cyrilzakka/clinical-trials huggingface dataset:
Dose-finding Study of Empegfilgrastim for Neutropenia Prophylaxis in Patients With Breast Cancer

The purpose of the study is to compare safety and efficacy of a single dose of empegfilgrastimt a dose of 3 or 6 mg versus daily administration of filgrastim at a dose of 5 μg/kg/day.

BCD-017-2 is an open-label randomized phase II clinical study to compare the incidence of CTCAE grade 3/4 neutropenia after a single administration of recombinant human pegylated filgrastim empegfilgrastim (Extimia®) at a dose of 3 or 6 mg versus daily administration of filgrastim at a dose of 5 μg/kg/day for neutropenia prophylaxis in breast cancer patients receiving myelosuppressive chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent form;
* Histologically verified diagnosis of stage IIb/III/IV breast cancer;
* Age of 18-70 years inclusive;
* If the patient had received the chemotherapy for breast cancer, it should be finished 30 days before the beginning of the study;
* ECOG Performance Status of 0, 1 or 2, not increasing within during 2 weeks before randomization;
* ANC level of 1500/μL and more at the beginning of the study
* Platelet count of 100 000/μL and more at the beginning of the study
* Hemoglobin level of 90 g/l and more
* Creatinine level \<1.5 mg/dl
* Total bilirubin level \<1.5 × the upper limit of normal (ULN)
* ALT and/or AST levels \<2.5×ULN (5×ULN for patients with liver metastases);
* Alkaline phosphatase \<5×ULN;
* Left ventricular ejection fraction \>50% and more;
* If the patient had received adjuvant and/or neoadjuvant therapy, the cumulative dose of anthracyclines should not exceed 500 mg/m2 for doxorubicin or 500 mg/m2 for epirubicin;
* Ability of the participant to follow the protocol requirements, according to the Investigator's opinion;
* Patients of childbearing potential must implement reliable contraceptive measures during the study treatment, starting 4 weeks prior randomization and for 6 months after the last administration of the study drug.

Exclusion Criteria:

* Patient has received two or more chemotherapy regimens for the metastatic breast cancer;
* Documented hypersensitivity to filgrastim, pegfilgrastim, docetaxel, doxorubicin, dexamethasone and/or its excipients, PEGylated drugs, recombinant proteins.
* Pregnancy or breastfeeding;
* Systemic antibiotic therapy within 72 h prior empegfilgrastim/filgrastim administration;
* Concomitant radiotherapy (except selective radiotherapy of bone metastases);
* Surgery, radiotherapy (except selective radiotherapy of bone metastases), administration of any experimental drugs within 30 days prior randomization;
* History of bone marrow/stem cell transplantation;
* Conditions limiting the patient's ability to follow the protocol;
* CTCAE grade 2/4 neuropathy
* HIV, HCV, HBV, T.Pallidum infection(s);
* Acute or active chronic infections.
Treatment of Acute Lymphoblastic Leukemia Ph '(BCR / ABL) Positive Patients Aged > 55 Years

This study proposes to provide adequate treatment and is based on current scientific evidence for elderly patients with ALL Bcr / Abl positive.

To determine whether low-dose chemotherapy associated with imatinib or dasatinib has acceptable tolerability in elderly patients.

To determine whether this association can increase the rate and quality of referrals to the results of the literature of imatinib as monotherapy for elderly patients

Prephase (days -5 to -1) Dexamethasone 10 mg/m2 bolus day EV for 5 days (-5 to -1).

Intrathecal treatment (diagnosis and prophylactic / therapeutic) -5 days:

Methotrexate 12 mg

Systemic treatment:

* Imatinib 400 mg daily and continuous VO.
* Vincristine (VCR) 1 mg (absolute dose) EV 1, 8, 15 and 22.
* Dexamethasone (DEX): 10 mg/m2 EV, IM or PO days 1-2, 8-9 days 15-16, 22-23. .

Intrathecal chemotherapy:

Triple therapy was administered with methotrexate (MTX), cytosine arabinoside (ARA-C) and hydrocortisone, days 1, 8, 15 and 22 (five doses total prophylactic between prophase and induction):

MTX 12 mg ARA-C 40 mg Dexamethasone 4 mg

Maintenance during the first year will start after full recovery after induction and after complete reassessment of the disease (including mielograma and Bcr-Abl/Abl or Bcr-Abl/Gus ratio in peripheral blood) and will last until one year from the time of complete remission.

The basic treatment included imatinib 400 mg / day (or dasatinib), mercaptopurine at doses of 50 mg/m2 PO day and methotrexate 20 mg/m2 IM weekly.

One week every 3 months maintenance treatment added a "mini-reinduction" consisting

* VCR: 1 mg (absolute dose), i.v., day 1.
* Dexamethasone 40 mg / day, i.v. or p.o., days 1-2.
* not considered more doses of triple intrathecal therapy. Reinduction only be practiced during the first year after remission, so a total of 4 quarterly.

Maintenance treatment of second year

After the first year of maintenance will perform a complete reassessment of the disease (including myelogram) and if the patient remains in complete remission maintenance will continue (without reinduction) until two years from the time of diagnosis.

Maintenance treatment of third year During the third year after complete remission imatinib administered alone (or dasatinib

Eligibility Criteria:
Inclusion Criteria:

Adults over 55 years diagnosed with acute lymphoblastic leukemia Ph 'positive (Bcr / Abl positive) and previously untreated

Exclusion Criteria:

1. Other LAL negative for t (9; 22) and Bcr / Abl.
2. biphenotypic acute leukemias or bilinear with t (9; 22).
3. blast crisis of chronic myeloid leukemia progression during or after polychemotherapy treatment (including allo-BMT) or with inhibitors of tyrosine kinases.

   The criteria for exclusion from treatment (but not patient record) any of the following
4. General condition affected (grades 3 and 4 WHO scale), not attributable to the LAL.
5. Lack of consent by the patient to use their clinical d
Escitalopram Combination Comparison Study for Adult Patients With Major Depressive Disorder

The purpose of this study is to evaluate the effectiveness, safety and tolerability of an escitalopram combination treatment compared to single treatments, and to placebo in patients with major depressive disorder.

Both active drugs being tested, alone and in combination, in this study are currently available antidepressants. However, the doses used in this study are lower than the standard approved doses.

Eligibility Criteria:
Inclusion Criteria:

* Patients must meet Diagnostic and Statistical Manual, Fourth Edition (DSM-IV) diagnostic criteria for Major Depressive Disorder
* The patient's current depressive episode must be at least 12 weeks in duration.

Exclusion Criteria:

* Women who are pregnant, women who will be breastfeeding during the study, and women of childbearing potential who are not practicing a reliable method of birth control.
* Patients who currently meet DSM-IV criteria for : a. bipolar disorder; b. schizophrenia or any psychotic disorder; c. obsessive-compulsive disorder; d. mental retardation or any pervasive developmental disorder or cognitive disorder.
* Patients who are considered a suicide risk.
* Patients with a history of seizure disorder, or any history of seizure, stroke, significant head injury, or any other condition that predisposes toward risk of seizure.
Local Application of Ozone Gas for Infected Ulcers

This study evaluates the efficacy of local application of ozone gas in healing of infected ulcers. Half the participants received conventional treatment with placebo generator and the other half received conventional treatment with ozone generator.

Ozone gas has been used since World war I and is known for its wound healing properties by way of being a powerful oxidant that stimulates the antioxidant system, immunomodulation, microbicidal and perhaps other unknown mechanisms. It has largely been regarded as a complementary therapy form but with elucidation of it's biological actions and availability of reliable ozone generators it may form a novel treatment option for a range of medical conditions with ample literature available on wound healing. In this study it was used as an adjunct to conventional treatment i.e surgical procedures, antibiotics and wound care. It was locally applied as a gas though there are various other routes of administration such as major and minor autohematotherapy, intramuscular and intraarticular injections, rectal and vaginal insufflation.

Eligibility Criteria:
Inclusion Criteria:

* infected ulcer size of atleast 10 cm.
* patient willing to participate in the study and for follow up.

Exclusion Criteria:

* patient unwilling for participation and follow up.
* chronic kidney disease,
* peripheral occlusive vascular disease,
* venous ulcers,
* pressure sores,
* use of immuno suppressant drugs,
* immunosuppressed state
Study of Prineo (Dermabond Protape) Versus Sutures in Breast Procedures

This is a prospective, controlled, randomized, multi-center clinical study of up to 80 patients with full thickness surgical incisions associated with bi-lateral breast procedures. Breast procedures where symmetrical incisions of at least 15cm in length are planned for both breast (bilateral procedure) will be randomised to receive final skin closure of one breast with Prineo (DERMABOND PROTAPE) and the other with intradermal sutures (control). Patients will be evaluated post-operatively at 24 hours (± 6 hours), 7 days (± 1 day), 12 - 25 days, and 90 days (± 10 days).


Eligibility Criteria:
Inclusion Criteria:

* Be at least 18 years of age;
* Be in good general health in the opinion of the Investigator with no conditions that would significantly impact wound healing as determined by medical history and review of recent concomitant medications;
* Require identical skin closure of full-thickness intersecting surgical incisions with a combined length of at least 15cm on each breast as part of elective breast procedures, requiring the placement of sutures in the superficial fascia and subcutaneous tissue to relieve skin tension prior to final skin closure;
* Be willing to follow instructions for incision care as instructed by the investigator, and refrain from swimming or soaking in a tub until suture removal occurs (during the first 12-25 days) of the study;
* Agree to return for all follow-up evaluations specified in this protocol \[7 days (± 1 day), 12 - 25 days, and 90 days (± 10 days)\], six (± 1 month) and twelve months (± 1 month)\];
* Agree not to schedule any additional elective surgical procedures that involve an incision that is randomized for inclusion in this study, until their participation in this study is complete; and
* Sign the informed consent.

Exclusion Criteria:

* Have peripheral vascular disease;
* Have insulin dependent diabetes mellitus;
* Be known to have a blood clotting disorder;
* Be receiving antibiotic therapy for pre-existing condition or infection;
* Be known to be HIV-positive or otherwise immunocompromised;
* Have known personal or family history of keloid formation or hypertrophy;
* Be currently taking systemic steroids;
* Have known or suspected allergy or sensitivity to cyanoacrylate, formaldehyde, tapes or adhesives
* Have incision type or location known to have an incidence of cyanosis or other healing abnormalities; and
* Be participating in any current clinical trial of an investigational product or have participated in any clinical trial of an investigational product within 30 days of enrolment in this study.
Scarpa´s Fascia in the Formation of Seroma Post Abdominoplasty After Bariatric Surgery

46 female postbariatric patients will be submitted to anchor-line abdominoplasty with drains insertion. Patients will be randomized to two groups. One group will have the Fascia Scarpa removed and in the other the Fascia Scarpa will be preserved. The drains will be removed when the volume is less than 30 ml in 24 hours. The primary outcome will be the volume of total drainage obtained in the drains of the abdominal region. Secondary outcomes will be the length of time the drains remain and the presence of seroma assessed by ultrasound on the twentieth postoperative day.

Morbid obesity has been increasing in Brazil and the world and bariatric surgery is the most effective and long-lasting treatment. This leads to large weight losses leading to large body deformities due to excess skin and subcutaneous tissue. The most common post-bariatric plastic surgery is post-bariatric abdominoplasty which main complication is seroma. PURPOSE: To evaluate the effect of Scarpa fascia preservation in seroma reduction. METHODS: A total of 46 patients were randomly assigned to two groups. One group will have the Fascia Scarpa removed and in the other the Fascia Scarpa will be preserved. The drains will be removed when the volume is less than 30 ml in 24 hours. The primary outcome will be the volume of total drainage obtained in the drains of the abdominal region. Secondary outcomes will be the length of time the drains remain and the presence of seroma assessed by ultrasound on the twentieth postoperative day.

Eligibility Criteria:
Inclusion Criteria:

* BMI between 22 and 30 Kg/m2
* Female post-bariatric patient

Exclusion Criteria:

* neoplasms
* Diabetes
* lymphatic system diseases
* abdominal scars except C section and bariatric surgery scars
* mental disorders
Treatment of Oral Warts in HIV+ Patients

This is a study to test lozenges of interferon-alpha that are dissolved in the mouth as a treatment of oral warts in HIV-positive adults.

The hypothesis of this study is that interferon-alpha will be safe and that a higher percentage of subjects given interferon-alpha will experience a complete or nearly complete remission of their oral warts compared to subjects given placebo.

Human papilloma virus (HPV) can cause warts to form in the mouth of infected patients, particularly those with reduced immunity such as people infected with HIV. This is a randomized, double-blind, placebo-controlled trial to determine whether interferon-alpha, delivered in low doses via orally dissolving lozenges, can reduce or eliminate these warts in HIV+ subjects who are receiving combination anti-retroviral therapy (HAART). All potential subjects will have their warts examined and measured at a screening visit. A small amount of one wart (i.e. a biopsy) will be removed for microscopic evaluation to confirm HPV infection and a small amount of blood will be collected for testing. Subjects that qualify for entry will return for a baseline visit at which they will be randomized to active or placebo treatment for 24 weeks. Three out of four subjects will receive active treatment in this study. Subjects must return to the clinic every 6 weeks during treatment to have their warts re-examined. At these follow-up visits, subjects will be asked to complete a brief questionnaire regarding any perceived changes in their warts and their overall mouth condition. A small amount of blood will be taken at the final study visit at week 24 to assess the safety of the interferon lozenges.

Eligibility Criteria:
Inclusion Criteria:

* Must have tested positive for HIV.
* Must have two or more warts inside the mouth.
* Must be receiving a standard course of anti-retroviral therapy (HAART).

Exclusion Criteria:

* Must not be receiving oral or injected steroids.
* Must not be taking other drugs for treatment of oral warts.
* Must not have other active HIV-related opportunistic infections.
Living With Multimorbidity: CO-ORDINATE Program

Multimorbidity is common and is the coexistence of two or more chronic conditions in the same individual. People with multimorbidity suffer from a high symptom burden, directly affecting quality of life (QOL). Hospitalization can be a window of opportunity to initiate interventions to promote recovery and resilience and enhance QOL. However, interventions targeting the symptom trajectory and burden of patients with multimorbidity are lacking. Thus, the investigators envisage a nurse-led pre-discharge intervention augmented by telephone support, focusing on care coordination and symptom management. This approach is anticipated to help reduce symptom burden and improve QOL.

Aim 1: Describe the symptom trajectory and burden from the perspectives of patients, family caregivers, and health professionals and collectively develop a symptom management toolkit; and

Aim 2: Refine and pilot test the nurse-driven symptom management toolkit/intervention to decrease the symptom burden and increase the QOL of critically ill adults with multimorbidity.

Interventional study (Aim 2):

The study aims to test the feasibility of the Care cOORDInatioN and sympTom managEment (COORDINATE) intervention developed from Aim 1 using an experienced-based co-design methodology. A single-arm feasibility study will be implemented with assumptions on the effectiveness of the COORDINATE intervention on outcomes such as symptom burden and quality of life will be evaluated.

Sample and Setting:

Individuals aged 55 years and older, living with two or more chronic health conditions, and willing to provide informed consent will be included in the study. The exclusion criteria include if participants cannot speak English or have a documented cognitive impairment that would prevent participation. Patients will be approached in the Intermediate Care Unit (IMCU) of an academic teaching hospital while the participants are in-patient before discharge.

Intervention Components and Timing:

The intervention consists of four components- i) needs assessment; ii) question prompt list; iii) goals discussion and; iv) symptom assessment and tracking. The intervention will start with the enrolment of a patient living with multimorbidity. The intervention consists of one in-person pre-discharge visit by the study team and four follow-up telephone calls (at 48 hours, 1 week, 4 weeks, and 6 weeks post-discharge).

Primary Outcomes

1. Symptom Burden
2. Quality of Life

Eligibility Criteria:
Inclusion Criteria:

* English speakers who are planned for discharge from Johns Hopkins Hospital (JHH) IMCU
* Who meet the criteria for being admitted to IMCU and planned discharge with multimorbidity as defined by two or more chronic conditions.

Exclusion Criteria:

* Who can not provide informed consent or have documented cognitive impairment
Isolated Deficits of the Lateral Semicircular Canal

There are only a few cases of isolated lateral canal deficit described in the literature. This study would focus on this group of patients in order to establish an evolving profile, a recovery behavior that we could compare to that in the literature.

In addition, the evolving profile as well as the other clinical criteria identified would allow investigators to make hypotheses as to the pathology responsible for a given evolutionary profile.

The population studied is represented by adult patients admitted by the emergency consultation service of otolaryngology of the University Hospitals of Strasbourg for an acute unilateral vestibular deficit whose examination at the VHOT shows a reduced and isolated gain of a lateral semicircular canal.


Eligibility Criteria:
Inclusion criteria

* Major patient
* Man or woman
* Patient who has given their consent to the use of their data.
* Patient treated in the ENT department for dizziness between June 2020 and July 2021.

Non-inclusion criteria

* Patient who expressed his opposition to participating in the study
* Inability to provide the subject with enlightened information (difficulties in understanding the subject, cognitive disorders)
* Subject under safeguard of justice
* Subject under guardianship or guardianship
* Neurological signs on clinical examination
Single vs Double Symphyseal Plating in Management of Vertically Unstable Open Book Pelvic Ring Injuries:

compare functional, radiological outcomes, implant failure and the incidence of recurrent diastasis of single superior symphyseal plate versus double plating in management of vertically unstable open book injuries

The real algorithm was the necessity for double superior \& anterior plating versus single superior symphyseal plate in management of APC III pelvic ring injuries, whether the incidence of intraoperative and short-term postoperative complications, recurrent diastasis, radiological and functional outcomes differed between these two methods. Our hypothesis was that the use of an additional anterior symphyseal plating could provide a more rigid fixation, with less complications of recurrent diastasis or implant failure. Also it will be applied through the same incision without increasing the patient overall morbidity.

Eligibility Criteria:
Inclusion Criteria:

* Anterior ring symphyses diastasis
* Tile C pelvic ring injuries
* Age between 16-60 years' old

Exclusion Criteria:

* Tile B pelvic ring injuries
* Isolated bony fractures of the anterior pelvic ring
* Open fractures
* Age less than 14 years and older than 60 years
* Associated internal organ injuries that require definitive intervention
Safety Study of CDP7657 in Healthy Volunteers and Patients With Systemic Lupus Erythematosus (SLE)

To evaluate safety, tolerability, pharmacokinetics and immunogenicity of CDP7657


Eligibility Criteria:
Inclusion Criteria:

* Healthy Volunteers and subjects with SLE

Exclusion Criteria:

* Severe neuropsychiatric or severe renal SLE
* History of chronic, recurrent, or recent severe infection
* Significant hematologic abnormalities
* History of cancer, heart failure, renal disease, liver disease or other serious illness
Comparing of the Pharmacokinetic, Safety and Immunogenicity of HS-20090-2 Injection and Prolia® in Healthy Adults

A randomized, single-blind and parallel group study to compare the pharmacokinetic, safety and immunogenicity of HS-20090-2 60mg#1ml#and Prolia® in healthy adults.

This is a phase I, single center, randomized, single-blind and parallel group clinical trial .The primary objective is to assess the pharmacokinetic similarity of single subcutaneously injection of HS-20090-2 or Prolia® in healthy volunteers.The secondary objectives are to assess the Clinical safety and immunogenicity similarity of single subcutaneously injection of HS-20090-2 or Prolia® in healthy volunteers.

Eligibility Criteria:
Inclusion Criteria:

1. Sign the informed consent form and fully understand the test content, process and possible adverse reactions, and be able to complete the study according to the test plan requirements;
2. Healthy males, Aged ≥18 years or ≤50 years old(including the boundary value);
3. Agree to take effective contraceptive measures throughout the study period until at least 6 months after the last drug is administered;
4. Clinical laboratory examination, chest X-ray, abdominal B-ultrasound, electrocardiogram, physical examination, vital signs and various examinations are normal or abnormal without clinical significance.

Exclusion Criteria:

1. Occurred or suffering from osteomyelitis or ONJ (mandibular necrosis) previously; The dental or jaw disease that is active, requiring oral surgery; or planned for invasive dental surgery during the study; or dental or oral surgery wounds have not healed;
2. Serum calcium levels are outside the normal range of the laboratory.
3. Subject has positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result viral hepatitis (including hepatitis B and hepatitis C), or positive HIV antibodies, or positive test for syphilis.
4. The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 3 months or 5 half-lives (whichever is longer).
5. Prior use of medications within 12 months before and during the study. This includes medications such as, but not limited to: Bisphosphonates Fluoride Calcitonin Strontium Parathyroid hormone or derivatives Supplemental vitamin D (\>1000 IU/day) Glucocorticosteroids (topical corticosteroids administered more than 2 weeks prior to enrolment are allowed) Anabolic steroids Calcitriol Diuretics