cyrilzakka/clinical-trials huggingface dataset:
SHR-A1904 Compared With Investigator's Choice of Therapy in Claudin18.2 Positive Patitens With Second-line Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

The study evaluated the overall survival (OS) of SHR-A1904 versus investigator-selected treatment in second-line CLDN18.2-positive advanced GC/GEJC patients


Eligibility Criteria:
Inclusion Criteria:

1. Age 18 to 75 years old (including boundary values)
2. Volunteer to participate in this clinical study and sign informed consent;
3. ECOG score 0-1;
4. Expected survival ≥3 months;
5. Gastric or Gastroesophageal Junction Adenocarcinoma;
6. positive CLDN18.2 expression in tumor tissue;
7. There is at least one measurable or evaluable lesion that meets the RECIST 1.1 criteria;
8. Adequate bone marrow and organ function.

Exclusion Criteria:

1. Received anti-tumor therapies such as chemotherapy, radiotherapy, biological therapy, targeted therapy, or immunotherapy within 4 weeks before the first dose of the study
2. HER2 posotive (IHC 3+ or IHC 2+/ISH +);
3. Toxicities caused by previous anticancer therapy were not recovered to CTCAE 5.0 Grade≤1;
4. Individuals with Leptomeningeal metastasis or Active brain metastases;
5. Individuals with a history of GI perforation or fistula, unstable GI bleeding;
6. Individuals with a history of severe cardiovascular and cerebrovascular diseases;
7. The researcher determined that there are other situations that are not suitable for participation.
Comparison of White Light, PDD and NBI in Detection of Flat Dysplasia and CIS at TURB - a Study of Trimodality

All patients planned for PDD guided TURB can be included in this study. Two different optics with PDD and NBI are applied to the resectoscope in addition to regular WL.

First, a WL cystoscopy is made and any suspect areas are noted on the registration form, then NBI is used and any suspect areas are noted and finally the cystoscopy is made with PDD with registration of any additional findings. To adjust for bias introduced by photo bleaching, the second part of the study will be performed with PDD as the second modality. Any flat lesions will be biopsied if they appear suspicious in one of the modalities.

The registration form is completed by the surgeon, once the pathology results are known.

A total number of 152 patients is planned to be included.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing PDD according to the Danish guidelines

Exclusion Criteria:

* Patients not fulfilling the inclusion criteria
Four Week Safety and Efficacy Study With a Topical Gel to Treat Common Warts in Adults

The primary purpose of this study is to evaluate the effectiveness in adults, of four different strengths of resiquimod gel applied to common wart(s) three times a week for four weeks.

A second purpose is to evaluate the safety of the drug.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of common warts
* Two forms of birth control

Exclusion Criteria:

* Pregnant or breast feeding
* Other types of warts, ie. plantar
* Currently participating in another clinical study
* Chronic viral hepatitis B or C
Feasibility of Preoperative Inspiratory Muscle Training for Patients With Peritoneal Metastases

The goal of this randomized controlled feasibility study was to evaluate the feasibility of preoperative inspiratory muscle training in patients undergoing surgery because of peritoneal metastases.

The main questions it aimed to answer was how feasible the intervention is regarding process and scientific feasibility as defined by Thabane et al 2010.

Participants in the intervention group were using a handheld device to increase their inspiratory muscle strength prior to surgery and researchers compared this group to a control group who were offered a sham treatment.


Eligibility Criteria:
Inclusion Criteria:

* Scheduled for cytoreductive surgery and hyperthermic intraperitoneal chemotherapy

Exclusion Criteria:

* Surgery scheduled less than two weeks from the date of inclusion
* Inability to speak and understand Swedish
Impact of Preterm Single Donor Milk in Very Low Birth Weight Infants

Human milk is the best source of enteral nutrition for the preterm infant. However during the infants first hours and days of life breastmilk from the own mother is usually not available. Until May 2012 the practice in the Neonatal Division of the Department of Pediatrics /Medical University Vienna was to start with formula feedings within the first 6 hours of life of a premature infant and switch over to breastmilk as soon it was available. In June 2012 the investigators changed this feeding regimen and started to use single donor milk of mothers of preterm infants for the first hours and days of the preterm infants life. In a prospective observational study the investigators evaluated the impact of single donor milk from preterm infants on time to full enteral feedings, gastrointestinal tolerance and NEC incidence in preterm infants with a birthweight below 1500 grams and a gestational below 32 weeks. Data will be compared with a historical control group starting with preterm formula as source of enteral nutrition. The investigators hypothesize that starting enteral nutrition with single donor milk of mothers from preterm infants with shorten time to full enteral feedings.


Eligibility Criteria:
Inclusion Criteria:

* very low birth weight infants with a birthweight \<1500g
* Gestational Age \<32 weeks
* Informed consent

Exclusion Criteria:

* major congenital malformations
* systemic metabolic diseases
* short bowl syndrome
* gastrointestinal abnormalities
* when preterm infant was transferred or discharged
Infant Glidescope® Learning Curve

A prospective trial evaluating the learning curve associated with the use of a videolaryngoscope compared to conventional direct laryngoscopy in infants intubated by anesthesiology residents. Hypothesis: The learning curves of both instruments are equivalent.


Eligibility Criteria:
Inclusion Criteria:

* infants under 10 kg undergoing general anesthesia and requiring tracheal intubation

Exclusion Criteria:

* Difficult airway, severe cardiorespiratory disease, emergency surgery
Identification of Biomarkers in Cervical Mucus

Cervical mucus is a biological fluid secreted by the endocervical glandular epithelium whose quantitative and qualitative characteristics vary in response to the hormonal stimulus produced by the ovary during the woman's menstrual cycle. As a fertility factor, it performs numerous biological functions: transport, nourishment, defense and capacitation of spermatozoa, defense against pathogens of the female genital tract.

The aim of this research will be to deepen the knowledge of the biochemical characteristics of cervical mucus, in particular to perform characterization by infrared spectroscopy, for the identification of diagnostic, prognostic and predictive biomarkers for disorders affecting the female reproductive system.

A healthy control population and a cohort of patients affected by unexplained infertility will be enrolled for the longitudinal study of the menstrual cycle with ultrasound and hormonal monitoring and serial sampling of cervical mucus.


Eligibility Criteria:
Inclusion Criteria:

* HEALTHY CONTROL

  * Women of 18-45 years old,
  * Use of the Billings Ovulation Method® for at least three months in the last three years
  * Proven fertility
* STUDY COHORT

  * Women of 18-45 years old,
  * Women affected by unexplained infertility

Exclusion Criteria:

* Virgo women
* Women incapable of understanding and wanting
* Women who have had sexual intercourse in the two days prior to cervical mucus sampling
* Pregnancy, exclusive breastfeeding
* Amenorrhea
* Gynecological hormone ongoing therapies or suspended for less than three months
* Cervico -vaginal infections
* Psychiatric pathologies
* Untreated/decompensated endocrine-metabolic disorders
* Coagulopathies and renal pathologies under dialysis treatment
* Refusal of informed consent
* Previous, current or suspected oncological pathology
My Team of Care: a Pilot Randomized Controlled Trial of an Online Communication Tool for Collaborative Care

This project will pilot and test a new online communication tool, Loop, developed within a research framework with participatory and user-centred design. This pilot trial focuses on advanced cancer as an example of complex care. Cancer care involves many healthcare providers, spanning hospital to home. There is no organized way for them to communicate. Loop is a practical tool for ongoing collaboration in the patient's actual team of care that engages patients. The study will answer the questions: does Loop improve communication efficiency, engage patients and family physicians, and show early benefits in quality and health care costs?


Eligibility Criteria:
Inclusion Criteria:

1. Patients with Stage IV cancer, or Patients with stage III cancer and poor prognosis as determined by a physician (\>3 months but \<2 years)
2. Eastern Cooperative Oncology Group (ECOG) performance status score ≤2
3. Each patient must have at least two healthcare providers, including an attending oncologist or palliative care physician
4. Patient and, if applicable, family caregiver must be ≥18 years of age
5. Literacy and language capacity and competency to provide informed consent
6. Patient or caregiver must have access to a computer and the internet

Exclusion Criteria:

1. Patients without the capacity to participate in use of the online tool, and do not have a caregiver who can engage in use of the tool on their behalf
2. Participants without the capacity to participate in evaluation of outcome measures, including, but not limited to, online and paper-based multiple-choice questions, checklists, and visual analogue scales, and do not have a family caregiver who can complete outcome measures
3. A potential candidate for or currently receiving hormone therapy for breast or prostate cancer
4. Patients with a prognosis of \<3 months as determined by attending physician
5. Patients with impaired mental status as previously assessed by a physician or judged by research staff using the Bedside Confusion Scale
6. It has been determined that the patient is participating in another study precluding them from taking part in this study, as determined by an agreed-upon algorithm, tracked and managed by study coordinators
Feasibility and Safety of Physical Exercise in Men With Prostate Cancer

Prostate cancer (PCa) is among the most widespread in the male population and represents 19% of all cancers diagnosed from the age of fifty, in Italy. Androgen deprivation therapy (ADT) and Radiotherapy (RT) are used for increase survival. However, both therapies are associated with significant side effects, such as fatigue, loss of muscle mass and strength, cognitive decline that together lead to an increase risk of accidental falls and fractures.

Guidelines for cancer survivors recommend Physical Exercise (PE) as a strategy to reduce several side effects of therapies. However, most people living with cancer do not meet current exercise recommendations.

Indeed, an effective PE program requires the application of long-term, moderate to high intensity activity. Thus it may be difficult to implement this type of recommendation in patient with PCa.

Therefore, this study aims to develop an experimental PE intervention testing their feasibility and safety and the patients' satisfaction, aimed at improving the health conditions of the patients with PCa receiving ADT and RT. Furthermore, long-term falls and fracture events will be monitored.

The non-randomized feasibility and pilot study aims to evaluate the feasibility and safety of a structured, multicomponent, supervised and unsupervised exercise program.

Secondary outcome will be evaluate the change in the health condition, in particular muscle strength, cognitive function, fatigue, balance, anxiety and depression level, and quality of life.

The PE program will be conducted at the "Virgilio Camparada" Municipal Athletic Track in the city of Reggio Emilia (IT). Patients will be participate in a supervised exercise program with three sessions per week, for eight weeks. Subsequently, the intervention will continue further for four weeks maintaining one supervised session and two unsupervised sessions a week. Finally, sessions will be performed without supervision for further eight weeks. The overall duration of the intervention will be twenty weeks. In addition, an evaluation will be performed at one year from baseline to monitor long-term fall and fracture events.

At baseline will be the following assessment:

- clinical and anthropometric data and the Six Minute Walking Test (6MWT) to determine the intensity of aerobic exercise.

Eligibility Criteria:
Inclusion Criteria:

* Histologically documented diagnosis of PCa;
* Undergo ADT and RT during the study period;
* At least 18 years old;
* Willing and able to give written informed consent;
* Able to read and understand Italian Language;

Exclusion Criteria:

* Musculoskeletal, cardiovascular, neurological or psychiatric disorders that contraindicate participation in an exercise program.
Effects of Transcutaneous Vagus Nerve Stimulation in Chronic Pain Patients and Healthy Controls

The tVNS-PP trial investigates the effects of transcutaneous vagus nerve stimulation (tVNS) on autonomic functions, immune responses, and disease severity in chronic pain and restless legs syndrome (RLS) patients as compared to healthy controls.

A pilot study with healthy participants will investigate whether transcutaneous vagus nerve stimulation at the inner tragus reduces heart rate variability and lowers blood pressure without causing undesirable, severe side effects. In addition, changes in immune markers will be analyzed in blood samples before and after the interventions. Patients with primary restless legs syndrome will undergo a similar experimental protocol, except that transcutaneous vagus nerve stimulation will be performed daily. The aim is to determine whether stimulation reduces disease severity and chronic pain while improving quality of life.

Eligibility Criteria:
Inclusion criteria:

* Male and female participants between 18 and 80 years old
* Written informed consent

Exclusion criteria:

* Age younger than 18 years or older than 80 years
* Participants with somatic or mental comorbidities, especially malignant tumor diseases, cardiac insufficiencies \> NYHA II, severe depressive episodes, psychosis or dementia
* Pregnancy or breast feeding
* Addictions to alcohol, medications or drugs (except tobacco)
* An existing legal guardianship
* Participation in another scientific study within the previous eight weeks before enrollment
* Restless Legs Syndrome patients with one of the following secondary predispositions: iron deficiency, polyneuropathy, prolapsed disk, spinal stenosis or chronic obstructive pulmonary disease
Impact of COVID19 Outbreak in Cardiac Acute Care

This registry will evaluate the impact of the COVID19 outbreak on Cardiac patients admitted in the Intensive Care Unit of the Pitie-Salpetriere Hospital in Paris, France

Registry on Characteristics and outcomes of Cardiac patients (COVID- and COVID+) hospitalized in the Intensive Care Unit of the Pitie-Salpetriere Hospital in Paris, France

Eligibility Criteria:
Inclusion Criteria:

* 18 years and older
* Admitted in the Cardiac Intensive Care Unit from March 20th 2020
* Patient informed and having expressed his non-opposition to participate in the research

Exclusion Criteria:

* Minor patient
* Patient who expressed opposition to participation in the study
Analysis T Cells Response for Identification of Aspergillus Bronchitis With Cystic Fibrosis Patients

The study aims to asses the ability of cell tests based on the analysis of the anti-Aspergillus cell responses and identify Aspergillus bronchitis with patients with cystic fibrosis.

In addition, the study will evaluate the contribution of biological classification of aspergillosis according to criteria recently proposed by Baxter et al. compared to the classification used in clinical practice in the hospital of Montpellier.


Eligibility Criteria:
Inclusion Criteria:

* Patient with cystic fibrosis followed at Resource Centers and Cystic Fibrosis Skills (CRCM) Montpellier
* Patient aged 15 or over
* Patient able to understand the nature, purpose and methodology of the study.
* Patient and his legal representative for minors who have given their free and informed consent
* Affiliate or beneficiary of a social security scheme.

Exclusion Criteria:

* Patients on antifungal treatment at the time of sampling
* Pregnant or breastfeeding
* Major protected by law (guardianship, curator or under Backup Justice)
* Inability to understand the nature and goals of the study and / or communication difficulties with the investigator
* Subject attending another search including a period of exclusion still going to run-in
Laser Therapy Versus Narrow Band Ultraviolet B for the Treatment of Acne Vulgaris

Forty-five participants with facial AV were assigned randomly to three groups of fifteen subjects each. Each group received various therapies. Group A (Study group A) had received both NBUB and akne-Mycin; Group B( study group B) had received Red LLLT and akne-Mycin and group C (Control group) received only akne-Mycin cream. All 45 participants are tested at the initial treatments, after 4 weeks and after 8 weeks by the acne count, the intensity scale and the photographic test.

Forty-five patient (18 male and 27 female) were recruited on a referral basis from the department of dermatology at Kasr Al- aini Teaching Hospital. Firstly, an interview was held with each participant to determine gender, age, skin type, acne severity and medical prescriptions,Randomization was performed by selecting numbers from opaque envelopes containing numbers that were chosen by a random number generator, selection was done by an independent person.

Patients in group (A) received a program of NBUB, ( DIXWELL EMLY 98 -ABRP 64 ,made in France) wavelength 311 to 313nm , in addition to topical aknemycin medications. Each treatment lasts one to eight minutes. The treatments were given three times a week. for 8 weeks.Participants in-group (B) received a program of R-LLLT that was conducted through laser equipment InGaAs (630 nm, 10 mW, continuous) (RIKTA, Russia) with fluence 12 J/cm2, two sessions per week for 8 weeks .Patients in the three groups were asked to apply topical erythromycin cream 2% (Akne-Mycin- Egypt) two times per day on the entire face from the beginning to the end of the treatment period .Evaluation was based on formal counts of active lesions (papule and pustule).facial photographs using a digital camera (PANASONIC, Tokyo, Japan). and Five-point scale of investigators assessment that reflect lesion count improved percentage.

Eligibility Criteria:
Inclusion Criteria:

* Ages ranged from 18-35 years.
* Skin type III and IV.
* Mild to moderate facial acne.

Exclusion Criteria:

* Treatment with oral retinoid within past 1 year.
* Treatment with other acne treatment within past 3 months.
* History of treatment with systemic and topical antibiotics for acne vulgaris within the last 1 month.
* Treatment with oral isotretinoin within the last 6 months.
* Participants received radiotherapy or chemotherapy.
* Any history of photosensitivity.
* Chemical peels during the previous 4 weeks.
* Seizures,
* Pregnancy
* Use of oral contraceptives.
* Breastfeeding .
A Integrated Study in Pediatric Patients with Cardiomyopathy

This observational study aims to manage children with cardiomyopathy in the long term. It collects baseline data, laboratory test data, and medical imaging data during the hospitalization and follow-up.

During their disease progress, participants will undergo cardiovascular magnetic resonance, echocardiography, electrocardiography, laboratory tests, and when hospitalization and follow-up, and the baseline data will be collected in the admission. All the above examination data will be analysed to assess the clinical characteristics, current status of diagnosis and treatment, and the prognostic risk factors for children with cardiomyopathy.


Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients diagnosed with cardiomyopathy.

Exclusion Criteria:

* a history of cardiovascular disease ( such as congenital heart disease, cardiomyopathy, rheumatic heart disease, valvular disease ).
* Mentally abnormal.
* Poor compliance.
* Heart, kidney and other important organs were seriously incomplete.
The Therapeutic Efficacy of Neurofeedback in Depression

The investigators examined the therapeutic efficacy of neurofeedback in depression subjects. The investigators hypothesize that 5 weeks neurofeedback training will be able to alleviate depressive symptoms.

Subject

* Fulfilled DSM-IV criteria for depressive disorders.
* Persons who had organic disorders were excluded.
* Who had been treated by psychoactive drugs for at least 2 months prior to the study were excluded.

Design

* Subjects were randomly assigned to two groups (EEG biofeedback /psychotherapy placebo) by block randomization.
* EEG biofeedback training was provided for 5 weeks(10 sessions, twice per week). Each training session was composed of 6 four minute trials followed by 5 thirty second rest periods
* Psychotherapy placebo session was provided for 5 weeks. These sessions consisted of additional assessment, interpretation of the test results and providing information on course and treatment of mood disorder.
* After subjects completed the training, they participated in a month-long (twice per week) self-training session to maintain a similar mental state during neurofeedback training sessions without feedback system's assistance.
* Subjects who had finished the psychotherapy placebo were referred to other therapists as necessary.

Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of mood disorder
* right handed
* current BDI-2 score exceed 10

Exclusion Criteria:

* with psychotic symptom
* with organic disorders
* treated by psychoactive drugs for at least 2 months prior to the study
* history of pathologic alcohol use
300 Antibody Diagnostic Test Kit

For the development of a Point of Care IVD test kit for acute phase disease detection against a variety of bacterial and viral infections. Phase one includes 100 clinical diagnosed positive and 200 clinically "normal" serum and whole blood matched specimens for specificity and sensitivity determination for each marker. The positive samples must be IgM positive using any FDA cleared ELISA test kit. The negatives samples must be negative for IgM.


Eligibility Criteria:
Inclusion Criteria:

* current acute infection
* age 18-70
* male or female
* any race
* currently active symptoms
The Role of Thyroid Function in the Development and Prognosis of Stanford Type A Aortic Dissection.

A total of 300 consecutive cardiac patients will receive preoperative thyroid function profile evaluation, including 150 patients with Standford type A aortic dissection (STAAD) and 150 normal human.For one thing, we will compare the two groups and study the role of thyroid function in the develoment of STAAD. For another, we will collect all the perioperative data of the STAAD group and study the role of thyroid function in the prognosis of STAAD.


Eligibility Criteria:
Inclusion Criteria:

Adult patients with STAAD will underwent aortic surgery who are willing and able to give informed consent for participation in the study.

Exclusion Criteria:

The main initial exclusion criteria included clinical evidence of sepsis or cachexia or concomitant presence of any predominant severe systemic disease.