cyrilzakka/clinical-trials huggingface dataset:
Sequential Use of Foley's Catheter and Misoprostol Versus Misoprostol Alone for Induction of Labour: a Multicentre Randomised Controlled Trial

Evaluation of efficacy of inducing labour using a Foley's catheter and low dose oral misoprostol sequentially, in comparison with low dose oral misoprostol alone.

a multicentre, open-label randomised controlled trial in 2 hospitals in the Almaty,Kazakhstan. Women with a term singleton pregnancy in cephalic presentation, an unfavourable cervix, intact membranes, and without a previous caesarean section will be randomly allocated to 2 groups: 1 group -cervical ripening with Foley's catheter for 16 hour and sequentially 25 μg oral misoprostol once every 2 hour, 2 nd group- 25 μg oral misoprostol once every 2 hour. The primary outcome will be vaginal delivery within 24 hours(to evaluate effectiveness) and secondary outcoms 1-5-min Apgar score and hospitalization in ICU, rate of hyperstimulation ,hemorrage,chorioamnionitis (for evaluating safety)

Eligibility Criteria:
Inclusion Criteria:

* women with an unfavourable cervix who will scheduled for induction of labour

Exclusion Criteria:

* Women with previous caesarean sections unable to give informed consent Multiple pregnancy History of allergy to misoprostol Ruptured membranes All cases when physiological childbirth is impossible (placenta previa,transverse position of the fetus )
Avastin and Doxorubicin Postoperatively for Patients With Anaplastic Thyroid Cancer

Anaplastic Thyroid Cancer is a very aggressive disease. The investigators believe that angiogenesis is very important for these tumors to progress. Preclinical data is suggesting this. This is why we we prospectively want to treat these patients with avastin (and doxorubicin). However, local control is of major concern. Therefore, patients are initially treated with hyperfractionated radiotherapy and undergo surgery. Then they can enter this study.

Patients with Anaplastic Thyroid Cancer have a poor prognosis. We will treat the patients initially with our standard radiochemotherapy, which consists of doxorubicin 20mg fixed dose/week and hyperfractionated radiotherapy 1,6 Gy twice daily up to 46 Gy in total. The first week during radiotherapy, they will also receive Avastin 15mg/kg. 1-2 weeks after radiotherapy patients will undergo surgery of their primary tumor. After this "standard" therapy patients can be included in this study. Treatment is 20 mg fixed dose doxorubicin q1w and avastin 15mg/kg q3w. Treatment will continue maximum 6 months or until progress or until intolerable side effects occur.

Eligibility Criteria:
Inclusion Criteria:

* cytologically or histologically verified anaplastic thyroid cancer
* completed standard therapy
* operated with R0 or R1 surgery
* Performance Status 0-2 (if pulmonary mets PS 0-1)
* normal wound healing
* neutrophils \> 1,5 million/ml
* platelets \> 100 million/ml
* bilirubin \< 2 ULN
* creatinin \< 150mikromol/L

Exclusion Criteria:

* PS 3-4 (if pulmonary mets 2-4)
* R2 resection of primary tumor
Intravitreal Bevacizumab for Diabetic Retinopathy

Background: to evaluate the 3-month efficacy of a single dose of intravitreal bevacizumab on the progression of severe non proliferative diabetic retinopathy, proliferative diabetic retinopathy and active photocoagulated diabetic proliferative by evaluation of ischemic areas and regression of retinal and disc neovasculrization.

Methods: 40 patients were enrolled in a prospective, interventional study. Patients were treated with intravitreal bevacizumab 0.1ml (0.25mg). We evaluated visual acuity, neovascularization leakage points, capillary closure ischemic areas and macular edema by clinical examination and fluorescein angiography. A clinical examination was performed at baseline and days 1,14 and 30. Active leakage points were measured by fluorescein angiography at 30 days.


Eligibility Criteria:
Inclusion Criteria:

* Severe nonproliferative
* Proliferative diabetic retinopathy
* Active photocoagulated diabetic retinopathy

Exclusion Criteria:

* Previous vascular occlusion
* Glaucoma
* Uncontrolled hypertension, thromboembolic event
* Renal abnormalities
* Recent or planned surgery
* Coagulation abnormalities
* Panretinal photocoagulation of less than one month before
* Patients with known serious allergies
A Study on Behavior of Healthcare Professionals Who Handle Oral Solid Drug

A study on behavior of healthcare professionals who handle oral solid drug

A study on behavior of healthcare professionals who handle oral solid drug

Eligibility Criteria:
Inclusion Criteria:

• Healthcare professionals in charge of drug preparation

Exclusion Criteria:

• There are not exclusion criteria
Comparing Transperineal to Transrectal MRI-US Fusion Prostate Biopsy

This will be a prospective cohort trial that compares transperineal to transrectal MRI-US fusion prostate biopsy

This will be a prospective cohort trial that compares transperineal to transrectal MRI-US fusion prostate biopsy among men. The target population are males that are schedule to undergo MRI-US Fusion prostate biopsy and have an MRI of the prostate. All the pathological samples would be conducted from the area in the prostate that was found as suspicious of malignancy by previous MRI imaging, and defined as region of interest (ROI).

First the prostate biopsy will be preformed in a transperineal approach; Then a transrectal approach would be used to sample a few more cores.

The primary endpoint will be To compare the detection rate for clinically significant prostate cancer between transperineal vs transrectal mp-MRI-fusion/TRUS biopsies. Additionally, the study aims to determine the accuracy of prostate cancer detection in transperineal vs transrectal mp-MRI-fusion/TRUS biopsies.

Eligibility Criteria:
Inclusion Criteria:

1. Men who are scheduled to undergo, transrectal or transperineal biopsy and have an MRI of the prostate.

   • Either primary biopsy or repeated biopsy
2. Age 18-90.
3. PI-RADS classification of 3-5

Exclusion Criteria:

1. Men who do not have an MRI of the prostate.
2. PI-RADS classification of 2 or lower
3. Men who were diagnosed with prostate cancer and have begun treatment
Cesarean Section Scar Niche: The Impact on ART Outcome

To evaluate the impact of the presence of cesarean section niche and its characteristics on the outcome of ART cycles.

The incidence of Cesarean section (CS) is increasing worldwide, with a corresponding increase in its associated complications. The well-known complications are infection, hemorrhage, and increased risk of obstetric complications in subsequent pregnancies, like morbidly adherent placenta, cs scar pregnancies and uterine rupture.

In addition, some studies emphasize the effect of cesarean sections on reduced fertility. A meta-analysis reported that a Caesarean section reduces the probability of subsequent pregnancy by 10%, compared with a previous vaginal delivery.

The cesarean section niche is defined as an indentation of the uterine myometrium of at least 2 mm at the site of the caesarean scar. The most common symptom of niche is abnormal uterine bleeding. Meanwhile, other symptoms include dysmenorrhea, chronic pelvic pain, dyspareunia, and sub-fertility/infertility.

The detection of a cesarean section niche depends on the operator and the diagnostic method used. This can be 2D, 3D transvaginal sonography, sonohysterography or hysteroscopy.

Regarding ART, the presence of cs niche was reported to reduce the chances of embryo implantation, and increase the rate of spontaneous miscarriages, especially if the implantation is close to it or in the niche.

The presence of a niche may increase the difficulty of embryo transfer procedure, clinicians need to be aware of its presence and the transfer should be done under ultrasound guidance to ensure the catheter bypasses the niche and enters the uterine cavity.

Still the impact of c.s niche and its characteristics on outcome of ART is not clear.

Eligibility Criteria:
Inclusion criteria:

1. Aged from 18 - 37 years old.
2. Having a history of one or more previous CS with ultrasonographic visible cesarean section niche (for the group with cs scar niche), which is regarding to European Niche Taskforce is an indentation of the uterine myometrium of at least 2 mm at the site of the CS scar (Jordans et al., 2019).
3. A normal uterus with no anomalies or pathologies.
4. At least one good-quality embryo available for transfer.

Exclusion criteria:

1. Younger than 18 or older than 37 years old.
2. Congenital uterine abnormality or pathology.
3. Presence of a hydrosalpinx.
4. ICSI cycles with TESE samples.
Safety of Mesentery-embedding Surgery in Patients With Ileocolic Crohn's Disease on Biotherapy

60% of patients with Crohn's disease will undergo surgery during their lifetime and without recurrence prevention treatment, 80% of patients will have an endoscopic recurrence within 1 year of surgery. This procedure is performed as close as possible to the gastrointestinal tract, but remaining mesenteric disease is a risk factor for recurrence. Mesentery resection has encouraging results on recurrence requiring reoperation, with a reduction of over 30% in recurrences compared with the standard technique. The study authors wish to evaluate the safety of ileocolic resection surgery involving the mesentery in patients with Crohn's disease treated with biotherapy.

The study hypothesis is that mesentery surgery is no more risky than conventional (gold standard) surgery, and reduces the 6-month endoscopic recurrence rate in patients with ileocolic Crohn's disease on biotherapy requiring ileocolic resection.


Eligibility Criteria:
Inclusion Criteria:

* The patient must have given their free and informed consent and signed the consent form
* The patient must be a member or beneficiary of a health insurance plan
* Patient with histologically proven Crohn's disease
* Patient who has undergone ileocolic resection and whose disease site is accessible to endoscopic follow-up (first or repeat operation)
* Patient on anti-TNF α: infliximab or adalimumab (ECCO 2014 recommendation), vedolizumab, ustkinumab, or other biotherapy (e.g. risankizumab)
* Patient able to understand, write and read French

Exclusion Criteria:

* The patient is participating in an interventional study
* The patient is under safeguard of justice or state guardianship
* Medical treatment other than biotherapies including anti-TNF α (infliximab or adalimumab), vedolizumab, ustkinumab, risankinumab
* Contraindication to surgery, such as major cardiovascular comorbidities
* Pregnant, breast-feeding or parturient women
Clinical Study of Injectable Ceramics Bone Graft Substitute Containing rhBMP-2

This is a prospective, outcomes assessor-blinded, randomized study to evaluate the efficacy and safety of "Inject BMP(Injectable Ceramics Bone Graft Substitute Containing rhBMP-2)" for socket preservation after extraction of a single-rooted tooth, compared to ExcelOS-inject(Injectable Ceramics Bone Graft Substitute).

Inject BMP is Injectable Ceramics Bone Graft Substitute(ExcelOS-inject) containing rhBMP-2. Recombinant human Bone morphogenetic protein 2 (rhBMP-2) stimulates the production of bone.

Eligibility Criteria:
Inclusion Criteria:

* Persons without periodontal disease

Exclusion Criteria:

* Women who are pregnant or plan to be pregnant within study period
Lopinavir/Ritonavir in PLWH With High-Grade AIN

This study is being done to assess the safety of lopinavir/ritonavir in patients with PLWH with AIN. 30 participants will be recruited and can expect to be on active study for approximately 3 months and long term follow up for 40 weeks.

This is a Phase I modified 3 + 3 design, in which the maximum tolerated dose (MTD) will be identified. The 3 + 3 dose escalation will consist of 6 dose levels (18 participants; planned escalation described in arms below) in combination with variation in dosing schedules of the drug lopinavir/ritonavir. This design also allows for some possible intermediate doses to be examined if dose-limiting toxicities (DLTs) occur and de-escalation is needed.

An expansion cohort of 12 participants will occur at the MTD. Once the MTD is determined, then secondary outcomes will be evaluated.

Primary Objective

* To evaluate the safety and tolerability of intra-anal administration of lopinavir/ritonavir, administered via suppository with 3 different schedules, in PLWH with high-grade anal intraepithelial neoplasia (HGAIN) (AIN 2/3).

Secondary Objectives

* To measure the effect of intra-anal topical lopinavir/ritonavir administration
* To evaluate clearance of human papillomavirus (HPV)
* To elucidate the mechanism of action of protease inhibitors

Eligibility Criteria:
Inclusion Criteria:

* willing to provide informed consent
* greater than or equal to 18 years of age
* Diagnosis of biopsy-confirmed HGAIN
* Human immunodeficiency virus (HIV)-positive with CD4 count greater than 200 cells/mm\^3 at screening and virologically suppressed on HIV-1 antiretroviral therapy (ART) within last 12 months
* willing to comply with all study procedures

Exclusion Criteria:

* Diagnosis of low-grade anal dysplasia (AIN, low-grade squamous intraepithelial lesion (LSIL)) by HRA.
* CD4 count less than 200 cells/mm\^3 at the time of consideration for entry into the study
* unable to provide informed consent
* Pregnant or breastfeeding female
* Currently receiving systemic chemotherapy or radiation therapy for another cancer.
* Have received topical therapy for anal dysplasia previously
Study to Evaluate the Abuse Potential of AZD7325 in Healthy Recreational Central Nervous System (CNS) Depressant Users

The purpose of this study is to examine the abuse potential of AZD7325.


Eligibility Criteria:
Inclusion Criteria:

* Recreational CNS depressant use, defined as at least 10 lifetime occasions of non-medical use of drugs with depressant/sedative properties and at least 1 non-medical use in the year prior to screening
* Body mass index (BMI) within the range of 19.0 to 33.0 kg/m2, inclusive, and a minimum weight of 50.0 kg at screening
* Willing and able to abide by all study requirements and restrictions

Exclusion Criteria:

* Unwillingness of inability to abstain from recreational drug use for the duration of the study from screening until follow-up
* Positive breath alcohol test prior to dosing
* Clinically significant abnormalities on physical examination, medical history, 12-lead ECG, vital signs, or safety laboratories
Trial Comparing Radioactive Seed Localization to Standard Procedure for Non-palpable Breast Cancers

The purpose of this study is to determine whether a new surgical technique (radioguided seed localization) for localizing nonpalpable breast tumours is better than the standard technique (needle localization).

Most breast cancers are removed by partial mastectomy/lumpectomy. The most important factor in ensuring that the cancer does not return in the breast is to ensure that it is completely removed during surgery. Complete removal is dependent on having a rim of normal tissue (clear margin) surrounding the cancer. If the margin is positive, or the cancer recurs, more surgery or mastectomy is required. Approximately one third of breast cancers are detected by mammograms or ultrasounds and cannot be felt by patients or physicians. Accordingly, a localization technique is required to help the surgeon to find and remove the cancer. The current technique (needle localization) has a higher chance of having cancer cells at the margin. This is a study about a surgical technique. The objective of this comparison study is to determine whether a new technique (radioguided seed localization) is a better way to remove nonpalpable breast cancers. The main objective of this study is to determine if the new technique generates fewer positive margins compared to the standard technique. An improved technique would benefit thousands of women every year.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed invasive or in situ breast carcinoma
* Nonpalpable breast tumour
* Candidate for breast conserving surgery (BCS) based on clinical and radiologic evaluation

Exclusion Criteria:

* Histological confirmation more than 3 months from enrollment
* Pregnancy or lactation
* Contraindication to BCS or patient requests mastectomy
* Age less than 18 years
* Male patient
Application of PNE in Postoperative Pain Management of Patients With Primary Total Knee Arthroplasty

This study intends to carry out pain neuroscience education intervention for TKA patients to clarify the effect of this method on the degree of postoperative pain, the incidence of pain catastrophizing, kinesiophobia, and knee joint function rehabilitation in TKA patients, so as to provide a basis for clinical nursing of such patients.


Eligibility Criteria:
Inclusion Criteria:

1. Patients diagnosed as KOA according to the criteria and undergoing unilateral total knee arthroplasty for the first time;
2. The subjects included in this study were men or women aged 45-74 years;
3. Clear self-cognition, can browse the text by themselves or can answer questions correctly;
4. Those who voluntarily participated in the study and signed an informed consent form after understanding the relevant information of the study;
5. Without serious physical diseases such as heart, liver or kidney;
6. No history of mental illness or drug dependence.

Exclusion Criteria:

1. Combined with severe trauma in other parts;
2. Accompanied by serious damage to other organs, such as heart and cerebrovascular diseases, lung and kidney diseases;
3. Patients with knee tumor and severe knee deformity who could not complete the rehabilitation;
4. With neurological diseases that limit physical activity;
5. Participating in other investigators during the same period.
Low-Level Laser in Head and Neck Chronic Lymphedema

The purpose of this study is to evaluate the effect of low-level laser treatment (LLLT) on the severity of lymphedema, symptom burden, functional status, and quality of life in HNC survivors.

Primary aim: To determine the impact of LLLT, as compared to wait-list control, on changes in severity of lymphedema.

Secondary aim: To determine the impact of LLLT, as compared to a wait-list control, on lymphedema-related symptom burden (e.g., tightness), functional impairments (e.g., range of motion in jaw and neck), and quality of life.

Eligibility Criteria:
Inclusion Criteria:

* \>18 years of age
* \>6 months post HNC treatment
* No evidence of cancer confirmed with imaging tests
* Having head and neck lymphedema with or without fibrosis
* Completion of initial lymphedema therapy
* Lymphedema duration between 3-24 months
* Ability to speak and read English
* Ability to provide informed consent

Exclusion Criteria:

Patients will be excluded if they have any of the following medical conditions that would prohibit the safe implementation of LLLT:

* Pregnancy
* Acute infection
* Photosensitivity
* Chronic inflammatory diseases
* Venous thrombosis
* Carotid artery stenosis
* History of severe trauma
* Medication that affects body fluid and electrolyte balance
* Use of high doses of non-steroidal anti-inflammatory drugs
* Pre-existing skin rash, ulceration, open wound in the treatment area
* Active lymphedema therapy or physical therapy
* Allergic and other systemic skin diseases
Estimation of Malignancy Rates Within Humedica Patient Populations Sampled to be Representative of Liraglutide Initiators and LEADER™ Trial Participants

This study is conducted in the United States of America. The aim of this study is to estimate incidence rates of all malignant neoplasms, specific subgroups of malignant neoplasms, and acute pancreatitis among cohorts of antidiabetic drug users standardized to be representative of LEADER™ trial participants or liraglutide initiators within the Humedica Electronic Health Record (EHR) database.


Eligibility Criteria:
Inclusion Criteria:

* All Cohort Members: Members of each of the cohorts must have at least 12 months of baseline coverage within Humedica prior to the patients' index date (cohort- specific index dates are defined below). Within Humedica, baseline coverage will be defined as the date from the earliest observed encounter up to and including the index date. Patients must have at least 1 diagnosis of T2DM (250.X0 or 250.X2) prior to and including the date of the qualifying prescription, no prior diagnosis (inclusive of the index date) of T1DM (250.X1 or 250.X3) and no diagnosis of gestational diabetes within the previous 12 months (inclusive of the index date). Patients will not be eligible for inclusion if they have prior prescriptions for GLP-1 analogues (including liraglutide and exenatide) during the interval that would be considered the baseline period
* Liraglutide-like Cohort: To be eligible for inclusion in the Liraglutide-like Cohort, patients must have at least one qualifying prescription for an OAD. Qualifying OADs will be specified that share similar labelled or unlabelled indications as liraglutide
* LEADER™-like Cohort: To be eligible for inclusion in the LEADERTM-like Cohort, patients must meet the following inclusion and exclusion criteria: Patients will be eligible for inclusion after meeting the overall inclusion and exclusion criteria in addition to the following: Ages 50 and over. HbA1c at least 7%

Exclusion Criteria:

* Patients will be excluded from the LEADER™-like Cohort if any of the following are observed prior to meeting the inclusion criteria defined above: Calcitonin \>= 50ng/L. Baseline DPP-4 or pramlintide. Chronic heart failure diagnosis, NYHA Class IV. Acute coronary or cerebrovascular event within 14 days prior to initiation. Current continuous renal replacement therapy. End-stage liver disease. Solid organ transplant. Malignant neoplasm