cyrilzakka/clinical-trials huggingface dataset:
Alternative Non-cross-resistant Adjuvant Chemotherapy for Operable Breast Cancer Non-response to Primary Chemotherapy

The purpose of this phase Ⅲ, multi-center, prospective, open-label, randomized,controlled study is to determine whether alternative non-cross-resistant adjuvant chemotherapy can increase distant disease free survival(DDFS) in operable patients non-response to primary chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Female patients, age ≦65 years
* Biopsy proven lymph node positive, estrogen receptor- positive primary breast cancer
* Must have completed a 4-cycle neo-adjuvant chemotherapy with a standard regimen(containing anthracycline or paclitaxel)
* Must have undergone surgery to remove the primary tumor by either a mastectomy or enlarged local excision
* Postoperative residual positive lymph nodes or G1/G2/G3 of Miller \& Payne Grading System
* Adequate recovery from recent surgery
* No history of other malignancies
* No currently uncontrolled diseased or active infection
* Not pregnant or breast feeding, and on appropriate birth control if of child-bearing potential
* Adequate cardiovascular function reserve with a myocardial infarction within the past six month
* Adequate hematologic function with:

  1. Absolute neutrophil count (ANC) ≥1500/mm3
  2. Platelets ≥100,000/ mm3
  3. Hemoglobin ≥10 g/dL
* Adequate hepatic and renal function with:

  1. Serum bilirubin ≤1.5×UNL
  2. Alkaline phosphatase and alanine aminotransferase (ALT) ≤2.5 x ULN. (≤5 x ULN is acceptable in the setting of hepatic metastasis)
  3. BUN between 1.7 and 8.3 mmol/L
  4. Cr between 40 and 110 umol/L
* Knowledge of the investigational nature of the study and Ability to give informed consent
* Ability and willingness to comply with study procedures.

Exclusion Criteria:

* Known or suspected distant metastases
* Concurrent malignancy or history of other malignancy
* Uncontrolled diseases(e.g., heart failure, myocardial infarction within 6 months, arrhythmia, unstable diabetes, hypercalcemia) or active infection
* Geographical, social, or psychological problems that would compromise study compliance
* Known or suspected hypersensitivity to anthracycline or paclitaxel
Secondary Pulmonary Hypertension in Adults With Sickle Cell Anemia

The purpose of this study is to determine how often people with sickle cell anemia develop pulmonary hypertension a serious disease in which blood pressure in the artery to the lungs is elevated.

Men and women 18 years of age and older with sickle cell anemia may be eligible for this study. Participants will undergo an evaluation at Howard University s Comprehensive Sickle Cell Center in Washington, D.C. or at the National Institutes of Health in Bethesda, Maryland. It will include the following:

* medical history
* physical examination
* blood collection (no more than 50 ml., or about 1/3 cup) to confirm the diagnosis of sickle cell anemia, sickle cell trait or beta-thalassemia (Some blood will be stored for future research testing on sickle cell anemia.)
* echocardiogram (ultrasound test of the heart) to check the pumping action of the heart and the rate at which blood travels through the tricuspid valve.

Following this evaluation, a study nurse will contact participants twice a month for 2 months and then once every 3 months for the next 3 years for a telephone interview. The interview will include questions about general health and recent health-related events, such as hospitalizations or emergency room visits.

Sickle cell anemia is an autosomal recessive disorder and the most common genetic disease affecting African-Americans. Approximately 0.15% of African-Americans are homozygous for sickle cell disease, and 8% have sickle cell trait. Acute pain crisis, acute chest syndrome (ACS), and secondary pulmonary hypertension are common complications of sickle cell anemia. Mortality rates of sickle cell patients with pulmonary hypertension are significantly increased as compared to patients without pulmonary hypertension. Recent studies report up to 40% mortality at 22 months after detection of elevated pulmonary artery pressures in sickle cell patients. Furthermore, pulmonary hypertension is thought to occur in up to 30% of clinic patients with sickle cell anemia.

This study is designed to determine the prevalence and prognosis of secondary pulmonary hypertension in adult patients with sickle cell anemia, and to determine whether genetic polymorphisms in candidate genes contribute to its development or response to treatment.

Eligibility Criteria:
* INCLUSION CRITERIA FOR SICKLE CELL PATIENTS:
* Male and females over 18 years of age.
* Diagnosis of sickle cell disease (electrophoretic documentation of SS, SC, or S-beta thallassemia genotype is required).

EXCLUSION CRITERIA FOR SICKLE CELL PATIENTS:

* Hb A-only phenotype and sickle cell trait.
* Decisionally impaired subjects.
* Pregnant or lactating women

INCLUSION CRITERIA FOR CONTROL SUBJECTS:

* Male and females African American subjects over 18 years of age.
* Exclusion of sickle cell disease (electrophoretic documentation of hemoglobin A is required).

EXCLUSION CRITERIA FOR CONTROL SUBJECTS:

* Diagnosis of sickle cell disease (electrophoretic documentation of SS, or SC, or SB thallassemia genotype is required.)
* Decisionally impaired subjects.
* Pregnant or lactating women
Study of Human Sensory Perception

This study will help describe how the human brain works when a person sees something, hears something, learns something, or thinks about something by recording brain activity that occurs when the person does a series of computer tasks. This study will be offered to people who are in the hospital to be monitored for epilepsy by using electrodes placed in the brain. The study will record brain activity that occurs when a patient does a memory task, for example.

Patients who have elected to have invasive electrophysiological monitoring for epileptic activity are invited to participate in this study. While the electrodes are in place, patients are asked to view several scenarios on a laptop computer. During these scenarios, for example, patients are asked to click a mouse button if they see the same picture twice in a row or to remember a film clip of a scooter ride. Trigger points in the computer scenarios are recorded on a separate channel alongside the brain-wave activity to allow correlation between the brain activity and the task requested in the scenario. Using this technique, researchers can determine what areas of the brain were active during recognition or recall activities.

Eligibility Criteria:
Inclusion Criteria:

* Primary diagnosis of epilepsy
* Between 10 and 65 years of age
* Scheduled to undergo invasive electrophysiological monitoring as part of a clinical evaluation for epilepsy treatment

Exclusion Criteria:

* None
ALTARGO(Retapamulin) PMS(Post-marketing Surveillance)

This is an open label, multi-centre, non-interventional post-marketing surveillance.

This is an open label, multi-centre, non-interventional post-marketing surveillance to monitor the safety of ALTARGO(retapamulin) treated in Korean patients according to the prescribing information.

ALTARGO is a trademark of the GlaxoSmithKline group of companies.

Eligibility Criteria:
Inclusion Criteria:

* All subjects must satisfy the following criteria at study entry:

  1. Subjects administered with ALTARGO(retapamulin) in the topical treatment of the following bacterial skin and skin structure infections (SSSI)
  2. Subjects who the investigator believes that they can and will comply with the requirements of the protocol and follow the administration regimen
  3. Subjects administered with ALTARGO(retapamulin) following the locally approved prescribing information

Exclusion Criteria:

* Considering the nature of observational study, GSK Korea encourages the doctors participating in this study to enrol the subjects prescribed with retapamulin following the locally approved Prescribing Information.

  1. Subjects with a known or suspected hypersensitivity to ALTARGO(retapamulin) or any component of the ointment
  2. Infants under nine months of age
International Clinical Trial to Evaluate Efficacy and Safety of Multiple Subcutaneous Injections of BCD-085 in Various Doses in Patients With Moderate to Severe Plaque Psoriasis

BCD-085-2 is a next step in clinical investigation of BCD-085. BCD-085 is a monoclonal antibody to interleukin 17. During BCD-085-2 trial patients with moderate to severe plaque psoriasis, in whom poor response to previous treatment including UV-therapy and biologic drugs was registered, will receive 40, 80 or 120 mg of BCD-085 subcutaneously at weeks 0, 1, 2, 4, 6, 8, 10. Efficacy and safety parameters will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Age between 18 and 65 years
* Diagnosis of plaque psoriasis with stable course of the disease during last 6 months prior to enrollment in the study.
* Patient have had at least 1 course of phototherapy or systemic therapy of psoriasis or are candidates for such treatment.
* BSA affected by psoriasis ≥ 10%, PASI score ≥ 12, sPGA score ≥ 3.
* If patient have had biologic therapy for at least 3 months, there was no positive results of such treatment or patient revealed intolerance to the drug. This therapy must be discontinued at least 12 weeks before enrollment in the study.
* Female patients have negative urine pregnancy test.
* Patient has no history of tuberculosis.
* Patients have negative results of Diaskintest.
* Patient has no history of alcohol or drug abuse.
* Patients are able to perform all procedures planed by protocol.
* Patients are ready for contraception with reliable methods starting 2 weeks before entering the study, and up to 4 weeks after the last dose of study drug.

Exclusion Criteria:

* Subject diagnosed with erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, medication-induced psoriasis, or other skin conditions at the time of the screening visit (e.g., eczema) that would interfere with evaluations of the effect of investigational product on psoriasis.
* Previous receipt of anti-interleukin 17 drugs or anti-interleukin 17 receptor drugs.
* Prior use of two or more biologics to tumor necrosis factor alfa.
* Prior use of two or more biologics to other targets.
* Previous receipt of monoclonal antibodies if they were cancelled less that in 12 weeks before signing informed consent.
* Patient is taking corticosteroids for up to 4 weeks in a dose more than 10 mg (recalculated to prednisolone) before signing informed consent and during screening, or in a dose less than 10 mg (recalculated to prednisolone) if it was not stable.
* Prior use of disease-modifying drugs including methotrexate, sulfasalazin and cyclosporin for up to 4 weeks before signing informed consent, if their dose was not stable for up to 4 weeks before signing informed consent and during screening Prior use of live or attenuated vaccines for up to 8 weeks before signing informed consent.
* Prior use of phototherapy including selective phototherapy and photochemotherapy for up to 4 weeks before signing informed consent.
Bupivacaine Plus Diclofenac Versus Bupivacaine Alone for Postoperative Pain Relief in Gynecologic Cancer Patients

compare the postoperative pain between Bupivacaine peritoneal Infiltration plus immediately postoperative intramuscular Diclofenac and Bupivacaine peritoneal infiltration alone by using visual analogue score (VAS).

The primary objective is to compare the postoperative pain between Bupivacaine peritoneal Infiltration plus immediately postoperative intramuscular Diclofenac and Bupivacaine peritoneal infiltration alone by using visual analogue score (VAS). The secondary objective is to evaluate the time to first dose and the total amount of morphine requirement after the operation in both groups.

Eligibility Criteria:
Inclusion Criteria:

* gynecologic cancer patients ,i.e. cervical cancer, endometrial cancer, or ovarian tumor suspicious for malignancy
* who has scheduled for operation via laparotomy route
* Women who has ASA physical status I-II
* All of the have age more than 20 years old
* able to communicate in Thai
* Women who agrees to participate in this study

Exclusion Criteria:

* patient who had emergency conditions - indication for emergency operation
* intraoperative cardiac arrhythmia
* operation purpose for only tumor biopsy

  * Women who have abnormal kidney function test (Cr \> 1.5)
  * Women with history of gastrointestinal bleeding
  * Women who take the antiplatelet or anticoagulant medications
  * Women with history of allergy to bupivacaine and NSAIDs
  * Women who cannot evaluated pain score
ED Lung Protective Ventilation to Reduce Complications

Early mechanical ventilation, if delivered with injurious settings, can lead to pulmonary complications, such as acute respiratory distress syndrome (ARDS). Mechanical ventilation in the emergency department (ED) has been studied infrequently when compared to the intensive care unit; however, data suggests that ED-based mechanical ventilation has significant room for improvement and may also be a causative factor in ARDS incidence.

This is a before-after study examining the impact of implementing lung protective ventilation in the emergency department.

Eligibility Criteria:
Inclusion Criteria:

* mechanically ventilated via an endotracheal tube in the ED

Exclusion Criteria:

* death in the ED,
* death or discontinuation of ventilation within 24 hours,
* chronic mechanical ventilation,
* ARDS while in the ED
* transfer to another hospital.
Mesenchymal Stem Cell-derived Pleiotropic Factor in Treating Non-healing Wounds

Chronic wounds do not heal for prolonged periods of time with the significant financial burden on the healthcare system. It has become increasingly essential to improve our clinical treatments. The most promising potential treatment options rely on stem cell-based therapies. A large body of evidence indicates that mesenchymal stem cells can promote wound closure of chronic wounds in animal models and in preclinical studies. MSCs efficacy depends mostly on their paracrine activity. All the bioactive factors and cytokines in MSCs secretions constitute can be collected in the conditioned medium. In here, stem cell-derived conditioned medium was further made into a lyophilized powder. Patients with chronic wounds were enrolled. The wounds in control group treated with fibroblast growth factor commonly used in clinical practice. The wounds in experimental group treated with lyophilized powder. The effectiveness and safety of lyophilized powder will evaluate for chronic wounds.


Eligibility Criteria:
Inclusion Criteria:

Clinical diagnosis of chronic wounds; Male or female over 17; Psychologically stable and able to complete the experimental process. -

Exclusion Criteria:

wound greater than 10cm ×10cm; Exposure to radiation or use of hormones, chemotherapy, growth factor dressings and immunosuppressants within 3 months; Participated in other similar tests within 3 months; Pregnant, or lactating women; Severe infectious disease; Severe heart, liver, and kidney dysfunction; Had a history of cancer -
Study of Psychological Defense Mechanisms Used by Liver Transplant Patients

Organ transplantation has a special place in the medical field. It symbolizes a medicine whose limits always seem to be repelled. Because transplantation is unusual, it places people in front of outstanding issues which he has to cope with his personality and history. Factors involved in the psychology of patient presenting with graft are past and present psychic functioning, object relations, experience of transplantation itself and quality of social environment.

Before or after graft defense mechanisms can be so intense that they can make the patient unable to overcome the graft. Yet as a pathological mechanism that denial was considered beneficial provided it is short.

The aim of this study is to evaluate on psychopathological influence of psychological defense mechanisms used by liver transplant patients on their somatic psychological and social outcome.

The objective is to measure the influence of variations of psychological defense mechanisms.

The investigators want to measure the influence of personal history of patients, causal disease pre-existing, conditions of graft's realization, structure of patient's social environment (family or institutional); and wish to identify which of those elements can be protective or vulnerability factors with a view to allow adequate support (especially for patients who had multiple poor prognostic factors)

The investigators will study pre-transplant psychological defense mechanisms of the subjects using the Bond Defense Style Questionnaire and structure of personality using the SCID II personality scale. They will evaluate post-transplant patient outcomes on clinical and social developments with DSQ 88 and General Health Questionnaire (GHQ 28) to six months, twelve months and five years after transplantation. Meanwhile, they will address each time you visit the data on consumption, misuse and alcohol dependence using the AUDIT questionnaire (Alcohol Use Disorders Identification Test).

The hypothesis is that the defense mechanisms, their variations and personality of the patients are both vulnerability factors as protective factors in different phases of the graft. Identification should allow to optimize care and improve overall health. Results of this research could make it possible to determine the factors used in liaison psychiatry in the long term to ensure an adequate medical and psychiatric support to transplant patients.

Eligibility Criteria:
Inclusion Criteria:

* adult patients between 18 and 65 years old
* liver disease requiring a liver transplantation
* registered on the waiting transplant list in the University Hospital of Lille

Exclusion Criteria:

* fulminant hepatitis
* mental incapacity
Non-interventional Trial About Treatment of Haemorrhages in Cholecystectomy With TachoSil (TC-027-DE)

* Effectiveness and reliability of TachoSil in cholecystectomy (elective and acute)
* Evaluation of TachoSil in laparoscopic cholecystectomy
* Risk profile of patient under anticoagulant therapy undergoing acute cholecystectomy
* Pharmaco-economic evaluation
* Recording of AE's/SAE's Considering the total number of cholecystectomies in Germany (170.000 cases/y), out of them about 75% laparoscopic and 10.000 conversions totally it seems urgent to record data about usage of TachoSil in such procedures. For the time being TachoSil is applied in about 2% of the gall bladder procedures.

Aim is to evaluate a possible patient and procedure profile where TachoSil is most beneficial.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing elective or acute cholecystectomy
* The only restrictions of use will be those resulting from the contraindications (see section 4.3 of the Summary of Product Characteristics)
Assisted Movement Neuro-rehabilitation: VA Multi-site Clinical Trial

The purpose of this study is to compare the effectiveness of a lower-dose and higher-dose therapy program for persons recovering from a recent stroke using mechanically-assisted upper limb movement with a device called MIME. A control group receives additional occupational therapy without the use of MIME.

This study continues our investigation of the optimal timing, intensity, and duration of robot-assisted training to improve motor performance in patients with hemiplegia following stroke. These hypotheses will be tested: 1) subjects receiving robot-assisted upper limb therapy with MIME in the initial phase of recovery from stroke experience greater functional gains than a control group receiving additional conventional therapy of equal intensity and duration, 2) robot-assisted therapy results in a dose-dependent response, and 3) robot-assisted therapy promotes greater control of movement, greater recovery of strength, and greater reduction of co-contraction than the control intervention. Research Plan - A multi-site clinical trial is in progress at the Houston VA Medical Center (VAMC), the VA Greater Los Angeles Health Care System (GLAHCS), the VA Palo Alto Rehabilitation Research and Development Center (RR\&DC), and the Central Texas Veterans Health Care System (CTVHCS). CTVHCS serves as the coordinating site. The RR\&DC provides training and technical assistance for the other sites. Methods - Subjects with hemiparesis due to a stroke are randomly assigned to 3 groups. Group 1 receives 1 hour/day of robot-assisted upper limb therapy in addition to usual physical and occupational therapy. Group 2 receives a total of 2 hours/day of robot-assisted therapy. Group 3 receives 1 hour/day of additional upper limb therapy that includes exposure to, but no manipulation by the robot. Outcome measures include assessment of strength, motor control, functional status, and patient satisfaction at intake, discharge, 6 and 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Over 21 years of age, weakness due to a recent stroke or other brain injury, and receiving rehabilitation. Subjects are inpatients at one of the participating VA hospitals.

Exclusion Criteria:

Unable to follow instructions; medically unstable.
A Study to Assess YH002 in Combination with YH001 in Subjects with Advanced Solid Tumors

A multicenter, open-label, phase I dose escalation study to evaluate the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of YH002 in combination with YH001 in subjects with advanced solid tumors


Eligibility Criteria:
Inclusion Criteria:

To be eligible for study entry patients must satisfy all of the following criteria:

1. Subjects must have the ability to understand and willingness to sign a written informed consent document.
2. Subjects must have histologically advanced or cytologically confirmed solid tumor and and must have at least 1 unidimensional measurable lesion by RECIST 1.1.
3. Subjects have progressed on after treatment with at least one standard therapy, or intolerant of the standard therapy, or no standard therapy accessible to the patients due to any reason.
4. Subjects must be age 18 to 80 years of age at the time of screening.
5. Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
6. Life expectancy ≥3 months based on investigator's judgement.
7. Subjects have adequate bone marrow and other organ function at the screening visit.
8. Women of reproductive potential must have negative serum beta human chorionic gonadotropin (β -HCG) pregnancy test within 7 days of the first dosing. Women of reproductive potential are those who have not been post-menopausal for at least 12 months or who have not undergone bilateral tubal occlusion, hysterectomy, or bilateral salpingectomy.

Exclusion Criteria:

Subjects who meet any of the following criteria cannot be enrolled:

1. Subjects have another active invasive malignancy within 5 years.
2. Previous exposure to TNFR such as anti-OX40 antibodies.
3. Subjects must not have received any anticancer therapy or another investigational agent within the shorter of 4 weeks or 5 half-lives before the first dose of the study treatment(subject to the longer one).
4. Continuance of toxicities due to prior radiotherapy or chemotherapy agents that have not recovered to ≤ Grade 1 per CTCAE 5.0, except alopecia ≤ Grade 2.
5. Primary central nervous system (CNS) malignancies or symptomatic CNS metastases.
6. Subjects must not have a known or suspected history of an autoimmune disorder, including but not limited to inflammatory bowel disease, celiac disease, Wegner syndrome, Hashimoto syndrome, systemic lupus erythematosus, scleroderma, sarcoidosis, or autoimmune hepatitis, within 3 years of the first dose of study treatment.
7. Clinically uncontrolled intercurrent illness, including but not limit to an ongoing active infection, active coagulopathy, uncontrolled diabetes (blood glucose \> 250 mg/dl), uncontrolled pleural and peritoneal effusion, psychiatric illness that would limit compliance with the study requirements and other serious medical illnesses requiring systemic therapies
8. Subjects must not have active infection of human immunodeficiency virus, hepatitis B, hepatitis C or Covid-19.