cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Response to the Neoadjuvant Chemotherapy for Advanced Ovarian Cancer by Multimodal Functional Imaging

This study evaluates the therapeutic response by modern FMRI and PET techniques with the perspective to exploit multimodal data (fusion MRI/PET). The Sponsor would like to optimize the respective performances and to define the early assessment criteria, at the first detox, of the treatment efficacy, with and without antiangiogenic agent.

This study evaluates the therapeutic response by modern FMRI and PET techniques with the perspective to exploit multimodal data (fusion MRI/PET). The Sponsor would like to optimize the respective performances and to define the early assessment criteria, at the first detox, of the treatment efficacy, with and without antiangiogenic agent. It is a single center evaluation of the study treatment.

Eligibility Criteria:
Inclusion Criteria:

* Epithelial ovarian carcinoma, fallopian tube, or primary peritoneal carcinoma FIGO IIIC-IV histologically confirmed by biopsy and documented stage and untreated
* Pre-treatment abdominopelvic PET-CT and MRI within 4 weeks before neoadjuvant chemotherapy.
* During laparoscopy performed by an experienced surgeon in the treatment of ovarian cancer, patient considered ineligible for tumor cell kill at the outset.
* A life expectancy of greater than three months
* An eligible patient for Paclitaxel and Carboplatine based chemotherapy.
* Membership of a social security scheme
* Patient information and signed, dated written informed consent

Exclusion Criteria:

* Pre-treated using chemotherapy, radiology, or surgery for an ovarian cancer.
* Contraindication to MRI with the injection of contrast product, i.e, the first three months pregnancy, claustrophobia, major allergic antecedents, pacemaker, some surgery clips, some heart valves, cava filter, implanter pumps, cochlear implants, metallic extraneous malter.
* Uncontrolled diabetes
* Pregnancy and nursing
* Other uncontrolled medical conditions as thyroid pathology, neuropsychiatric disease, infection, coronary insufficiency or grade 3 - 4 heart disease established by association "New York Heart"
* Patient deprived of liberty and legally protect adult, or not in position to give consent.
Effect of Veramyst on the Nasal and Ocular Symptoms of the Early Reaction to Nasal Challenge With Allergen

The purpose of this study is to help us to a better understanding of how nose and eye symptoms are related in patients with allergies.


Eligibility Criteria:
Inclusion Criteria:

1. Males and females between 18 and 45 years of age.
2. History of grass and/or ragweed allergic rhinitis.
3. Positive skin test to grass and/or ragweed antigen.
4. Positive response to screening nasal challenge.

Exclusion Criteria:

1. Physical signs or symptoms suggestive of renal, hepatic or cardiovascular disease.
2. Pregnant or lactating women.
3. Upper respiratory infection within 14 days of study start.
Efficacy and Safety of Quetiapine Fumarate (SEROQUEL®) in the Treatment of Alcohol Dependency in Patients With Bipolar Disorder

The purpose of this study is to determine whether treatment with Quetiapine Fumarate (SEROQUEL) in conjunction with mood stabilizers (Lithium or Divalproex) for 12 weeks helps patients who have Bipolar I Disorder with Alcohol Dependence


Eligibility Criteria:
Inclusion Criteria:

* Meets criteria for Bipolar I Disorder with Alcohol dependence
* Outpatient Status
* Recent history of heavy drinking

Exclusion Criteria:

* Unstable medical illness
* Recent antipsychotic use
* Poorly controlled Diabetes Mellitus or Diabetes related illness
Influence of Depth of Anesthesia on Pupillary Reactivity to a Standardized Stimulus

A standardized tetanic stimulation is applied to patients under propofol-remifentanil TCI, in a cross-over fashion, at two different levels of anesthesia monitored by the BIS: BIS 25 and BIS 55. Remifentanil target remains constant during the whole study period (1 ng/ml). Pupillary reflex dilation is recorded after each stimulation.


Eligibility Criteria:
Inclusion Criteria:

* ASA 1-2
* scheduled for an idiopathic scoliosis surgical correction

Exclusion Criteria:

* Ophtalmologic pathology
* Neurologic or muscular pathology
* Metabolic pathology
* Chronic pain
A Study of Acthar Gel Alone or With Tacrolimus to Reduce Proteinuria in Fibrillary Glomerulopathy Patients

A Multicenter, Comparative Safety and Efficacy Study of Acthar gel alone or in combination with oral Tacrolimus to reduce urinary proteinuria in patients with idiopathic DNAJB9 Positive Fibrillary glomerulopathy.

A Multicenter, Comparative Safety and Efficacy Study of Acthar gel alone or in combination with oral Tacrolimus to reduce urinary proteinuria in patients with idiopathic DNAJB9 Positive Fibrillary glomerulopathy. This study will be a multi-center, prospective, randomized, open-labeled intervention trial of 34 patients randomized to 52 weeks of ACTHar gel alone or Acthar gel plus oral Tacrolimus.

Eligibility Criteria:
Inclusion Criteria:

* Male/Female age \> 18
* Biopsy proven Fibrillary glomerulonephritis within 3 years of study randomization
* Stable Maximum Renin-Angiotensin-Aldosterone System inhibition times 4 weeks prior to randomization Note: Maximum RAAS inhibition will be left to the discretion of the site Principal Investigator
* Estimated Glomerular Filtration Rate \> 25 mls/min calculate by the Chronic Kidney Disease-EPI formula
* Protein/creatinine ratio \> 2000 mg/gm 5) Note: If protein/creatinine less than 2000 mg/gm, a formal 24- hour urine collection for total protein can be performed. The total 24-hour protein will need to \>/= 2000mg.
* Blood pressure targeted to \< 140/90 at the time of randomization
* Patients with Monoclonal Gammopathy without history of myeloma will be eligible.
* Patients with monoclonal staining for fibrillary fibers will be excluded
* Patients with Type II non-insulin dependent diabetes will be eligible provided the renal biopsy does not show nodular Kimmelstiel Wilson lesions

Exclusion Criteria:

* Patients with MGUS and history of myeloma will not be eligible
* Patients with active viral production of either hepatitis B or C as evidence by historical polymerase chain reaction test positive for active viral shedding
* HIV seropositivity
* Renal biopsy data with \> 50% Interstitial Fibrosis
* Patient with active or a known history lymphoma
* Patients with insulin dependent diabetes mellitus will be excluded Note: patients with Type II diabetes mellitus that are well controlled without the need for insulin will be eligible for the study.
* Patients with Type II non-insulin dependent diabetes will be eligible provided the renal biopsy does not show nodular Kimmelstiel Wilson lesions.
* Patients receiving steroids, mycophenolate mofetil, cyclophosphamide, Azathioprine or other immunosuppressive agent with 4 weeks of study randomization Note: Washout of these medications will be allowed at the screening visit
* Patients having received Rituximab or B cell modifying biologic therapy within 6 months of randomization
Prolonged Hospital Stay After Thoracoscopic Anatomical Lung Resections

In this study, the reasons for prolonged hospital stay after thoracoscopic (video- or robot-assisted) anatomical lung resections are investigated. Currently, whenever possible, these anatomical lung resections are performed thoracoscopically, as they offer significant improvements in terms of postoperative pain, number of postoperative complications, rehabilitation, tolerance for adjuvant chemotherapy, and length of hospital stay. The development of an 'Enhanced Recovery After Surgery' (ERAS) protocol for lung surgery has further reduced hospital stay and the need for opioids for analgesia. Despite the optimal implementation of the ERAS protocol, there are still patients who need to stay in the hospital longer than the median. The aim of this research is to investigate the reasons for this.


Eligibility Criteria:
Inclusion Criteria:

* Patients referred for elective minimally invasive (uniportal or multiportal video- or robot-assisted) anatomical lung resection (lobectomy or segmentectomy)
* Informed consent obtained pre-operatively
* Age 18 years or older

Exclusion Criteria:

* Patients younger than 18 years old
* Traumatic event as indication for lung resection
* Non-anatomical lung resections
* Thoracotomy
* Patients already hospitalized for other pathologies, pre-existent and not related to the lung surgery
* Urgent/emergency procedures
Clinical Effect Evaluation of Laparoscopic Surgery for Ovarian Benign Tumors by Different Approaches

Main purpose: To compare the intraoperative and postoperative recovery of laparoscopic surgery for ovarian benign tumors through different approaches; Secondary objective: Will vNOTES increase the risk of cesarean section during pregnancy and affect the quality of sexual life after surgery.


Eligibility Criteria:
Inclusion Criteria:

Preoperative consideration was for benign ovarian tumors requiring surgical treatment.

Exclusion Criteria:

* (1) Ovarian malignant tumor or borderline tumor was considered before surgery or proved during surgery. (2) Severe endometriosis, previous severe pelvic inflammation, peritonitis, and other serious pelvic adhesions are considered. (3) Pregnancy status. (4) Postoperative follow-up is not convenient and lost visitors.
Antibacterial Effect of Zinc Oxide Nanoparticles on Acinetobacter Baumannii Isolated from Patients with Hospital Acquired Infections in Sohag University Hospitals, Egypt

A. baumannii is known as the most frequently isolated organism in intensive care units (ICUs), causing a variety of nosocomial infections, including pneumonia, urinary tract infections (UTIs), bacteremia as well as skin and soft tissue infections. These infections are usually associated with high mortality rates ranging between 26% among hospitalized patients and 43% among ICU patients.

Acinetobacter baumannii (A. baumannii) is Gram- negative, aerobic, glucose non-fermentative, non-motile coccobacillus, ubiquitous in nature, and persistent in healthcare settings. It is regarded as a significant opportunistic human pathogen.

This bacterium become a growing problem in hospitals as a predominant multidrug-resistant (MDR) bacterium. Horizontal acquisition of resistance genes is the main factor involved in the emergence of MDR .

There are many mechanisms to confer resistance to different classes of antibiotics in A. baumannii, one of them is multidrug efflux pumps. These efflux pumps are important source of MDR, which export antibiotics from the cell, increasing their antibiotic resistance.

AdeABC is one of the most important efflux systems, belonging to the RND family in Acinetobacter, which plays an important role in the resistance to a broad group of antibiotics; its genes are chromosomal and encode three genes, i.e., AdeB, AdeA, and AdeC, forming an operon in the vicinity. In addition, the expression of AdeABC is done by a two-component system, which includes a response regulator (AdeR) and a sensor kinase (AdeS) .

The ability of Acinetobacter spp. to form biofilm that enables bacterial survival in hospital settings, especially in ICUs, is the most significant contributing factor to their virulence, and this trait is also responsible for their notable antibiotic resistance. Several biofilm-related genes influence antimicrobial susceptibility, suggesting an association between the biofilm-forming ability of Acinetobacter spp. and their antibiotic resistance patterns (MDR/XDR)

Zinc oxide nanoparticles (ZnO NPs) are one of the most important nanoparticles of metal oxides; it is a unique and inorganic materials that can be used in several biological applications (anti-bacterial, anti-inflammatory). ZnO NPs exhibit distinctive properties other than other nanoparticles such as higher solubility, better biofilm penetration and effective drug delivery . ZnO NPs have been reported to have antimicrobial properties such as disrupting the cell membrane of pathogens, accumulating in the cell and producing toxic H2O2 (hydrogen peroxide)

Eligibility Criteria:
Inclusion Criteria:

* All patients suffering from infections that can be caused by A. baumannii.

Exclusion Criteria:

* All patients suffering from infections that aren\&#39;t caused by A. baumannii.
Use of ACA 125 in Patients With Ovarian Cancer: Safety and Immune Response

The purpose of this study is to use an immunologic approach following the treatment for recurrent disease in patients with ovarian, fallopian tube, or peritoneal cancer.

Patients with epithelial ovarian, fallopian tube or peritoneal cancer who receive surgical cytoreduction and platinum/taxane containing chemotherapy have a significant chance of entering complete clinical remission but about 70% will eventually relapse. Many patients respond to additional cytotoxic treatment with partial or complete responses, yet approximately 100% of these patients will ultimately progress. Novel consolidation strategies following treatment for recurrent disease are needed and an immunologic approach is an attractive option.

Eligibility Criteria:
Inclusion Criteria:

* Patients with epithelial carcinoma arising in the ovary, fallopian tube or peritoneum, stages I-IV. These patients must have received initial surgery and chemotherapy with at least one platinum based chemotherapy regimen.
* Patients must have relapsed and now have completed chemotherapy for recurrent disease within the last 6 weeks.
* Eligible patients may have asymptomatic residual measurable disease on CT scan, and/or may have an elevated CA-125, or may be in complete clinical remission.
* Patients must have adequate hematologic, renal and hepatic functions.

Exclusion Criteria:

* Patients with any other active malignancy concomitantly
* Patients within 3 weeks of prior cytotoxic or investigational chemotherapy
* Patients within 4 weeks of prior radiotherapy
* Patients within 6 weeks of prior immunotherapy
* Patients who have received any prior anti-cancer vaccine
Prevention of Post-partum Haemorrhage

The primary purpose of the trial is to evaluate whether the management of placental delivery with controlled cord traction (CCT) reduces the incidence of postpartum haemorrhage, compared with management waiting for clinical signs of spontaneous placental separation, in women with vaginal delivery receiving prophylactic oxytocin for the management of the third stage of labour.

The hypothesis is that CCT, by reducing the length of the third stage of labour, facilitates early postpartum uterine contraction and local haemostasis and decreases post partum blood loss.

In this randomized controlled trial, conducted in 6 maternity units, information will be provided to eligible women during a prenatal visit in late pregnancy. Once in labour ward, during labour and before delivery, and if eligible and willing to participate, the woman will be randomly allocated to the intervention or reference group.

In all women, immediately after the birth of the baby, 5 IU prophylactic oxytocin will be intravenously administered, the umbilical cord will be early clamped and cut, and a collector bag placed under the woman's buttocks.

In the intervention group, controlled cord traction will be applied as soon as a firm uterine contraction is obtained, and until placental delivery occurs.

In the reference group, clinical signs of placental separation will be awaited for, and then placental expulsion may be helped through maternal pushing and/or hypogastric pressure.

All other aspects of the management of the third stage will be standardized and common to all women.

On day 2 postpartum, a venous blood sample will be collected to measure plasma haemoglobin and haematocrit. On the same day, a questionnaire will be filled in by the woman to assess her satisfaction.

Eligibility Criteria:
Inclusion criteria :

* Age ≥ 18
* Expected vaginal delivery
* Gestational age ≥ 35 weeks
* Singleton pregnancy

Exclusion criteria :

* Age \<18
* Planned caesarean delivery
* Severe hemorrhagic disease
* Multiple Pregnancy
* Placenta praevia
* Intra uterine fetal death
* No health insurance coverage
Virtual Reality-based Eye Movement Desensitisation and Reprocessing Therapy for Specific Phobias

The goal of this clinical trial is to study the effectiveness of a virtual reality-based eye movement desensitization and reprocessing (EMDR) application in treating phobia. It will also learn about the feasibility and safety of the application for independent use.

The main questions it aims to answer are:

Does the VR EMDR application reduce distress, improve positive cognitions, and decrease avoidance of specific phobias? Can the application help diminish phobia-related bodily sensations and encourage cognitive shifts toward positive beliefs and greater confidence in confronting previously avoided situations? Can the participants independently administer the treatment with minimum assistance?

Participants will:

Visit the site and take the VR EMDR phobia treatment every day for one week. Report their phobia and simulator sickness symptoms through self-report questionnaires or semi-structured interviews.


Eligibility Criteria:
Inclusion Criteria:

* Have a specific phobia (not necessarily clinically significant)

Exclusion Criteria:

* Diagnosis of mental health disorders
* History of trauma associated with their phobia
* History of panic attacks associated with their phobia
* History of psychosis
* Current self-harm
* Current suicidal ideation
* Regular use of substances that might affect mental state
* Regular use of medications that might affect mental state
* Significant visual impairments
* Severe motion sickness
Controlled Study in Cranioplasty Reconstruction

Multicenter, prospective, comparative, observational study with regular follow-up visits.

The project's aim is long-term follow-up of patients affected by large and complex craniolacuniae treated, in standard clinical practice, with CustomBone Service™ Cranial (porous bio-mimetic hydroxyapatite custom-made medical device for cranioplasty), autologous bone or polymethilmethacrylate customized prosthesis and to compare the clinical outcome and safety among the three treatments.

Elegibility to each treatment will respect the standard clinical practice. Each investigator will respect his own hospital criteria for cranial reconstruction.

Each centre's agreement to participate the study is totally voluntary.

The study sample size has not been defined on statistical criteria: the study population was set at 100 consecutive patients treated with cranioplasty reconstruction with one of the three foreseen group.

Each investigator will not be allowed to enrol more then 20 patients to avoid an enrolment imbalance between centres involved.

Primary study end-points are: evaluation of adverse event incidence after surgical treatment.

Secondary end-points are: quality of life improvement, evaluation of bone continuity restoration evaluated by CT scan analysis, neurological improvement.

Cranioplasty surgery is necessary everytime a craniolacuniae has to be reconstructed to ensure protection to the central nervous system. Cranioplasty surgery is classified into first line surgery, due to traumatic events or degenerative pathologies, and second line treatment, when due to first treatment failure, for example because of autologous bone reabsorption/infection or other material reject.

Clinical evaluation scores Specific and validated clinical scores will be employed for End-points evaluation.

CT scan will required in the pre-operation visit and in the post-operation time during the follow up visits to evaluate the bone-implant osteointegration process and osteointegration will be evaluated applying a specific score.

Data have been recorded in a e-CRF with limited access, protected by personal password.

Data will always be collected in an anonymous way, subjects identity will always be undisclosed.

Each patient will be asked to give informed consent to partecipate the study.

Eligibility Criteria:
Inclusion Criteria:

1. Patients which need cranial reconstruction,
2. Cranioplasty reconstruction by autologous bone, hidroxyapatite or polymethylmethacrylate,
3. Patients of both sex in age range between 14 and 75 years old,
4. Craniolacuniae size \> 25 cm2 ,
5. Patients affected by complex pathologies or fracture or infection of a previous implant.
6. Elegibility to CustomBone Service™ Cranial treatment will respect the product leaflet instructions.
7. Each investigator will respect his own medical centre internal inclusion criteria to cranial reconstruction.

Exclusion Criteria:

1. Patients affected by important emocoagulation pathologies,
2. Patients affected by mellitus diabetes,
3. Patients affected by autoimmune pathology,
4. Patients unable to intend,
5. Patients affected by immunodepression.
Breast Cancer in Young Women: Is it Different?

Breast cancer is the leading cancer among women in Saudi Arabia representing almost the third of cancer diagnosed in Saudi women. Breast cancer in Saudi women is more frequently observed at young age. The data on this observation is either lacking or scares. Furthermore, the pathological and molecular features of breast cancer in young women are not clear. The study will provide important information to the national health care planner about this disease in young women including shedding light on possible genetic risk factors

The study is a prospective longitudinal cohort study of young women with breast cancer. Over a 3-year period, we aim to identify a total of 600 women with newly diagnosed breast cancer, of those 300 women age 40 and younger and 300 older women from academic and community health care institutions across the Riyadh area. It is anticipated at least 400 of these women will agree to participate in the study. The comparable control group of older patients with breast cancer will be used for study comparison. Patient surveys, medical record review, and blood and tissue collection will be utilized. Women will be surveyed every 6 months after diagnosis. The study will investigate short and long-term disease and treatment issues, and psychosocial concerns. We will also collect tumor and blood samples to characterize the pathological and molecular aspects of tumors, and establish tumor bank for future studies.

Eligibility Criteria:
Inclusion Criteria:

* Female
* Diagnosis of breast cancer
* Age 40 or younger at diagnosis for study group and older women for control group
* Informed consent obtained from patient

Exclusion Criteria:

* Absence of informed consent
Clinical Outcome After Total Knee Arthroplasty Using CR or PS Inlay

Compare knee flexion after cruciate-retaining and cruciate substituting Total Knee Arthroplasty.

The aim of this study is to compare knee Flexion after cruciate-retaining (CR) and cruciate-substituting (posterior stabilized - PS) Total Knee Arthroplasty (TKA).

For this purpose, flexion and extension of the knee joint are measured using a goniometer preoperatively and up to ten years after surgery In addition, the clinical outcome will be assessed and evaluated using internationally recognised and evaluated scores (Knee Society Score, Oxford Knee Score, EQ5D, UCLA Activity Score).

Patients are randomized to receive a PS or CR TKA. Patients are assessed before surgery, after 3 months, 1 year, 2 years, 5 years, 7 years and 10 years postoperatively.

Eligibility Criteria:
Inclusion Criteria:

* Indication for TKA with a non-linked, bicondylar total knee replacement
* written informed consent

Exclusion Criteria:

* Chronic pain patients
* Neuromuscular Diseases
* general illnesses that make mobilisation more difficult and/or prevent follow-up
* Known posterior cruciate ligament insufficiency
* Need for a higher degree of linkage
* BMI over 40 kg/m²
* Study doctor, his family, employees or other dependent persons