cyrilzakka/clinical-trials huggingface dataset:
Polyethylene Glycol Interferon Alfa-2b (PEG Intron) Versus Interferon Alfa-2b (INTRON^® A) in the Treatment of Newly Diagnosed Chronic Myelogenous Leukemia (CML) (C98026)

The primary purpose of this study is to compare the efficacy of polyethylene glycol (PEG; pegylated) interferon alfa-2b (PEG Intron, C98026) versus interferon alfa-2b (Intron® A) in the treatment of participants with newly diagnosed CML.


Eligibility Criteria:
Inclusion Criteria

* Has chronic phase CML diagnosed within 3 months prior to study enrollment
* Has chronic phase CML positive for Ph\^1 as confirmed by cytogenetic studies, performed by a central laboratory
* Has platelet count \>/= 50,000/microl
* Has hemoglobin \>/= 9.0 g/dL
* Has WBC count \>/=2000/microl but \</= 50,000/microl
* Has adequate hepatic and renal function, as defined by the following parameters obtained within 14 days prior to initiation of study treatment

  * serum glutamic oxaloacetic transaminase (SGOT) \<2 times upper limit of laboratory normal (ULN)
  * serum glutamic pyruvic transaminase SGPT \<2 times upper ULN
  * serum bilirubin \<2 times ULN
  * serum creatinine \<2.0 mg/dL
* Is fully recovered from any prior major surgery and must be at least 4 weeks postoperative
* Has Eastern Cooperative Oncology Group Performance Status of 0-2
* Has signed a written, voluntary informed consent before study entry, is willing to participate in this study, and is willing to complete all follow-up assessments

Exclusion Criteria:

* Has accelerated phase CML as defined by any of the following criteria.

  * peripheral blood myeloblasts \>/=15%
  * peripheral blood basophils \>/= 20%
  * peripheral blood myeloblasts plus promyelocytes \>/=30%
  * platelets \<100,000/microl, unrelated to therapy
* Has blastic phase CML (30% myeloblasts in peripheral blood or bone marrow)
* Is a candidate for and is planning to receive allogeneic, syngeneic, or autologous bone marrow transplantation within the next 12 months
* Has received prior treatment for their CML, except for hydroxyurea (collection of stem cells without using high dose chemotherapy for mobilization is acceptable)
* Has severe cardiovascular disease (i. e., arrhythmias requiring chronic treatment, congestive heart failure \[New York Heart Association (NYHA) Class III or IV\], or symptomatic ischemic heart disease)
* Has a history of a neuropsychiatric disorder requiring hospitalization
* Has thyroid dysfunction not responsive to therapy
* Has uncontrolled diabetes mellitus
* Has a history of seropositivity for human immunodeficiency virus
* Has active and/or uncontrolled infection, including active hepatitis
* Has a medical condition requiring chronic systemic corticosteroids
* Has a history of prior malignancies within the last 5 years, except for surgically cured non-melanoma skin cancer, or cervical carcinoma in situ
* Has received any experimental therapy within 30 days prior to enrollment in this study
* Is known to be actively abusing alcohol or drugs
* Is pregnant, nursing, or of reproductive potential and is not practicing an effective means of contraception
A Study Evaluating Safety and Tolerability of YM150 Compared to Warfarin in Subjects With Atrial Fibrillation

The purpose of this study is to investigate the optimal daily dose and dose regimen of YM150 in subjects with non-valvular atrial fibrillation (NVAF), primarily based on safety and tolerability data.


Eligibility Criteria:
Inclusion Criteria:

* Subject with paroxysmal, permanent or persistent Nonvalvular Atrial Fibrillation (NVAF)
* Subject has prothrombin time international normalized ratio (INR) of 2.0 or below at the baseline visit

Exclusion Criteria:

* Subject has current or recent (within 12 months prior to screening) history of stroke and/or systemic embolism (including TIA)
* Subject has active bleeding or any condition associated with increased risk of bleeding
* Subject has NVAF secondary to other reversible disorders (e.g. thyrotoxicosis)
* Subject has an indication for warfarin other than AF (including planned cardioversion)
* Subject has had a diagnosis of Acute Coronary Syndrome (ACS), coronary artery bypass graft (CABG) or percutaneous transluminal coronary angioplasty (PTCA) within previous 3 months of screening
* Subject has a diagnosis of left ventricular aneurysm or atrial myxoma
* Subject requires use of prohibited previous and concomitant medication (i.e., thrombolytics \[such as tissue Plasminogen Activator (tPA), streptokinase\], antiplatelet agents \[such as cilostazol, clopidogrel, ticlopidine, dipyridamole\], anticoagulants \[such as vitamin K antagonists, heparin, unfractionated or low molecular weight heparin, fondaparinux, thrombin inhibitors\] and chronic use of nonsteroidal anti-inflammatory drugs \[NSAIDs\] or acetylsalicylic acid use of \>100 mg/day). (see Section 5.1.3 and Appendix 1 for details)
* Subject has active infective endocarditis
* Subject is planned for invasive procedures with potential for bleeding
* Subject has participated in another clinical trial of an investigational drug (including placebo) or device within 30 days (or the limit set by national law, whichever is longer) of signing informed consent for the present study
* Subject has participated in any YM150 clinical trials
Analgesic Efficacy of Saphenous Nerve Blockade for Outpatient Knee Anterior Cruciate Ligament Surgery

The purpose of this study is to determine whether blockade of the saphenous nerve can provide the same degree of analgesia postoperatively for ACLS as a femoral nerve block without resulting motor blockade enhancing shortening of hospital stay en functional outcome.


Eligibility Criteria:
Inclusion Criteria:

* age 18-65 years
* ASA status I - III
* rupture of the anterior cruciate ligament.

Exclusion Criteria:

* contraindication for regional anesthesia
* allergy against local anesthetics
* BMI \> 35
* pre-existing diagnosed neuropathy of the operated leg
* ingestion of strong opioids
* pregnancy or breastfeeding status
* History of significant cardiovascular disease (MI, CVA, peripheral vascular disease)
A Study of Neutropenia and Anemia Management in Patients With Solid Tumors Receiving Myelotoxic Chemotherapy

The primary objective was to describe the incidence of febrile neutropenia based on granulocyte-colony stimulating factor (G-CSF) use (primary, secondary, treatment, or no usage) in patients receiving myelotoxic chemotherapy.

This is a multi-center international observational study of patients receiving myelotoxic regimens, with an investigator assessed risk of febrile neutropenia ≥ 20%, for the treatment of solid tumors (breast, ovarian and lung).

This is an observational study in which patient risk factors were qualitatively (but not quantitatively) assessed, and adherence to G-CSF primary prophylaxis was at the discretion of physicians and not mandated by the protocol.

Eligibility Criteria:
Inclusion Criteria:

* Subjects greater than or equal to 18 years old with breast, ovarian or lung cancer receiving chemotherapy in any schedule, e.g. dose dense or standard chemotherapy.
* These subjects must have an Investigator assessed risk of febrile neutropenia (FN) ≥20% (based on 2006 European Organisation for Research and Treatment of Cancer (EORTC) G-CSF Guidelines

Exclusion Criteria:

- Subjects with concurrent administration of radiotherapy are not eligible (previous radiotherapy is permitted if terminated at least 2 weeks prior to commencing applicable chemotherapy in this study).
A Safety Follow Up Study in Australian Subjects Implanted With the SMF Short Modular Femoral Stem Hip System

This is a prospective, single arm, sequential enrolment study to collect relevant clinical and radiological data in approximately 26 subjects, at one site in Australia, who have been implanted with the SMF Short Modular Femoral Stem Hip System in a primary THA procedure to assess its safety and efficacy up to 20 years post-surgery.

This is a single arm, consecutive series study to collect relevant clinical, laboratory and radiological data in up to 26 subjects, who have been implanted with the SMF Short Modular Femoral Stem THA system at 1 site in Australia.

The Baseline visit will be determined as the first visit to site after Ethics approval. This will be approximately 8-9 years post implant. Enrolled subjects will be followed up to 20 years post SMF implant.

Eligible patients will be contacted and patient status and implant revision status will be assessed at this initial contact. The subject will be given the option to participate in a prospective 12 year on-site follow-up visits for which they will provide written informed consent. Subjects who are lost to follow-up, deceased or are unwilling/unable to participate in the prospective study will be noted in the subject files and this data will be captured for analysis of study results. Data will be collected on the operative date, and implant status.

Post Baseline, the study will allow for metal ion assessments every 3 years for asymptomatic subjects and annual assessments for subjects with pain, swelling, and/or functional limitations if assessed by the Principal Investigator to be related to the SMF implant, having ruled out all other probable causes for the subject. If the subject has elevated whole blood cobalt or chromium (defined as \>7ppb) a MARS MRI or CT will be obtained. These types of imaging techniques are aimed at detecting inflammatory degenerative evolution of peri articular soft tissues including pseudo-tumours. A functional Questionnaire, HOOS JR Questionnaire will be completed at all patient site visits.

Safety will be evaluated by assessing the frequency and nature of adverse events, serious adverse events and revisions.

Eligibility Criteria:
Inclusion Criteria:

* The participant has undergone primary total hip arthroplasty with the SMF short modular femoral stem at the study site and still has the original implant at the time of Ethics Committee approval of the study.
* The participant is willing and able to participate in follow-up visits at the study site.

Exclusion Criteria:

* The Subject, in the opinion of the PI, has an emotional or neurological condition that would affect their ability or willingness to participate in the study including mental illness, mental retardation, drug or alcohol abuse.
* Subject is known to be at risk for lost to follow-up or failure to return for scheduled visits.
A Phase 3 Study to Confirm the Efficacy and Safety of Linzagolix to Treat Endometriosis-associated Pain

The primary objective of this study is to demonstrate the efficacy and safety of linzagolix administered orally once daily for 3 months at a dose of 75 mg alone or of 200 mg in combination with add-back hormone replacement therapy (ABT: estradiol (E2) 1 mg / norethisterone acetate (NETA) 0.5 mg) versus placebo, in the management of moderate to severe endometriosis-associated pain (EAP).

This is a prospective, randomized, double-blind, placebo-controlled study to demonstrate the efficacy and safety of linzagolix administered orally once daily at doses of 75 mg alone and 200 mg in combination with low dose ABT (E2 1 mg/NETA 0.5 mg) versus placebo in the management of moderate to severe EAP in 450 women.

Eligible subjects who have completed the 6-month treatment period may enter a separate extension study for 6 additional months of active treatment (no placebo control). Subjects who do not continue in the extension study will enter a 6 month treatment-free follow-up phase.

Eligibility Criteria:
Key Inclusion Criteria:

The subject must have:

* Her most recent surgical and - if available - histological diagnosis of pelvic endometriosis up to 10 years before screening.
* Moderate to severe endometriosis-associated pain during the screening period.
* Regular menstrual cycles.
* BMI ≥ 18 kg/m2 at the screening visit.

Key Exclusion Criteria:

The subject will be excluded if she:

* Is pregnant or breast feeding or is planning a pregnancy within the duration of the treatment period of the study.
* Is less than 6 months postpartum or 3 months postabortion/ miscarriage at the time of entry into the screening period.
* Has had a surgical history of any major abdominal surgery within 6 months or any interventional surgery for endometriosis performed within a period of 2 months before screening.
* Did not respond to prior treatment with GnRH agonists or GnRH antagonists for endometriosis.
* Has a history of, or known, osteoporosis or other metabolic bone disease.
* Has chronic pelvic pain that is not caused by endometriosis and requires chronic analgesic or other chronic therapy which would interfere with the assessment of endometriosis-associated pain.
The Effect of Clip Material on the Retention of Implant Supported Mandibular Overdenture

This study is aiming to evaluate the retention of implant supported mandibular overdenture using two different clip materials namely polyoxymethylene (POM) and poly-ether-ether-ketone (PEEK) on PEEK bar at three-time intervals; immediately after placement, after 3 months and after 6 months.


Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria:

  * Male.
  * Completely edentulous.
  * Age: 50-60 years.
  * Free from any systemic diseases that affect bone metabolism.
  * Good intraoral condition.
  * Anterior mandibular bone height \> 13mm and width \> 5mm.
  * The inter-arch space from 15mm to 17mm.

Exclusion criteria:

* Smoking and drug abusing.
* Severe maxillomandibular skeletal discrepancy.
* Bone metabolic disorders.
* History of head and neck radiotherapy.
* Intravenous bisphosphonate therapy.
* Presence of para-functional habits.
* Temporomandibular joint disorders.
* Severe bony undercuts.
To Evaluate the Cardiac Safety of Pegylated Liposomal Doxorubicin Concurrently Plus Trastuzumab and Pertuzumab in the Adjuvant Setting for Early-stage HER-2-positive Breast Cancer: a Multicenter, Randomized Controlled Clinical Study

To evaluate the safety and efficacy of pegylated liposomal doxorubicin/cyclophosphamide/trastuzumab/pertuzumab followed by docetaxel/ trastuzumab/pertuzumab compared with epirubicin/cyclophosphamide followed by docetaxel/trastuzumab/pertuzumab in the adjuvant treatment of early breast cancer.


Eligibility Criteria:
Inclusion Criteria:

1. 18-70 years old, Female;
2. Subjects with histopathologically confirmed invasive breast cancer;
3. HER2-positive breast cancer (Immunohistochemistry score of 3+ or fluorescence in situ hybridization positivity);
4. No distant metastasis;
5. Lymph node positive or negative, primary tumour≥2cm;
6. Lymph node negative，primary tumour≤2cm and any of the following factors; 1) Histological grade 3; 2) ER negative (\<10%) and PR negative (\<20%); 3) Age\<35 years old; 4) Pathological hint: vascular invasion or intravascular cancer thrombus;
7. Surgery was completed and chemotherapy was started within 8 weeks after surgery;
8. Before and after chemotherapy LVEF≥55%;
9. ECOG performance status of 0-1;
10. Signed the informed consent.

Exclusion Criteria:

1. Subjects who are known to be allergic or intolerant to chemotherapy drugs or their excipients;
2. Previously suffered from invasive breast cancer, and other malignant tumors within 5 years (excluding carcinoma in situ of the cervix, carcinoma in situ of the rectum, carcinoma in situ of melanoma, basal cell carcinoma of the skin, and squamous cell carcinoma);
3. For breast cancer, have received any anti-tumor therapy before randomization (except surgical treatment before enrollment);
4. Hematopoietic function, renal function and liver function meet one of the following conditions: 1) Neutrophil count ≤1.5×109/L; 2) Platelet count ≤ 50×109/L; 3) Hemoglobin ≤ 8.0g/dL; 4) Creatinine clearance rate ≤30ml/min; 5) AST and ALT ≥ 2.5 times the upper limit of normal in subjects without liver metastases; 6) Bilirubin ≥ 2 times the upper limit of normal; 7) APTT/PT≥1.5 times the upper limit of normal;
5. Have a history of cardiovascular disease or associated with severe cardiovascular disease, lung disease;
6. Active hypertension: systolic blood pressure ≥ 180mmHg, diastolic blood pressure ≥ 90mmHg;
7. NYHA cardiac insufficiency grading ≥ Ⅲ grade;
8. Severe, uncontrollable systemic disease;
9. Subjects who are pregnant or breastfeeding, or subjects who cannot ensure effective contraceptive measures during the study treatment;
10. Subjects who participated in other clinical trials at the same time;
11. Subjects determined by the investigator to be inappropriate to participate in this study.
Dose/Response of Exercise on Long Term Weight Loss

To examine the dose-response of exercise on long-term weight loss in overweight adult women.

BACKGROUND:

Exercise is a key component of behavioral weight loss programs because of its effect on weight loss, body composition, cardiovascular disease risk factors, and other obesity related diseases such as type 2 diabetes mellitus. Despite these benefits, it is unclear whether there is an optimal exercise duration and/or intensity that will enhance long-term weight loss. The current public health recommendation for physical activity is for individuals to participate in at least 30 minutes of moderate intensity physical activity on most days of the week (approximately 150 minutes per week total). However, it is unclear whether this amount of exercise is adequate for long-term weight loss. Moreover, cross-sectional studies have shown that individuals that have been successful at long-term weight loss participate in levels of physical activity that are greater than the current public health recommendations.

DESIGN NARRATIVE:

The researchers hypothesized that adopting higher levels of exercise duration and/or intensity, coupled with a strong behavioral intervention would enhance long-term weight loss. To test this hypothesis, they recruited 200 overweight women and randomly assigned them to one of four treatment groups: (1) moderate intensity, moderate 1000cal/wk duration exercise, (2) vigorous intensity moderate duration exercise, (3) moderate 2000cal/wk intensity, high duration exercise, and (4) vigorous intensity, high duration exercise. All subjects participated in a 24-month behavioral weight loss program, with subjects attending group meetings and receiving periodic telephone contacts from the weight loss program, with subjects attending group meetings and receiving periodic telephone contacts from the interventionists. In addition, to facilitate the adoption of the exercise protocols, all subjects were provided with a home treadmill. Assessment of body weight occured at 0, 6, 12, and 24 months and exercise participation was measured throughout the program. In addition, body composition, cardiorespiratory fitness, cardiovascular disease risk factors, and mediators of behavior change were measured at 0, 6, 12, and 24 months.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
Interest of a Systematic Biopsy for Hard-to-heal Leg Ulcers

Primary aim of the study : to evaluate the prevalence of ulcerated cutaneous carcinoma or malignant degeneration, in leg ulcers, presumed of vascular origin and without evidence of healing despite 3 months of adequate treatmentSecondary aims of the study : to evaluate the interest of immunostainings for desmogleins 1-2 and p16 on biopsies to differentiate between pseudo epitheliomatous hyperplasia and squamous cell carcinoma ; and the prognosis of diagnosed carcinomas at 12 monthsStudy hypothesis : systematic biopsies of hard-to-heal leg ulcer may help to detect ulcerated carcinomas misdiagnosed as vascular ulcer or malignant degeneration of leg ulcer.

Prospective multicentric inclusion of 150 patients with leg ulcers without any evidence of healing (no change or increase of ulcer area) despite 3 months of adequate treatment The study population consisted of consecutive patients with one or more leg ulcers, diagnosed as related to venous insufficiency, associated or not with concomitant arterial insufficiency. All patients undergo a standard treatment including compression therapy adapted to the ankle brachial index and a local treatment depending on the wound stage.At inclusion, systematic punch biopsies (5-6 mm) are taken as part of routine clinical care under local anaesthetic by an experienced clinician: 1 to 2 biopsies in the edges and 1 to 2 biopsies in the wound bedSpecimens are transported in formalin solution to the usual pathology laboratory of the investigator. At the end of the study, specimens will be sent for immunostainings in a single pathology laboratory (Rouen, France)Treatments and/or other investigations are decided by the investigatorAt 12 months of usual follow-up, final diagnosis and prognosis are noted in the study file by the investigator.

Eligibility Criteria:
Inclusion Criteria:

* leg ulcer of more than 3 months of duration
* leg ulcer presumed of vascular origin
* adequate etiologic treatment since 3 months
* absence of evidence of healing : absence of reduction of wound area or increase in wound area and/or in depth

Exclusion Criteria:

* hypertensive ulcer
* vasculitis
* treatment by cytotoxic agents or steroids in the previous 3 months
3-midline-ports Cholecystectomy

The 3-midline-ports technique is a safety approach and associates lower postoperative pain, when compared with the standard "French" technique.

The patients will be randomized into 2 groups: those patients undergoing laparoscopic cholecystectomy following the "French" technique (Group 1) and those ones undergoing the 3-midline-ports approach (Group 2).

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing elective cholecystectomy for symptomatic gallstones.

Exclusion Criteria:

* Diagnosis of acute cholecystitis