cyrilzakka/clinical-trials huggingface dataset:
The Incidence of Pelvic Hematoma Following Hysterectomy

Hysterectomy is one of the common operations in gynecology. With population aging in modern society, the incidence of these surgeries is expected to increase even more. One of the major complications of pelvic surgery is symptomatic pelvic hematoma, which can present with pain, fever, and foul smelling discharge. The incidence of pelvic hematoma is 40%, and varies according to the type of hysterectomy and the diagnostic procedure. Those hematoma increase the risk for infection. Diagnosis usually is not a clinical one unless symptoms occur, and then the diagnosis is made by CT or ultrasound. Number of interventions are mentioned in the literature to try and decrease post operative complications and infections, none have suggested effective enough. This is a prospective study which objective is to characterize the incidence of pelvic hematoma following hysterectomy using ultrasound. The investigators will also try to identify preoperative, intraoperative and postoperative risk factors for infection of this hematomas. This identification might decrease the incidence of postoperative hematoma and infection.

aging in modern society, the incidence of these surgeries is expected to increase even more. One of the major complications of pelvic surgery is symptomatic pelvic hematoma, which can present with pain, fever, and foul smelling discharge. The incidence of pelvic hematoma is 40%, and varies according to the type of hysterectomy and the diagnostic procedure. Those hematoma increase the risk for infection. Diagnosis usually is not a clinical one unless symptoms occur, and then the diagnosis is made by CT or ultrasound. Number of interventions are mentioned in the literature to try and decrease post operative complications and infections, none have suggested effective enough. This is a prospective study which objective is to characterize the incidence of pelvic hematoma following hysterectomy using ultrasound. The investigators will also try to identify preoperative, intraoperative and postoperative risk factors for infection of this hematomas. This identification might decrease the incidence of postoperative hematoma and infection.

Eligibility Criteria:
Inclusion Criteria:Women following Hysterectomy in the gynecologic division Carmel Medical Center

Exclusion Criteria:

* not relevant
Influence of Osteoarthritis Information on Treatment Beliefs

The aim of this study is to evaluate the effect of educational information, with and without a general practitioner recommendation to exercise, on willingness to undertake exercise/physical activity for knee osteoarthritis. Eligible participants will be aged 45+ years and will not currently have osteoarthritis, knee pain, or any condition that makes them unable to exercise. Participants will be asked to complete an online survey, during which they will be randomised to one of three groups and shown different types of educational information to read. Outcome measures will be collected as part of the survey before and after participants read the educational information presented to them.

3-arm superiority online randomised controlled trial (delivered within one survey). Participants will complete an online survey, during which they will be presented with a hypothetical scenario asking them to imagine that they had recently developed knee pain and have gone to see their general practitioner. Participants will then be randomised to one of 3 different groups (described below). Each group will be shown different types of educational material and asked to read the information carefully. Once they have finished reading the material, they will be asked to complete follow-up outcome measures to determine whether their beliefs about osteoarthritis management strategies have changed.

The 3 trial groups are:

I. Control group: asked to read a single-A4 page of brief osteoarthritis information ("what is osteoarthritis"); II. Treatment options group: asked to read brief osteoarthritis information + two A4 pages of information on treatment options ("osteoarthritis treatment options"), and; III. Treatment options + recommendation group: asked to read brief osteoarthritis information + information on treatment options + receive a hypothetical GP recommendation for exercise

Eligibility Criteria:
Inclusion Criteria:

* Aged 45+ years

Exclusion Criteria:

* Been told by a health professional that they have osteoarthritis in any joint/anywhere in the body
* Have experienced any knee pain in the prior 3 months
* Unable to read English
* Have had a joint replacement in any knee or hip joint
* Have any health condition that makes unable to exercise
CDI Synbiotic Study

The investigators hypothesize that treatment with a synbiotic mixture consisting of inulin Lactobacillus rhamnosus (LGG®), Lactobacillus acidophilus (LA-5®), Lactobacillus paracasei (L. casei 431®) and Bifidobacterium lactis (BB-12®) can reduce the number of C. difficile recurrences significantly.

Probiotics have been tested for their efficacy in preventing infection with C. difficile after antibiotic exposure. Some of the most effective probiotics tested Lactobacillus rhamnosus (LGG®), Lactobacillus acidophilus (LA-5®), Lactobacillus paracasei (L. casei 431®) and Bifidobacterium lactis (BB-12®). However, most studies have focused on prevention of the first incidence of C. difficile infection rather than prevention of re-infection with C. difficile. Recurrence rates of C. difficile infection (CDI) among hospitalized patients are 15-25% - either as relapses caused by the original organism or re-infection following treatment. The potential of probiotics in preventing re-infection is less studied in these patients. Further, prebiotics which are carbohydrates only metabolized by beneficial bacteria have gained much attention the recent years for their health benefits through stimulating growth of specific types of bacteria in the gut, and recent data from mouse studies show that the prebiotic inulin can eliminate C. difficile growth, but the use of prebiotics in relation to C. difficile elimination has yet to be proven in humans. The investigators hypothesize that treatment with a synbiotic mixture consisting of inulin Lactobacillus rhamnosus (LGG®), Lactobacillus acidophilus (LA-5®), Lactobacillus paracasei (L. casei 431®) and Bifidobacterium lactis (BB-12®) can reduce the number of C. difficile recurrences significantly.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with primary CDI
* Treatment with Vancomycin
* Subjects over 18 years of age
* Signed informed consent

Exclusion Criteria:

1. Chemotherapy within two months and an absolute neutrophil count of \< 1000 neutrophiles/mm3
2. Acute leukemia
3. Serious immunodeficiency
4. Pancreatitis
5. Planned or recent intraabdominal operation within a time window of 14 days
6. Terminal disease with expected survival time \< 3 month
7. Probiotic consumption within two weeks prior enrollment
8. Pregnant or lactating women
9. A history of inflammatory or irritable bowel disease
10. Colectomy and cirrhosis
11. Septicemia
12. Toxic megacolon
B7.1/IL-2 Leukaemia Cell Vaccine for Non-Transplant AML RFUSIN2-AML2 (NTX)

The study will be an open label, single arm, phase I study intended to identify the safety and tolerability of "AML Cell Vaccine" given to eligible MDS RAEB-2 and AML patients who have achieved a best response of complete remission or partial remission following their first or second course of standard induction chemotherapy.


Eligibility Criteria:
Key Inclusion Criteria:

* Diagnosis of MDS RAEB-2 or primary (de novo) or secondary AML defined according to the WHO classification either as a new diagnosis or as a relapse.
* Patients for whom the optimal therapy in CR1 would be to undergo allogeneic bone marrow transplantation, but for whom this procedure is either not recommended (e.g. due to comorbidities) or not available (e.g. lack of a suitable donor).

Key Exclusion Criteria:

* Patients with MDS RAEB-2 or AML and favourable prognostic profile (good risk cytogenetics: t(15;17)(q22;q12\~21), inv16(p13q22)/t(16;16)(p13;q22), t(8;21)(q22;q22) or cytogenetically normal AML with NPM1 mutation and absence of Flt-3 ITD).
* Patients unsuitable for standard induction chemotherapy.
* Patients who have previously undergone or will be able to undergo allogeneic transplantation.
* Patients who have had previous or current treatment with any form of investigational immunotherapy.
HR-HPV Multi-site Opportunistic Screening in Liaoning, China

It is universally accepted that the persistent infection of high-risk human papillomavirus(HR-HPV) is the cause of cervical intraepithelial neoplasias and cancer. Some researches indicate that the virus load may relate the extent of the disease. The objective of the study is to detect the virus load of 14 types HR-HPV among the participants, using a new HPV DNA hybrid capture technology,sequentially find the diagnostic significance of virus load of HPV.

Cervical cancer is the most common malignancy in women, the persistent infection of high-risk human papillomavirus(HR-HPV) is the definite cause,especially the infection of human papillomavirus 16/human papillomavirus 18(HPV16/HPV18). Some researches indicate the virus load may relate the extent of the disease, but the sample capacity is not enough to receive a conclusive conclusion. And a specific quantity or a range of virus load which closely relates to cervical intraepithelial neoplasia 2(CIN2) or worse is not studied. The aim of the study is to prove the association between the virus load and development of cervical intraepithelial neoplasias by detecting 14 types HR-HPV, and find the specific quantitative value or the range to assist physician to diagnose.

A detect reagent named Dalton hybrid 3(DH3) is used in the study, the mechanism of which is HPV DNA hybrid capture technology, the experimental process include seven steps, denaturation, hybridization, the formation of DNA-RNA heterozygote, capture, detect, rinse panel, read data.

Study design: The organizations of the study contain ten hospitals in Liaoning province in China,patients accord with inclusion criteria(N=10000) sign informed consent and fill out a information form. Gynecologist collect cervical cell with sampling instrument. Detecting the virus load of HPV16/HPV18 and other 12 types HR-HPV, the positive result is cut-off ≥1.0pg/ml, HPV16/HPV18(+) need colposcopy. The abnormal result of colposcopy requires biopsy, the participant who has abnormal result of biopsy need operative treatment. Follow-up observation of all participants lasting 5 years are required.

Eligibility Criteria:
Inclusion Criteria:

The patients who are voluntary to accept screening with sexual life

Exclusion Criteria:

uterectomy, cancer, other serious illness, physical examination(pregnant women are not exclusive)
Integration of Refugees Into Public Mental Health Care

There are specific barriers to utilise psychotherapeutic services for refugees with mental health problems in the German public health care system. This study aims to evaluate additional organisational components that are hypothesised to improve service utilisation.

In a randomised controlled trial, refugees with mental health problems are identified by peers, subsequently assessed by professional staff and referred to public psychotherapeutic health services who offer standard care. Participants are assigned to care as usual or to "coordinated and peer supported mental health care"; the latter includes several additional organisational assistance components, i.e. a coordination center, trained peers to support treatment utilisation, a support and training center for therapists, and a interpreter pool. Measures include service utilisation and symptom change after 6 months. Furthermore the study evaluates whether trained peers can correctly identify participants with mental health problems.


Eligibility Criteria:
Inclusion Criteria:

* Psychiatric diagnosis from Chapters 3 and 4 of ICD10
* Participant applied for asylum in Germany
* Entry to Germany after 2012
* Participants is motivated to utilise psychotherapeutic services
* Patient speaks one of the languages in which services are offered (i.e. German, English, French, Arabic, Kurdish, Dari, Farsi, Urdu, Pashto, Tirginya, Somali)

Exclusion Criteria:

* Mental disorder that requires inpatient treatment
Gases Humidification During Noninvasive Ventilation : Heat and Moisture Exchanger or Heated Humidifier ?

To humidify gases during non invasive ventilation, both to heated humidifier (HH) and heat and moisture exchanger (HME) are routinely used. Patients receiving non invasive ventilation for acute respiratory failure were randomized to HME or HH. The purpose of this study was to evaluate respiratory parameters and arterial blood gases (ABG) of patients during NIV with small dead space HME compared to HH.

Objective: Few data are reported in the field of noninvasive ventilation (NIV) regarding humidification devices. It was previously suggested that standard heat and moisture exchangers (HME) had adverse gasometrical and clinical outcomes in acute respiratory failure (ARF) of chronic respiratory failure patients (CRF). This study was performed to evaluate respiratory parameters and arterial blood gases (ABG) of patients during NIV with small dead space HME compared to heated humidifier (HH).

Design: Prospective randomized cross-over study. Setting: A 16-bed medical intensive care unit (ICU) and a 14-bed medico surgical ICU.

Patients: Patients receiving NIV for ARF in the context of CRF or hypoxic ARF and patients with persistent weaning failure receiving NIV just after extubation.

Measurements: HME and HH were randomly compared during 2 NIV periods of 30 minutes separated by a 20 to 30 minutes period of spontaneous breathing with oxygen. ABG were collected at baseline and at the end of each period. As well as respiratory parameters including volumes, pressures, P0.1, a comfort score, capnometry and oxygen saturation. Two sets of patients were successively studied whether they have a flex tube added to the ventilatory circuit or not.

Eligibility Criteria:
Inclusion Criteria:

* Patients receiving NIV for ARF in the context of CRF, hypoxic ARF or patients with persistent weaning failure receiving NIV just after extubation

Exclusion Criteria:

-
Risk Factors for Rebleeding in Patients With Obscure Gastrointestinal Bleeding

The investigators investigated the rebleeding rate the risk factors for rebleeding after long-term follow-up (≥12 months) in patients who underwent capsule endoscopy for obscure gastrointestinal bleeding.


Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent capsule endoscopy in Shanghai Renji Hospital(China) from June 2002 to January 2012 for obscure gastrointestinal bleeding

Exclusion Criteria:

1. patients who did not undergo a gastroscopy and colonoscopy performed before capsule endoscopy examination; and
2. patients with follow-up examination for other know clinical diseases.
Study of the Safety of KSP Heptapeptide (KSP-910638G)

The purpose of this study is to evaluate the safety of orally administered KSP-910638G, a topically administered li-cor IRDye800CW labeled heptapeptide specific for human epithelial growth factor receptor 2 (HER2).

This is a Phase IA study of the safety of an orally administered KSP-910638G heptapeptide for detection of neoplastic tissues in multiple areas of the gastrointestinal tract in humans. The investigators intend to enroll 25 evaluable subjects. The investigators expect to be able to enroll about 1-2 subjects per week, so the study should take about 4-6 months to complete.

Interested, healthy subjects ages 25-100 who respond to recruitment advertising on UMHealthResearch.org and appear to be eligible based responses to inclusion/exclusion criteria questions will be scheduled for a study visit at MCRU. At the study visit, the subjects will review and sign the informed consent and eligibility will be confirmed. If eligible, subjects will provide a blood sample for clinical labs and a urine sample for urinalysis. A negative urine pregnancy test for women of child-bearing potential is required to be eligible. Eligible subjects will consume the reconstituted KSP-910638G. After 5 minutes, subjects will drink a minimum 4-8 ounces of tap water and vital signs will be taken. Subjects will remain in MCRU for observation for 30 minutes. Vital signs will be recorded after 30 minutes. Subjects are required to return to MCRU to have a repeat blood draw for clinical labs and urinalysis within 24 to 48 hours after KSP-910638G ingestion. The study team will conduct a verbal assessment for toxicity at this visit.

Eligibility Criteria:
Inclusion Criteria:

* Not pregnant (willing to have pregnancy test if applicable)
* No recent illness (infection, URI, virus or flu) within 2 weeks,
* Stable health status (i.e. no medication changes within 2 months, no recent surgery, etc. per PI)
* Willing and able to sign informed consent
* Willing and able to drink the peptide and a tap water chaser
* Willing and able to get baseline and 24-48 hours post ingestion labs

Exclusion Criteria:

* Known allergy to li-cor IRDye800CW, a near infrared fluorosphore or derivatives
* Subjects on active chemotherapy or radiation therapy
* Diabetics on insulin/hypoglycemic (due to fasting requirements)
Accuracy of Digital Models Using Open-access Software Programs

Background: Despite the clear drive toward digital model transformation, there are limitations to some paid software necessary for digital model production. The aim of the study is to compare the accuracy of open-access software against paid software regarding the segmentation process to produce a digital model. Four groups of software programs will be assessed regarding their accuracy in the segmentation process to produce a digital dental model. The reference models will be scanned by a desktop scanner and will be set as the gold standard. The same models will be scanned by the same CBCT machine. The obtained DICOM data will be converted into STL files by four different software programs.


Eligibility Criteria:
Inclusion Criteria:

* Complete records of patients (upper and lower).
* Intact models with complete anatomy.
* Complete permanent dentition

Exclusion Criteria:

* Broken or damaged stone models.
* Models of patients with orthodontic appliances or dental prosthesis
Influence of Cerebral Oedema in Intracerebral Haemorrhage

In 2020, IntraCerebral Haemorraghe (ICH) remains the most devastating type of stroke. Besides stroke unit care, no specific treatment has been proven effective yet. Perihaematomal oedema (PHO) could be a promising therapeutic target. However, the mechanisms, the natural history as well as the clinical impact of this PHO remain unclear. The COPITCH study has been designed to answer these questions


Eligibility Criteria:
Inclusion Criteria:

* With a spontaneous ICH, i.e. non traumatic
* Admitted within 12 hours of stroke onset. For wake-up strokes, time of last seen well will be considered as stroke onset
* Patient insured under the French social security
* Consent form signed

Exclusion Criteria:

* Pure intraventricular haemorrhages
* "secondary" ICH: ICH resulting from intracranial vascular malformation, intracranial venous thrombosis, head trauma or tumour; haemorrhagic transformation within an infarct
* Pre-admission modified Rankin score of 4 or 5
* Life expectancy of less than 1 year related to comorbidities (end stage cancer, end stage organ failure)
* Pregnancy or breastfeeding or Women of childbearing age without effective contraception (a pregnancy test will be done)
* Adults who are deprived of their liberty by judicial or administrative decision
* Referral from other hospitals
* Contra-indication to MRI : claustrophobia, ocular metallic foreign bodies (accidental or other) or in a risk area (nervous or vascular system);irremovable implanted medical device (pacemaker, neurostimulator, cochlear implants and others);metallic heart valve (mainly old heart valves) or vascular clips previously implanted on cranial aneurysms; gadolinium allergy
* No consent form
Bicycle Ergometer Training in Duchenne Muscular Dystrophy

The progressive muscle weakness and contractures of the patients adversely affect their gait and balance. It is known that the disorder of the patients' balance and gait affects their functional capacity. The aim of this study is to examine the effects of bicycle ergometer training on gait and balance in children with Duchenne Muscular Dystrophy. Twenty-four children with DMD included in the study will be divided into two groups as home program and home program+bicycle ergometer training with block randomization method. Home program including stretching, respiratory, range of motion, posture and mild resistance exercise with body weight will be asked to apply 3-5 days a week for 12 weeks, aerobic training will be performed 3 days a week for 12 weeks at 60% of their maximum hearth rate with 40 minutes total duration consisting of 5 min warm up and 5 min cool down period. Gait and balance were evaluated with GAITrite and Bertec Balance Check Screener, successively. Assessments will be applied at pre-training and after 12 weeks of training.


Eligibility Criteria:
Inclusion Criteria:

* Children have diagnosis of DMD confirmed by genetic analysis,
* Children can walk with unsupported.

Exclusion criteria:

* Children have undergone any surgery or suffered injury of the lower limbs,
* Children have severe contractures of lower limbs,
* Children have low cooperation
* Children have comorbid disease,
* Children were applied regular aerobic training such as bicycle training and hydrotherapy in last 6 months.
An Intervention Delivered by App Instant Messaging to Increase Use of Effective Contraception Among Young Women in Bolivia

This randomised controlled trial will establish the effect a contraceptive intervention delivered by mobile phone app instant messaging on use of effective contraception in Bolivia. Woman aged 16-24 will be randomised to have access to Centro de Investigacion, Educacion y Servicios's sexual and reproductive health app (control) or the app plus 0-3 instant messages a day for 4 months (intervention). Participants will complete a questionnaire at baseline and 4 month follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Aged 16-24
* Own a personal Android mobile phone
* Live in El Alto or La Paz Bolivia
* Sexually active
* Not using the pill, implant, injection, intrauterine device or patch
* Want to avoid a pregnancy

Exclusion Criteria:

* Cannot read Spanish
A Study of 99m Tc Pertechnetate Produced in High Energy Cyclotron in Patients With Thyroid Scan Indication

Prospective, open label single site study to demonstrate the safety and efficacy of Tc-99m pertechnetate produced by high energy cyclotron at CHUS.

The proposed clinical trial will be a prospective, case-controlled Phase I, open label, single site study. The first 10 consecutively enrolled patients will receive CYCLOTEC standard procedure thyroid imagery and an additional whole-body scans, and 20 subsequent case-matched controls, will receive GPERT and will also have additionnal whole body scan.

Eligibility Criteria:
Inclusion Criteria:

* Prescribed thyroid scan
* Provided written informed consent prior to participation
* Biochemical parameters within 5 times of the normal limits for age
* WBC count \> 3.0/μL
* ANC count 1.5/μL
* Platelets \> 75,000/μL
* Haemoglobin \> 10 g/dL
* Karnofsky Performance Scale score \> 50

Exclusion Criteria:

* Nursing or pregnant females
* Biochemical parameters as measured outside 5 times the normal limits for age within 14 days of the scan
* WBC \< 3.0/μL
* ANC \< 1.5/μL
* Platelets \< 75,000/μL
* Haemoglobin \< 10 g/dL
* Unable and unwilling to follow instructions and comply with the protocol
* Unable or unwilling to provide written informed consent prior to participation in the study
* Karnofsky Performance Scale score \< 50