cyrilzakka/clinical-trials huggingface dataset:
Correlation Study of Serum HER 2 Against HER 2-ADC Drug Efficacy in HER 2 Low-expressing Breast Cancer

Breast cancer is one of the most common malignancies in women worldwide, with HER2-positive breast cancer accounting for about 15-20% of all breast cancer cases. HER2 (Human epidermal growth factor receptor 2) is a tyrosine kinase receptor that, when overexpressed, promotes the growth and spread of tumor cells. The advent of anti-HER2 therapy, particularly antibody-coupled drugs (ADCs), has resulted in significant survival benefits for HER2-positive breast cancer subjects.

At present, the value of serum HER2 in the monitoring of anti-HER2-ADC drug therapy is insufficient. The purpose of this study was to investigate changes in serum HER2 expression levels in breast cancer subjects treated with anti-HER2-ADC drugs and the relationship between these changes and treatment effect. The therapeutic effect of HER2 was evaluated by continuous detection of HER2 serum, which provided a theoretical basis for the selection of clinical drug treatment.

ADC drugs are a new type of targeted therapy. ADC drugs are composed of monoclonal antibodies, linkers and drug carriers, which bind to the target antigen on the surface of tumor cells through antibodies, endocytosis/internalization to form early endosomes in cells, and then mature into late endosomes and fuse with lysosomes. ADC drugs break apart in the lysosome and release the drug carrier, eventually leading to apoptosis or death while minimizing damage to normal cells. However, not all subjects with HER2-positive breast cancer respond well to ADC drugs, and resistance may develop during treatment. Therefore, effective biomarkers are needed to monitor treatment effects and guide individualized treatment. Serum HER2 refers to the HER2 protein fragment present in the subject's serum. Serum HER2 levels may be more readily available than HER2 expression in tumor tissue and can be sampled multiple times during treatment, allowing real-time monitoring of disease progression and drug efficacy. If monitoring of serum HER2 levels accurately reflects tumor sensitivity to ADC drugs, it could be a valuable therapeutic monitoring tool.

In view of the excellent efficacy of ADC drugs in HER2-positive and low-expression breast cancer patients, this study intends to judge the therapeutic efficacy of breast cancer patients treated by anti-HER2-ADC drugs (such as T-DXd) through continuous detection of their serum HER2, providing a theoretical basis for the selection of clinical drug therapy.

Eligibility Criteria:
Inclusion Criteria:

* 1. Subjects with pathologically confirmed breast cancer; 2. The therapeutic drugs are anti-HER2-ADC drugs; 3. No history of other tumors; 4. Age \> 18 years old; 5. Have relatively complete clinical case characteristics data.

Exclusion Criteria:

* 1. Male breast cancer subjects; 2. Suffering from other malignant neoplasms; 3. Subjects with incomplete clinical case characteristics.
3D Video Virtual Reality Exposure Therapy Study

This study seeks to examine a Virtual Reality Exposure Therapy (VRET) using the 3D Video Virtual Reality (VR) technology for the fear of spiders.

An estimated 10-11% of the US population experiences a specific phobia at some point in their lives (American Psychiatric Association, 1994; Magee et al., 1996). About 60-85% of those individuals with a specific phobia never seek treatment (Agras, Sylvester, \& Oliveau, 1969; Boyd et al., 1990; Magee et al., 1996). Clinical psychologist can help improve the number of phobia sufferers to seek treatment. Advances in technology are helping clinicians create novel treatment strategies for different anxiety disorders. Virtual reality exposure therapy (VRET) may help these individuals confront their fears and treat their phobia.

While virtual reality exposure therapy has shown promise in research (Powers \& Emmelkamp, 2008), studies have shown that many users complain that the computer generated virtual reality (VR) stimuli looks unrealistic, eccentric and too much like a video game (Kwon, Powell, \& Chalmers, 2013). Virtual reality environments have been traditionally created by programmers using video game assets and computer generated imagery (CGI). While CGI can be used to make intricate virtual environments, unless there is a team of expert digital artists, the virtual stimulus may end up looking rudimentary and exhibit a number of graphical glitches which could prove distracting in therapy. Furthermore CGI often suffers from the uncanny valley effect: the tendency of CGI representations of people to be viewed as unsettling as the representations become more lifelike. In addition the many current CGI virtual reality packages are expensive and only available for limited number of fear domains. Recently however an exciting alternative to traditional computer generated virtual reality has emerged: ortho-stereoscopic 3D Video VR. Ortho-stereoscopic 3D refers to 3D videos that are designed to mimic the natural depth we normally see, as opposed to exaggerating it (i.e. Commercial 3D movies). The benefit of 3D VR as opposed to CGI VR is that it is photo realistic, does not suffer from a uncanny valley effect of CGI, and is able to capture nuances of real life fears that are hard to reproduce with CGI.

Eligibility Criteria:
Inclusion Criteria:

* • Between the ages of 18 and 65

  * At least one standard deviation above the SONA pool mean on Fear of Spiders Questionnaire or Acrophobia Questionnaire.

Exclusion Criteria:

* • Hearing or visually impaired where they cannot use the VRET gear

  * Currently (or in the last 3 months) receiving exposure-based treatment for acrophobia or arachnophobia
Phase 2 Clinical Trial to Evaluate OC-01 Nasal Spray in Subjects With Neurotrophic Keratopathy

The objective of this study is to evaluate the safety and effectiveness of OC-01 (varenicline) nasal spray as compared to placebo nasal spray for mean change from baseline in corneal fluorescein staining in subjects with Stage 1 (corneal epithelial hyperplasia/punctate keratopathy) neurotrophic keratopathy (NK) in one or both eyes.

Protocol OPP-102 is a Phase 2, multicenter, randomized, controlled, double- masked study designed to evaluate the safety and efficacy of OC-01 (varenicline) nasal spray in subjects with NK. Approximately 100 subjects at least 18 years of age with a physicians' diagnosis of Stage 1 NK as defined by the Mackie Criteria and meeting all other study eligibility criteria will be randomized 1:1 and will receive OC-01 (varenicline)/ nasal spray or placebo nasal spray for 8 weeks three times daily (TID) as follows:

* OC-01 (varenicline) nasal spray, 1.2 mg/mL
* Placebo (vehicle control) nasal spray All doses will be delivered as a 50 microliter (µL) nasal spray.

Eligibility Criteria:
Inclusion Criteria:

1. Be at least 18 years of age at Visit 1.
2. Patients with Stage 1 (corneal epithelial hyperplasia/punctate keratopathy) NK in one or both eyes, as defined by the Mackie Criteria.
3. Evidence of decreased corneal sensitivity (≤ 4 cm using the Cochet-Bonnet aesthesiometer) in at least 1 corneal quadrant.
4. Schirmer's test without anesthesia ≥3 mm/ 5 minutes in the affected eye.
5. If a female is of childbearing potential, they must: use an acceptable means of birth control (acceptable methods of contraception include hormonal - oral, implantable, injectable, or transdermal contraceptives, mechanical - spermicide in conjunction with a barrier such as a diaphragm or condom, IUD, or surgical sterilization of partner), and have a negative urine pregnancy test on Day 1.

Exclusion Criteria:

1. Have Stage 2 or Stage 3 NK affecting one or both eyes.
2. Have ocular graft versus host disease or Stevens-Johnson syndrome.
3. Have any active ocular infection (COVID-19 conjunctivitis, bacterial, viral, fungal, or protozoal) or active ocular inflammation not related to NK in the affected eye.
4. Be currently receiving autologous serum tears, amniotic membrane, cenegermin, fresh frozen plasma or cord blood derivative tears.
5. Have severe blepharitis and/or severe meibomian gland disease in the study eye.
Chemotherapy Plus Endostatin in Advanced Pancreatic Neuroendocrine Tumor

Temozolomide or dacarbazine-based chemotherapy combined with endostatin have efficacy in well-differentiated pancreatic neuroendocrine tumor


Eligibility Criteria:
Inclusion Criteria:

1. 18 years of age and older
2. ECOG ≤2
3. Pathologically confirmed locally advanced or metastatic well-differentiated pancreatic neuroendocrine tumor.
4. Prior treatment with one-line chemotherapy is allowed, with the exception of prior treatment with temozolomide or dacarbazine or endostatin within the past 6 months
5. Disease progressed during or after last therapy
6. Minimum of 4 weeks since any major surgery, completion of radiation, or completion of all prior systemic anticancer therapy
7. Disease progressed within the past 12 months。
8. Patients must have at least one measurable site of disease according to RECIST1.1 criteria that has not been previously irradiated.
9. Adequate bone marrow, liver and renal function
10. Life expectancy 3 months or more
11. Patient informed consent。

Exclusion Criteria:

1. Concurrent use of Octreotide or other drug that may have efficacy in neuroendocrine tumor.
2. 2 or more lines of prior chemotherapy。
3. Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study
4. Uncontrolled infectious disease。
5. Other malignancies within the past 5 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinoma of the skin
6. Uncontrolled brain or leptomeningeal metastases
7. Patients with known hypersensitivity to temozolomide or endostatin。
8. Patient could not take tablets。
Evaluation of the Electronic Cigarette Withdrawal Syndrome

The goal of this project is to rigorously evaluate the nature of e-cigarette withdrawal in exclusive e-cigarette users during a monitored abstinence period and the role of nicotine in the expression of this withdrawal syndrome.

This project will use a rigorous residential laboratory design to evaluate e-cigarette withdrawal expression and experimentally determine the role of nicotine in this syndrome. Healthy adults who exclusively use e-cigarettes will undergo monitored e-cigarette abstinence over seven days (1 week) in a residential unit. The investigators will evaluate the contribution of nicotine to withdrawal expression by assigning participants to one of three conditions: active nicotine patch, placebo patch control, or no patch to control for expectancies. Standardized behavioral and biological measures associated with withdrawal including patient report, cognitive task performance, and biometrics will be collected throughout to establish a rigorous timecourse of withdrawal and evaluate the contribution of nicotine to these symptoms.

Eligibility Criteria:
Inclusion criteria:

1. 21-55 years old
2. good general health as reviewed by study medical team
3. vital signs in normal range as reviewed by study medical team
4. negative urine test for illicit drug use (excluding THC) and negative breath alcohol test
5. daily use of a nicotine-containing e-cigarette for at least 6 months
6. no regular use of other tobacco products (e.g., smokeless products) for at least 6 months
7. urine cotinine \>100ng/mL (i.e., recommended cutoff for confirming current nicotine use)
8. exhaled breath carbon monoxide (CO) \<6ppm
9. Penn State E-cigarette Dependence (PSED) score \>=4, indicating mild dependence or greater
10. have an interest in reducing e-cigarette use

Exclusion criteria:

1. psychoactive drug use (aside from cannabis, nicotine, alcohol, caffeine) in past month
2. current use of over-the-counter (OTC) or prescription medications that may impact safety
3. use cannabis \>2 times per week
4. history of or current significant medical condition that would impact participation or safety according to the study investigators and medical staff
5. current psychiatric condition or substance use disorder (aside from tobacco use disorder) that would impact participation or safety according to the study investigators and medical staff
6. enrollment in another trial
7. positive pregnancy test
8. currently using a nicotine/tobacco cessation product
9. seizure disorder or traumatic brain injury (TBI)
Organization of the Cingulate Cortex

Efficient evaluation and monitoring of actions and outcomes are a key feature of primates' efficient adaptive cognition. Deficits in evaluating one's own actions and their consequences is a key feature of prominent disorders such as obsessive compulsive disorders (OCD), schizophrenia, and anxiety. The Investigators know that these evaluative processes implicate medial structures of the brain that are related both to old limbic functions and to more recently evolved higher executive functions. Brain potentials related to performance monitoring have attracted a lot of interest in cognitive neuroscience but also in the clinical domain because they appear to be altered in different neurological or psychiatric disorders, such as schizophrenia, OCD, or anxiety, and could become biomarkers of pathologies. But the neural sources of these markers are not fully determined and are currently highly debated. In addition, our work suggests that non pathological factors, such as normal morphological cortical variations, could affect those markers. Understanding performance monitoring, acting directly on medial cortex, or using electrophysiological markers in clinic are thus currently problematic and challenging. This is mostly because structure-function relationships in the medial wall are ill defined for historical, conceptual, and methodological reasons. Importantly, although individual variability of brain morphology impedes precise assessment of structure function relationships, this variability is almost never taken into account. EEG-Feedback aims to resolve these issues by evaluating the consequences of individual variability in cingulate cortex morphology on 1) surface EEG markers of feedback monitoring and 2) functional connectivity patterns thanks to resting-state fMRI.


Eligibility Criteria:
Inclusion Criteria:

* being able to provide a writen consent form
* having a social insurance
* have a normal vision (with or without corrections)
* Right-handed

Exclusion Criteria:

* Subjects with MRI contraindications (e.g. pacemaker, claustrophobia, metal in the body, etc...).
* Subjects must be willing to be advise in case of discovery of brain abnormality.
* No history of known neurological or psychiatric illness
* Pregnant or nursing women
* Persons under guardianship, curatorship or any other administrative or judicial measure of deprivation of rights or liberty, as well as legal persons protected by law
An Effectiveness Study of Paromomycin IM Injection (PMIM) for the Treatment of Visceral Leishmaniasis (VL) in Bangladesh

The purpose of this study is to evaluate the effectiveness of treatment with PMIM in patients with visceral leishmaniasis within the VL-endemic region of Bangladesh at EOT (21/22 days after treatment begins), and at 6 months after end of treatment (Day 202/203, -15 to +30 days).

Safe, effective and affordable treatments for visceral leishmaniasis (VL) that are widely available to the poorest populations are urgently needed in Bangladesh in areas where the disease is endemic. Paromomycin IM Injection (PMIM) was approved for the treatment of VL in August 2006 by the Drugs Controller General of India (DCGI), and it offers an attractive alternative to treatments that are currently available.

Eligibility Criteria:
Inclusion Criteria:

1. Signs and symptoms of VL including:

   * History of intermittent fever for at least two weeks
   * History of weight loss and/or decrease in appetite
   * Enlarged spleen
2. VL serologically confirmed using the rK39 test:
3. Willingness / ability to understand and provide informed consent prior to participation in this study:
4. Age ≥ five years and ≤ 55 years, and weighing at least five kg
5. Adequately hydrated as assessed by clinical criteria and able to maintain adequate hydration on an outpatient basis through oral intake of fluids
6. Clinically stable and appropriate for treatment with PMIM as an outpatient, if possible (subjects may be hospitalized to receive 21-day dosing at the discretion of the investigator)
7. Living in the VL-endemic areas in Bangladesh

Exclusion Criteria:

1. Active tuberculosis or taking anti-tuberculosis medications
2. Previous treatment with Paromomycin IM Injection (PMIM)
3. Clinically significant severe anemia as determined by the investigator
4. Clinically significant renal or hepatic dysfunction as determined by the investigator, or history of clinically significant renal or hepatic dysfunction
5. History of Hepatitis B or C; or known HIV positive
6. History of hearing loss
7. Other serious illness or medical condition that, in the opinion of the doctor, would interfere with the patient's ability to receive PMIM treatment or comply with the study procedures, or that could obscure toxicity of or response to PMIM
8. Major surgery within 30 days prior to first dose of PMIM
9. History of hypersensitivity to aminoglycosides or to any of the components of PMIM, including sulfite
10. Any history of VL or treatment of VL at any time
11. Patients who have received any investigational (unlicensed) drug within the last six months
12. Concomitant use of other aminoglycosides (e.g., gentamicin, tobramycin, amikacin), nephrotoxic and ototoxic drugs, or immunosuppressive drugs
13. Proteinuria (results \> 1+ ) on urine dipstick analysis at screening visit and/or
14. Serum creatinine above the upper limit of normal (ie, serum creatinine \>1.1 mg/dl in males and \>0.9 mg/dl in females
15. Pregnant or lactating women
A Novel Lung Function Imaging Modality As a Preoperative Evaluation Tool (LIME)

To evaluate the correlation between pre-surgical 4DCT-ventilation imaging and post-surgical lung function.

To evaluate the correlation between pre-surgical 4-Dimensional Computed Tomography-ventilation (4DCT-ventilation) imaging and post-surgical lung function. To determine whether 4DCT-ventilation is a better predictor of post-surgical lung function than nuclear medicine imaging using pulmonary function tests (PFTs). To determine whether 4DCT-ventilation is a better predictor of post-surgical lung function than nuclear medicine imaging using quality of life (QOL) questionnaires. Evaluate cost-effectiveness of using 4DCT-ventialtion and VQ scans for pre-surgical assessment. To use longitudinal (pre and post-surgical) 4DCT-ventilation imaging to derive novel post-surgical prediction formulas.

Eligibility Criteria:
Inclusion Criteria:

1. Provision to sign and date the consent form.
2. Stated willingness to comply with all required (non-optional) study procedures and be available for the duration of the study.
3. Be a male or female aged 18 to 100.
4. Patient with lung cancer (presumed or biopsy proven) currently undergoing or having undergone evaluation for resection.
5. Lung function assessment required for pre-surgical evaluation at the discretion of the cardiothoracic surgeon.
6. Life expectancy greater than 3 months.

Exclusion Criteria:

1. Patients getting a planned wedge resection as the only thoracic resectional procedure.
Thin Prep Versus Traditional Cytological Procedure for Lung Cancer

In the diagnosis of lung cancer, the cytological sample obtained during Bronchoscopy (FBS), has an increasingly important role in the characterization of malignancy. The cytological sample can be harvested during bronchoscopy by bronchial brushing, bronchial lavages or fine needle aspiration. Immunocytochemical staining allows not only to discriminate between small cell lung cancer versus non-small cell lung cancer (NSCLC), but also to identify the expression of specific markers such as TTF-1, CK7, CK20, 4A4, 34βE12 and p63. Thin Prep is a technique for cytological assay already validated and largely used in the immunocytochemical determination of gynaecologic specimens. Further Studies are required to asses the accuracy of this technique compared to conventional smear in cytological airway samples obtained by fine needle aspiration.

Patients undergoing FBS for lung cancer diagnosis purpose will be enrolled in the study. During FBS Fine Need Aspiration (FNA) will be performed. Four samplings by FNA will be performed in each patient. Two samplings will be processed with thin prep technique and two samplings with the traditional procedure. To avoid sampling procedures-related bias, the first harvested sample will be randomly tested with Thin Prep or Traditional technique.

Eligibility Criteria:
Inclusion Criteria:

* FBS undergoing bronchoscopy for diagnostic purpose of lung cancer.
* Informed consent.
* ASA Classification 1-3.

Exclusion Criteria:

* Patients intubated.
* Patients with respiratory failure.
Focusing on the Maryam's Flower During the Birth

To determine the Effect of Focusing on the Virgin Mary Flower during the Birth Process on Labor Pain, Labor Duration and Perceived Fatigue in Birth.

Method: The study will be completed in a randomized controlled manner with a total of 126 primiparous pregnant women, 63 in the experimental group and 63 in the control group. Pregnant women in the experimental group will focus on the Virgin Mary flower in the water-filled jar and imagine that their uterus and birth path are opening like the branches of the Virgin Mary flower that blooms as labor pains come. There will be no intervention in the control group other than routine midwifery care. Research data will be collected with the Pregnant Introduction and Birth Process Follow-up Form, Visual Analog Scale, and Visual Similarity Scale for Fatigue.

Design and Settings: This randomized controlled experimental study will conducted in the delivery room of the, Turkey between the dates of November 2023 and April 2024

Eligibility Criteria:
Inclusion Criteria:

* Being 18 years or older,
* being in 37-42 weeks of pregnancy,
* being primiparous,
* having a single healthy fetus,
* cervical dilatation not more than 3 cm.the one which,
* in the first stage of labor,
* Does not have any complications preventing vaginal birth,
* volunteer women who do not have disabilities in communication and perception

Exclusion Criteria:

* maternal and fetal complications
* pregnant with assisted reproductive techniques,
* having a presentation anomaly,
* having a twin pregnancy,
* electing cesarean section,
* Women whose cervical dilatation exceeds 3 cm and who are not willing to participate in the study
Taxonomy of Neurorehabilitation Treatments and Outcome Measures: a Multicentre Italian Study

The main aims of the observational study are to taxonomize the contents of rehabilitation understanding goals and treatments provided to people with Parkinson Disease(PD) and Multiple Sclerosis(MS) and Stroke and their impact on the outcomes

In recent years, neurological rehabilitation focused on evaluating patient's problems, with no rationalization of therapeutic interventions. Few researches investigated the contribution of the components of a neurorehabilitation program to the clinical outcome in everyday clinical practice. Moreover, there is no a standard method to categorize rehabilitative interventions, making difficult to explain why subjects improve and which of the various treatments is more effective. Thus, it was decided to build a multicentre network to collect data using a taxonomy tool developed to provide information on the goals of rehabilitation and to categorize rehabilitation interventions

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Multiple Sclerosis
* Diagnosis of Parkinson Disease
* Diagnosis of Stroke
* Participants' rehabilitation program must include at least 10 sessions of physical therapy.

Exclusion Criteria:

- Unable to understand the aim of the study or unable to sign the informed consent form;