cyrilzakka/clinical-trials huggingface dataset:
Supplemental Therapeutic Oxygen for Prethreshold Retinopathy of Prematurity

The purpose of this trial was to determine the efficacy and safety of supplemental therapeutic oxygen for infants with prethreshold retinopathy of prematurity (ROP) to reduce the probability of progression to threshold ROP and the need for peripheral retinal ablation.

Retinopathy of prematurity (ROP) is an abnormal growth of the blood vessels in the eye that occurs primarily in very premature infants. Eye development occurs normally in the womb; in infants born prematurely, however, the blood vessels must finish developing outside the protective environment of the uterus. Retinopathy of prematurity (also known as retrolental fibroplasia) is a leading cause of blindness and other vision impairments (myopia, strabismus, and amblyopia) in children, both in developed and developing countries.

This study was a randomized trial comparing the effects of 2 oxygenation strategies on the progression of ROP. Infants with prethreshold ROP in at least one eye were eligible for the study. Enrolled infants were randomized to receive either conventional oxygenation at a pulse oximetry target of 89% to 94%, or supplemental oxygen to achieve a pulse oximetry target range of 96% to 99%. Infant were placed on continuous pulse oximetry monitoring and to maintain oxygen saturation, as much as possible, in the assigned target range.

Eligibility Criteria:
Inclusion Criteria:

* Infants with prethreshold retinopathy of prematurity, confirmed by 2 certified ophthalmologic exams
* Median pulse oxygen saturation \<94% in room air
* Median pulse oxygen saturation can be kept safely \>96% on oxygen/ventilator

Exclusion Criteria:

* No fatal congenital anomaly or congenital eye anomaly
Use of Chitosan Powder in Loop Electrosurgical Excision Procedure

Early treatment of cervical intraepithelial neoplasia (CIN) II-III gives rise to a decrease in the incidence of invasive cervical cancer. Though there is no obvious consensus from randomized studies as to the optimal management of CIN II-III, loop electrosurgical excision procedure (LEEP) is the most extensively used method because of its technical ease, inexpensive, steep learning curve, and low rate of complications.

In spite of these benefits, current literature suggests that some patients experience some complications such as postoperative vaginal bleeding, abnormal vaginal discharge, abdominal pain, and infection. These adversely affect the recovery period, increase patient anxiety, readmission to the hospital for further treatment and encumber patients' daily life. Postoperative vaginal bleeding (PVB) is one of the most common and unpleasant of these complications. Its incidence has been reported to vary between 2% to 78%.

Many different types of treatments have been applied to avert or diminish PVC such as the use of vasopressin, tranexamic acid, Monsel's solution, and local hemostats (e.g., TachoSil or Tisseel), but these attempts have failed to show precise benefits over routine clinical approaches. Chitosan is a biodegradable, natural polyaminosaccharide with a nontoxic, non-allergenic, positively-charged polysaccharide derived from the deacetylation of chitin. Due to its molecular characteristics, chitosan has been used for improved hemostasis. Furthermore, chitosan has an antimicrobial and wound-healing effect. The current literature concerning the influence of using chitosan after the LEEP is limited to only one trial. The authors of that study reported that using chitosan after the LEEP can reduce vaginal bleeding and enhancing wound healing. However, that study has some limitations. Therefore, investigators designed this randomized trial to assess the effect of local chitosan implementation on postoperative vaginal bleeding and wound healing in LEEP


Eligibility Criteria:
Inclusion Criteria:

* women were aged \> 21 years old
* women were not pregnant
* women who were undergoing LEEP.

Exclusion Criteria:

* Women with pelvic infection
* Women with abnormal vaginal bleeding
* Women with coagulopathy
* Women with chronic pain syndromes
* Women with psychiatric disorders
* Women with the previous hysterectomy with removal of the cervix,
* Women with a history of cervical cancer
* Women who could not complete follow-up calls
Safety and Feasibility of TMLI as Conditioning Regimen in Allogeneic Hematopoietic Stem-cell Transplantation

Multiple conditioning regimens have been used for the HSCT, some of which include radiotherapy. Total body irradiation (TBI) has demonstrated to be superior to chemotherapy alone in the phase III FORUM trial. However, concerns for long-term toxicity have made TBI less used. Total marrow and lymphoid irradiation (TMLI) has emerged as a new alternative that can potentially keep the benefits of radiation but reducing toxicity to healthy tissues.

The primary objective of this trial is to evaluate the feasibility and safety of TMLI as part of conditioning schemes with or without etoposide for HSCT in patients between age 16 and 45 years with ALL in first line or relapsed disease. As secondary endpoint the efficacy will be assessed by minimal residual disease at 60 days post-transplant, as well as other outcome measures such as non-relapse mortality (NRM), relapse free survival (RFS) and overall survival (OS).

TMLI will be administered as part of the conventional reduced intensity conditioning scheme of our institution:

Fludarabine 25 mg/m2 + cyclophosphamide 350 mg/m2 on days -6 to -3, for patients with positive measurable residual disease TMLI will be added in doses of 12 Gy on days -3 to -1 divided into 6 fractions of 2 Gy every 12 hours for 3 days, which will be administered through a computed tomography tomotherapy system.

Infusion of peripheral blood hematopoietic stem cells will be performed on day 0 and after this, prophylaxis for GVHD with post-transplant cyclophosphamide 50 mg/kg will be administered on days +3 and +4, followed by tacrolimus or cyclosporine A plus mycophenolate mofetil regardless of HLA matching.

The procedure for the donation of hematopoietic cells will be done through a peripheral blood apheresis with previous stimulation with filgrastim at 10 mcg/kg for 4 days according to the standardized procedures of our institution.

The leukocyte and platelet count will be monitored by serial complete blood count, and a bone marrow aspiration (BMA) and minimal residual disease (MRD) will be performed on day 60 after transplantation.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of ALL confirmed by flow cytometry.
* Patients between age 16 and 45 years with ALL in first remission, refractory, or relapsing
* Patients who have an identical or haploidentical allogeneic donor by high resolution HLA

Exclusion Criteria:

* Patients who do not meet the age previously mentioned.
* Patient with comorbidities that rule them out for HSCT, with a Hematopoietic cell transplantation-specific comorbidity index (HCT-CI) greater than 2.
* Poor performance status or Karnofsky less than 70%
* Transthoracic echocardiogram with alteration in myocardial function with left ventricular ejection fraction (LVEF) less than 50%
* Patients who previously and for another reason have already received radiotherapy or who refuse to receive it
Evaluation of an Ascensia Blood Glucose Meter and App System

The purpose of this study is to assess the usability of the Onyx system in the hands of subjects with Insulin Dependent Diabetes Mellitus (IDDM) or insulin-using subjects with Non-IDDM.


Eligibility Criteria:
Inclusion Criteria:

* Be aged 18-75 years, male or female
* Read and understand English
* Have diagnosis of type 1 or insulin-using type 2 diabetes for at least 6 months
* Be taking multiple daily injections (MDI) of at least two pre-meal bolus injections daily or using an insulin pump
* Performing self-monitoring of blood glucose at home at least twice daily
* Have an iOS mobile device or Android mobile device with blue tooth capability
* iOS device: iPod or iPhone 5 or later version with iOS 8.0 software or higher (no tablets)
* Android: smart phone, 4.4 version and higher (no tablets)
* Be willing to utilize the ONYX App on personal mobile device which communicates to meter to manage diabetes (including use of the bolus calculator)
* Be ambulatory and have transportation to the study site

Exclusion Criteria:

* Hemophilia or any other bleeding disorder
* Pregnancy
* Physical, visual or neurological impairments that would make the person unable to perform testing with the BGM
* Working for a competitive medical device company, or having an immediate family member or someone who is not a family member but is living within the household of someone who works for such a company.
* A condition, which in the opinion of the investigator or designee, would put the person or study conduct at risk (reason for exclusion will be clearly documented by investigator or designee on the subject disposition form).
* Proliferative retinopathy or history of retinal laser surgery
Enhanced Recovery After Surgery (ERAS) Total Knee Replacement (TKR) with a Transitional Pain Service

A comparison of two anesthetic techniques for total knee replacements: (1) Peri-Articular Injection (PAI), local infiltration between the popliteal artery and capsule of the knee block (IPACK) and single-shot adductor canal block (ACB) vs. (2) PAI, IPACK and continuous adductor canal block catheter (ACC).

Patients will be randomized to one of two groups: one group will receive a PAI, IPACK and single-shot adductor canal block; one group will receive PAI, IPACK and continuous adductor canal block catheter.

Eligibility Criteria:
Inclusion Criteria:

* Patients with osteoarthritis scheduled for a primary total knee arthroplasty with a participating surgeon
* Planned use of regional anesthesia
* Ability to follow study protocol
* English speaking (secondary outcomes include questionnaires validated in English only)
* Lives within one hour of the hospital
* Has a smart phone

Exclusion Criteria:

* Hepatic or renal insufficiency
* Younger than 18 years old or older than 65 years ol
* Patients undergoing general anesthesia
* Allergy or intolerance to one of the study medications
* BMI \>40
* Diabetes
* American Society of Anesthesiologists (ASA) status III or IV
* Chronic gabapentin/pregabalin use (regular use for longer than 3 months)
* Patients with chronic pain (from a referral to chronic pain service) or a pain catastrophizing scale (PCS \>30)
* Patients with severe valgus deformity or flexion contracture
* Patients unable to follow home catheter instructions and unwilling to go home with an infusing catheter
* Patients who have no home caregivers in the event that a catheter is to be sent home with the patient
* Patients with planned stay at rehab facility (to avoid medical device being tampered with at the rehab facility)
* Non-English speakers (secondary outcomes include questionnaires validated in English only)
A Study of Rituximab Alternative Dosing Rate in Patients With Previously Untreated Diffuse Large B-cell or Follicular Non-Hodgkin's Lymphoma (RATE)

This was a prospective, open-label, Phase III, multicenter, single-arm trial designed to assess the safety, pharmacokinetics, and pharmacodynamics of an alternative dosing rate of rituximab in previously untreated patients with diffuse large B-cell lymphoma (DLBCL) and follicular non-Hodgkin lymphoma (NHL).


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Age ≥ 18 years
* Patients with previously untreated diffuse large B-cell lymphoma (DLBCL) who are scheduled to receive rituximab 375 mg/m\^2 plus CHOP (cyclophosphamide, hydroxydaunorubicin \[also called doxorubicin or adriamycin\], Oncovin \[vincristine\], prednisone or prednisolone) chemotherapy, or previously untreated follicular non-Hodgkin lymphoma (NHL) who are scheduled to receive rituximab 375 mg/m\^2 plus CVP (cyclophosphamide, vincristine, prednisolone) chemotherapy
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2

Exclusion Criteria:

\* Clinically significant cardiovascular disease (eg, uncontrolled hypertension, myocardial infarction, unstable angina), New York Heart Association (NYHA) Classification Grade II or greater congestive heart failure, a ventricular arrhythmia requiring medication within 1 year prior to Day 1, or NYHA Grade II or greater peripheral vascular disease on Day 1 (first day of treatment)

Patients who meet any of the following criteria will be excluded from further study participation after Cycle 1:

* Circulating lymphocyte count \> 5,000/μL before the Cycle 2 rituximab infusion
* Development of a serious and/or Grade 3 or 4 adverse event during Cycle 1 judged by the investigator to be related to the rituximab infusion
* Prior premedication with additional corticosteroids other than the prednisone included in the chemotherapy regimens
Endostar in Combination With Chemotherapy in HER-2 Negative Advanced Breast Cancer

This research study is studying endostar in combination with chemotherapy as a possible treatment for HER-2 negative advanced breast cancer.

This is a multi-center phase II open label single-arm study to assess the safety and efficacy of endostar in combination with chemotherapy for patients with locoregionally recurrent or metastatic HER-2 negative breast cancer.

Endostar is an anti-angiogenesis drug. It is prepared by adding 9 amino acids to the N-terminal of the peptide chain on the basis of endostatin. Studies have shown that there may be a synergistic effect between endostar and chemotherapeutic agents.

Eligibility Criteria:
Inclusion Criteria:

* locoregionally Recurrent or metastatic breast cancer confirmed by histology.
* HER-2 Negative Breast Cancer.
* At least one measurable lesion according to RECIST 1.1..
* Chemotherapy for recurrent and metastatic lesions should be discontinued for more than 2 weeks.
* 18-70 years old.
* ECOG PS 0～1.
* Participants must have normal organ and marrow function as defined below: ANC ≥ 1.5×109/L,PLT ≥ 75×109/L,Hb ≥ 100 g/L;TBIL≤1.0ULN；ALT and AST≤3×ULN（ALT and AST≤5×ULN if liver metastasis）;BUN and Cr≤1.5×ULN and CCr≥50 mL/min.
* life expectancy is not less than 12 weeks.
* Signed informed consent.

Exclusion Criteria:

* Uncontrolled central nervous system metastasis.
* Not recovered to 0-1 degree (CTC AE 4.0) from toxic reactions of previous treatments..
* History of allergy to biological agents in the past.
* Important organ dysfunction and severe heart disease, including congestive heart failure, uncontrollable arrhythmia, angina, valvular disease, myocardial infarction, and refractory hypertension.
* Pregnant or lactating women..
* The patient had a history of other malignant tumors, except for the cured skin basal cell carcinoma and cervical cancer.
* The risk of uncontrolled infection, thrombosis and bleeding exists.
* A history of immunodeficiency, including HIV positive, HCV, active hepatitis B, or other acquired, congenital immunodeficiency disorders, or organ transplantation, is known.
* Researchers consider it inappropriate to carry out the study.
Statin Monotherapy or Statins in Combination With Ezetimibe in Patients for Prevention of CVD

Retrospective observational study of the efficacy and safety of statin monotherapy or statins in combination with ezetimibe in patients receiving lipid-lowering therapy in both primary and secondary prevention of cardiovascular diseases (CVD). The study will include patients receiving lipid-lowering therapy in both primary and secondary prevention of CVD who have received therapy of interest for ≥ 3 months in the 2 years preceding the signing of informed consent, i.e. statins as monotherapy or in combination with ezetimibe in a stable mode (without dose adjustment and/or statin replacement). Effectiveness of therapy will be evaluated based on the data on changes in baseline levels of total cholesterol (CS), low density lipoproteins (LDL), high density lipoproteins (HDL), triglycerides (TG), data on which will be obtained from primary medical records. Demographic and anthropometric data on patients, information on the history of hyperlipidemia and concomitant diseases will also be obtained. Also, the study will collect data on the development of adverse reactions of particular interest during therapy (liver/muscle damage, major cardiovascular events (MACE).


Eligibility Criteria:
Inclusion Criteria:

Patient can be included in the study only once.

1. Age \> 18 years.
2. Patient receiving lipid-lowering therapy with statin monotherapy or statins in combination with ezetimibe for both primary and secondary prevention of CVD.
3. Receiving statins as monotherapy or statins in combination with ezetimibe in a stable dosing regimen for 3 or more months at the time of enrolment in the study.
4. Willingness and ability to sign an informed consent to participate in the study.
5. Availability of primary medical documentation, which allows assessment of all parameters necessary for the study from the moment of initiation of statin monotherapy or statins in combination with ezetimibe.
6. Initiation of lipid-lowering therapy not earlier than 2 years before enrolment into the study.

Exclusion Criteria:

1. Age \< 18 years.
2. A diagnosis of familial hypercholesterolemia made prior to study enrolment or the investigator's suspicious of the possible presence of familial hypercholesterolemia.
3. Change in lipid-lowering therapy within 3 months prior to study enrolment.
4. Concomitant administration of omega-3 PUFA with statin monotherapy or combination therapy of statins and ezetimibe, as well as the use of any methods of extracorporeal filtration and/or plasmapheresis.
5. Clinically significant impairment of liver and/or kidney function, which may impede interpretation of test results
6. Presence of hypothyroidism
7. Ezetimibe monotherapy
8. Intolerance to statins at any dose
Post-Marketing Surveillance (All Case Surveillance) on Treatment With Alhemo® in Patients With Haemophilia A or Haemophilia B With Inhibitors

The purpose of the study is to investigate the safety and effectiveness of Alhemo® in all participants under real-world clinical practice in Japan. Participants will get Alhemo® as prescribed by the study doctor. The study will last for about 2 years.


Eligibility Criteria:
Inclusion Criteria:

* Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol)
* The decision to initiate treatment with commercially available Alhemo® has been made by the patient/LAR and the treating physician before and independently from the decision to include the patient in this study
* Male or female patients, regardless of age
* Diagnosis with HAwI/HBwI

Exclusion Criteria:

- Previous participation in this study. Participation is defined as having given informed consent in this study
The Impact of Anxiety or Depression on the Sedative Concentration of Propofol

120 consecutive female patients, 18-65 years old, American Society of Anesthesiologists (ASA) physical status I to II, scheduled for hysteroscopic surgery under propofol-based intravenous anesthesia will be recruited in this cohort study. The day before surgery, participants will be assessed the state of preoperative anxiety and depression. On the day of surgery, propofol will be administered by target controlled infusion (TCI) pump. During induction of anesthesia, the level of sedation will be evaluated. The induction dose of propofol, target effect-site concentration(Cet), plasma concentration(Cp) and effect-site concentration (Ce) of propofol will be recorded.

120 consecutive female patients, 18-65 years old, American Society of Anesthesiologists ( ASA) physical status I to II, scheduled for hysteroscopic surgery under propofol-based intravenous anesthesia will be recruited in this prospective cohort study. The day before surgery, participants were asked to complete the modified HADS questionnaire in an isolated calm room, and the score was used to assess the patients' anxiety and depression level in the past 6 months. On the day of surgery, propofol (Fresenius Kabi Austria GmbH, Graz, Austria)was administrated by using an intravenous target controlled infusion (TCI) pump (Alaris PK, Basingstoke, UK) with Schnider kinetic model. The initial effect-site concentration (Ce) was set as 1.0 μg/ml. After the TCI system displayed that Cp and Ce were at equilibrium, the target concentration of propofol was increased by an increment of 0.5 μg/ml until the patients achieved the three desired levels of sedation.The Ce and dose of propofol and the consuming time were recorded.

Eligibility Criteria:
Inclusion Criteria:

* female
* American Society of Anesthesiologists（ASA） physical status I or II
* Body Mass Index(BMI) 18-25kg/m2
* scheduled for hysteroscopic surgery under propofol-based intravenous anesthesia.

Exclusion Criteria:

* suffering from psychiatric diseases.
* chronic use of anxiolytics, antidepressants, and sedative-hypnotics.
* any sedative premedication.
* a history of alcohol abuse.
* allergy to propofol.
* declining to participate and cooperate.
The Use of NMES as a Home-based Therapy Following Total Knee Arthroplasty

The use of neuromuscular electrical stimulation (NMES) as a home-based therapy following total knee arthroplasty. Measures of interest: lower limb venous hemodynamics, joint range of motion, lower limb swelling, walking speed, quality of life, activities of daily living, device usability, device compliance, activity levels, and pain (VAS).

The use of neuromuscular electrical stimulation (NMES) as a home-based therapy following total knee arthroplasty. All participants receive and use a research stimulator for approximately 5 weeks following total knee arthroplasty. Participants randomised to either a stimulation group or placebo-controlled group. Stimulation of the soleus muscle to investigate the effects on lower limb venous hemodynamics, joint range of motion, lower limb swelling, walking speed, quality of life, activities of daily living, device usability, device compliance, activity levels, and pain (VAS) in both groups.

Eligibility Criteria:
Inclusion Criteria:

* Any patient undergoing knee arthroplasty in the Galway Clinic with an ability to understand the nature of the study
* Ability to give informed consent
* Not excluded based on exclusion criteria

Exclusion Criteria:

* history of symptomatic heart disease or severe arterial disease
* pregnancy
* presence of a pacemaker
* history of neurological disorder
* presence of cognitive difficulties which may prevent the patient or his/her carer from using the stimulator properly