recurrent disease
* Multi-focal disease
* Diffuse disease

Exclusion Criteria:

* Extension of tumor into eye or orbit.
* Regional spread or metastatic disease
* Pregnancy (positive pregnancy test) or lactation.
* Premenopausal women not using adequate contraception. The following are considered effective means of contraception: surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an IUD, or contraceptive hormone implant or patch.
* Current infection or inflammation in either eye
* Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
* Participation in another simultaneous medical investigation or trial
InformationSeekingMesolimbicEngagementStudy1

Study 1 will use a novel Game Show task, in which the investigators manipulate participant's agency to control their learning environment to specify unguided exploration.

Study 1 will use a novel Game Show task, in which the investigators manipulate participant's agency to control their learning environment to specify unguided exploration. In the encoding session, participants play the producer for a game show. On each trial, participants are shown a trial-unique contestant (2s), and then they select one of 3 presented doors to reveal a hidden object (4 seconds). The selected door is then highlighted (2-4s), which is then removed to show a trial-unique object image, which is framed as a prize (2s). On exploration trials, participants actively select which door to open. On control trials, the participant is forced to select a highlighted door, fostering passive rather than active information seeking. Unbeknownst to participants, there is no relationship between selected doors and revealed objects, as objects are pre-selected for each trial. Thus, timing, motor demands, and visual information are fixed across conditions. Participants will complete 3 runs of both the exploration and control condition, with each run containing 20 trials. Temporal jitters are placed between cues and outcomes and between trials, as determined by design optimization software77. Run will be pseudo-randomized across participants so no more than 2 runs of the same condition will appear in a row. Following encoding, participants will complete immediate and delayed item-associative memory test. On each trial of the memory test, participants will view the characters presented during exploration and control trials as well as new foil characters. If a participant indicates that they have previously seen a character before, the participants will be shown three object images encountered during encoding, and decide which item served as a prize for that specific character. In this way, the investigators can resolve memory for contestants (i.e., cues), and associative binding across contestants and prizes (i.e., cue-outcome). Participants memory will be tested for half the stimuli immediately and at a 24-hour delay.

Eligibility Criteria:
Inclusion Criteria:

* 20/40 far acuity (either corrected or uncorrected)
* In good medical health

Exclusion Criteria:

* History of head injury
* History of illness with Central Nervous Systems implications
* On Medications that Affect blood flow response and alertness
* Consumption of smoking and/or coffee 30 minutes prior to laboratory testing
* Placement of a device contraindicated for magnetic resonance imaging including cardia pacemaker, aneurysm clip, cochlear implants, pregnancy, intra-uterine device, shrapnel, metal fragments in the eyes, neurostimulators
* Weight \> 250lbs
* Claustrophobia
Pan European Collaboration on Antipsychotic Naive Schizophrenia (PECANS)

The investigators want to relate disturbances in first-episode schizophrenic patients in (dopaminergic) D2 receptors, brain structure, brain function, and information processing to each other and to psychopathology. Additionally, the investigators want to examine the influence of D2 receptor blockade on these disturbances. The investigators expect disturbances in the dopaminergic system at baseline to correlate with specific structural and functional changes and with disruption in information processing as measured with psychophysiological and neurocognitive methods - and investigators expect D2 receptor blockade to reverse some of the functional and cognitive impairments.

The study is designed as a 6 week case-control follow-up study of 70 AN FE pt. with SCZ and 70 controls matched with regard to age, gender, and parental socio-economic status. All subjects will be examined with a diagnostic interview (SCAN, Schedule for Clinical Assessment in Neuropsychiatry), medical and family history, and physical examination before inclusion. At baseline all subjects will be examined with single photon emission computed tomography (SPECT), MRI, fMRI, psychophysiology, neurocognition. In addition, they will be screened for drugs, genetic testing, and ECG. Patients will further be examined with clinical validated rating scales to measure psychopathology, subjective well-being, and side-effects. After a period of 6 weeks all assessments are repeated. During that period patients will be treated with amisulpride, while healthy controls will receive no treatment at all. Efficacy of antipsychotic treatment will be evaluated after this initial period of 6 weeks. Based on this evaluation it will be decided to either continue the current (amisulpride) antipsychotic treatment, or to switch to aripiprazole. Efficacy of aripiprazole is evaluated on a monthly basis, if the patient does not respond well enough, than the treatment will be adapted individually. Regardless of treatment, all subjects will be re-assessed in the same test battery as mentioned above, except for SPECT and fMRI, after a period of 6, 12, and 24 months. The developement in specific disturbances and the relationship between these will be analysed.

Eligibility Criteria:
Inclusion Criteria:

For patients: meeting diagnostic criteria for schizophrenia according to ICD 10 or DSM IV antipsychotic naive The controls will be matched to the patients according to gender age and parental socio-economic status.

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Exclusion Criteria:

Patients: mental retardation, other chronic diseases, use of antidepressive medicine during the last month,being pregnant, on going substance abuse

Controls: psychiatric diagnosis, psychiatric diagnosis in first-degree relatives,on going drug abuse, mental retardation -
Combination of Active or Placebo Attentional Bias Modification Treatment (ABMT) to Either Cognitive Behavioral Group Therapy (CBGT) or Psychoeducational Control Intervention (PCI) for Anxiety Disorders in Children

The objective of this project is to test the combination of active or placebo Attentional Bias Modification Treatment (ABMT) to either Cognitive Behavioral Group Therapy (CBGT) or Psychoeducational Control Intervention (PCI) for anxiety disorders in children.


Eligibility Criteria:
Inclusion Criteria:

* Primary diagnosis of Generalized Anxiety Disorder (GAD), Separation Anxiety Disorder (SeAD) or Social Anxiety Disorder (SoAD) according to KSADS-PL psychiatric interview

Exclusion Criteria:

* Other psychiatric disorder that causes more impairment and suffering than GAD, SeAD or SoAD in the clinical evaluation
* Current or previous treatment (behavioral or pharmacological) for a psychaitric disorder in childhood
* IQ \< 70 (Raven)
A Study of NT-112 in HLA-C*08:02-Positive Adult Subjects With Unresectable, Advanced, and/ or Metastatic Solid Tumors Positive for the KRAS G12D Mutation

Phase I Study of NT-112, an autologous T-cell therapy product genetically engineered to express an HLA-C\*08:02-restricted T cell receptor (TCR), targeting KRAS G12D mutant solid tumors.

This is a Phase 1, open-label, multicenter study to evaluate the safety and preliminary antitumor activity of NT-112 in HLA-C\*08:02 subjects with unresectable, advanced, and/or metastatic NSCLC, colorectal adenocarcinoma, pancreatic adenocarcinoma, endometrial cancer, or any other solid tumor histology that is positive for the KRAS G21D mutation.

Eligibility Criteria:
Key Inclusion Criteria:

* Age ≥18 years
* Diagnosed with NSCLC, Colorectal adenocarcinoma, Pancreatic adenocarcinoma, Endometrial Cancer or any other solid tumor
* Tumors must harbor a KRAS G12D variant mutation and subject must be HLA-C\*08:02 positive
* Subject has advanced solid cancer, defined as unresectable, advanced, and/or metastatic disease (Stage III or IV) after at least 1 line of approved systemic standard of care (SOC) treatment regimen and for which there are no available curative treatment options.
* Presence of at least 1 measurable lesion per RECIST v1.1
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at the time of enrollment

Key Exclusion Criteria:

* Any other primary malignancy within the 3 years prior to enrollment (except for non-melanoma skin cancer, carcinoma in situ (eg, cervix, bladder, breast) or low-grade prostate cancer
* Known, active primary central nervous system (CNS) malignancy
* History of prior adoptive cell and gene therapy, allogeneic stem cell transplant or solid organ transplantation.
* History of stroke or transient ischemic attack within the 12 months prior to enrollment.
* History of clinically significant cardiac disease within the 6 months prior to enrollment or heart failure at any time prior to enrollment.
* Systemic therapy within at least 2 weeks or 3 half-lives, whichever is shorter, prior to enrollment.
* Any form of primary immunodeficiency.
* Active immune-mediated disease requiring systemic steroids or other immunosuppressive treatment (except if related to prior checkpoint inhibitor therapy)
* Female of childbearing potential who is lactating or breast feeding at the time of enrollment
Patient Directed Intervention to Improve the Quality of Life for Patients With Soft Tissue Sarcoma

The primary objective of the study is to compare quality of life (QoL) between patients suffering from soft tissue sarcoma, receiving a multidimensional intervention with those receiving standard treatment.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of advanced or metastatic soft tissue sarcoma
* Treatment with trabectedin in an in-label prescription
* Age at least 18 years (inclusive) at the first visit
* Patients with a life expectancy of at least 6 months
* The informed consent form must be signed before any study specific tests or procedures are done
* Confirmation of the subject's health insurance coverage prior to the first visit
* Ability to understand and follow study-related instructions

Exclusion Criteria:

* ECOG PS \>2
* Estimated life expectancy of less than 6 months
* Patients with STS not receiving trabectedin
* Contraindications according to the local SmPC of Yondelis®
* Subject is in custody by order of an authority or a court of law
* Exclusion periods from other studies or simultaneous participation in other clinical studies
* Previous assignment to treatment during this study
* Close affiliation with the investigator (e.g. a close relative) or persons working at the study site
* Subject is an employee of GWT-TUD GmbH or Pharma Mar S.A.
* Criteria which in the opinion of the investigator preclude participation for scientific reasons, for reasons of compliance, or for reasons of the subject's safety
Safety and Efficacy of the Effect of Isosorbide Mononitrate in Reducing Pain During Levonorgestrel-releasing Intrauterine Device Insertion

the aim of the study is to evaluate the safety and efficacy of isosorbide mononitrate vaginal administration in reducing pain during LNG-IUD insertion in adolescents and young women


Eligibility Criteria:
Inclusion Criteria:

* adolescents and young women requesting LNG-IUD insertion

Exclusion Criteria:

* heavy vaginal bleeding,pregnancy, contraindications to IUD insertion, allergy or contraindication to isosorbide mononitrate, uterine anomaly
Evaluation of Using Self-adhering Flowable Resin Composite in Repairing Old Defective Resin Composite Restorations Over 18 Months Follow up. (A Randomized Clinical Trial)

This research proposal is evaluating the clinical performance of using self-adhering flowable resin composite in repairing old occlusal defective resin composite versus conventional flowable resin composite restoration over 18 months.


Eligibility Criteria:
Inclusion Criteria:

* Patients (18-35 y)
* patients with defective resin composite class I restorations that need repair.
* dental motivated patients who attends regularly.
* Vital posterior teeth with repairable defective resin composite class I restorations.
* Localized marginal defect or marginal staining FDI 3\& 4.
* Teeth with no or minimum mobility \& healthy peridontium.
* No history of any irreversible pulpal pain or necrosis in the teeth to be restored.

Exclusion Criteria:

* • Patients with defective restorations that dictate replacement

  * Uncooperative behavior limits the isolation techniques throughout the procedure.
  * Presence of parafunctional habits.
  * Patient with history of systemic medical disease, or any other serious relevant problem.
  * High caries risk patients. Periodontal disease that may affect the prognosis of the restoration or the tooth itself.
  * Fractured or visibly cracked teeth.
  * Symptoms of any pulp pathosis.
  * Defective resin composite restorations that dictate replacement.