cyrilzakka/clinical-trials huggingface dataset:
Wearable Robotic Upper Body Exoskeleton for Workers

The main aim of the project is to evaluate a novel upper body exoskeleton during simulated industrial work. In a first stage of the project, an extensive study involving the end-user companies will be carried out to clearly identify the operator target tasks and typical target task loads for which the exoskeleton will be designed. Based on standard ergonomic evaluation scales (RULA and NIOSH, the Need for Recovery Scale and the Ovako Working Posture Analysing System), high risk tasks will be identified in the field, based on the evaluated information about the workspace configuration, the performed operations and their physical constraints. These will include, but will not be limited to, non-ergonomic postures, for example performing operations above the head or reaching in front, to the side, or behind the body; flexing the arms for extended periods of time; and bending or twisting the torso to lift an object from low or distant locations. Important items to assess in this task are the frequency and duration of tasks and activities, lifting characteristics, perceived physical effort and work-induced fatigue.


Eligibility Criteria:
Inclusion Criteria: Industrial employees

-

Exclusion Criteria:

* non-able bodied individuals
A Dental Pain Study Comparing The Analgesic Efficacy Of Ibuprofen/Caffeine

An efficacy study assessing analgesic effect of ibuprofen/caffeine in post-surgical dental pain.

The purpose of this study is to assess the analgesic efficacy of a fixed dose combination of ibuprofen/caffeine compared to ibuprofen alone and also to placebo.

Eligibility Criteria:
Inclusion Criteria:

* Males and females 16 years to 40 years of age (inclusive).
* Subjects who have undergone outpatient surgical extraction of 3 or more third molars, of which at least 2 must be a partial or complete bony mandibular impaction within 30 days of Screening and have met baseline pain criteria as described in this protocol
* Examined by the attending dentist or physician and medically cleared to participate in the study.

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, metabolic or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing) determined by the Investigator to place the subject at increased risk including the presence or history within 2 years of screening of the following medical conditions/disorders:

  * Bleeding disorder;
  * Gastrointestinal ulcer or gastrointestinal bleeding;
  * Paralytic ileus or other gastrointestinal obstructive disorders.
* Pregnant female subjects; breastfeeding female subjects; fertile male subjects and female subjects of childbearing potential who are unwilling or unable to use a highly effective method of contraception
* Hypersensitivity to ibuprofen, naproxen, aspirin, or any other NSAID, caffeine, or other component of the product.
Unintended Home Injuries in Under-5 Children in Sohag Governorate

Child injuries are a major public health problem . Globally, unintended injury is one of the top 15 causes of death across all age groups of children aged؛ 0-19 years, In children under the age of five, the majority of injuries occur in the home.

Injuries is a health concern in every country around the world, affecting both developed and developing countries, causing over 5.8 million deaths per year or 15,000 deaths per day .

A WHO surveillance study conducted in four developing countries showed that Egypt had a prevalence of 32 % of childhood injuries which was the highest one .

The home is the place where children spend most of their time, the home environment is the most common place for childhood injuries

There is a lack of studies related to unintended home injuries in under-5 children in Sohag Governorate , unintended home injuries may result in temporary or permanent disability and requires medical attention and continuous care .

A limited number of child home injuries lead to hospitalization , so hospital based studies may ignore small scale injuries which couldn't be registered.

Unintended home injuries may influence health, education, and family economy of the affected children.

Unintended home injuries is one of the preventable causes of child morbidity and mortality , so we should know the prevalence and factors predisposing to it .

The aim of the study is to decrease morbidities and mortalities associated with unintended home injuries in under-5 children in Sohag Governorate by assessing prevalence and epidemiology of unintended home injuries in under-5 children in Sohag Governorate ,measuring extent of morbidities and mortalities associated with unintended home injuries in under-5 children in Sohag Governorate , determining factors predisposing to unintended home injuries in under-5 children in Sohag Governorate .

Eligibility Criteria:
Inclusion Criteria:

* The study will be conducted through personal interview with caregivers of under-5 children who accept to participate in it .

Exclusion Criteria:

* Caregivers who refuse to participate in the study and caregivers of children who experienced intended home injuries will be excluded from the study.
Time Longitudinal Study of the Microbiome in Colorectal Cancer Subjects

Researchers are trying to determine whether certain microbiome cause cancer or whether they are part of the microbiome in the gut due to the presence of cancer.

The purpose of this research is to learn about how the gastrointestinal bacteria (microbiome) can contribute to colon cancer, and how it may change due to colon cancer. In addition, we are going to study the features of the microbiome that can help predict recovery after colon resection. To do this, we are going to compare the microbiome from subjects with colon cancer to subjects without colon cancer.

Study participation involves collection of stool samples before and after your surgery, as well as samples of residual (left-over) colon tissue from your surgery. We would also like to collect optional samples from your follow-up colonoscopy. You may be in the study for up to 5 years.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Patients undergoing bowel resection by any standard surgical approach.

Exclusion Criteria:

* Female that are pregnant
* Currently receiving or have received pelvic cancer radiation therapy in the past 2 weeks.
* Currently receiving or have received chemotherapy in the past 2 weeks.
Standardized Time- and Score-oriented Treatment of Moderate and Severe Atopic Dermatitis

The study was designed to test the hypothesis whether a standardized, time-and score-oriented treatment following a strict evidence based algorithm is equally effective to a standard treatment regimen for moderate to severe atopic dermatitis.

Study Type: Mono-centre study, patients are blinded, physicians are randomized to either treat study- or controll group

Eligible are patients age 2 years or older with SCORAD \>= 20 Duration: 12 Months, study visits every 4 weeks.

Primary endpoint is Difference between Baseline SCORAD and mean SCORAD under treatment.

Secundary endpoints are quality of life, safety and economic burden in both treatment groups.


Eligibility Criteria:
Inclusion Criteria:

* Moderate to severe atopic dermatitis (SCORAD 20 or more) fulfilling the diagnostic criteria by Raika and Hanifin

Exclusion Criteria:

* Pregnancy
* Nursing
* Women in childbearing age without contraception
* Drug - and or alcohol abuse
* Gene defects that are associated with increased light sensibility, e.g. Xeroderma pigmentosum, Cockayne Syndrome, Bloom Syndrome
To Exam the Effects of Phyllanthus Niruri Extracts on Human Neutrophils

To exam the effects of Phyllanthus niruri extracts(corilagin, phyllanthin and brevifolin) on human neutrophils

Phyllanthus niruri extracts have anti-inflammatory effects in various cellular systems (monocytes, neutrophil). However, the underlying effects and mechanisms of Phyllanthus niruri extracts on neutrophils have not yet been investigated in detail.

In this study, first we would like to systemic exam the effects of corilagin, phyllanthin and brevifolin, three major active components, on human neutrophils.

Further to clarify whether Phyllanthus niruri extracts have any effect on neutrophils that may provide some insights on the ability of these compounds to modulate the innate immune response in acute organ injury.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers who aged 20-35 years.
* Do not have coagulopathy, systemic infection disease and severe liver and renal function impairment
* Accept venipuncture

Exclusion Criteria:

* Healthy volunteers who aged over 35 years.
* Have coagulopathy, systemic infection disease and severe liver and renal function impairment
Urine Adiponectin Concentration in Prediction of Contrast Induced Nephropathy

The present study is to determine the ability of urinary total adiponectin and its isoforms excretion in the prediction of contrast induced nephropathy (CIN) in the patients undergoing PCI.

Contrast induced nephropathy (CIN) is a severe complication after percutaneous coronary intervention (PCI). CIN is responsible for approximately genic renal insufficiency and is the third cause of hospital-acquired renal failure and the injury of endothelial of renal tubule is responsible for the CIN. However markers reliably identifying CIN in the patients undergoing PCI are rare. Adiponectin is a 30-kDa adipocyte-derived vasoactive peptide closely linked to components of the metabolic syndrome. Recent study demonstrates that the quantification of urinary adiponectin excretion appears to be an independent indicator of vascular damage potentially identifying an increased risk for vascular events. Therefore, the investigators presume that the adiponectin excretion may predict the incidence of the CIN. The present study is to determine the ability of urinary total adiponectin and its isoforms excretion in the prediction of CIN in the patients undergoing PCI.

Eligibility Criteria:
Inclusion Criteria:

* All patients \> 18 of age who are undergoing elective PCI and are able to give informed consent are eligible for study.

Exclusion Criteria:

* The end-stage renal failure
* The patients who are relieving dialysis
Spatial Analysis and Validation of Glioblastoma on 7 T MRI

Currently, patients with a glioblastoma multiforme (GBM) are treated with a combination of different therapeutic modalities including resection, concurrent chemo- and radiotherapy and adjuvant temozolomide. However, survival is still poor and most of these tumours recur within one to two years within the previously irradiated target volume.

The radiation target volume encompasses both the contrast-enhanced lesion on T1-weighted magnetic resonance imaging (MRI), plus a 1.5 - 2 cm isotropic margin in order to include microscopic speculated growth. These margins result in a high dose to surrounding healthy appearing brain tissue. Moreover, the short progression-free survival indicates a possible geographical miss. There is a clear need for novel imaging techniques in order to better determine the degree of tumour extent at the time of treatment and to minimize the dose to healthy brain tissue.

The development of Ultra-High Field (UHF) MRI at a magnetic field strength of 7 Tesla (T) provides an increased ability to detect, quantify and monitor tumour activity and determine post-treatment effects on the normal brain tissue as a result of a higher resolution, greater coverage and shorter scan times compared to 1.5 T and 3 T images. Up to now, only few investigators have examined the use of UHF MRI in patients with malignant brain tumours. These studies show its potential to assess tumour microvasculature and post-radiation effects such as microhaemorrhages.

This study analyzes the accuracy of the 7T MRI in identifying the gross tumour volume (GTV) in patients with an untreated GBM by comparing biopsy results to 7T images. These biopsies will be taken from suspected regions of GBM based on 7T MRI that do not appear as such on 3T MRI. We hypothesize that with the 7T MRI the GTV can be more accurately and extensively identified when compared to the 3T MRI.


Eligibility Criteria:
Inclusion Criteria:

* Supratentorial tumour
* Suspected GBM on diagnostic MRI
* Eligible for biopsy
* Minimum age 18 years or older
* World Health Organization (WHO) Performance scale ≤2
* American Society of Anaesthesiologist (ASA) class ≤ 3
* Understanding of the Dutch language
* Ability to comply to study procedure

Exclusion Criteria:

* Recurrent tumour
* Tumour location deemed unfit for extra biopsies
* Prior radiotherapy to the skull
* Prior chemotherapy
* World Health Organization (WHO) Performance scale ≥ 3
* American Society of Anaesthesiologist (ASA) class ≥ 3
* Eligibility for immediate debulking
* Contra-indications for gadolinium
* Contra-indications for the MRI
Immune Modulators and IVF

Exploring the immune mediators of early pregnancy prospectively may help to identify new early interventions that will increase the likelihood of success and help women make informed decisions regarding their pregnancies.

Sera will be obtained from 500 women undergoing IVF at five time periods: cycle Day 2, post HCG, Day 24, Day 28, and/or Day 35.Aliquots of sera will be tested by commercial ELISA kits for concentrations of immune modulators suggestive to be predictive of IVF outcome, such as cytokines (interleukins, tumor necrosis factor, and interferon), neurotrophins (BDNF), protease inhibitors (HE4) and insulin-like growth factors (IGF-1, IGF-2, IGFBP). The results will be correlated with IVF outcomes.

Eligibility Criteria:
Inclusion Criteria:

* All fresh transfers

Exclusion Criteria:

* PGD
Addition of Popliteal Plexus Block to Continuous Femoral Nerve Block for Total Knee Arthroplasty

The popliteal plexus block has been described as an alternative analgesic postoperative pain treatment for total knee arthroplasty. It consists of injecting local anaeshetics inside the distal end of the adductor canal close to the adductor hiatus, adjacent to the femoral artery, between the medial vastus muscle and the adductor magnus muscle, in order to anesthetize the popliteal plexus. However, the analgesic efficacy has never been demonstrated in a randomized controlled trial. Therefore the objective of this study is to investigate the analgesic benefit of this block combined with a continuous femoral nerve block, on patients scheduled for total knee athroplasty.

Patients scheduled to undergo total knee arthroplasty under general anesthesia will be randomly allocated to two groups: continuous femoral nerve block alone or continuous femoral nerve block with addition of a popliteal plexus block.

The continuous femoral nerve block will be performed by the anesthesiologist with 15 mLs of ropivacaine 0.5%, under ultrasound guidance before the beginning of the general anesthesia. The popliteal plexus block will be done by the anesthesiology, under ultrasound guidance, before the beginning of the surgery, under general anesthesia.

Postoperative analgesia will include acetaminophen (4 x 1000 mg), ibuprofen (3 x 400 mg) and a continuous infusion of Ropivacaine 0.2%.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for total knee athroplasty under general anesthesia
* ASA 1-3

Exclusion Criteria:

* Kidney disease with GFR \< 50 ml/mn
* Daily opioid consumption \> 1 month
* Allergy to local anesthetics
* Neurological problems of the lower extremity
* other contraindications to peripheral nerve blocks
Safety of Toremifene and Tamoxifen Therapy in Premenopausal Patients With Operable Breast Cancer

To compare the safety of toremifene and tamoxifen therapy in premenopausal patients with operable breast cancer by monitoring gynecological abnormality,blood lipid level,hepatic abnormality,estrogen level and perimenopausal symptoms.


Eligibility Criteria:
Inclusion Criteria:

1. Women aged ≥18 years, premenopausal
2. Histologically confirmed invasive breast cancer by core needle biopsy, hormonal receptor positive, defined as estrogen receptor(ER)/progesterone receptor(PR) positive
3. Patients must have received standard local therapy: normalized modified radical mastectomy or breast conserving surgery with negative margin and post-surgical radiotherapy. Patient should completed adjuvant therapy according to conditions, including adjuvant radiotherapy, neoadjuvant or adjuvant chemotherapy.
4. Leukocyte ≥ 3\*109/L; Platelets ≥ 75\*109/L; Serum glutamate oxaloacetate(AST/SGOT) or serum glutamic-pyruvic transaminase(ALT/SGPT) \<2.5 times of upper limit of normal (UNL) range Serum creatinine/blood urea nitrogen(BUN) ≤ upper limit of normal (UNL) range; Written informed consent according to the local ethics committee requirements.
5. Has Eastern Cooperative Oncology Group(ECOG) Performance Score 0-2;

Exclusion Criteria:

1. Histologically confirmed hormonal receptor negative.
2. Have received neoadjuvant/adjuvant endocrine therapy.
3. With metastatic tumor.
4. Family history of endometrial cancer or ovarian cancer or any other kind of gynecological malignant tumor.
5. Have already been detected of ovarian abnormality or endometrial thickening by transvaginal ultrasound.
6. With any of complications that will increase sex hormone level: pituitary adenoma，ovarian tumor, thymic cancer，etc.
7. With any of complications that will decrease sex hormone level:hyperthyroidism，hypothyroidism，liver cirrhosis，severe malnutrition，Turner's syndrome，sex hormone synthetase deficiency, intracranial tumor, pituitary atrophy, etc.
8. Ovarian ablation or suppression
9. With severe non-malignant co-morbidity that will influence long-term follow up.
10. With severe hepatic dysfunction, Child-Pugh C.
11. With severe cardiac dysfunction, New York Heart Association (NYHA) grading III or worse.
12. Known severe hypersensitivity to any drugs in this study;
Generating Health Evidence From Dietary Supplementation With a Micro-vegetable Blend

Micro-vegetables (MV) are seedlings of larger vegetables. They can be grown quickly and are a concentrated source of micronutrients. MV are thought to have broad health benefits, including many inflammatory conditions. These include metabolic, cardiovascular, and cognitive diseases. This could have important implications for the health of an ageing UK population. Less than a third of British adults consume 5 portions of fruit and vegetables per day; this is the level that reduces risk of morbidity and mortality. Vegetables, including MV may - at least in part - exert their health effects by changing the level and type of bacteria in the mouth and gut. Despite their promise, the MV scientific literature is not yet extensive enough to support definitive health claims. It requires the addition of high-quality studies that are relevant to humans. This study will firstly investigate the anti-inflammatory effects on skeletal muscle and adipose tissue in older adults, using a proteomics approach. Second, this study will assess concentrations of circulating inflammatory markers in the sera collected from participants at baseline and at the conclusion of a 6-week period. Further, this study will describe the effects of six weeks MV consumption on cognition, and the oral and gut microbiome. As the bioactive compounds in the MV are owed to the potential beneficial effects for human health, these will be characterised in sera collected from participants.


Eligibility Criteria:
Inclusion Criteria:

* Aged 60 years and above
* Body mass index \> 25kg/m2
* Able to give written informed consent to participate in the study

Exclusion Criteria:

* Not meeting any inclusion criteria
* Have had an adverse reaction to a local anaesthetic in the past
* Hepatitis B, Hepatitis C or HIV positive
* Have a bleeding disorder or are regularly taking a medication that will impair their blood's capacity to clot (e.g., aspirin, clopidogrel, warfarin, heparin)
* Have had a severe adverse reaction to plasters
* Have a gastrointestinal disorder that may impair the absorption of the supplement from the gastrointestinal tract
* Have an autoimmune condition
* Have a diagnosed neurocognitive disorder
* Have a skin condition that is likely to increase the risk of infection at the biopsy site
* Frequent use of medication or recreational drugs likely to affect our results
* Recent infection or vaccination
* Known allergy to any vegetables
* Participated in a nutrition supplementation study in the last month
The Role of 18F-FDG-PET for Staging and Prognostication

A retrospective, multicenter, non-interventional, imaging study ancillary to FIL_MCL0208 clinical trial (NCT02354313) in untreated adult patients with mantle cell lymphoma.

This is a retrospective, multicenter, non-interventional, imaging study devoted to patients diagnosed with MCL and enrolled in the MCL0208 international randomized, phase III clinical trial (NCT02354313).

The study is aimed at addressing a number of prognostic issues that still need to be clarified in MCL patients, by taking advantage of the PET performed within the MCL0208 trial and available for the analysis, and the clinical records and molecular data generated in the context of the trial.

In the clinical trial PET was optional at baseline (b-PET), before ASCT (i-PET) and after-ASCT (eot-PET), and none of the exams was used in the decisionmaking strategy. All the PETs available will be collected and considered for analysis. The study will not require additional treatment or procedures except those required for the MCL0208 trial. The participation of the patient to the MCL0208 trial is a pre-requisite to be involved in this study.

Eligibility Criteria:
Inclusion Criteria:

* Enrollment of the patient in the MCL0208 clinical trial documented by the signature of the study informed consent;
* Patient's treatment in one of the centers that participated in the MCL0208 trial and that has joined the MCL0208-PET study as well;
* Evidence of signed informed consent for the MCL0208-PET study.