cyrilzakka/clinical-trials huggingface dataset:
Detection of Chlamydia DNA by Polymerase Chain Reaction in Primary Tubal and Ovarian Cancers Tissues : a Pilot Study

PCR for chlamydia DNA is done in paraffin blocks of cases of primary tubal cancer and is compared to cases of high grade serous ovarian cancer and normal tubes .

The investigators shall review the early cancer detection unite pathology records for the past 10 years , for cases diagnosed with primary Fallopian tube cancers , cases of high and low grade serous ovarian cancer and cases underwent hysterectomy and salpingectomy for non oncological reasons. Paraffin blocks for suitable selected patients will be examined histologically to confirm the primary diagnosis . Chlamydia DNA in these paraffin blocks of the Fallopian tubes and ovarian tissues will be examined using PCR techniques . The possible correlation between the presence of Chlamydia DNA and the ovarian serous tumours and primary tubal cancer will be analyzed statistically .

Eligibility Criteria:
Inclusion Criteria:

* any patient with primary tubal cancer and high grade serous cancer and normal tubes.

Exclusion Criteria:

* clinical pelvic inflammatory disease
* salpingectomy for ectopic
Activator vs the EF Class II Standard in the Treatment of Severe Overjet in Angle Class II Division 1 Malocclusion

Objective: The purpose of this study was to compare the clinical effectiveness of reducing severe overjet in Angle Class II division 1 malocclusion between Activator and the EF (Functional Education) class II standard in treating.

Methods: A randomized clinical trial was conducted on a total of ̉60 patients with an Angle Class II, division 1 malocclusion (ANB angle ≥ 4°, basic normal maxillary status), and an overjet of ≥ 6 mm in the developmental stage (CS1-CS3) who were eligible for the study. Thus, the sample consisted of 60 subjects (29 girls and 31 boys) with a mean age of 9.7 ± 1.31 years. The investigators designed the study to treat patients, randomly assigning them by lottery to receive either an activator or the EF (Functional Education) class II standard. The activator versus the EF (Functional Education) class II standard group consisted of 30 subjects (17 girls, 13 boys) and 30 subjects (12 girls, 18 boys), respectively. The changes in skeletal, dental, and soft tissue were recorded before, at 6 months of treatment. Blinding was not performed. After six months of treatment, the study's endpoint was reached.

A randomized clinical trial was conducted on a total of ̉60 patients with an Angle Class II, division 1 malocclusion, and an overjet of ≥6 mm who were eligible for the study. Thus, the sample consisted of 60 subjects (29 girls and 31 boys) with a mean age of 9.7 ± 1.31 years. We designed the study to treat patients, randomly assigning them by lottery to receive either an activator or the EF (Functional Education) class II standard. The activator versus the EF (Functional Education) class II standard group consisted of 30 subjects (17 girls, 13 boys) and 30 subjects (12 girls, 18 boys), respectively. The changes in skeletal, dental, and soft tissue were recorded before, at 6 months of treatment. Blinding was not performed. After six months of treatment, the study's endpoint was reached and then selected those who achieved the standards for sampling at Can Tho University of Medicine and Pharmacy. The Can Tho University of Medicine and Pharmacy Ethics Council in Biomedical Research No. 23. 340.HV/PCT-H signed the study on April 12, 2023.

Eligibility Criteria:
Inclusion Criteria:

* Vietnamese children between the ages of 7 and 12 with central incisors erupted
* Angle Class II division 1 malocclusion (ANB angle ≥ 4°, basic normal maxillary status)
* Severe overjet ≥ 6mm
* The developmental stage (CS1-CS3)
* No previous orthodontic treatment
* Agreeing to engage in the study

Exclusion Criteria:

* The young with crossbite
* Severe crowding
SGI-110 in Combination With an Allogeneic Colon Cancer Cell Vaccine (GVAX) and Cyclophosphamide (CY) in Metastatic Colorectal Cancer (mCRC)

This study will be looking at whether CY/GVAX in combination with SGI-110 is effective (recruits CD45RO+ T cells to the tumor which may be a marker of anti-tumor activity) and safe in patients with metastatic colon or rectum cancers.


Eligibility Criteria:
Inclusion Criteria:

1. Documented cancer of the colon or rectum who have received and are stable on first or second-line therapy regimens for metastatic colorectal cancer
2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1
3. Adequate organ function as defined by study-specified laboratory tests
4. Must use acceptable form of birth control through the study and for 28 days after final dose of study drug
5. Signed informed consent form
6. Willing and able to comply with study procedures

Exclusion Criteria:

1. Currently have or have history of certain study-specified heart, liver, kidney, lung, neurological, immune or other medical conditions
2. Systemically active steroid use
3. Another investigational product within 28 days prior to receiving study drug
4. Major surgery or significant traumatic injury (or unhealed surgical wounds) occurring within 28 days prior to receiving study drug
5. Chemotherapy, radiation, hormonal, or biological cancer therapy within 28 days prior to receiving study drug
6. Pregnant or lactating
7. Unwilling or unable to comply with study procedures
A Single Ascending Dose Study of BMS-650032 in HCV Infected Subjects

The primary purpose of this study is to evaluate the safety profile and tolerability of single oral doses of BMS-650032 in subjects with chronic hepatitis C infection


Eligibility Criteria:
Inclusion Criteria:

* Chronically infected with HCV genotype 1
* Treatment naive or treatment non-responders or treatment intolerant
* HCV RNA viral load of ≥10\*5 IU/mL
* BMI 18 to 35kg/m²

Exclusion Criteria:

* Any significant acute or chronic medical illness which is not stable or is not controlled with medication and not consistent with HCV infection
* Major surgery within 4 weeks of study drug administration and any gastrointestinal surgery that could impact the absorption of study drug
* Co-infection with HIV or HBV
* Women of childbearing potential
Acute Kidney Injury After Cardiac Surgery on CPB

The purpose of this retrospective study is to determine the incidence and severity of acute kidney injuries (AKI) after heart surgery on cardiopulmonary bypass (CPB) in the pediatric intensive care unit (PICU) in Lausanne, Switzerland.

The investigators will review in a retrospective way, all patients aged between 0 and 16 years, admitted in the PICU after cardiac surgery on CPB from 01.01.2014 to 31.12.2016. They will asses for AKI. The first step is to determine the incidence and severity, the second step is to determine the risk factors for AKI and/or protecting factors.

Eligibility Criteria:
Inclusion Criteria:

- all pediatric patients (0-16 years) admitted to PICU after cardiac surgery with CPB.

Exclusion Criteria:

* Preexisting kidney injury,
* no preoperative creatinine lab value
Cellular Pharmacodynamics of Small Molecules in Lysosomal Storage Disorders

The purpose of this study is to evaluate the effect of small molecule therapy in primary cells derived from patients with lysosomal storage disease. The study will focus on activity of small molecules, in terms of measurements enzymes activity and level of substrates accumulations. Also, the effects of small molecules on cell function, including autophagy-lysosomal pathways, metabolism, mitochondrial function and immune reaction will be investigated.

Lysosomal storage diseases (LSD) often cause severe disability and have a devastating effect on quality of life. The current standard of care of a majority of LSD is enzyme replacement therapy (ERT). ERT, however, becomes less effective during the advanced stages of a disease. Another therapy is substrate reduction therapy (SRT). For example, SRT therapy for Gaucher disease with small molecules acts on ceramide synthesis pathway by decreasing production of the substrate. But, none of the above therapies are effective for treatment of a neuropathic form of LSD. Neurodegenerative changes in the central nervous system are a major problem in Sanfilippo disease. They cause severe disability and behavioral disturbance. This is the main reason for the absence of therapeutic options for MPS3 (Sanfilippo) patients. The future of neuropathic form of LSD therapy may lie in small molecules acting as agents for enzyme-enhancement therapy (EET). EET is based on the ability of small molecules to fold the misfolded mutant enzyme, activate autophagy-lysosomal pathways or mitochondrial function. This treatment approach has the potential to cross the CNS and carries the potential to treat the neurological symptoms of Sanfilippo disease or other types of LSD.

The purpose of this study will evaluate the effect of small molecule therapy in primary cells derived from patients with lysosomal storage disease. The study will be focused on activity of small molecules, in terms of measurements enzymes activity and level of substrates accumulations. Also, the effects of small molecules on cell function, including autophagy-lysosomal pathways, metabolism, mitochondrial function and immune reaction will be investigated.

Eligibility Criteria:
Inclusion Criteria:

Subjects with

1. confirmed diagnosis of any lysosomal storage disorder
2. family members with history of lysosomal storage disorders

Exclusion Criteria:

Subjects excluded from the study include those who:

1. present with severe cognitive deficits impairing decision making
2. are unable to or for whom it is medically unsafe to withdraw from their current medications, such as subjects on SSRI s and other psychoactive drugs. The subjects on SSRIs may be included in the study only with an approval from the prescribing physician to discontinue their medications temporarily for the study.
3. are pregnant or nursing. All women of child bearing potential will undergo a pregnancy test.
4. have a history of neurologic conditions such as stroke or any focal brain lesion that may result in parkinonian manifestations. Individuals with such MRI findings will be excluded from the study.
A Phase 3 Study to Evaluate the Long-Term Safety of ThermoProfen™ in Patients With Mild to Moderate Pain Associated With Osteoarthritis of the Knee.

ThermoProfen is a transdermal ketoprofen patch that is integrated with a long-lasting CHADD (Controlled Heat-Assisted Drug Delivery) unit for the treatment of chronic pain associated with osteoarthritis. This study will evaluate the safety of long-term administration of ThermoProfen™ for the pain associated with osteoarthritis of the knee in adults. The study will be conducted in patients with pain associated with osteoarthritis and who have completed a previous efficacy study of ThermoProfen.

The objective of the study is to evaluate the safety of long-term administration of ThermoProfen for the pain associated with osteoarthritis of the knee in adults.

Eligibility Criteria:
Inclusion Criteria:

* Patient completed a previous efficacy study of ThermoProfen.

Exclusion Criteria:

* Patient has a known allergy to nonsteroidal anti-inflammatory drugs (NSAIDs) (including aspirin).
* Patient has a suspected hypersensitivity, allergy, or other contraindication to any compound present in the study medication or has a known sensitivity to adhesive components similar to those used in ThermoProfen (such as that found in adhesive bandages, e.g. Band-Aid®).
* Patient has asthma that has been induced or made worse by the use of aspirin or any other NSAID.
* Patient has a relevant history of serious gastrointestinal disease.
* Patient has a defect, injury, or dermatologic disease or condition on the skin area where the study patch will be applied that may interfere with tolerability or post-application evaluations.
* Patient has neurological or psychiatric disease sufficient to compromise data collection or integrity.
* Patient is taking warfarin, heparin, or low molecular weight heparin.
* Patient, if female, is pregnant or breastfeeding or is of childbearing potential and not practicing adequate birth control.
Rescue Immunotolerance Study in Induction of Immune Tolerance (ITI)-Experienced Patients (RES.I.S.T. Experienced)

The purpose of this study is to evaluate whether a concentrate containing both FVIII and von Willebrand Factor (VWF) given at a high dose will induce immune tolerance in subjects who have already experienced and failed ITI with VWF-free FVIII concentrates. The treatment on this study is expected to last up to 33 months.

The presence of Factor VIII (FVIII) inhibitor prevents FVIII infusions from working properly and makes treatment of bleeding episodes very difficult. Having an inhibitor is a serious and life-threatening complication in patients with Hemophilia. The usual treatment of patients with FVIII inhibitors involves what is called "immune tolerance induction" (ITI). Immune Tolerance means that the body can accept infused FVIII and that FVIII is again effective in controlling bleeds. ITI involves giving high doses of FVIII regularly until the inhibitor disappears. This treatment is not always effective. The inhibitor persists in about 1 in 5 patients who undergo ITI.

There are 2 types of FVIII concentrates: FVIII concentrates derived from human plasma, which contain VWF, and concentrates of FVIII without VWF. Both types of concentrates are commonly used to induce immune tolerance in patients with Hemophilia A. Retrospective studies on subjects who were treated with VWF containing Factor VIII concentrates after failing ITI with pure factor VIII concentrates, have shown that tolerance can be achieved in a large percentage of patients. This study will access prospectively whether treatment with a FVIII concentrate containing VWF given at a high dose (200 units per kilogram) daily for up to 33 months is able to induce immune tolerance after previous attempts with concentrates containing only FVIII have failed.

Eligibility Criteria:
Inclusion Criteria:

1. severe hemophilia A (FVIII\<1%) with high responding inhibitors (peak levels \>5 BU)
2. male, any age;
3. any inhibitor level at study enrollment;
4. ability and willingness to participate to the study;
5. previous ITI course of at least 9 months with a VWF-free FVIII concentrate at any dosage, such as recombinant FVIII and/or monoclonally purified FVIII.

Exclusion Criteria:

1. concomitant systemic treatment with immunosuppressive drugs;
2. concomitant experimental treatment;
3. previous history of myocardial infarction and/or cerebral stroke
Extended Work Schedules, Sleep Loss and Health

This study aims to determine whether abnormal bodily rhythms contribute to elevate the risk of diabetes, independently of the amount of sleep loss.


Eligibility Criteria:
Inclusion Criteria:

* normal healthy men and women between the ages of 21 years and 39 years (inclusive) with normal weight (i.e., body mass index under 28 kg/m2 in men, 27 kg/m2 in women)
* normal findings on clinical examination, normal results on routine laboratory tests, normal EKG, normal glucose tolerance test, negative pregnancy test for women
* no personal history of psychiatric or endocrine illness
* no personal history of sleep disorder, usual total sleep time of at least 7 hours
* only female volunteers with normal ovulatory cycles will be included

Exclusion Criteria:

* subjects with irregular life habits (shiftworkers and subjects having traveled across time zones less than one month prior to the beginning of the baseline study)
* subjects taking any medication (including hormonal contraceptive therapy), and smokers are excluded
* subjects with significant sleep apnea (apnea index above 10) or significant arousal-associated periodic leg movements are excluded
After Eighty Study

The rationale of the present clinical trial is to study whether an invasive strategy in clinical stable patients over 80 years with NSTEMI/UAP may improve rates of death, reinfarction, stroke, need of urgent revascularisation, myocardial function and quality of life. The invasive approach involves coronary angiography with immediate evaluation for three different treatment options; 1. Percutaneous coronary intervention (PCI), 2. Coronary artery bypass graft (CABG) or 3. medical treatment. Clinical practice shows that older patients are commonly treated less vigorously than younger patients and the present guidelines are based on a considerably younger population.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 80 years.
* Acute coronary syndrome (NSTEMI/UAP) with chest pain \> 10 minutes, with or without ST-segment depression in ECG, and normal or elevated levels of troponin T or I. Elevated troponin levels are defined as values exceeding the 99 percentile of a normal population at the local laboratory at each participating site.
* Clinical stable

Exclusion Criteria:

* Age \< 80 years.
* ST-segment elevation in ECG (STEMI)
* Clinical unstable with ongoing chest pain or other ischaemic symptoms/signs.
* Cardiogenic shock.
* Short life expectancy due to extra cardiac reason, ie. COPD, disseminated malignant disease, or other reason.
* Anamnestic indications for significant mental disorder, including dementia.
* Any condition which interferes with patients possibility to comply with protocol.
Patient and Physician Survey on Satisfaction With Somatostatin Analogue (SSA) Injections in Acromegaly in China

The purpose of the protocol is to achieve an in-depth understanding of the current satisfaction status of somatostatin analogue (SSA) treatment for acromegaly through patient and physician surveys.


Eligibility Criteria:
Inclusion Criteria:

For Patients:

* Age 18 years or older
* Diagnosed with acromegaly
* Receiving current SSA injections for acromegaly treatment for at least 3 months
* Signed electronic Informed Consent Form (eICF)

For Physicians:

* Licensed endocrinologists or neurosurgeons
* Having prescribed SSAs for at least five patients with acromegaly in the past 6 months
* Signed eICF

Exclusion Criteria:

* Patients will not be included in the survey if they meet any of the following criteria:
* Patients who are not able to successfully complete the questionnaire independently
* Pregnant patients
Prehabilitation in Adult Patients Following Selective Cardiac Surgery: A Randomized Controlled Trial

Aim: To determine the impact of an evidence-based comprehensive prehabilitation (EBCPrehab) program on pre- and postoperative capacity, functional capacity and health related quality of life (HRQoL) in patients awaiting elective coronary artery bypass graft surgery (CABG) or valvular surgery. Design: A single-center randomized controlled trail. SUBJECTS: Overall 160 preoperative elective cardiac surgery patients will be randomly assigned to an intervention or control group. Intervention: one-week EBCPrehab intervention, including supervised exercise, mindfulness and nutrition assessment. Control group: usual care. Main measures: At baseline, one day before surgery, three days after surgery and before discharge. The following measurements will be performed: six-minute walk test, ICU delirium, health related quality of life and flow state.

Enhanced recovery improves the quality of recovery following cardiac surgery, while the evidence of prehabilitation is still limited. We hypothesize that the implementation of a comprehensive prehabilitation program, including physical, mental and nutrition support could optimize the postoperative outcomes during hospital stay.

A randomized controlled study of patients undergoing cardiac surgery with prehabilitation approach, is designed to compare patient outcomes. The samples will be collected from hospital registration and the invention will be conducted before surgery. During the 5-day prehabilitation intervention, patients will receive exercises, mindfulness and nutrition risk assessment. After surgery, the 6-minute walk test, delirium assessment, flow state and health related quality of life will be assessed to explore the effects of prehabilitation on patient outcomes.

Eligibility Criteria:
Inclusion Criteria:

* adult patients awaiting selective coronary artery bypass graft surgery (CABG) or valvular surgery

Exclusion Criteria:

* Disability, severe psychiatric disease.
Crystalline Exposition During Pediatric Cranial CT Imaging

This study focuses on reduction of X-rays dose applied to eye's lens during cranial CT in children. Principal objective is to analyse the efficiency of ocular bismuth masks, which are associated with an eye's lens dose modulation

Eye's lens radiosensitivity represents an important subject of investigation in radiology. Indeed, eye's lens is recognised as one of the most radiosensitive organs in human body.\[1,2\] Radiation induced cataracts represent a determining effect of ionising radiations and has been widely studied. "International Commission for Radiological Protection" has evaluated cataract appearance threshold at 15 Gy in 1977 ",\[3\] then at 8 Gy \[4\] and 5 Gy in 2007.\[5\] Finally, in 2011 new studies gave rise to a new limit of appearance of 0.5 Gy. Eye's lens radiosensitivity seems to have been underestimated for several years and so there is a significant improvement to be made in radioprotection in order to protect to the best of the investigator's ability both patient and manipulator. This was also confirmed by the Directive EURATOM 2013/59 (which is in the process of being transposed in French legislation)\[6\] that reduces legal limit dose delivered to eye's lens from 150mSv to20mSv, for categories A workers.

This study is performed on 4 sequential groups, of ten patients, whereby one control group without ocular protection added. Other groups benefit either from a bismuth ocular protection, from a dose modulation applied to the eye's lens, or from both techniques associated. For each group, experiment is then focused on dose received by the eye's lens (measured using TLD detectors) as well as on Image quality obtained. Currently, there is no recommendation regarding lens protection for patient who benefit of a head tomodensitometry. Some practices are already used routinely but without a critical analysis of a comparison of their respective benefits.

Eligibility Criteria:
Inclusion Criteria:

* Children between 5 and 16 yrs old
* Indication of cerebral CT with or without contrast regardless to indication or exam specificity
* Patients beneficiary or affiliated to health system security
* Oral consent for data processing from the child and his/her representative of parental authority

Exclusion Criteria:

* Children anxious or agitated
* Sedated patients or patients under general anaesthesia
* Impossibility to position the skull on the orbito-meatal plane (intubation for example)
* Patients under legal protection
Clinical Study, Non Inferiority Between Noex® 32µg Versus Budecort Aqua® 32µg in Treatment of Alergic Rhinitis

This study is to evaluate non inferiority of Eurofarma budesonide nasal spary x referral Astrazeneca budesonide. Half patients will receive Eurofarma medication and half patients will receive Astrazeneca medication. There is no placebo group.

Budesonide is a medicine already very used and registered about 20 years. Eurofarma has the intention to collect more data about safety and efficacy and present them to local authority.

This study was draw to treat patients with persisntent rhinits moderate to severe in sites localted locally in Brasil.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 12.
2. History of alergic persistent rhinitis moderate to severe at least 2 years.
3. Proved alergic using PRICK or RAST test.
4. Nasal symptoms (NIS) \> 3 and nasal obstruction \>1.
5. Indication of nasal corticorteroids use..
6. Washout of nasal corticorteroids for 14 days.
7. ICF.

Exclusion Criteria:

1. Other types of rhinitis;
2. Asthma non controled
3. Use of oral/injectable corticoids 30 days before screening.
4. patients not eligible to complete diaries.
5. patients with alergy to any substance of medicines.
6. non controlled desease.