cyrilzakka/clinical-trials huggingface dataset:
A Study of Adebrelimab Combined With Famitinib and Chemotherapy in the Treatment of ES-SCLC.

This is a single arm, multi-center, phase II trial to evaluate the efficacy, and safety of adebrelimab combined with famitinib and chemotherapy for the treatment of first-line extensive stage small cell lung cancer.

This study plans to recruit 40 patients with extensive-stage small cell lung disease who have not received treatment, observe and evaluate the effectiveness and safety of adebrelimab combined with famitinib and chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

1. Age: 18-80 years old, male or female
2. Patients with pathologically confirmed extensive stage small cell lung cancer (according to the Veterans Administration Lung Study Group, VALG staging)
3. Never received prior systemic therapy for extensive stage small cell lung cancer
4. Have a measurable tumour target lesion (meeting RECIST 1.1 criteria)
5. Expected survival \> 3 months
6. ECOG PS: 0-1 points
7. Normal function of major organs
8. Women of childbearing potential must undergo a negative pregnancy test (βHCG) prior to initiation of treatment, and women of childbearing potential and men (who are sexually active with women of childbearing potential) must agree to use effective contraception uninterruptedly for the duration of the treatment period and for 6 months after the administration of the last therapeutic dose
9. Patients voluntarily enrolled in this study by signing an informed consent form

Exclusion Criteria:

1. Previous or concurrent other malignant tumours within 5 years, except cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, superficial or non-invasive bladder cancer
2. Active tuberculosis infection, or a history of previous tuberculosis infection
3. Uncontrolled, symptomatic brain metastases that are not effectively controlled or a history of psychiatric illness that cannot be easily controlled or severe intellectual or cognitive dysfunction
4. Subjects with active, known or suspected autoimmune disease, hypothyroidism requiring only hormone replacement therapy, skin disorders not requiring systemic therapy (e.g., vitiligo, psoriasis, or alopecia areata) may be eligible for enrolment
5. Uncontrollable pleural effusion, pericardial effusion or ascites requiring repeated drainage
6. Subjects with the presence of any severe and/or uncontrolled disease
7. Imaging showing tumour invasion of large vessels or poor demarcation from large vessels
8. Susceptibility to bleeding, risk of hemoptysis, and history of significant coagulation disorders
9. History of psychotropic substance abuse, alcoholism or drug addiction
10. Active hepatitis (Hepatitis B reference: HBsAg positive with HBV DNA test value exceeding the upper limit of normal value Hepatitis C reference HCV antibody positive with HCV viral titre test value exceeding the upper limit of normal value)
11. Human immunodeficiency virus (HIV, HIV 1/2 antibody) positive
12. Patients who are unable to comply with the trial protocol or who are unable to cooperate with follow-up visits
13. Patients who, in the opinion of the investigator, should not be enrolled in the trial
Reduced Immunosuppressive Therapy With or Without Donor White Blood Cells in Treating Patients With Lymphoproliferative Disease After Organ Transplantation

RATIONALE: Some types of lymphoproliferative disease are associated with Epstein-Barr virus. Combining reduced immunosuppressive therapy with donor white blood cells that have been treated in the laboratory to kill cells infected with Epstein-Barr virus may be an effective treatment for lymphoproliferative disease.

PURPOSE: Randomized phase III trial to compare the effectiveness of reducing immunosuppressive therapy with or without donor white blood cells in treating patients who have Epstein-Barr virus-associated lymphoproliferative disease after organ transplantation.

OBJECTIVES:

* Determine the efficacy of treatment with partially HLA-matched allogeneic cytotoxic T cells and reduction of immunosuppression, in terms of survival rate and time to remission in patients with Epstein-Barr virus-associated B-cell lymphoproliferative disease after solid organ transplantation.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to transplanted organ type and transplant center. Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients undergo sliding-scale reduction of immunosuppressive drugs from 1 of 5 regimens at physician's discretion. Patients then receive partially HLA-matched allogeneic cytotoxic T cells IV over 5 minutes once weekly for a total of 4 weeks.
* Arm II: Patients undergo reduction of immunosuppression as in arm I alone. Patients are followed monthly for 6 months and then every 3 months for 2 years.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of post-transplant lymphoproliferative disease (PTLD) after solid organ (heart, heart/lung, liver, liver/gut, pancreas, or kidney) transplantation

  * Epstein-Barr virus-positive tumor
  * Newly diagnosed disease
* Measurable disease by clinical methods or radiography
* Must have partially matched donor cytotoxic T cells (CTL) available
* No known panel reactivity to any of the HLA types of CTL available for therapy

PATIENT CHARACTERISTICS:

Age:

* Any age

Performance status:

* Karnofsky 20-100%

Life expectancy:

* Not specified

Hematopoietic:

* Not specified

Hepatic:

* Not specified

Renal:

* Not specified

Other:

* Not pregnant

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* Not specified

Endocrine therapy:

* Not specified

Radiotherapy:

* Not specified

Surgery:

* Not specified

Other:

* No prior therapy for PTLD
* No concurrent antiviral drugs (e.g., acyclovir or ganciclovir) for PTLD
Single-incision Sling vs Urethral Bulking During Prolapse Surgery for Occult Stress Incontinence

The aim is to compare outcomes of two different procedures to prevent occult stress urinary incontinence (SUI) in patients who are having pelvic organ prolapse surgeries

The aim is to compare outcomes of two different procedures to prevent occult stress urinary incontinence (SUI) in patients who are having pelvic organ prolapse surgeries. Charts will be reviewed for patients who had single- incision sling or urethral bulking injection with other prolapse surgeries to address occult stress incontinence at The Christ Hospital from the period of January 2019 to June 2021. Patients who didn't have any occult stress incontinence pre-operatively and didn't receive any anti-incontinence procedure during their prolapse surgery will be included as a control group. Surgical details, adverse events and postoperative voiding times will be collected from the chart. Patients will be contacted by a telephone to administer a validated questionnaire; a 3-day bladder diary to quantify urinary incontinence will be send to the patient to complete and return by mail.

The purpose of the study is to investigate whether urethral bulking is as effective as single- incision sling in treating occult stress incontinence.

Eligibility Criteria:
Inclusion Criteria:

* -Females who are 18 years or old who were scheduled to either urethral bulking (Bulkamid) or single-incision sling (Altis sling) to address occult SUI with prolapse surgery. All patients reported no history of SUI preoperatively and during office physical exam, positive SUI was demonstrated during prolapse reduction.
* Females who are 18 years or old who didn't have occult stress incontinence before their prolapse surgery and didn't receive any stress incontinence surgery during their prolapse surgery during the same period will be included as a control group.
* English speaking patients.

Exclusion Criteria:

* Patients who had either single-incision sling or urethral bulking with documented preoperative history of stress incontinence. Patients with a history of previous surgery for SUI.
Lactose-free Milk in Infants With Acute Diarrhea in a Developing Country

The purpose of this study is to determine whether lactose-free milk will shorten the diarrhea duration and decrease its severity in formula-fed infants presenting to the Emergency Department (ED) or pediatric clinics with acute diarrhea.

Acute gastroenteritis is a major cause of pediatric morbidity and mortality accounting for 15 % of all childhood death worldwide, and is a major public health burden, especially in developing countries. A recent Cochrane review of 33 randomized or quasi-randomized trials reported a modest reduction in the duration of diarrhea in children younger than 5 years who were on reduced or lactose-free diet. Those trials however were conducted on inpatients in high or middle-income countries. None were from developing countries where diarrheal diseases are severer and result in higher morbidities and mortalities. This study aims at investigating the effect of lactose-free milk on the duration and severity of diarrhea in infants from a developing country, who present with acute gastroenteritis to the Emergency Department (ED) or pediatric clinics. The findings from this study will help provide evidence-based dietary recommendations for infants with acute diarrhea in developing countries who are treated in the ambulatory setting.

Eligibility Criteria:
Inclusion Criteria:

* Infants on artificial milk formula
* Presenting to the ED or pediatric clinics of the American University of Beirut Medical Center
* Chief complaint: acute gastroenteritis (three or more loose or liquid stools in 24 hours, for at least 24 hours, and not exceeding 2 weeks from presentation, with or without fever, vomiting, mucus or blood per stools).

Exclusion Criteria:

* Exclusively or partially breast-fed infants
* Severe dehydration requiring hospitalization
The Different Effectiveness of Single Acupoint（PC6 or CV12) vs Matching Acupoints(PC6 and CV12) in Chemotherapy-induced Nausea and Vomiting

The purpose of this study is to clarify whether the matching acupoints are more effective than a single point by electro-acupuncture in the management of chemotherapy-induced nausea and vomiting .


Eligibility Criteria:
Inclusion Criteria:

1. Be diagnosed as cancer and need to accept chemotherapy.
2. The score of Karnofsky ≥70
3. Patients of either gender and older than 18 years
4. Patients receiving chemotherapy both outpatients and inpatients
5. Patients receiving chemotherapy either the first or multiple cycle, but the patient will be taken in only one time
6. To receive chemotherapy containing cisplatin(DDP≥75mg/m2) or joint chemotherapy programmes of Anthracyclines(Adriamycin≥40mg/m2 or epirubicin≥60mg/m2)
7. Life expectancy≥ 6 months
8. Willing to participate in the study and be randomized into one of the four study groups.

Exclusion Criteria:

1. To receive radiotherapy and chemotherapy
2. Gastrointestinal tumors
3. Patients with serious liver disease or abnormal hepatorenal function (AST,ACT, and TBIL are 3 times more than normal, BUN and Cr are 2 times more than normal)
4. Presence of cardiac pacemaker
5. Active skin infection
6. Nausea and/or vomiting resulting from opioids or metabolic imbalance (electrolyte disturbances)
7. Patients unable to provide self-care or communication
8. Nausea and/or vomiting resulting from mechanical risk factors (i.e., intestinal obstruction)
9. Brain metastases
10. Women in pregnant and lactating period
Determination of Carboplatin's Optimal Plasmatic Exposure

To determine Carboplatin's optimal exposures(optimal AUCs)and parameters they depend on.


Eligibility Criteria:
Inclusion Criteria:

* Carcinoma histologically proved and which must be treated by Carboplatin, excepted weekly administered Carboplatin treatments
* Age \> 18 years
* Neutrophils \> 1500/mm3, blood-platelets \> 100000/mm3
* Patient with intravenous administration route for chemotherapy independent of the one used for blood samples ( for Investigators centers achieving pharmacokinetic examination)
* Well-informed written consent, signed by the patient

Exclusion Criteria:

* Carboplatin treatment's contra-indication
* Patient with clinically detectable cerebral metastasis
* Pregnant or nursing women
* Patient under guardianship or trusteeship
* Patient whose venous status don't permit a peripheral intravenous administration route's placing (for Investigators centers achieving pharmacokinetic examination)
Knowledge Assessment of Women About Pictograms Associated With the Danger of Medicines Taken During Pregnancy

Women's awareness about the danger of certain medicines taken during pregnancy presents a real public health issue. To enhance awareness and information for women and healthcare professionals, new pictograms " pregnant women " appeared on medication boxes, on October 16, 2017. These new pictograms can change women's perception of self-medication during pregnancy and of the danger of taking certain medicines for the unborn development. Furthermore, the investigators can wonder if the meaning of these pictograms is well understood. Therefore, the study's primary aim is to assess the knowledge of pregnant or childbearing age women about the pictograms associated with the danger of certain medicines taken during pregnancy.


Eligibility Criteria:
Inclusion Criteria:

* women who agree to participate to the study
* women who understand french language (oral and written)
* pregnant women and women of childbearing age from 18 to 45 years old.

Exclusion Criteria:

* Women who have already answered the questionnaire
* women who don't want to answer the questionnaire
* women who don't understand french language
* women who are under the age of 18 or over the age of 45
Group Interpersonal Psychotherapy for Treatment of Major Depressive Disorder Following Perinatal Loss

The purpose of this study is to conduct a randomized pilot trial in a sample of 60 women who meet criteria for Major Depressive Disorder (MDD) 1-18 months after a perinatal loss to demonstrate the feasibility of the proposed recruitment methods and research design, of the therapist training methods, and of delivering the adapted Interpersonal Psychotherapy group treatment.

The investigators would like to examine preliminary evidence for the following hypotheses:

* Perinatal-loss specific IPT-G will be more acceptable to women who experience MDD following perinatal loss than will Coping with Depression (CWD).
* Perinatal-loss specific IPT-G will result in reduced time to remission from MDD and reduced depressive symptoms relative to CWD.
* Perinatal-loss specific IPT-G will result in increased social support and social functioning, reduced couple distress, and reduced grief relative to CWD.


Eligibility Criteria:
Inclusion Criteria:

* Current Major Depressive episode.
* Experience perinatal loss 1-18 months prior to intake (including early and late fetal death and the death of a live born neonate within the first 28 days).

Exclusion Criteria:

* Untreated thyroid difficulties (TSH levels out of the normal range).
* Anemia (hemoglobin or hematocrit out of the normal range).
* Onset of current major depressive episode prior to news of difficulties with the pregnancy or health risk to the infant (women with prior episodes will be included).
* Current or past diagnosis of bipolar I disorder, schizophrenia or other psychotic disorder.
* Primary diagnosis of substance dependence or eating disorder.
* Acute suicidal or homicidal risk.
* Non-stable course of antidepressant medication or psychotherapy (i.e., beginning or changing dose of either within the previous 8 weeks).
* Any IPT or cognitive-behavioral treatment in the previous 8 weeks.
Deep Learning Model for Pure Solid Nodules Classification

The purpose of this study is to compare the predictive performance of a CT-based deep learning model for pure-solid nodules classification and compared with the tumor maximum standardized uptake value on PET in a multicenter prospective cohort.


Eligibility Criteria:
Inclusion Criteria:

* Participants scheduled for surgery for radiological finding of pulmonary pure-solid lesions from the preoperative thin-section CT scans;
* The maximum short-axis diameter of lymph nodes less than 3 cm on CT scan;
* Age ranging from 18-75 years;
* definied pathological examination report available;
* Obtained written informed consent.

Exclusion Criteria:

* Multiple lung lesions;
* Poor quality of CT images;
* Participants with incomplete clinical information;
* Participants who have received neoadjuvant therapy before initial CT evaluation.
Study of Cardiopulmonary Exercise Testing in Women Who Have HER2-Positive Breast Cancer With Mild Cardiotoxicity

The purpose of this study is to find out how much oxygen is used during a cardiopulmonary exercise test (CPET) in women who have mild cardiotoxicity after standard treatment for HER2-positive breast cancer, and to see whether the results of this test can be used to predict how well participants' heart and lungs will work if they continue to receive this kind of treatment.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Female
* Diagnosed with a HER2-positive solid tumor (stage I-IV)
* Left ventricular dysfunction prior to the start of HER2-targeted therapy, defined by a LVEF \< 53% (or lower limit of normal), or diagnosed with mild cardiotoxicity associated with HER2-targeted therapy, defined by an absolute decrease in LVEF ≥ 10% from pre-treatment to \< 53%
* Planning to undergo treatment with HER2-targeted therapy (e.g. trastuzumab, pertuzumab, or ado-trastuzumab) for a minimum of 3 months (i.e. 4 cycles administered every 3 weeks).
* Willing and able to comply with the requirements of the protocol

Exclusion Criteria:

* Symptomatic heart failure (New York Heart Association Class III or IV)
* Subjects must not have any of the following absolute contraindications to cardiopulmonary exercise testing:

  * Acute myocardial infarction (within 30 days of any planned study procedures),
  * Unstable angina
  * Uncontrolled arrhythmias causing symptoms or hemodynamic compromise,
  * Symptomatic severe aortic stenosis
  * Recurrent syncope
  * Active endocarditis
  * Acute myocarditis or pericarditis
  * Acute pulmonary embolus or pulmonary infarction (within 3 months of any planned study procedures)
  * Thrombosis of lower extremities (within 3 months of any planned study procedures)
  * Suspected dissecting aneurysm
  * Uncontrolled asthma
  * Pulmonary edema
  * Room air desaturation at rest ≤ 85%
  * Respiratory failure
  * Acute noncardiopulmonary disorder that may affect exercise performance or be aggravated by exercise (i.e., infection, renal failure, thyrotoxicosis)
  * Mental impairment leading to inability to cooperate.
* Enrollment onto any other interventional investigational study
* Inability to provide informed consent
Photodynamic Lasertherapy (PDT) in Periodontal Treatment (in Vivo)

The purpose of the study is to evaluate the effect of the photodynamic therapy in periodontal patients

The purpose of the study is to evaluate the effect of the photodynamic therapy in periodontal pockets and to assess the reduction of subgingival bacteria.

The first step will include the evaluation of the quantity of the light which will activate the photosensitizer in the various niches in the periodontal pocket.

The second step will evaluate the distribution of the photosensitizer in the periodontal pocket.

The third step will assess the woundhealing of the the photodynamic therapy compared to conventional periodontal therapy with an ultrasonic device.

Eligibility Criteria:
Inclusion Criteria:

* systemic healthy
* \>15 teeth
* ≤ 6 mm \>2 teeth
* age \> 35 years

Exclusion Criteria:

* - systemic ill
* cardiac pacemaker
* \< 15 teeth
Innovative Brain Stimulation for Induction of Learning Plasticity

Recent studies have identified new neurobiological biomarker (i.e. functional connectivity of the parietal cortex) of motor learning among healthy people. This enables to refine our current model of motor learning wherein specific cortical processes are key factors for motor acquisition. Furthermore, recent evidence suggests that new technical approaches such as repetitive magnetic stimulation (rTMS) can efficiently influence this key factor. However, up to now, no rTMS studies have target this new biomarker. Therefore, the effect of rTMS are unknown. Hence, the investigators want to develop a new rTMS setup able to induce specific brain processes in healthy individuals that are likely to benefit. This has the potential to obtain critical information in order to improve treatment of motor re-learning in patients with neurological diseases.

Participants will participate in 1 session of neuronavigated (TMS Navigator, Localite, Schloss Birlinghoven, D-53757, Sankt Augustin, Germany ) iTBS (patterned form of rTMS) coupled with motor learning. Participants will be randomly assigned to one of 2 groups: real iTBS over parietal cortex and sham iTBS over the parietal cortex.

One day before (Day1) and after the motor learning (Day 2), participants will undergo high-density 128-channel resting state electroencephalography (EEG) and motor evoked potential (MEP) in order to characterize the effects of rTMS on our markers of plasticity. Performance on the task will be measure immediately after learning (Day 2) and again 24h later (Day 3) in order to test for retention and offline consolidation (time and errors). The task will consist in realizing a computerized mirror-drawing task, in which right-left movements of the mouse were reversed on the screen.

Eligibility Criteria:
Inclusion Criteria:

* man or woman aged between 18-40 years,
* ability to give informed consent,
* ability to follow protocol instructions,
* normal or corrected-to-normal vision,

Exclusion Criteria:

* history of epileptic seizure (ci. TMS),
* skull breach (ci. TMS),
* metallic object in the brain (ci. TMS),
* pacemaker (ci. TMS),
* severe co-morbidity (ex, traumatic, rheumatologic, neurodegenerative diseases),
* pregnancy.
BI 655130 Long-term Treatment in Patients With moderate-to Severe Ulcerative Colitis

To evaluate the long-term safety of BI 655130 (SPESOLIMAB) in patients with moderate to severely active ulcerative colitis, who have completed treatment in previous trials

To evaluate the long-term efficacy of BI 655130 (SPESOLIMAB) in patients with moderate to severely active ulcerative colitis, who have completed treatment in previous trials


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients, aged ≥18 years
* Signed and dated written informed consent for 1368.17, in accordance with GCP and local legislation prior to admission into the trial
* Women of childbearing potential (WOCBP) must be ready to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the patient information. Note: A woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming postmenopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. Tuba ligation is NOT a method of permanent sterilisation. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause.
* Have completed treatment and the EOT visit in the previous trial and are willing and able to continue treatment in 1368.17.

Exclusion Criteria:

* Have experienced study treatment-limiting adverse events during induction treatment with study drug
* Have developed any of the exclusion criteria from the original induction study with the following exceptions:

  * Cases of disease limited to the rectum extending \<15 cm past the anal verge are allowed to be included in study 1368.17
  * Cases of latent TB. Patients with newly emerging latent TB during preceding study are allowed to be included in study 1368.17, provided they receive appropriate treatment according to local guidelines