cyrilzakka/clinical-trials huggingface dataset:
Laparoscopic Myomectomy With Morcellation or Transvaginal Extraction of Surgical Specimens.

Laparoscopic myomectomy represents the fertility-sparing gold standard approach for the management of subserosal and intramural uterine myomas: this technique allows faster recovery, less complications and improved surgical outcomes than laparotomy.

Despite these validated cornerstones of minimally invasive gynecology, the best approach for specimen retrieval is still debated. Among these approaches, surgical specimen retrieval after laparoscopic myomectomy could be performed by mini-laparotomy, by power morcellation using morcellator inserted through one of the ancillary trocars, or by transvaginal extraction through an endobag inserted at level of the posterior vaginal fornix (between the utero-sacral ligaments).

Unfortunately, mini-laparotomy has poor esthetic outcome and does not conform the current standards of minimally invasive surgery.

In addition, on 24 November 24 2014 the Food and Drug Administration updated a Safety Communication about Power Morcellation, warning against the use of laparoscopic power morcellators in the majority of women undergoing myomectomy or hysterectomy for treatment of fibroids, due to the risk of spreading an unsuspected uterine sarcoma within the abdomen and pelvis.

Considering this scenario, transvaginal extraction may represents a feasible approach for specimen retrieval. In this view, the current study aims to retrospectively compare surgical outcomes in women that underwent laparoscopic myomectomy with subsequent power morcellation (before the issuing of the abovementioned Safety Communication by the Food and Drug Administration) or transvaginal extraction (after the issuing of the abovementioned Safety Communication by the Food and Drug Administration) of the surgical specimens.


Eligibility Criteria:
Inclusion Criteria:

* Women affected by single or multiple uterine myomas.
* Signed informed consent.

Exclusion Criteria:

* Human papilloma virus-related pathologies at pap-smear within the 12 months preceding surgery.
* Women with obliteration of the cul-de-sac.
* Women with the suspected cancer of gynecological origin.
* Women who had never experienced complete sexual intercourse before the operation.
Preliminary Validation of an in Vitro Diagnosis-medical Device for Hepatitis B Screening

The principal objective of the study is to perform a first step of technical adjustment and preliminary validation of a diagnostic test for hepatitis B (HBsAntigen, anti-HBs Antibody and anti-HBc Antibody) on capillary blood with the device under study in non-immunized subjects against hepatitis B, in subjects with hepatitis B, in subjects with old or cured hepatitis B and in hepatitis B vaccine recipients, compared with the values obtained with the reference technique of medical biology laboratory on serum. The analysis will be performed on the entire cohort.

The diagnosis of hepatitis B in precarious populations is often difficult. The use of a in vitro diagnosis-medical device in point of care could alleviate this difficulty. It would identify whether or not the subjects are infected with the virus, whether they are immunized or not. Then, depending on the results, the subjects could be directly vaccinated or referred to a laboratory of medical biology for confirmation / invalidation of the diagnosis.

Eligibility Criteria:
Inclusion Criteria:

* Group 1: HBsAg negative, Anti HBc negative, Anti HBs negative, during a laboratory assay on serum
* Group 2: HBsAg negative, Anti HBc negative, Anti HBs positive, during a laboratory assay on serum
* Group 3: HBsAg negative, Anti HBc positive, Ab anti HBs positive or negative, during a laboratory assay on serum
* Group 4: HBsAg positive, Anti HBc positive, Anti HBs negative, during a laboratory assay on serum
* all: affiliated to social security or beneficiary of such a scheme

Exclusion Criteria:

* Infection by a confounding factor: HIV, HCV and / or HDV
* Protected person: Pregnant woman, parturient, mother who is breastfeeding, person deprived of liberty by judicial or administrative decision, person subject to a legal protection measure
* Exclusion period for other research studies involving the human person
* Annual threshold of allowances for participation in research involving the affected human person.
"MecPain", a New Questionnaire to Assess Chronic Pain Mechanisms.

Validation of a new clinical questionnaire, called 'MecPain', including 12 questions, aimed at better defining the pathophysiological mechanisms of a chronic pain condition. This questionnaire includes 8 components/sub-components, reflecting various aspects of the 3 main mechanisms of chronic pain: nociceptive, neuropathic, nociplastic. A series of 240 patients with well-characterized chronic pain syndrome (for more than 6 months) of the nociceptive, neuropathic or nociplastic type will be recruited (80 patients per type of pain). The patients will be interviewed by a pain specialist to complete the 12 questions of the questionnaire during a routine visit in a Pain Center (CHU Grenobles Alpes, Grenoble, France or CHU Henri Mondor, Creteil, France). The scoring obtained with the 'MecPain' questionnaire will be compared to the presence of neuropathic pain assessed by two previously validated questionnaires, the 'DN4' and the 'PainDETECT' questionnaires. The expected outcome is a validation of the 'MecPain' questionnaire to provide a better understanding of the pathophysiological mechanisms relating to the presence of a chronic pain syndrome in a given patient.

The main objective of this study is to specify the physiopathological mechanisms of a chronic pain syndrome according to 5 main components (+ 3 "sensory" sub-components) reflecting various aspects of the 3 main mechanisms of chronic pain: nociceptive, neuropathic, nociplastic.

A score will be assigned based on the answers to each of the 12 questions of the 'MecPain' questionnaire for each of the 8 components/sub-components mentioned above.

240 chronic pain patients will be included (in two centers), according to 3 categories: 80 patients with nociceptive pain (mechanical or inflammatory joint or spinal pain), 80 patients with neuropathic pain (painful peripheral neuropathy, neuralgia or radiculalgia, pain related with spinal cord or brain injury), and 80 patients with nociplastic pain (fibromyalgia, glossodynia, temporomandibular joint pain, irritable bowel syndrome, painful bladder syndrome).

Eligibility Criteria:
Inclusion Criteria:

* Presence of a chronic pain syndrome (pain for more than 6 months);
* well-characterized pain syndrome of the nociceptive, neuropathic or nociplastic type

Exclusion Criteria:

* Opposition to the use of data obtained in the context of standard clinical follow-up.
Feasibility of Mini-EEG in the Prehospital Setting

The EEG is widely used in the diagnosis of central nervous system pathology, including epileptic seizures and epilepsy. Presently, EEG is available only during office hours in most hospitals, pending on the availability of a clinical neurophysiologist and the lack of oncall possibility outside these hours. Standard EEG devices are large and their operation require meticulous application of several leads. The department of clinical neurophysiology at Helsinki University Central Hospital has developed a mini-EEG device for use in the emergency department as well as in the prehospital setting. The aims of this pilot study is to evaluate the feasibility of the mini-EEG in the prehospital setting. Patients with a decreased level of consciousness, as evaluated by the emergency medical provider on the scene, are included. The mini--EEG device is to be used by a specially trained emergency medical supervisor. EEG is otherwise obtained in a normal fashion, but only three electrodes are used. The sample size is 30. Data are collected as a part of the clinical work in daily practice. The aim is to collect observational data on feasibility, no clinical interventions will be performed based on the EEG. No funding is needed as data is collected during daily work.

The mini-EEG is a prototype EEG/EKG-adapter, designed by Helsinki Univeristy Central Hospital, and as such, does not have a trade name. It is to be connected to a monitor/defibrillator used by the EMS personel, currently the LifePak 15, manufactured by Physio-Control, Redmond, WA 98052. (www.physio-control.com)


Eligibility Criteria:
Inclusion Criteria:

* Unconsciousness resulting in activation of the local EMS units

Exclusion Criteria:

* Cardiac arrest
* Traumatic unconsciousness
* Transient unconsciousness
Study of TRPH-222 in Patients With Relapsed and/or Refractory B-Cell Lymphoma

This is a Phase 1, multi-center, open-label study of TRPH-222 monotherapy in subjects with relapsed and/or refractory B-cell NHL. The study will be conducted in two Stages: Dose-Escalation, Dose-Expansion.

In Dose Escalation, patients with DLBCL, FL (including transformed FL), MZL, and MCL were to be enrolled per dose cohort. In Dose Expansion, additional response-evaluable patients were to be enrolled in NHL subtype-specific cohorts including DLBCL and FL to confirm the RP2D identified in Escalation. Each stage consisted of screening, baseline, treatment, and follow-up periods. During the treatment period, patients were to be treated indefinitely in 21 day cycles. The EOT assessments were to occur 28 and 60 days after the last study treatment.

Eligibility Criteria:
Inclusion Criteria

* Age ≥ 18 years at the time of signing the informed consent
* Histologically confirmed (2016 WHO lymphoma classification) B-cell NHL that is DLBCL, FL (including transformed FL), MZL, or MCL
* Relapsed and/or refractory NHL requiring systemic therapy and have failed, are intolerant to, or are considered ineligible for standard of care anticancer treatments that are known to be potentially curative. Subjects must not be current candidates for HSCT. Participants who refuse standard treatments may also be considered provided that documentation is provided that the subject has been made aware of all therapeutic options
* Eastern Cooperative Oncology Group (ECOG) status 0-2

Exclusion Criteria

* Presence of a leukemic phase of the lymphoma
* "Double hit" or "triple hit" germinal center B cell lymphoma
* Previous solid organ allograft (except for corneal transplant)
* Peripheral neuropathy \> NCI-CTCAE Grade 1
* Significant organ dysfunction that would preclude study participation
* Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias
* Any other serious active disease or co-morbid medical condition, according to the Investigator's decision or Medical Monitor, that will substantially increase the risk associated with the subject's participation in the study
Oral Hygiene Reminders in Orthodontic Patients

Objective: To determine the effect of WhatsApp and Email reminders on oral hygiene compliance of orthodontic patients.

Methods: A Randomized, parallel group, double blinded study was conducted on 54 patients undergoing orthodontic treatment at MAHSA University. They were randomized to 3 groups, namely WhatsApp (W) group, Email (E) group and Control (C) group with 18 subjects in each group. Group (W) and Group (E) received oral health messages once a week through WhatsApp and E-mail reminders respectively, while Group (C) did not receive any reminders. Plaque was measured at baseline (T0), after 4 weeks (T1), and after 8 weeks (T2). For each subject, two intraoral photographs were taken after application of plaque disclosing agent; and the area covered by plaque was measured on 12, 13, 43, 22, 23 and 33 teeth by planimetry.

Fifty-four patients undergoing orthodontic treatment were recruited from the dental clinic of MAHSA University between Jan 2018 to April 2018. Voluntary written informed consent was obtained from all the subjects before the start of the study. They were randomly assigned into 3 groups namely WhatsApp (W) group, Email (E) group and Control (C) group with 18 subjects in each group. Oral hygiene messages through WhatsApp and Email were sent once a week for 8 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Patients having fixed maxillary and mandibular orthodontic appliances with 0.022 AO conventional metal brackets,
* Aged ≥ 15 years,
* Undergone 3 months of orthodontic treatment,
* No significant medical or dental history
* Have access to cellular telephone and are online daily

Exclusion Criteria:

* Patients undergoing single arch treatment
* Missing maxillary lateral incisor, maxillary canine and mandibular canine
* Patients' orthodontic treatment duration \< 3 months and \> 4 months.
Biologic Basis Of Increased Susceptibility Of Smokers To Pulmonary Infection With Mycobacterium Tuberculosis

Identify a biologic (molecular) basis for the increased susceptibility of cigarette smokers to pulmonary TB (Mtb) by testing the hypothesis that smoking reprograms AM polarization towards a distinct phenotype associated with impaired host defense function against Mtb and that normalization of that phenotype via therapeutic modulation of the Alveolar Macrophage (AM) polarization or smoking cessation can restore the anti-Mtb host defense function of AM.

Samples from Non-Smokers with TB, Smokers with TB and Smokers with COPD and TB will be collected in Qatar under JIRB 14-00055. All subjects will be undergoing a clinical bronchoscopy as part of their disease evaluation and will be asked to give additional samples for research. All "in vivo" processing of specimens from subjects with TB will be performed in Qatar. Mycobacterium tuberculosis infection (Mtb) continues to have a detrimental impact of public health worldwide. Based on the epidemiological evidence linking smoking, COPD and Mtb, and our preliminary data we hypothesize that smoking reprograms Alveolar Macrophages (AM) polarization towards a distinct phenotype associated with impaired host defense function against Myobacterium tuberculosis (Mtb) and that normalization of that phenotype via therapeutic modulation of the Alveolar Macrophages (AM) polarization or smoking cessation can restore the anti-Mtb host defense function of AM.

Eligibility Criteria:
Smokers and Non-smokers with TB

Inclusion Criteria:

* Must provide informed consent
* Current smokers and non-smokers
* Undergoing clinical bronchoscopy as required by their doctor for evaluation of their disease
* Diagnosis of pulmonary tuberculosis without extra-pulmonary TB, confirmed by at least one of the following:
* Symptoms consistent with TB
* Chest xray and or chest CT with TB
* Positive PPD test
* Positive sputum test

Exclusion Criteria:

* Females who are pregnant or nursing
* History of allergies to xylocaine, lidocaine, versed, valium, atropine, isoproterenol, terbutaline, aminophylline, or any local anesthetic

Smokers with TB and COPD

Inclusion Criteria:

* Must provide informed consent
* Current smokers with COPD
* Undergoing clinical bronchoscopy as required by their doctor for evaluation of their disease
* Diagnosis of pulmonary tuberculosis without extra-pulmonary TB, confirmed bu at least one of the following:
* Symptoms consistent with TB
* Chest xray and or chest CT consistent with TB
* Positive PPD test
* Positive sputum test

Exclusion Criteria:

* Non-smokers
* Females who are pregnant or nursing
* History of allergies to xylocaine, lidocaine, versed, valium, atropine, isoproterenol, terbutaline, aminophylline, or any local anesthetic
Effect of a Physical-activity-promoting Environment on Motor Skills, Physical Activity and Quality of Life of Children in Childcare Settings

The purpose of the study is to evaluate the effect of a project promoting unstructured spontaneous physical activity (PA) through an adaptation of the built environment and the provision of a supportive social environment of childcare centers on motor skills, physical activity, desire to move around, body mass index (BMI), quality of life and PA and behavior of the family.

The study will last one school year and includes 58 childcare centers in 3 provinces (JU, NE, VD) of the French part of Switzerland.

Eligibility Criteria:
Inclusion Criteria:

* Children in selected childcare centers
Evaluation of ColdZyme® on Experimentally Induced Common Cold.

This study evaluates the performance of ColdZyme® mouth spray on prevention of common cold symptoms on experimentally induced rhinovirus upper respiratory tract infection in healthy volunteers. Half of participants will receive ColdZyme® mouth spray while the other half will receive placebo.

88 subjects will be inoculated with rhinovirus 16 via the nasal route. The subjects will be randomized 1:1 to ColdZyme® or placebo. Treatment (6 doses per day) will be applied for 11 days from the day of inoculation. The subjects will visit the investigational clinic on 6 occasions. During these visits the subjects will leave nasal (lavage) and pharyngeal (swab) samples for quantification of virus replication. All subjects will have a diary for scoring of cold symptoms.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female subjects between 16-70 years. The investigator judges the definition of healthy by detailed medical history and physical examination.
* Females of childbearing potential: shall use reliable method of birth control. Reliable methods are hormonal contraceptives (combination pills, injections or implants), intrauterine device, condom or declared absence of sexual contact. Post-menopausal woman is defined as absence of menstrual discharge for at least two years.
* Signed informed consent form prior to any study-related procedures.
* Willingness and ability to adhere to the prohibitions and restrictions specified in this protocol.
* Perceived to have had at least one cold per year

Exclusion Criteria:

* Smoker, during the last 12 months
* Any cold symptom within the last month such as sore throat, sneezing, rhinorrhoea, malaise, nasal obstruction or cough.
* Presence (at screening) of serum rhinovirus 16 neutralising antibody titers at greater than or equal to one in two dilution.
* Active allergic rhinitis, asthma or chronic obstructive pulmonary disease during study period.
* Nasal disease, e.g. nasal polyposis, significant septal deviation, chronic rhinosinusitis, etc.
* Females: Pregnant, breast-feeding or intentions to become pregnant during the study.
* Evidence or history of drug or alcohol abuse.
* Use of any prescribed or non-prescribed medication (except for contraceptives, paracetamol and ibuprofen) within 2 weeks prior to the first administration of investigational product.
* Use of any over the counter cold prophylaxis products such as ColdZyme®, C-vitamins, zinc or Echinacea within 1 month prior to the first administration of investigational product.
* Participation in other clinical trial with medical investigational product within 60 days prior to the first administration of investigational product.
* Hypersensitivity/allergy to any of the device ingredients
* Individuals with close contact to at risk patient group:
* infants (less than 6 months);
* the extremely elderly or infirm;
* pregnant women;
* patients with severe lung disease (asthma/cystic fibrosis (CF)/COPD);
* patients with immunosuppression.
Comparison of 2.0 mg/kg Sugammadex and Neostigmine at Reappearance of T2 in Chinese and European Subjects (Study 19.4.324)(P05768AM1)(COMPLETED)

The present trial was set up to evaluate the efficacy and safety of 2.0 mg.kg-1 sugammadex compared to neostigmine administered at reappearance of T2 in Chinese and Caucasian subjects for registration purposes in China.


Eligibility Criteria:
Inclusion Criteria:

-Subjects who are willing to provide informed consent; be between 18 and 64 years old; are American Society of Anaesthesiology (ASA) class 1-3 (extremes included); scheduled for elective surgery under general anesthesia, allowing stable neuromuscular monitoring, which requires neuromuscular blockade using rocuronium; be compliant with the dose/visit schedules, and use an accepted method of contraception (if applicable).

For China only: Subjects of Chinese descent born in China, never emigrated out of China and have a Chinese home address. For Europe only: Subjects of Caucasian descent born in Europe, never emigrated out of Europe and have a European home address.

Exclusion Criteria:

-Subjects with expected difficult intubation, neuromuscular disorders affecting neuromuscular blockade, significant renal/hepatic dysfunction, use of a tourniquet, (family) history of malignant hyperthermia, allergy to general anesthesia medications, contraindication to study drugs, breast feeding, pregnant, participation in previous or new trials, a clinically significant condition that may interfere with the trial, or membership in the (family of) study/sponsor staff.
A Clinical Study to Limit Physiologic Intestinal FDG Uptake Uptake on PET-CT Scans

Patients who undergo PET-CT scans to look for cancer are given an intravenous contrast (FDG) that is taken-up by active cells such as cancer cells. This contrast can then be seen in the body using the PET-CT scanner. However, cells in the colon also take up the FDG, and can produce "false positive" signals from the colon. Our hypothesis is that much of this signal comes from bacteria that are present in high concentrations in the colon. If this is the case, using an antibiotic to suppress the activity of bacteria may improve the ability of PET-CT to distinguish abnormal cells from normal cells in the colon.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing clinically-indicated PET-CT scan for non-GI lymphoma

Exclusion Criteria:

* Patients with known Inflammatory Bowel Disease
* Patients with known colon cancer
The Peer-Delivered Body Project for Young Women in High School

This study will evaluate the impact of the Body Project (a dissonance-based program designed to address body image concerns and prevent eating disorders) on key eating disorder risk factors and relevant social and self-constructs at three time-points (pre, post, and one-year follow-up). Young women will be recruited from two high schools and will be randomized to receive the Body Project or to the control group. The Body Project will be facilitated by college-aged women.

Preventive models that can avert the onset of eating disorders and innovative delivery methods that increase engagement with care offer a promising approach to improving the mental health and wellness of young women. This study aims to implement and evaluate the Body Project, a 4-hour dissonance-based program designed to address body image concerns and prevent eating disorders with high school young women using a peer delivery model. This study will evaluate the impact of the Body Project on key eating disorder risk factors and relevant social and self-constructs at three time-points (pre, post, and one-year follow-up). Young women will be recruited from two high schools and will be randomized to receive the Body Project program or to the control group. The Body Project will be facilitated by college-aged young women who have been trained to deliver the Body Project.

Eligibility Criteria:
Inclusion Criteria:

- Female high school student

Exclusion Criteria:

- Previous participation in the Body Project program