cyrilzakka/clinical-trials huggingface dataset:
A Study of Herceptin (Trastuzumab) in Combination With 2nd-Line Chemotherapy in Patients With HER2 Positive Metastatic Breast Cancer.

This 2 arm study will compare the efficacy and safety of continuation or discontinuation of Herceptin treatment in combination with 2nd line chemotherapy, in patients with HER2 positive metastatic breast cancer whose condition has progressed on 1st line chemotherapy plus Herceptin. Patients will be randomized either to continue or discontinue Herceptin treatment (6mg/kg iv infusion every 3 weeks) while receiving second-line chemotherapy of the investigator's choice. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.


Eligibility Criteria:
Inclusion Criteria:

* female patients, \>= 18 years of age;
* metastatic breast cancer;
* HER2 overexpression (IHC 3+ and/or FISH positive);
* disease progression during or after previous 1st line chemotherapy + Herceptin;
* scheduled to receive 2nd line chemotherapy.

Exclusion Criteria:

* concurrent immunotherapy or hormonal therapy;
* anthracyclines as part of previous 1st line chemotherapy or planned 2nd line chemotherapy;
* cardiac toxicity during previous 1st line chemotherapy + Herceptin;
* history of other malignancy within last 5 years.
Aspiration of Subglottic Secretions Using Hi-Lo Evac Endotracheal Tube: Tube Size and Incidence of Suction Lumen Dysfunction

To evaluate the correlation between endotracheal tube size and incidence of dysfunction of suction lumen of Hi-Lo Evac endotracheal tube in critically ill patients who required mechanical ventilation for more than 48 hours.

In mechanically ventilated patients, aspiration of subglottic secretions is a widely used intervention for prevention of ventilator-associated pneumonia. Using Hi-Lo® Evac endotracheal tube (Hi-Lo Evac; Mallinckrodt; Athlone, Ireland), dysfunction of suction lumen and subsequent failure to aspirate the subglottic secretions is not uncommon. The objective of this prospective observational study is to determine the causes and the incidence of suction lumen dysfunction of Evac endotracheal tube.

Eligibility Criteria:
Inclusion Criteria:

* Critically ill patients with orotracheal intubation and anticipated duration of intubation more than 48 hours
Intra-Anally Administered Artesunate in Patients With High-Grade Anal Intraepithelial Neoplasia (AIN 2/3)

This open label study investigates a novel non-surgical approach to the treatment of HPV-associated anal intraepithelial neoplasia, using Artesunate suppositories.

Patients diagnosed with AIN 2/3 will be enrolled sequentially in treatment cohorts receiving different doses of Artesunate suppositories administered trans-anally. Doses of escalation will be 200 mg, 400 mg, and 600 mg. Treatment cohorts will consist of 2 or 3 cycles at each dose level. Suppositories will be administered daily for 5 days. Five days constitutes 1 cycle. Up to 3 cycles will be administered at Weeks 0, 2, and 4.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Biopsy-confirmed high-grade anal dysplasia (AIN 2, AIN 3, HSIL) by high resolution anoscopy (HRA)
* Female of childbearing potential: negative urine pregnancy test
* Able to provide informed consent
* Patients who have the ability to collaborate with planned follow-up (transportation, compliance history, etc.).
* Weight ≥50 kg.

Exclusion Criteria:

* Diagnosis of low-grade anal dysplasia (AIN 1, LSIL) by high resolution anoscopy
* Known anal, vulvar, cervical, or penile cancer
* CD4 count \< 200 at the time of consideration for entry into this study
* Unable to provide informed consent
* Currently receiving systemic chemotherapy or radiation therapy for another cancer.
* Patients who are on medical treatment with systemic immunosuppressants or steroids (e.g., active autoimmune disease)
* Extensive anal condyloma precludes the ability for the clinician to visualize HSIL during HRA
A Single-portal Endoscopic Approach Through Subcutaneous Tunnel for Carpal Tunnel Release

Traditional endoscopic release directly accesses the carpal tunnel and thus carries a higher risk of nerve irritability, even nerve injury. Based on our anatomical study, the investigators developed a new endoscopic technique through a single-portal palm approach that passes superficially to palmar aponeurosis, and cut the full transverse carpal ligament. The investigators will compared the technique with the standard dual-portal endoscopic technique.

Conduct a multi-center, comparison clinical trial according to clinical Trial Reporting Standards (CONSORT). Patients in the single-portal group were treated with a single-portal palm approach that passes superficially to palmar aponeurosis and cut the full transverse carpal ligament. The comparison group were treated with Chow endoscopic technique. In order to assess efficiency of single-portal palm approach, the investigators will compared the technique with the standard dual-portal endoscopic technique. The study was approved by Shenzhen People's Hospital and informed consent was signed.

Eligibility Criteria:
Inclusion Criteria:

* A confirmed diagnosis of carpal tunnel syndrome based on Evidence for Surgical Treatment issued by the British Society for Surgery of the Hand
* Symptoms of carpal tunnel syndrome had lasted\>2 months or inadequate responses to the non-surgical treatments≥3 months
* moderate to severe symptoms.

Exclusion Criteria:

* mild symptoms or prior injuries to the extremity
* bilateral wrists involved, a combined nerve compression, gout, diabetes or chronic renal failure.
Internet-based Self-help for Negative Life Events

The purpose of the study is to investigate the efficacy of an internet-based self-help intervention for dealing with stressful life events.

The purpose of the study is to investigate the efficacy of an internet-based self-help intervention for dealing with stressful life events compared to a waiting list, in a randomized controlled trial design. Assessments are at baseline, 4-week and 3 months post-randomization. After 4 weeks, participants in the waiting control group get also access to the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Negative life event in a period between two weeks and two years before the study
* Internet account
* Sufficient German language skills
* Informed consent

Exclusion Criteria:

* Persons with moderate or severe depressive symptoms
* Acute suicidality
* Psychotic disorder, bipolar disorder
* Severe, acute mental or physical disorder
DOvEE - Diagnosing Ovarian & Endometrial Cancer Early

This study hopes to improve early detection of ovarian and endometrial cancers. It will determine if women with bloating, abdominal distension, abdominal/pelvic pain, increased urinary frequency and/or early satiety, benefit from earlier surgery after screening by CA-125 ovarian cancer biomarker and transvaginal ultrasound.


Eligibility Criteria:
Inclusion Criteria:

1. Sign an approved informed consent form (ICF).
2. Be ≥ 45 years of age.
3. Have at least one symptom outlined in below for a period of ≥2 weeks but ≤ 1 year:

   * Feeling full after eating only a few bites, loss of appetite
   * Diarrhea, constipation, bowel or rectum feels full, change in bowel habits, constant urge to have a bowel movement, painful or burning bowel movements, rectal pain, painful defecation
   * Bloating, distension of abdomen, clothes around the waist feel too tight, feel an abdominal mass
   * Weight loss not because of dieting
   * Nausea, vomiting, heartburn, gas, burping, indigestion
   * Increased urinary frequency, need to urinate urgently, pressure on the bladder, leaking urine, burning sensation when urinating, need to urinate but unable to do so, unable to empty bladder completely, feeling full after urinating
   * Vaginal discharge, bleeding, spotting, deep pain on intercourse
   * Discomfort or pain in abdomen, or pelvic region, or lower back
4. Subjects must be willing to comply with study protocol

Exclusion Criteria:

1. Previous bilateral salpingo-oophorectomy (BSO)
2. Previous diagnosis of cancer in the ovaries, fallopian tubes, or peritoneum
3. Current bleeding per rectum, not due to haemorrhoids
4. Current frank haematuria
5. Symptoms that suggest the need for urgent clinical evaluation outside of a research protocol
Identification of Drug-drug Interaction Between Tacrolimus and Mycophenolate Mofetil in Healthy Adults

Coadministration of tacrolimus and mycophenolate mofetil is frequent in kidney transplantation. Due to narrow therapeutic range of tacrolimus and mycophenolate mofetil, therapeutic drug monitoring with dose adjustment is required. Investigating pharmacokinetic interplay between two drugs enables fine dose adjustment, while mechanism of drug interaction between two drugs is still not well understood. Therefore, an open-label, three period, single dose trial is planned to investigate the drug interaction between tacrolimus and mycophenolate mofetil.

Study consists of three periods with fixed sequence: 1) single dose of mycophenolate mofetil 1,000mg; 2) single dose of tacrolimus 5mg; 3) single dose of mycophenolate mofetil 1,000mg and tacrolimus 5mg. All subjects have one week of washing period between single dose administration. Blood samples are drawn up to 72 hours after drug administration. Single nucleotide polymorphisms known to result in pharmacokinetic variability of study drug are also investigated. Drug interaction is going to be assessed through the ratio of area under the concentration curve of one drug in the presence or absence of another drug.

Eligibility Criteria:
Inclusion Criteria:

* Male adult with age of 19-45
* Weight difference between ideal and actual body weight is less than 20%
* Previous healthy with no known disease
* Considered normal on physical exam, clinical laboratory tests(complete blood count, electrolyte, renal and hepatic function) and electrocardiogram
* Never been heavy-drinker within one month prior to trial initiation and able to abstain from alcohol during trial

Exclusion Criteria:

* Ever smoked within one year prior to trial initiation
* Took other drugs (including herbal medicine) within one month prior to trial initiation
* Alcohol or drug abuser
* Participated another clinical trial within three months
* Considered inadequate under investigator's discretion
PAtient NOtifier Feature for Reduction of Anxiety

This study is intended to look at the effect of the SJM vibrating Patient Notifier™ system, which will warn the patient of possible failures of the implanted system, on reducing patient device related anxiety


Eligibility Criteria:
Inclusion Criteria:

* Patient has recently (min. 2 weeks - max. 14 weeks) been implanted with an SJM ICD with the Patient Notifier™ feature;
* Patient is willing and able to independently comprehend and complete the study-related questionnaires;
* Patient has signed the study specific informed consent form.

Exclusion Criteria:

* have already had a Patient Notifier™ alert since implant;
* had a prior device implant (PM or ICD);
* have not been discharged from the hospital since device implant;
* have evidence of psychosis, dementia or cognitive impairment as documented in the patients' hospital records;
* cannot commit to the follow-up schedule;
* have a life expectancy of less than 1 year;
* are on a waiting list for a heart transplant;
* are less than 18 years old;
* are pregnant;
Effect of Shockwave Therapy on Low Back Pain in Primary Dysmenorrhea

Primary dysmenorrhea (PD), defined as menstrual pain without any structural lesions, usually begins shortly before or immediately after the onset of the menstrual cycle and commonly lasts for 48 to 72 hour

Dysmenorrhea is one of the most common gynecological conditions in women. Primary dysmenorrhea (PD), defined as menstrual pain without any structural lesions, usually begins shortly before or immediately after the onset of the menstrual cycle and commonly lasts for 48 to 72 hour. It is accompanied by general symptoms, such as nausea and vomiting, malaise, weakness, lower backache, and diarrhea. In ovulatory cycles, women secrete high levels of or have increased sensitivity to prostaglandins. These prostaglandins may stimulate myometrial contractions and sensitize pain fibers, and thus induce pelvic pain.

Females of reproductive age often suffer from dysmenorrhea, a painful condition. Despite dysmenorrhea being generally considered a benign condition, a significant disability can result from it. Researchers suggest that dysmenorrhea has been linked to migraines, headaches, and fibromyalgia, among other painful disorders. The authors reported further evidence that dysmenorrhea can alter noxious sensory processing.

Primary dysmenorrhea usually begins six to 12 months after menarche and is characterized by spasmodic cramping pain in the lower abdomen that can radiate to the lower back and anterior or inner thighs. The pain usually has a clear temporal pattern: it begins a few hours before or at the start of menstruation, is most intense at onset, gradually waning over two to three days.

The purpose of this study was to investigate the effectiveness shockwave therapy on low back pain in primary dysmenorrhea.

Eligibility Criteria:
Inclusion Criteria:

* Their ages ranged from 18 to 30 years.
* Their BMI were not exceeding 29 Kg/m2.
* All patients were clinically diagnosed as low back pain during Primary Dysmenorrhea according to the Primary Dysmenorrhea Consensus Guideline

Exclusion Criteria:

* Any known chronic disease (such as cardiovascular or renal diseases) or secondary dysmenorrhea.
* Being pregnant or planning to get pregnant any time during the trial.
* Having received other treatments for PD in the past half year.
* Irregular menstrual cycles.
* Mental or neurological disorder
The Combination of Iguratimod and Danazol as the Treatment of Steroid-resistant/Relapse Immune Thrombocytopenia

Randomized, open-label, multicenter study to compare the efficacy and safety of combination of iguratimod and danazol versus danazol for the treatment of adults with steroid-resistant/ relapse immune thrombocytopenia (ITP).

The investigators are undertaking a parallel group, multicenter, randomized controlled trial of 100 adults with steroid-resistant/ relapse ITP in China. Patients were randomized to Iguratimod plus danazol and danazol monotherapy group. Platelet count, bleeding and other symptoms were evaluated before and after treatment. Adverse events are also recorded throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* Primary immune thrombocytopenia (ITP) confirmed by excluding other supervened causes of thrombocytopenia;
* Platelet count of less than 30×109/L at enrollment;
* Patients who did not achieve a sustained response to treatment with full-dose corticosteroids for a minimum duration of 4 weeks or who relapsed during steroid-tapering or after its discontinuation;
* 18 years older;

Exclusion Criteria:

* Secondary immune thrombocytopenia (e.g., patients with HIV, HCV, Helicobacter pylori infection or patients with systemic lupus erythematosus)
* Congestive heart failure
* Severe arrhythmia
* Nursing or pregnant women
* Aspartate aminotransferase and alanine transaminase levels ≥ 3× the upper limit of the normal threshold criteria
* Creatinine or serum bilirubin levels each 1•5 times or more than the normal range
* Active or previous malignancy
* Unable to do blood routine test for the sake of time, distance, economic issues or other reasons.
Safety Study of Replagal® Therapy in Children With Fabry Disease

The purpose of this study is to assess the safety of Replagal in children with Fabry disease who who have not previously been treated with enzyme replacement therapy (ERT).

In 2008, a change in the agalsidase alfa drug substance manufacturing process was made. There are no changes to the drug product formulation, manufacturing site, manufacturing process, or container closure.

An agalsidase alfa bioreactor manufacturing process (agalAF1) utilizing animal component-free media replaced the previous roller bottle (RB) process.

This study will evaluate the safety of Replagal AF, manufactured using the new bioreactor process at a dose of 0.2 mg/kg infused IV over 40 minutes, every other week (EOW) in children with Fabry disease who are 7 years to less than 18 years of age and who are naive to ERT.

Eligibility Criteria:
Inclusion Criteria:

Patients must meet all of the following criteria to be enrolled in this study.

1. All patients must be diagnosed with Fabry disease by the following criteria:

   * Male Patients: The patient is a hemizygous male with Fabry disease as confirmed by a deficiency of alfa-galactosidase A activity measured in serum, leukocytes, or fibroblasts or has a confirmed mutation of the alfa-galactosidase-A gene.
   * Female Patients: The patient is a heterozygous female with Fabry disease as confirmed by a mutation of the alfa-galactosidase A gene.

   Note: If the diagnosis of Fabry disease is previously documented in the patient's medical record, screening tests do not need to be repeated.
2. The patient is 7 to \<18 years of age
3. The patient is ERT-naïve
4. Adequate general health (as determined by the Investigators) to undergo the specified phlebotomy regimen and protocol-related procedures and no safety or medical contraindications for participation
5. The minor child must assent to participate in the protocol and the parent(s) or legally authorized representative(s) must have voluntarily signed an Institutional Review Board/Independent Ethics Committee (IRB/IEC) approved informed consent form after all relevant aspects of the study have been explained and discussed with the child and the child's parent(s) or legally authorized representative(s)

Exclusion Criteria:

Patients who meet any of the following criteria will be excluded from the study.

1. Patient and/or the patient's parent(s) or legally authorized representative(s) are unable to understand the nature, scope, and possible consequences of the study
2. Patient is unable to comply with the protocol, eg, uncooperative with protocol schedule, refusal to agree to all of the study procedures, inability to return for evaluations, or is otherwise unlikely to complete the study, as determined by the Investigator or the medical monitor.
3. Otherwise unsuitable for the study, in the opinion of the Investigator.
Perspectives on Bone Marrow Donors Who Donate for Their Parent

The purpose of this pilot study is to explore the role of family function on decision-making for bone marrow donors who donated for their parent, and to assess the unique supportive care needs of these participants. Semi-structured interviews were conducted with participants to identify overarching themes of the donation experience.


Eligibility Criteria:
Inclusion Criteria:

* Donated bone marrow or peripheral blood stem cells for their parent in the past 1-6 months
* Willing to participate in mandatory audio recorded telephone interview
* Able to participate in interview without assistance
* Must be English speaking
* Transplant recipient (parent) must be living

Exclusion Criteria:

* Unable to provide oral consent for participation (for minors- unable to obtain parental consent and/or oral assent from child for participation)
COrticosteroids in acUte uRticAria in emerGency dEpartment

To demonstrate the non-inferiority of the efficacy of a single antihistamine in comparison with an association of antihistamine and corticosteroid in the treatment of acute urticaria in emergency departments

Acute urticaria (hives) is a common skin disease. The prevalence of acute urticaria in life is about 15 to 20% in the general population. It is responsible for a frequent use of emergency departments (ED). The usual treatment is based on early administration of an association of antihistamines and corticosteroid. The therapeutic efficacy of corticosteroids has never been established by high evidence studies. However, corticosteroids are frequently used. When stopped, corticosteroids could promote the occurence of urticaria recurrences, and a transition to chronic urticaria. In addition, corticosteroids may be rarely responsible for gastrointestinal bleeding, hypertension and diabetes.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Isolated acute urticaria (acute hives): spontaneous urticaria, inducible urticaria
* Acute urticaria with angioedema without laryngeal edema
* Obtain patient's consent
* Social security affiliation

Exclusion Criteria:

* Pregnancy or breastfeeding
* Acute hives with anaphylaxis
* Bradykinin angioedema
* Angioedema without urticaria (hives)
* Laryngeal edema with urticaria (hives)
* Corticosteroid administration in the previous 5 days visiting the emergency department
* Antihistamines greater than 1 tablet per day in the previous 5 days visiting the ED
* Other treatment for urticaria : omalizumab, montelukast, ciclosporin A
* Chronic urticaria before acute urticaria diagnosis
* Atopic dermatitis
* Eczema
* Bullous pemphigoid
* Acute exanthematous pustulosis
* Diabetes mellitus
* Gastrointestinal ulcer
* Refusal to participate
* Known allergy to the study drugs or formulation ingredients
* Known Renal failure defined by creatinine clearance \< 10 mL/min or cardiac failure defined by ejection fraction \< 40%.
* Corticoid use in 5 days prior to randomisation
* Contra-indication to corticotherapy:
* Any live vaccine
* Psychotic states still uncontrolled by treatment limiting the participant's compliance with the research
Special Access Program IMVAMUNE®

Prophylactic smallpox vaccination for personnel actively working with or in the vicinity of replicating vaccinia virus


Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects, aged 18-65 years, who will work with or in the vicinity of a replicating vaccinia virus and who volunteer for the program. Subjects may be vaccinia-naïve or vaccinia-experienced.
* Women of child-bearing potential (WOCBP) must have a negative urine pregnancy test within 48 hours prior to vaccination.
* WOCBP must have used an acceptable method of contraception for at least 30 days prior to the first vaccination and must agree to use an acceptable method of contraception during the vaccination period until at least 28 days after the last vaccination. A woman is considered of child-bearing potential unless post-menopausal or surgically sterilized. (Acceptable contraception methods are restricted to barrier contraceptives which include Food and Drug Administration (FDA)-approved spermicides, intrauterine contraceptive devices, or licensed hormonal products.)
* Read, signed and dated Informed Consent Form.

Exclusion Criteria:

* Pregnant or breast-feeding women.
* Uncontrolled serious infection i.e., not responding to antimicrobial therapy.
* History of or active autoimmune disease. Persons with vitiligo or thyroid disease taking thyroid replacement are not excluded.
* Known or suspected impairment of immunologic function including, but not limited to, clinically significant liver disease; uncontrolled diabetes mellitus; moderate to severe kidney impairment or post organ transplant subjects.
* History of malignancy, other than squamous cell or basal cell skin cancer, unless there has been surgical excision that is considered to have achieved cure.
* History of coronary heart disease, myocardial infarction, angina, congestive heart failure, cardiomyopathy, stroke or transient ischemic attack, uncontrolled high blood pressure, or any other heart condition under the care of a doctor.
* History of allergies or reactions to eggs, egg products, or gentamycin.
* Having received any vaccinations or planned vaccinations with a live vaccine within 28 days or a killed vaccine within 14 days prior to or after IMVAMUNE®vaccination.
* Chronic administration (defined as more than 6 days) of systemic corticosteroids within 30 days of the first planned vaccination.
* Use of any investigational or non-registered drug or vaccine other than IMVAMUNE® within 30 days preceding the first vaccine dose.