cyrilzakka/clinical-trials huggingface dataset:
Low Weight Heparin prOphylaxis for Placental-Mediated Complications of PrEgnancy

This is a Multicenter, randomized, open-label, parallel groups study to test the hypothesis that prophylactic low molecular weight heparin (LMWH) (enoxaparin) initiated before 14 weeks of gestation could improve maternal and perinatal outcome in women at high risk for developing placental-mediated pregnancy complications.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women ≥18 years
* Gestational age \< 14 weeks at randomisation
* One or more of the following complications in a previous pregnancy:

  * Severe PE resulting in delivery before 32 weeks of gestation
  * Newborn weight less than the 10th percentile and documented abnormal Doppler in the umbilical artery during pregnancy before 32 weeks gestation
  * Abruption of placenta
  * Unexplained intrauterine death between 20-41,6 weeks of gestation secondary of placental insufficiency or
* Uterine arteries Pulsatility Index (mPI) Doppler ≥95th percentile at 11-14 weeks of gestation.

Exclusion Criteria:

* Multiple pregnancy
* Abnormal thrombophilia study
* Alcohol or illicit drug use
* Severe fetal malformations or chromosomal abnormalities
* Previous history of infertility ( 3 or more early miscarriages)
* Maternal HIV, Cytomegalovirus or toxoplasma infection
* Known fetal abnormality or chromosomal defect at randomisation
* Women with previous venous or arterial thrombotic event
* Organic lesions that could increase the hemorrhagic risk: gastric ulcus, stroke, a recent hemorrhagic event, high risk situations for hemorrhagic event
* Known allergy to heparin or LMWH, thrombopenia or thrombosis episode due to heparin treatment
* Contraindication to LMWH
* An absolute indication for anticoagulant therapy: venous deep thrombosis, pulmonary embolism, ovaric hyperestimulation, cardiophaty, others
* Metabolic disorders a risk for development of PE and/or IUGR: Type I diabetes, hipertiroidism, chronic renal insufficiency
Human Papillomavirus (HPV) Type Distribution in Adult Women Diagnosed With Invasive Cervical Cancer in New Zealand

The aim of this study is to assess the distribution of the most frequent types of human papillomavirus in women diagnosed with invasive cervical cancer in New Zealand.


Eligibility Criteria:
Inclusion Criteria:

* A female aged 18 years and above at the time of cervical specimen collection, and currently residing in New Zealand.
* Histological diagnoses of invasive cervical cancer stage IB or greater, within at least the last 3 years.
* Written informed consent obtained from the subject/ next of kin/ Legally acceptable representative.
* Availability of cervical specimen on which the diagnosis was made prior to any chemotherapy or radiotherapy.
* The cervical specimen should be of appropriate size and with regular tissue specimens.
* The cervical specimen should be adequately preserved.
* All links to the subject's identity should be removed from the paraffin block.

Exclusion Criteria:

Not Applicable.
Foot Pressure Mapping and Tendon Length After Nonoperative Treatment of Acute Achilles Tendon Rupture

Using a population of patients from another study, who was originally randomized to 2 different types of nonoperative treatment after an acute achilles tendon rupture, the length of the achilles tendon is examined using ultrasound, and foot pressure mapping is performed, 4-5 years after the injury.

A total of 56 patients from an earlier study (see reference) on Achilles tendon rupture using nonoperative treatment with or without early weight bearing was invited for an additional follow up, where we examine the length of the Achilles tendon using ultrasound, as well as functional influence of the injury, using foot pressure mapping (FPM) during barefoot gait. Additionally the mobility of the ankle is measured with the Achilles Tendon Resting Angle (ATRA) as well as passive plantar- and dorsiflexion. Strength is measured using Heel Raise Work (height of lift, number of lifts and the total work), and supplemented with calf circumference.

Eligibility Criteria:
Inclusion Criteria:

* Suffered acute Achilles tendon rupture from April 2011 to March 2012, and then referred to Copenhagen University Hospital Hvidovre.
* Participated and completed the original study.
* The patient must be able to speak and understand Danish, as well as be capable to give informed consent to participating.

Exclusion Criteria:

* Terminal disease or serious illnesses with an ASA score of 3 or above.
* Any injury significantly influencing gate and function of the lower extremities other than re-rupture of the Achilles tendon.
Traditional Chinese Medicine Constitution Study and the Diagnosis and Treatment of Chronic Disease in Taiwan Population

Several questionnaires have been developed for clinical research in Traditional Chinese Medicine. The objective of this study is to evaluate the consistency and relevance of two questionnaires, the Constitution in Chinese Medicine Questionnaire (CCMQ) and the Body Constitutions Questionnaire (BCQ).

Aim: Several questionnaires have been developed for clinical research in Traditional Chinese Medicine. The objective of this study is to evaluate the consistency and relevance of two questionnaires, the Constitution in Chinese Medicine Questionnaire (CCMQ) and the Body Constitutions Questionnaire (BCQ).

Method: Between December 2015 and December 2016, a sample of 150 participants aged above 20 years from the Chinese Medical University "elder college" curriculum and outpatients at the Hospital in Taichung, Taiwan, will be interviewed to complete both questionnaires based on subjective symptoms in a 3-d interval. There are three common patterns of body constitutions in CCMQ and BCQ: gentleness/plain, Ying-deficiency, and Yang-deficiency. As for other body constitutions, Qi-deficiency, phlegm-dampness, dampness-heat, blood-stasis, Qi-depression, and special diathesis are described only in CCMQ, while stasis is a feature only defined in BCQ. Average and standard deviation will be used to describe the measurement scores of the questionnaires and the percentages of constitution distribution. Statistical analysis of the Kappa value, Pearson Chi-Square, odds ratio, and Pearson's correlation coefficient would be employed to examine the consistency and association between the two questionnaires.

Expected result: The investigators hope to 1) describe the constitution profile of the study population; 2) assess the consistency between two questionnaires; and 3) examine the associations between CCMQ and demographic life style factors.

Eligibility Criteria:
Inclusion Criteria:

* people above 20 years old

Exclusion Criteria:

* people who cannot understand the description of questionnaire
Educational Video for Genetic Testing

Develop and evaluate the acceptability, feasibility, and preliminary efficacy of an informational video on paired tumor/normal testing for children and adolescents with a new diagnosis of cancer, tumors or other diagnosis.

As over 15% of pediatric cancers are associated with a cancer predisposition, it is increasingly becoming standard of care for children with cancer, as well as those with suspected hereditary risk, to be evaluated for germline cancer predisposition. Unfortunately, the increase in pediatric genetic testing has exceeded the pace of research establishing best practices to optimize delivery of care for patients undergoing testing and their families. Tumor/normal genetic testing (testing of both tumor tissue and a paired normal sample) at time of cancer diagnosis or relapse is now widespread in pediatric oncology to improve cancer diagnostics, prognostics, and treatment; this testing also has potential to uncover underlying cancer predisposition syndromes with lifelong implications. Disseminating information at the time of cancer diagnosis is difficult, and is best done by a provider with expertise in cancer genetics. Thus, Investigators will develop an informational video for use prior to tumor/normal genetic testing to augment genetic counseling resources to support patients and families.

In this study, Investigators will develop and evaluate the acceptability, feasibility, and preliminary efficacy of an informational video on paired tumor/normal testing for children and adolescents with a new diagnosis of cancer, tumors or other diagnosis. Investigators will use a non randomized trial whereby a convenience sample of patients/families will be recruited to be controls in Year 1, followed by a convenience sample that will be allocated the video intervention In Year 2. To evaluate the impact of the video intervention, Investigators will compare assessments of two cohorts- an unexposed (no video intervention, Year 1) and exposed (video intervention, Year 2).

Eligibility Criteria:
Inclusion Criteria:

Parents

1. Parent or Legal Guardian of a patient with a new diagnosis of cancer, tumor, or other diagnosis referred for tumor/normal sequencing (proband) in the Cancer Center at the Children's Hospital of Philadelphia (CHOP)
2. Able to be approached within 1-4 weeks of tumor/normal sequencing
3. Appropriate to approach per oncology team
4. No cognitive impairment limiting ability to complete measures
5. Ability to read and speak English fluently

Adolescent/Young Adult (AYA) probands

1. Child proband receiving germline testing in the Cancer Center at CHOP
2. Ages 12+
3. Able to be approached within 1-4 weeks of tumor/normal sequencing
4. Appropriate to approach per oncology team
5. No cognitive impairment limiting ability to complete measures
6. Ability to read and speak English fluently

Exclusion Criteria:

1) Not meeting any of inclusion criteria.
Follow-Up Study of Mesenchymal Stem Cells for Bronchopulmonary Dysplasia

This is a follow-up study to investigate the long-term safety and efficacy of human umbilical cord -derived mesenchymal stem cells (hUC-MSCs), for the treatment of BPD in premature infants. Subjects who participated in and completed the initial stage of the PhaseⅠtrial (NCT03558334 ) will be followed-up until 48 months after the hUC-MSCs transplantation.

Subjects who completed the initial stage of the PhaseⅠclinical trial will be followed-up at 5 additional visits: 1, 3, 6, 12 and 24 months after the hUC-MSCs transplantation.

Eligibility Criteria:
Inclusion Criteria:

1. Subject who completed the safety and efficacy evaluations in hUC-MSCs PhaseⅠ clinical trial
2. Subject with a written consent form signed by a legal representative or a parent

Exclusion Criteria:

1. Subject whose parent or legal representative does not agree to participate in the study
2. subject who is considered inappropriate to participate the study by the investigator
MRI-based Approaches for Multi-parametric Model to Early Predict Pathological Complete Response to Neoadjuvant Therapy in Breast Cancer

The purpose of this clinical research is to evaluate the accuracy of a multi-parametric model based on magnetic resonance imaging (MRI) in predicting pathological complete response (pCR) after the first cycle of neoadjuvant therapy (NAT) given to patients with locally advanced breast cancer, thus allowing early chemotherapy regimen modification to increase number of patients achieving pCR or save patients from toxic effects of ineffective chemotherapy.

Breast cancer is the most prevalent cancer among women worldwide. NAT has been well established in managing breast cancer for patients with locally advanced cancer and early-stage operable breast cancers of specific molecular subtypes. Though pCR has been demonstrated to be associated with better survival, it can only be judged by pathological testing of surgically resected specimens. Thus, predicting pCR earlier during NAT is imperative and can timely switch to a new personalized treatment strategy and exempt from unnecessary chemotherapy toxicity for patients.

This is a multicenter, prospective cohort study of 301 patients undergoing MRI after the first cycle of neoadjuvant chemotherapy. This project plans to establish and validate a model for determining pCR during NAT in breast cancer based on clinical information, imaging and pathological information of patients in multiple centers, in order to provide important references for further early diagnosis and personalized treatment.

1. Collecting MRI images data, clinical and pathological information, treatment regimens, and curative effect information to build an MRI-based, multi-parametric model.
2. Evaluating the performance of model through internal and external validation cohort by using the receiver operating characteristic (ROC) curve, the area under the curve (AUC), discrimination and calibration measures.

Eligibility Criteria:
1. For training cohort:

   Inclusion Criteria:
   * Age ≥18 years;
   * Histologically confirmed invasive breast carcinoma;
   * Clinical stage II-III at presentation;
   * Complete basic information and image data;
   * Have MRI imaging data at baseline and after the first cycle of NAC;
   * Finish the standard NAC treatment and undergo surgery;

   Exclusion Criteria:
   * With chemotherapy contraindications;
   * Multifocal of multicentric lesions;
   * Poor quality of MRI images;
2. For validation cohort:

Inclusion Criteria:

* Age ≥18 years;
* Complete basic information and image data;
* Clinical stage II-III at presentation;
* Scheduled for neoadjuvant chemotherapy;
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
* Signed informed consent;

Exclusion Criteria:

* With chemotherapy contraindications;
* Metastatic breast cancer;
* Multifocal of multicentric lesions;
En-bloc vs Conventional Resection of Primary Bladder Tumor

Based on current evidence, we hypothesize that eTURB represents an improvement in the surgical management of NMIBC. The resection is more precise and complete compared to cTURB. Moreover, the quality of an en-bloc specimen, including the tumor with its adjacent bladder wall layers, allows an accurate pathological review which leads to correct risk allocation and therapy.

To answer these questions, we designed a RCT comparing eTURB with cTURB. Primary outcome of our study will be the accuracy of pathological staging assessment measured by the presence of detrusor muscle in the specimen as a surrogate parameter for quality of resection.


Eligibility Criteria:
Inclusion Criteria

Subjects must meet all the following inclusion criteria to participate in this study:

* Diagnosis by cystoscopy of primary papillary non-muscle invasive bladder urothelial carcinoma (cTa, cT1)
* Imaging examinations shows that the bladder muscle has not been affected, no lymph node metastasis or distant metastasis;
* Diameter of tumor between 1cm and 3cm
* Number of lesions ≤3 (The position of small lesions relatively concentrated as one place)
* Patients who agree to eTURB or cTURB surgery, and will be effected to the postoperative follow-up treatment such as conventional infusion after the operation

Exclusion Criteria

* Pure carcinoma in situ
* Contraindications to surgery (i.e. bladder fibrosis)
* Diameter of tumor \>3cm
* Number of lesions \>3
* Poor performance status making a surgical intervention too risky
* Life expectancy of less than one year
* Patient refused to participate
* Pregnancy
* History of upper urinary tract malignancy
Extracorporeal Membrane Oxygenation Physical Training

Critically ill patients who require extracorporeal membrane oxygenation (ECMO) are the sickest in the hospital. More patients are surviving but survivors have compromised functional recovery for months or years. This trial aims to determine if early, physical training commenced within 48 hours of ECMO is feasible and improves muscle strength and functional status in patients compared to standard practice in a randomised controlled trial of 30 ICU patients.

The use of extracorporeal membrane oxygenation (ECMO) has expanded dramatically in Australia and globally. While life-saving in the short-term, it is typically associated with prolonged immobility and inflammation, which contributes to severe muscle weakness and wasting. Standard care delivers minimal physical training while patients remain on ECMO because standard care prioritises concerns about catheter dislodgement and cardio-respiratory strain. However, in other intensive care unit (ICU) conditions, techniques have been developed to allow early physical training in patients previously thought too unstable to be exercised, with important patient-centred and long-term cost-saving benefits. Our preliminary work shows that early individualised physical training is safe in ICU patients. A multicentre pilot study to establish feasibility in ECMO patients is urgently needed.

The primary aim is to test the hypothesis that early, individualised, physical training (commenced within first 48 hours of ECMO) is feasible and improves functional recovery (the highest level of activity and duration). This has previously been reported to be associated with improved independent function at hospital discharge and discharge to home.1 The secondary aims are to test the hypothesis that early individualised physical training is (i) safe; (ii) improves muscle strength at day 7 and 10 and 20; and (iii) improves functional status (IMS) at day 7, 10 and 20 in ECMO patients relative to standard care.

We are also aiming to describe the acute physiological effects of early physical training (commenced within 48hours of ECMO initiation) Respiratory and haemodynamic parameters, along with ECMO settings, will be recorded 30 minutes prior to each physical training session, during the session and 30 minutes post the training session. In addition, the range of values (min to max) for these parameters will be recorded for each 24hour period over the 7 days.

Eligibility Criteria:
Inclusion Criteria:

* adults ≥ 18 years of age
* were physically independent prior to the current admission;
* receiving ECMO (veno-arterial or veno-venous) for at least 24 hours;
* clinician in charge of patient care has no objection to randomisation

Exclusion Criteria:

* have been in ICU \> 5 days prior to the commencement of ECMO;
* have received ECMO for more than 48 hours;
* in the opinion of the treating clinician, is not expected to recover in 90 days (e.g. intracerebral haemorrhage);
* whom death is expected within 24 hours;
* are unable to communicate in English
Research on the Economics of Artemisinin Combination Therapy (ACTs) for the Treatment of Malaria

The objective of the REACT project is to evaluate the effectiveness and cost-effectiveness implications of interventions designed to improve health worker practice in providing treatment for uncomplicated malaria to febrile patients attending health facilities in Cameroon and Nigeria.

NIGERIA

Two interventions will be evaluated: (i) provider intervention including introducing RDTs with detailed instructions, one-off training, job aides and on-the-site supportive supervisory visits and (ii) combined provider intervention \[as under (i)\]and community-based intervention (using primary and secondary schools as focal points)including school malaria events with drama, peer-health education, distribution of health education materials. Types of facilities include: public primary health facilities, private pharmacies and private Patent Medicine Dealers (PMDs)in Enugu State. The two sites in Enugu State are: Enugu urban (comprising of Enugu East, Enugu South and Enugu North Local government areas (LGA) and Udi LGA. The impact of the interventions will be evaluated using a 3-arm stratified, cluster randomized trial with a cluster defined as a geographical community and the two study sites as the strata. The three arms of the trial are:

* Intervention - Provider intervention
* Intervention - Provider plus school-based malaria activities
* Control - Expected practice (once RDTs have been introduced)

CAMEROON

Two interventions will be evaluated: (i) the introduction of rapid diagnostic tests (RDTs) with basic provider training on malaria diagnosis and treatment; and (ii) the basic provider training \[as under (i)\] plus enhanced provider training to improve the quality of care that includes aspects of interactive self awareness, communication modules between health workers and also between health workers and patients. Types of facilities include: public district hospitals, public health centres (including integrated health centres), mission hospitals and mission health centres (including integrated health centres)in Yaoundé and Bamenda Health Districts. A stratified, cluster randomized trial will be used in which health facilities are the cluster and the two study sites are the strata. The three arms of the trial are:

* Intervention - RDTs with basic provider training;
* Intervention - RDTs with basic plus enhanced provider training;
* Control - which represents current practice and neither intervention will be implemented.

Eligibility Criteria:
Inclusion Criteria:

* the patient (or their caregiver) reports that the patient is suffering from a fever or has a history of fever in this illness episode
* the patient is present at the health facility

Exclusion Criteria:

* the patient is pregnant
* the patient is \<6 months old
* the patient has signs or symptoms of severe malaria
Shock Wave Versus Low Level Laser on Chronic Venous Ulcer

To find out the difference in the effect of shock wave therapy and low level laser therapy on venous ulcer patient As regards the following outcomes;

1. medical state of patient no ( diabetes, hypertension,obesity,cancer , rheumatoid)
2. The degree of ulcer
3. recurrence of ulcer
4. The degree of pain and disabilities
5. inflammatory marker

45 venous ulcer patient of both sexes will be recruited in this study from cardiovascular units in nasser institute hospital , their age ranged from 45 to 60 years old and randomly divided into 3 equal groups

1. study group (A) include old age patients with venous ulcer will receive extra corporeal shock wave therapy along with conservative treatment (compression therapy (pressure garment),lifestyle changes, physical activity) plus medical treatment
2. study group (B) include old age patient with chronic venous ulcer will receive low level laser therapy along with conservative treatment (compression therapy (pressure garment), lifestyle changes,physical activity) Plus medical treatment
3. control group (C) include old age patients with venous ulcers will receive conservative treatments ( compression pandaging, lifestyle changes, physical activities) plus medical treatment The study will be conducted when the patient stable medically and will be conducted until complete healing of ulcer

Eligibility Criteria:
Inclusion Criteria:

* All old age patients will be
* Ranging from 45-60 years old
* With BMI from (25-30)
* Chronic venous ulcer grade 2 or 3
* Ulcers non infected with superficial blood insufficiency
* open ulcers.

Exclusion Criteria:

* -Diabetes
* hypertension
* rheumatoid arthritis
* Obesity
* Musculoskeletal disorders
* Dementia
* cerbrovascular stroke
* Deep venous thrombosis
* deep venous ulcer
* venous ulcer grade 4
* smokers