cyrilzakka/clinical-trials huggingface dataset:
Study of the Safety and Effectiveness of Motiva Implants®

This study evaluates the safety and effectiveness Motiva Implants® in women who are undergoing primary breast augmentation, primary breast reconstruction or revision breast surgery.

Prospective, Single Arm, Multicenter Study. Following FDA approval, follow-up data will continue to be collected for all cohorts on adverse events, reoperations, patient satisfaction, physician satisfaction and quality of life for a total of 10 years.

Eligibility Criteria:
Inclusion Criteria

* Genetic female.
* Patient is seeking one of the following procedures:

Primary Breast Augmentation Primary Breast Reconstruction Revision Augmentation Revision Reconstruction

* Patient has adequate tissue available to cover implant(s).
* Willingness to follow all study requirements including agreeing to attend all required follow-up visits and signs the informed consent.
* Agrees to have device returned to Establishment Labs if explanted.
* Willing to undergo Magnetic Resonance Imaging (MRI) evaluation of medically advised.

Exclusion Criteria:

* Has any breast disease considered to be pre-malignant in one or both breasts or is reporting mutations in BRCA1 or BRCA2 without a previous bilateral mastectomy or an untreated cancer of any type.
* Has inadequate or unsuitable tissue (e.g., due to radiation damage, ulceration compromised vascularity, history of compromised wound healing).
* Has an abscess or infection.
* Is pregnant or nursing or has had a full-term pregnancy or lactated within 6 months of enrollment.
* Is taking any drugs that would interfere with blood clotting, or that might result in elevated risk and or significant postoperative complications.
* Has any medical condition such as obesity (BMI ≥ 40), diabetes, autoimmune disease, chronic lung or severe cardiovascular disease that might result in unduly high surgical risk and or significant postoperative complications.
* Has any connective tissue/autoimmune disorder or rheumatoid disease, such as systemic lupus erythematosus, discoid lupus, scleroderma, or rheumatoid arthritis, among others.
* Has any condition that impedes the use of magnetic resonance imaging (MRI) including implanted metal device, claustrophobia or other conditions that would make MRI scan prohibited.
* Has a history of psychological characteristics that are unrealistic or unreasonable given the risks involved with the surgical procedure.
* Has been implanted with any non-FDA approved breast implant.
* Has been implanted with any silicone implant other than breast implants.
* HIV positive (based on medical history).
* Has been diagnosed with anaplastic large cell lymphoma (ALCL).
* Works for Establishment Labs, Motiva USA or any of their subsidiaries, the study surgeon, or ICON the Contract Research Organization (CRO) that is helping to conduct the study or are directly-related to anyone that works for Establishment Labs, Motiva USA or any of their subsidiaries, the study surgeon, or the CRO.
Effect of Trophectoderm Biopsy for Sex Selection on the Pregnancy and Miscarriage Rates of Women Undergoing IVF/ICSI

Records of women who had trophectoderm biopsy for sex selection over the last 3 years will be reviewed and its outcome will be compared to other records of women who had IVF/ICSI without embryo biopsy.

Records of women who had trophectoderm biopsy for sex selection over the last 3 years will be reviewed. Women will be divided into 3 groups: group 1 will comprise fertile women who had embryo biopsy for sex selection/family balancing, group 2 will comprise infertile women who had trophectoderm biopsy and group 3 will comprise infertile women who had IVF/ICSI without embryo biopsy.

The pregnancy and miscarriage rates of the groups will be compared. Before starting the embryo biopsy process couples were seen by a geneticist to assess the feasibility of the procedure for each couple. Couples were then counselled by a gynaecologist specialised in IVF to assess their fertility status and explain the whole procedure including the expected success rates and risks of IVF.

Women had standard pituitary down-regulation with GnRHa (Triptorelin 0.1mg, Decapeptyl® Ferring, Germany) day 7 after ovulation of previous cycle or on day 21 of the oral contraceptive cycles. GnRHa was continued for 2 weeks. Human menopausal gonadotrophin(HMG) (Merional ®IBSA) 150-300 IU/day was administered until the day of HCG administration, Transvaginal oocyte retrieval will be performed 34-36 h after the administration of HCG.

Day 5 embryos were incubated in calcium/Magnesium free culture. A laser beam was used to produce a hole in the zona pellucida. Trophectoderm cells were collected by gentle suction using the biopsy pipette.

Florescent in situ hybridization of the trophectoderm nuclei with probes specific to the X- and Y-chromosomes was performed. the embryos were frozen and the cycles deferred.The embryos were thawed in the following cycle and if possible 2 embryos of the desired sex were transferred.

Eligibility Criteria:
Inclusion Criteria:

* Women undergoing IVF/ICSI

Exclusion Criteria:

* Women with expected poor ovarian response according to the Bologna criteria.
177Lu-EB-PSMA617 in Patients With Metastatic Castration-resistant Prostate Cancer

This is an open-label, non-controlled, non-randomized study to assess the safety and measure image-based absorbed dose of 177Lu-EB-PSMA-617 in patients with metastatic castration-resistant prostate cancer (mCRPC) who will undergo radioliagnd therapy using 177Lu-EB-PSMA-617. All patients underwent whole-body 68Ga-PSMA PET/CT for selection and accepted intravenous injection with single dose 0.80-1.1 GBq (21.5-30 mCi) of 177Lu-EB-PSMA-617 within one week, then monitored at 2, 24, 72, 120 and 168 h after 177Lu-EB-PSMA617 administration with serial whole body planar and SPECT/CT imaging.

Prostate cancer is the most frequent malignant tumor in men worldwide. Prostate-specific membrane antigen (PSMA), is a surface molecule specifically expressed by prostate tumors which was shown to be a valid target for radiotherapy. 177Lu-PSMA-617, a urea-based compound, provide an effective target for the treatment of metastatic castration-resistant prostate cancer. However, a major problem in the therapeutic use of 177Lu-PSMA-617 has been its short half-life and fast rate of clearance. This study was designed to investigate the safety, dosimetry and preliminary effects of 177Lu-EB-PSMA-617 in patients with metastatic castration-resistant prostate cancer.

Eligibility Criteria:
Inclusion Criteria:

* All the patients had progressive metastatic castration-resistant prostate cancer that did not respond to androgen-suppression therapy and/or systemic chemotherapy. Distant metastases with high PSMA expression were confirmed on 68Ga-PSMA PET/CT within one week before the injection of 177Lu-EB-PSMA-617.

Exclusion Criteria:

* The exclusion criteria were a serum creatinine level of more than 150 μmol per liter, a hemoglobin level of less than 10.0 g/dl, a white-cell count of less than 4.0× 109/L, a platelet count of less than 100 × 109/L, a total bilirubin level of more than 3 times the upper limit of the normal range and a serum albumin level of more than 3.0 g per deciliter, cardiac insufficiency including carcinoid heart valve disease, a severe allergy or hypersensitivity to radiographic contrast material, claustrophobia, and pregnancy or breastfeeding.
A Research Study of How NNC0174-0833 Behaves in Chinese Volunteers Who Are Normal Weight, Overweight or With Obesity

The aim of this study is to look at how the study medicine behaves in participants body and how it is removed from their body.

The study compares three different doses of the study medicine in Chinese healthy men.

Participant will either get 0.3 mg, 0.9 mg or 1.8 mg NNC0174-0833 which dose participant get is decided by chance.

NNC0174-0833 is a new medicine and has not been approved by the Center for Drug Evaluation.

We are testing the study medicine to make a medicine that can help people lose weight.

Participant will get 1 injection by a study nurse or doctor at the clinic. The injection will be with a needle in a skin fold in the stomach area.

The study will last for about 5 months. But participants participation will last about 2 months.

Participant will have 8 clinic visits with the study staff. One of these visits will be a 7-day, 6-night stay.

At all visits, except the information visit, participant will have blood drawn along with other clinical examinations.

Participants will be asked about their health, medical history and habits including mental health.


Eligibility Criteria:
Key inclusion criteria

* Chinese male subject aged 18-55 years (both inclusive) at the time of signing informed consent.
* Body mass index (BMI) between 20.0 and 39.9 kg/m\^2 (both inclusive) at screening.
* Body weight between 60.0 and 110.0 kg (both inclusive) at screening.

Key exclusion criteria

* Male subject who is not sexually abstinent or surgically sterilised (vasectomy) or who or whose partner(s) is not willing to use highly effective contraceptive methods (as required by local regulation or practice) throughout the trial (until 'end of trial').
* Any disorder, which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol.
Evaluation of the Safe Use and Tolerance of a Peptide-based Formula in a Pediatric Population

The objective of this study is to determine the safe use and tolerance of a peptide-based formula in children with gastrointestinal dysfunction and/or feeding intolerance.


Eligibility Criteria:
Inclusion Criteria:

* Male or nonpregnant female between 1 and 13 years of age.
* Subject is diagnosed with gastrointestinal dysfunction and/or feeding intolerance.
* Subject requires enteral tube feeding as sole source of nutrition.

Exclusion Criteria:

* History of diabetes.
* Requires artificial ventilation.
* Requires parenteral nutrition.
* Subject has intestinal obstruction.
* Subject is receiving dialysis treatment.
* Subject has an allergy or intolerance to any ingredient in the study product.
Imaging Study of Glioblastomas Treated With Avastin

This study aims to assess the effect of Avastin on brain vascularity and blood-brain permeability using dynamic contrast ct scans (DECT) and MRI imaging. Previous publications have documented the method by which DECT can determine alterations in vascular volume and tissue permeability within tumors and normal brain tissue. Functional maps of cerebral blood flow cerebral blood volume and permeability-surface area can be generated from the DECT studies to assess tumor perfusion. MRI spectroscopy analyzes brain chemistry to detect tumour versus edema versus normal brain. Thirty patients will receive MRI spectroscopy and DECT imaging at the time of presumed recurrence and 3 months later. 15 patients who do not receive Avastin and 15 patients who do receive Avastin as standard treatment for recurrence will be studied with DECT and MRI spectroscopy at baseline and then again in 3 months.

The clinical determination of the point of tumour progression or response is difficult to determine using standard diagnostic imaging ie CT/MRI especially following previous treatment with surgery, radiation and chemotherapy. Hemorrhage, edema, inflammation and vascular necrosis.

Both MR spectroscopy and DECT have been reported as being able to define areas of recurrent tumour as opposed to treatment-related effects. We wish to investigate the correlation between MR spectroscopy and DECT in assessing tumour progression or response to Avastin in comparison with patients not receiving Avastin.

Health Canada has approved Avastin for clinical use in patients with recurrent glioblastoma who have previously received temozolomide and radiotherapy. We propose to perform a DECT scan at baseline at presumed tumour progression and again 3 months to determine the effects of tumour progression/response on blood brain barrier permeability and vascular volume. The group of 15 patients will be compared to a group of 15 patients who do not receive Avastin at recurrence involving DECT scanning and MR spectroscopy at the time of the radiological progression and 3 months later.

Eligibility Criteria:
Inclusion Criteria:

* Histological diagnosis of glioblastoma with clinical or radiological evidence of progression as indicated by the RANO criteria 19
* Previous radiation and temozolomide chemotherapy
* Patients must be receiving Avastin chemotherapy as second-line treatment if in the Avastin group
* Study-specific consent

Exclusion Criteria:

* Failure to meet inclusion criteria
* Pregnant or lactating patients
* Allergy to iodine or CT contrast precludes DECT component of study
* Claustrophobia precludes MR Spectroscopy component of study
* Internal metal which would preclude an MRI scan
Randomized Clinical Trial Aimed at Comparing Unclamped Robotic Partial Nephrectomy With or Without Renorrhaphy

Intended to minimize ischemia during robotic partial nephrectomy (RPN) procedures "by any means possible".

Before starting enucleation, the boundaries of the tumor are marked during SL-ocRPN surgery cautery. Once the tumor is removed, the resection bed is cauterized by dispensing monopolar energy with "quasi-contact" mode, and hemostasis is progressively improved.

Since RR impacts postoperative renal function, we believe the use of cautery instead of suture of the parenchymal breach after tumor enucleation provides at least postoperative functional results not lower, shorten the intervention time and reduce the direct costs associated with the procedure.

Based on available pilot studies, SL-ocRPN is safe, fast, and both the transfusion rate and duration of the hospital stay are not affected by the lack of renorrhaphy at the end of the enucleation. At the same time, this surgical approach does not require the use of a robotic needle holder and this can result in a reduction of direct costs related to treatment.

Furthermore, based on the preliminary data available, the rate of positive surgical margins would also not result influenced by the absence of RR and the risk of local recurrence could even be reduced by the extended one coagulation of the tumor bed after enucleation.

Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18 years;
* radiological diagnosis of organ-confined renal neoplasm (cT1-2 cN0);
* patient who is a candidate, due to personal or tumor characteristics, for ocRPN intervention;
* compliant patient, able to follow the procedures/follow-up;
* patient who agrees to participate in the clinical study and the planned randomization, by signing the informed consent.

Exclusion Criteria:

* preoperative evidence of unilateral/bilateral synchronous renal neoplasms;
* personal history of renal surgery for benign or malignant pathology.
Ontario ICU Clinical Best Practices Demonstration Project

The pragmatic issue at hand how to get physicians and nurses to use best practices... and how to measure consequences of their implementation. This is the science of "knowledge translation", which we are realizing is an "organic" entity. As part of our Critical Care Strategy our goal is to improve the quality and continuity of critical care within our health care system. Toward this goal we are implementing a program which links 16 Ontario hospitals through their critical care units in a Provincial Network.


Eligibility Criteria:
Inclusion Criteria:

* Cohort of hospitals with Intensive Care Units in Ontario
Human Brown Adipose Tissue and Mitochondrial Respiration

This study is focused on measuring mitochondrial activity of human brown adipose tissue. During surgery, adipose tissue biopsies from white and brown adipose tissue will be collected from the deep neck area. These biopsies will be used to examine mitochondrial function via histological analysis, biochemical analysis and in vitro experiments based on precursor cells present in the biopsies.


Eligibility Criteria:
Inclusion Criteria:

* Indication for surgery in the supraclavicular and neck region (more specific patients diagnosed with hyperparathyroidism, struma, benign thyroid gland tumours, implantation of a vagal neurostimulator for epilepsia and cervical neurologic disorders)
* In the thyroid gland group, euthyroid function

Exclusion Criteria:

* Pre-operatively diagnosed malign tumour
* Patients undergoing acute surgery because of critical illness
Perioperative Complications Linked to COVID-19 History in Elective Cardiac Surgery Patients

A. Primary objective

Identifying risk factors for peri-operative complications in patients who have had COVID-19.

B. Secondary objectives

Identifying peri-operative complications in patients who have had COVID-19. Follow-up of peri-operative complications during hospitalization. Identifying the safe distance at which a patient can be operated after a Sars CoV2 infection without having an increased risk of peri-operative complications.

C. Study inclusion and exclusion criteria

1. Inclusion criteria

   Patients should be included if:
   * are scheduled for elective cardiac surgery with extracorporeal circulation (bypass);
   * they give their consent for their data to be included in studies;
2. Exclusion criteria

Patients should be excluded if:

* they have emergency surgery;
* have had Sars Cov 2 infection more recently than 3 months;

D. Data Collection

It is done in an excel table. Data collection is done anonymously. No patient-identifying data will be collected. The collected data will be about comorbidities, COVID-19 status - disease and vaccination, postoperative complications.

Types of data collection from the patients:

The type of surgery Age Sex Smoking Diabetes History of renal disease Preoperative anemia Preoperative creatinine Preoperative urea BMI NYHA class ASA score EuroScore I Preoperative LVEF Disease COVID -19 Date of illness Hospitalization for COVID-19 COVID 19 vaccination status Necessary vasopressor peri-operative duration and Maximum dose Perioperative positive inotrope required Bypass duration Duration of Aortic clamping Intraoperative transfusions Post operative creatinine - peak level Post-operative urea peak level Duration of post-operative oro-tracheal intubation NIV required Duration of hospitalization in Cardiac Intensive Care Unit Duration of postoperative hospitalization

Eligibility Criteria:
Inclusion Criteria:

* are scheduled for elective cardiac surgery with extracorporeal circulation (bypass);
* they give their consent for their data to be included in studies;

Exclusion Criteria:

* they have emergency surgery;
* have had Sars Cov 2 infection more recently than 3 months;
SPI-1005 for the Treatment of Meniere's Disease

The study is a randomized, double-blind, placebo-controlled, multi-center clinical trial (RCT) with open-label extension study (OLE), of SPI-1005 in adult subjects with definite Meniere's disease with active symptoms within three months preceding study enrollment.


Eligibility Criteria:
Inclusion Criteria:

* Adult males/females, 18-75 years of age at the time of enrollment.
* Diagnosis of definite Meniere's Disease by AAO-HNS Amended 2015 Criteria.
* Hearing loss of ≥30 dB at 250, 500, or 1000 Hz at study enrollment.
* At least two of three active symptoms (tinnitus; aural fullness; vertigo or dizziness) of Meniere's disease by AAO-HNS Amended 2015 Criteria, within 3 months of study enrollment.

Exclusion Criteria:

* Current, or within 60 days prior to study enrollment, use of IV ototoxic medications
* History of otosclerosis or vestibular schwannoma.
* History of significant middle ear or inner ear surgery in the affected ear.
* Conductive hearing loss with air-bone gap ≥15 dB, otitis media, or mixed hearing loss.
* Significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, neurological, or psychiatric disease.
* Current use or within 30 days prior to study enrollment systemic steroids.
* Current use or within 7 days prior to study enrollment intratympanic steroids.
Power-speed-endurance Profile (Cycling/Rowing) : Optimize Performance of the French Athletes at the Paris Olympics 2024

As part of the preparation at the Paris 2024 Olympic Games, the French rowing and cycling federations and a consortium of researchers met to reach an ultimate goal: to increase the number of medals in these two disciplines for Paris 2024 Olympics.

The objective of this study is to evaluate the maximum capacity of power production of athletes by describing their power-endurance profile and the physiological factors underlying this maximum power generation capacity. These assessments will guide coaches and athletes for:

1. the best use of athletes' physical abilities (for race strategy, cycling gear ratio or rowing levers)
2. adaptation of training program to improve the maximum capacity of power production of the athletes, in order to increase the number of medals at the Paris Olympics 2024.

Eligibility Criteria:
Inclusion Criteria:

* experienced, well-trained (national to international level) rowers and cyclists
* written consent

Exclusion Criteria:

* taking medications interfering with measured parameters
* contraindication to competitive sport practice
* currently participating in an other structured exercise program
* muscular, bone or joint injuries
* neurologic disease
* pregnant
Investigation of Fecal Microbiota Transplant in Chronic Intestinal Pseudo-obstruction Patients

Chronic Intestinal Pseudo-Obstruction (CIPO) is a rare gastrointestinal disorder that primarily affects the movement of the intestines, leading to symptoms that resemble a true bowel obstruction but without a physical blockage. This condition is characterized by impaired motility of the gastrointestinal tract, which can result in severe symptoms and complications. In previous studies, the investigator found that sequential microbiota transplantation therapy can improve clinical symptoms of chronic pseudo-obstruction. Building on this foundation, the current study further investigates the effects of sequential interventions involving intestinal cleansing, small intestine bacterial treatment, fecal microbiota transplantation, and nutritional therapy on the short-term and long-term clinical symptom improvement in patients. Additionally, the investigator aim to elucidate the changes in gut microbiota phenotypes before and after treatment.


Eligibility Criteria:
Inclusion Criteria:

1. aged over 18 years old;
2. met the current diagnosis criteria for Chronic Intestinal Pseudo-obstruction;
3. can tolerate nasojejunal tube and complete full course of FMT treatment;
4. the clinical data are relatively complete and there is follow-up available for evaluation

Exclusion Criteria:

1. accompanied by chronic wasting diseases such as malignant tumor and hyperthyroidism;
2. associated with gastrointestinal organic diseases such as short bowel syndrome, intestinal fistula, and inflammatory bowel disease; c) severe destruction of the intestinal mucosa, severe immunosuppression, combined with severe systemic infection; d) Intervention with antibiotics during treatment