cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Discarded Laboratory Pathological Specimens and Media

The researchers propose to investigate the causes, incidence, and time-related events of chromosomal and physiologic abnormalities as they relate to patient diagnosis, fertility drugs utilized, and in vitro laboratory culture conditions.

We propose to identify a group of parameters that have significant predictive value for assisted reproductive technology outcomes. We seek to test, standardize and implement better methods for the freezing of oocytes and sperm prior to these techniques being used in the clinical setting. We seek to develop new methods to optimize the determination of genes and chromosomes in gametes. We hope to develop new cell surgery or micromanipulation techniques (e.g. use of cell drills and lasers in order to enhance the efficiency of procedures such as ICSI, assisted hatching, biopsy) as well as other manipulations. We will test the safety and efficiency of micro fluidics and automation in the Embryology lab. This has the potential to reduce cost, human errors, temperature and physical changes. We hope to develop new methods and media and media supplements normally found in the reproductive tract that allow for higher survival of gametes in vitro. We will also test the proficiency of laboratory staff members on techniques and/or procedures performed in the in-vitro fertilization laboratory. We will perform Quality Control to review how changes in temperature and setting can effect specimens

Eligibility Criteria:
Inclusion Criteria:

none

Exclusion Criteria:

none
Intervention Study on the Health Impact of Air Filters in Chinese Adults

This study aimed to evaluate whether a short-term indoor air purifier intervention improves cardiopulmonary health based on a randomized double-blind crossover trial

We conducted a randomized double-blind crossover trial among 35 healthy college students in Shanghai, China in 2014. These students lived in dormitories that were randomized into two groups and alternated the use of true or sham air purifiers for 48 hours with a 2-week wash-out interval.All participants and research staff were blinded to the group assignment. We requested all participants to stay in their dormitory room with the windows/doors closed throughout each 48-hour intervention period. We delivered foods and drinks to each room during the intervention period. All interventions started at 8 a.m. to avoid issues related to diurnal variation. We evaluated health endpoints and drew blood immediately after the completion of each 48-hour intervention. We measured 14 circulating biomarkers of inflammation, coagulation and vasoconstriction, lung function, blood pressure (BP), and fractional exhaled nitric oxide (FeNO).

Eligibility Criteria:
Inclusion Criteria:

* Healthy college students aged between 18 and 26
* All the subjects should stay indoor almost the entire time, and stayed within the central urban area of shanghai during the wash-out period.

Exclusion Criteria:

* current smokers or ever smokers
* chronic respiratory diseases
* chronic cardiovascular diseases
* acute infections
* medication use in recent one month
Multicentric Prospective Validation of a Universal Test to Quantify Apixaban, Rivaroxaban, Danaparoid and Fondaparinux Levels

Despite their usefulness in perioperative and acute care settings, factor-Xa inhibitors-specific assays are scarcely available, contrary to heparin anti-Xa assay. The investigators aimed at assessing whether the widely used heparin anti-Xa assay can quantify the apixaban, rivaroxaban, fondaparinux and danaparoid levels.


Eligibility Criteria:
Inclusion Criteria :

* Blood sample from adult patients treated with apixaban or rivaroxaban or danaparoid or fondaparinux

Exclusion Criteria :

* Patients treated with unfractionated heparin or low molecular weight heparin
Effects of Polyvinylpyrrolidone Iodine on Postoperative Trismus and Swelling During Impacted Third Molar Surgery

The aim of the present study was to evaluate the effects of different concentrations of povidone iodine (PVP-I) on postoperative swelling and trismus when used as a coolant and irrigation solution during the surgical removal of impacted mandibular third molars.


Eligibility Criteria:
Inclusion Criteria:

* Totally impacted mandibular third molars of class C, 1, 2, and 3 according to the Pell-Gregory classification;
* Has no systemic disease

Exclusion Criteria:

* The use of medications that could interfere with the healing process;
* Smoking;
* Pregnancy or lactation;
* Presence of any condition, such as inflammation, periodontitis, gingivitis and dental abscess in the area of the impacted teeth;
* Undergoing antibiotic or anti-inflammatory drugs therapies in the 7 days before surgery;
* History of hypersensitivity to iodine;
* Has any thyroid diseases.
Evaluation of a Nutritional Product for People With Type 2 Diabetes

The objective of this trial is to evaluate a nutritional product for people with Diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Subjects will be eligible for the study if they meet all of the following inclusion criteria:

  1. Diagnosis of Type 2 Diabetes.
  2. Age between 18 and 75 years.
  3. HbA1c \> 6.0 but ≤ 8.5
  4. If female and of childbearing potential , subject is non-pregnant, non- lactating, at least 6 weeks postpartum and agrees to practice birth control throughout study duration.
  5. BMI is \> 18.5 kg/m2 and \< 40.0 kg/m2.
  6. Chronic medication dosage must be stable for at least two months prior to Screening Visit.
  7. Subject states that they are a habitual consumer of a morning meal.

Exclusion Criteria:

* Subjects will be excluded from the study if they meet any of the following criteria:

  1. Use of exogenous insulin or GLP-1 agonists for glucose control.
  2. Diagnosis of Type 1 diabetes.
  3. History of diabetic ketoacidosis.
  4. Current infection (requiring medication or hospitalization), has received corticosteroid treatment in the last 3 months, or has had surgery or received antibiotics in the last 3 weeks.
  5. Active malignancy.
  6. Significant cardiovascular event \< 12 weeks prior to study entry.
  7. End stage organ failure or status post organ transplant.
  8. Active metabolic, hepatic, or gastrointestinal disease.
  9. Chronic, contagious, infectious disease.
  10. Currently taking herbals, dietary supplements, or medications (other than antihyperglycemic medications) that could profoundly affect blood glucose.
  11. History of fainting or other adverse reactions in response to blood collection.
  12. Clotting or bleeding disorders.
  13. Allergy or intolerance to study product ingredient.
A Single-blind, Dose-titration Study of KWA-0711 in Patients With Chronic Constipation

The purpose of this study is to evaluate the efficacy and safety of titrated KWA-0711 dose in chronic constipation patients.


Eligibility Criteria:
Inclusion Criteria:

* The patients who experienced fewer than three spontaneous bowel movements per week for more than 6 months prior to the enrollment.
* The patients who experienced one or more of the following signs or symptoms during more than 25% of bowel movements for more than 6 months: straining, lumpy or hard stools, and a sensation of incomplete evacuation

Exclusion Criteria:

* Patients who have secondary constipation caused by systemic disorder.
* Patients who have organic constipation.
* Patients who received intestinal resection
Screening of Gonococcal and Chlamydial Infections in the Third Trimester

Untreated maternal infection with gonorrhea and/or chlamydia can have serious complications in pregnancy and the neonatal period. In Ontario, routine screening for these infections is done in the first trimester of pregnancy, positive cases are treated with antibiotics, and all newborns are given antibiotic eye ointment within 24 hours of birth. Recently, the Canadian Pediatric Society recommended stopping universal prophylaxis for newborns, with instead, focus on screening and treatment of these infections in pregnancy. Given that these infections can occur at any time in pregnancy, and exposure at delivery provides a significant risk to infants, more information is needed about the rates of infection throughout pregnancy and health-care provider compliance with guidelines to make this change without undue risk. With this information optimal timing of testing can be evaluated.

The primary objective of this study is to retrospectively examine the incidence rates of N. gonorrhoeae (NG) and C. trachomatis (CT) in the first and third trimester for the obstetrical population at St. Michael's Hospital over the course of six months. Secondary objectives include (1) feasibility of instituting third trimester screening for sexually transmitted infections, and (2) assessment of physician compliance with Canadian screening and treatment guidelines. This information will help us to deduce the optimal timing of screening for NG and CT in the obstetrical population at St. Michael's Hospital.

It is hypothesized that the incidence rates of both NG and CT infections will be low, but that much can be learned from the positive cases in terms of risk factors and optimal timing of screening. Further, the feasibility of screening in the third trimester will offer options for future guidelines.

Eligibility Criteria:
Inclusion criteria:

* all consecutive prenatal patients attending the obstetrical clinic at St. Michael's Hospital for a six-month period from May 1, 2016 to November 1, 2016, inclusive.

Exclusion criteria:

* none.
Analgesic Efficacy of Transmucosal Fentanyl for Breakthrough Pain Caused by Interventional Gastrostomy

Patients with Head \& Neck Squamous Cell Carcinoma often need a gastrostomy. It can be performed with a radiological approach. This procedure is usually not performed under general anesthesia, but local anesthesia is not sufficient to counteract pain due to gastric insufflation and incision of the abdominal wall. Standard analgesic treatments are usually not well-fitted due to onset of action or route of administration. An alternative solution could be fentanyl nasal spray, a treatment with a fast onset of action and with easy use allowing repetition if needed, during the procedure.

The purpose of this study is to compare analgesic efficacy of nasal instillation of PECFENT® to usually administered morphinic analgesic treatment with fast onset of action (ORAMORPH®), in radiologic percutaneous gastrostomy tube placement:

* during the procedure
* following the procedure (measured by Visual Analog Scale (VAS) for Pain at 15 min, 30 min, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours and 12 hours after procedure).

Secondary purposes are to compare easiness of 2 treatments and their adverse effects.


Eligibility Criteria:
Inclusion Criteria:

* Patient care for cancer of the upper aerodigestive tract (except sinonasal)
* \> 18, all weights, all sexes
* Under balanced background opioid treatment since longer than 7 days (VAS \< 5)
* Needing a radiologic gastrostomy under local anesthesia
* Informed consent
* Affiliation to social security plan
* Preliminary medical examination

Exclusion Criteria:

* Non balanced morphinic treatment : modification of analgesic treatment during 7 previous days
* Radiotherapy of nasal fossae/sinus
* Technical impossibility or contraindication to PECFENT®, ORAMORPH® and associated drugs
* Impossibility of pain evaluation by patient
* Belonging to protected class: pregnant or breastfeeding woman, person deprived of liberty for judiciary or administrative decision, under-18, person under legal protection or incapable of giving consent, person in life-and-death emergency incapable of giving a preliminary consent
Effectiveness of Melissa Officinalis for the Treatment of Probable Sleep Bruxism in Children and Adolescents

Objective: To investigate, through a controlled and randomized clinical trial, the effectiveness of using Melissa officinalis in different concentrations in the treatment of children and adolescents with probable sleep bruxism. Methodology: This is a randomized, triple-blind, crossover, and placebo-controlled clinical trial. The research participants will be children aged 5 to 10 years old and adolescents aged 11 to 16 years old who attend dental treatment at the FO/UFRJ Pediatric Dentistry Clinics. After approval by the Human Research Ethics Committee, children and adolescents will undergo homeopathic treatment with Melissa officinalis in different concentrations for possible sleep bruxism. In addition, research participants will undergo an assessment of TMJ, sleep, circadian cycle, quality of life, and quality of life related to oral health. The data will be tabulated and analyzed according to sex, age group, presence of possible sleep bruxism, presence or absence of TMD, circadian characteristics, presence or absence of sleep disorders, daytime and nighttime behavioral characteristics. The data will be tabulated and evaluated using SPSS 21.0. Absolute and relative frequency, odds ratio, correlation analysis and other relevant analyzes and statistical tests (p\<0.05) will be carried out in accordance with the objectives proposed by the study


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 5 to 16 years;
* Patients with complete primary dentition, mixed or secondary dentition;
* Patients with probable sleep bruxism.

Exclusion Criteria:

* Patients with special needs (psychological, psychiatric and neurological, diagnosed with anxiety disorder or any systemic impairment);
* Patients with parafunctional habits (finger sucking and/or pacifier, onychophagia, biting objects, etc.)
* Patients with caries lesions in dentin in one or more elements (ICDAS values 4, 5 and 6);
* Patients affected by molar-incisor hypomineralization (MIH)
* Patients with dental anomalies such as dentinogenesis imperfecta, amelogenesis imperfecta, dysplasia dentin, hypoplasia, and enamel hypocalcification;
* Patients with severe malocclusions: Class II and III or crossbite and open bite type;
* Patients using orthodontic appliances;
* Patients who are taking medications for anxiety disorders or any other that cause alterations in the central nervous system or that alter salivary flow.
A Study to Investigate the Safety, Tolerability and Pharmacokinetics of SUVN-911 in Healthy Subjects

This is a Phase 1, conventional, double-blind, placebo-controlled, single-center clinical study comprised of 2 segments (Segment 1 and Segment 2) in which single and multiple doses of SUVN-911 or placebo will be orally administered to healthy male subjects to evaluate the safety, tolerability, and pharmacokinetic profile.

This is a single and multiple ascending dose study to assess the safety, tolerability and pharmacokinetics of SUVN-911 administered orally once a day to healthy male subjects. The study will be conducted under double-blind conditions.

The primary objectives are to evaluate the safety and tolerability of SUVN-911 following oral administration of single or multiple ascending doses and estimate the maximum tolerated dose of SUVN-911, if possible.

The secondary objectives are to evaluate the single and repeat dose plasma and urine pharmacokinetics of SUVN-911 following oral administration of single and multiple ascending doses in healthy male subjects.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male aged 18 to 45 years with a body mass index (BMI) between 18 and 30 kg/m2, (inclusive).

Exclusion Criteria:

* Standard exclusion criterion for Phase 1 clinical trial in healthy subjects:

  * History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the volunteer at risk because of participation in the study, or influence the results or the volunteer's ability to participate.
  * History or presence of gastro intestinal (GI), hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs as judged by Investigator.
A Retrospective Study of Prognostic Factors and Survival of Breast Cancer Patients with Brain Metastesis

The aim of the study is to to describe the pattern of BM in breast cancer patients, assess the prognostic significance of patient related-factors and to evaluate the efficacy of various treatment modalities. clinicopathological factors and prognostic factors that affect the occurrence of brain metastases and which factors affect the survival after the occurrence of brain metastases remain to be identified . This may help identify patients at high risk for brain metastases and patients with poor prognosis after brain metastases, thus providing them with some preventive or therapeutic measures.

Breast cancer (BC) has become the malignancy with the highest morbidity rate in women. Despite significant advances in the diagnosis and treatment of breast cancer, metastasis is still an important factor that seriously affects patients' quality of life and prognosis. It has been reported that distant metastases have been found at the initial diagnosis of breast cancer in about 6-10% of patients The bones, lungs, liver and brain are the four most common distant metastatic sites of breast cancer Compared with bone metastases and visceral metastases, patients with brain metastases have significantly worse prognosis The median time from diagnosis of breast cancer to CNS metastasis has been reported to be 33 month The survival of these patients may be affected by factors including molecular subtypes, performance status, ressectability of BM and visceral metastasis burden. When detected, its treatment is usually difficult and unfortunately has reverse effects on life expectancy Multi-disciplinary therapy (MDT) is the first choice for the treatment of brain metastases in breast cancer MDT for breast cancer brain metastasis includes surgery, whole brain radiation therapy (WBRT), stereotactic radiosurgery (SRS), chemotherapy, endocrine therapy, targeted therapy, etc. For patients with multiple brain metastases and neurological symptoms, WBRT combined with palliative care is the preferred option In general, patients with brain metastases of 3 or less were recommended to receive surgical resection. Patients with 4 to 5 brain metastases but less 3cm in diameter can undergo SRS .

Eligibility Criteria:
Inclusion Criteria:

* -Age \>18
* Histological proven breast cancer
* Radiological documentation of BM by computed tomography (CT) OR magnetic resonance imaging (MRI)
* Patients who had been followed up for at least 6 months.

Exclusion Criteria:

* -Not histologically proven Breast cancer
* Patient without full medical data
* Those with previous or concurrent diagnosis of second primary malignancy
* Patients with leptomeningeal or dural metastases without co-existent parenchymal metastatic lesions
The Effect of Different Masks Used by Pregnant Women on Vital Signs and Non Stress Test During The COVID-19

This study was conducted to examine the effects of different masks used by pregnant women on vital signs and non stress test (NST) during the COVID-19. This study was conducted as a single-blind randomized controlled trial. Healthy pregnant women aged 19 years and older, who were followed up on an outpatient basis, and who were in the 37-40th week of pregnancy, were included in the study. The study consisted of a single surgical mask group (n=30), double surgical mask group (n=30), and N95 mask group (n=31). Masks were given to the resting pregnant women 30 minutes before the NST, and they were provided to wear masks. After 30 minutes, the vital signs of the pregnant women were measured just before and after the NST, and the images of the NST traces were taken.


Eligibility Criteria:
Inclusion Criteria:

1. Being 19 years or older
2. Being pregnant at 37-40 weeks of pregnancy and having healthy pregnancy
3. Being followed on an outpatient basis

Exclusion Criteria:

1. Having a multiple pregnancy
2. Having a systemic, psychiatric disease or psychological problem (thyroid, heart, schizophrenia, etc.)
3. Being in the category of risky pregnancies (Preeclampsia, gestational diabetes, etc.)
4. Smoking
5. Having alcohol and substance use
6. Never done NST before
7. Having an identified risk factor in the fetus
8. Having barriers to communication
9. Being a foreign national
10. Being in contact with, or having, or suspected of having COVID-19 and previously had COVID-19.
Effects of Motivational Interviewing in Prison

Motivational Interviewing (MI) is a communication style demonstrated to decrease drug and alcohol use. A five session MI intervention (BSF) was implemented in the Swedish correctional system. The intervention was delivered by counsellors with workshop only MI training (BSF) or by counsellors with workshop MI training followed by peer group supervision based on audio taped feedback (BSF+).

Aim was to examine whether BSF in prisons reduces drug and alcohol use more effectively than interviews conducted according to the usual planning interview routine (UPI).


Eligibility Criteria:
Inclusion Criteria:

* Born between 01-01-1954 and 31-12-1984;
* Conditional release no later than 30-06-2005 (this was extended to 19-09-2005 and again to 31-03-2006);
* Swedish or Norwegian speaker;
* Not having previously received BSF in remand or any other prison;
* Heavy use of alcohol or drugs, measured by the standard prison and probation system: 1= occasional use; 2= heavy use;
* ASI interview at intake;
* No order for deportation after release from prison

Exclusion Criteria:

-
Long-Term Safety, Tolerability, and Efficacy of DTX101 (AAVrh10FIX) in Adults With Moderate/Severe to Severe Hemophilia B

A long-term follow-up study to evaluate the safety, tolerability, and efficacy of DTX101 in adult males with moderate/severe to severe hemophilia B.

Hemophilia B is an X-linked recessive genetic bleeding disorder caused by mutations in the factor IX (FIX) gene. FIX is produced in the liver and is critical for fibrin clot formation. Hemophilia B is characterized by frequent, spontaneous internal bleeding that can lead to chronic arthropathy (joint damage), intracranial hemorrhage, and even death. In patients with moderate/severe to severe hemophilia B, the majority of bleeding episodes occur in the joints and, if not treated, lead to debilitating damage and a decreased quality of life.

Study 101HEMB02 is a long-term follow-up study to evaluate the safety, tolerability, and efficacy of AAVrh10-mediated gene therapy of human FIX in subjects with moderate/severe to severe hemophilia B. The primary objective of the study is to determine the long-term safety and efficacy of DTX101 following a single IV infusion (administered during Study 101HEMB01) in adults with moderate/severe to severe hemophilia B.

This study was previously posted by Dimension Therapeutics, which has been acquired by Ultragenyx.

Eligibility Criteria:
Inclusion Criteria:

1. Willing and able to provide written informed consent.
2. Completed the Week 52 visit in Study 101HEMB01.
3. Willing to stop prophylactic treatment with recombinant FIX at specified time points during the study if medically acceptable.
4. Willing, able, and committed to comply with scheduled study site visits, study procedures, and requirements.

Exclusion Criteria:

1. Planned or current participation in another interventional clinical study that may confound the efficacy or safety evaluation of DTX101 during the duration of this study.
2. Any clinically significant medical condition that, in the opinion of the investigator, would pose a risk to subject safety or would impede the study