cyrilzakka/clinical-trials huggingface dataset:
Analysis of Impact on Nasal Obstruction by Commercially Available Internal Nasal Stents

Commercially-available internal nasal stents placed inside the nostril should produce decreased nasal obstruction detectable subjectively (volunteers will fill out a survey) and objectively (degree of obstruction will be measured with a rhinomanometer which measure resistant of airflow while breathing through nose).

Nasal rhinomanometry provides a measure of the airflow through the nose during inspiration and expiration. The effect of static obstructions, such as septal deviation, as well as dynamic obstructions, such as lateral nasal wall collapse, can be measured by the rhinomanometer. The effect of commercially available nasal stents on nasal airflow will be measured. In subjects chosen from the general population, some of whom may not complain of nasal obstruction, the airflow will be measured before and after the placement of removable nasal silastic stents. In addition, these subjects will complete a one question scale in the Likert model to rate the degree of their subjective nasal obstruction; they will complete this both before and after placement of the stents. The results of the scale before and after application of the stents will be correlated with the objective measurements of airflow by rhinomanometry taken before and after stent insertion.Several studies have measured the effect of external nasal splints (such as Breathe-Rite strips) on nasal airflow and nasal airway size (as measured by acoustic rhinometry), but few have studied internal nasal stents. No studies have correlated rhinomanometric evaluation of effect on nasal obstruction by nasal stents with the validated NOSE survey (Nasal Obstruction Symptom Evaluation). In patients with a chief complaint of nasal obstruction and who are noted to have anterior nasal obstruction, nasal stents may provide a satisfactory improvement in nasal airflow without surgical or medicinal intervention. For patients who are determined to be candidates for surgical intervention, the surgical procedure is tailored to their specific anatomic deformities, as determined by the staff facial plastic surgeon. While the patient's complaint of nasal obstruction as well as the surgeon's assessment of the nasal anatomy are important components in the determination of the need for surgical intervention, no studies have utilized the validated NOSE instrument of subjective complaint of nasal obstruction combined with objective measurements of dynamic airflow. Rhinomanometric measurements can be used to further validate the NOSE instrument both preoperatively and postoperatively.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older

Exclusion Criteria:

* history of nasal surgery, currently using topical nasal steroid spray, over the counter decongestant, history of recurrent epistaxis or history of nosebleed within 2 weeks prior to data collection, currently pregnant
A Randomised Controlled Trial to Investigate the Effects of a Mindfulness Smartphone App on Well-being in the Workplace

We propose a randomised controlled trial in a workplace setting to investigate whether a smartphone-delivered programme of mindfulness meditation influences psychological and biological indicators of well-being.

We hypothesise that after 8 weeks participants who complete the meditation programme will show increases in psychological well-being and reduced activation of stress-related biological pathways.

Mindfulness-based therapies can reduce depressive symptoms in patients and healthy subjects. Therapies such as MBSR (mindfulness-based stress reduction) typically consist of 8 group sessions led by an experienced practitioner, plus home practice and one full day of meditation. In this study we aim to investigate whether a mindfulness programme delivered as a series of podcasts on a mobile phone app could lead to gains in well-being and a reduction in stress.

Eligibility Criteria:
Inclusion Criteria:

* Employees of a UK high-tech company
* Raised levels of work stress (overcommitment\>2) or depression (CESD\>1)

Exclusion Criteria:

* treated for anxiety, depression or hypertension
* taking medication containing steroids
Identification of Non-gal, Non-HLA Antigens in Patients Implanted With Xenogenic Material

This study involves collecting serum samples from patients presenting for aortic valve replacement at Mayo Clinic, Rochester, MN. Serum samples will be collected pre-op, between 2 weeks and 3 months, between 3-11 months (optional), and between 12-18 months post-operatively. The patients antibodies in these serum samples will be used to capture proteins from the same type of tissue their replacement heart valves are made from (i.e., bovine/porcine pericardium - a non-human tissue which is currently used to make glutaraldehyde-fixed heart valves). The captured proteins will be identified, and compared over time (i.e., 0, 1, 3 and 12 months) to determine which proteins (i.e., antigens) in bovine/porcine pericardium that the patient is mounting an immune response towards.

Protein G HP SpinTrap columns will be used to capture IgG antibodies from patient serum pre-implant, between 2 weeks-3 months, between 3-11 months and between 12-18 months post-implant. These antibodies will be cross-linked to the column and then protein extracted from implant tissue (ie Native bovine/porcine pericardium) will be deglycosylated and run through the column. Antigenic proteins will be trapped and non-antigenic proteins will be washed through the column. These antigenic proteins will be eluted off the column and identified using LC-MS/MS. The proteins identified in the pre-implant elutant will be compared to the proteins in post-implant elutant to identify xenoantigens. Success criteria will be method validation by identification of previously known and new currently unknown xenoantigens.

Eligibility Criteria:
Inclusion Criteria:

* patients who will receive either a biological or mechanical heart valve

Exclusion Criteria:

* Currently receiving therapy for cancer requiring treatment with concurrent radiotherapy and/or chemotherapy
* Cancer in remission for less than 5 years if previously treated with radiotherapy and/or chemotherapy
* Previous tissue valve implants
* Current pregnancy
Computer Aided Screening for Tuberculosis in Low Resource Environments

People living with HIV (PLHIV) who require admission to hospital in WHO Africa region have poor outcomes. TB is very common in this group, but can be difficult to diagnose.

The CASTLE trial aims to determine whether systematic screening for tuberculosis using digital chest X-ray with computer-aided diagnosis (DCXR-CAD) plus urine lipoarabinomannan testing with Fujifilm SILVAMP TB LAM (FujiLAM) plus usual care can improve admission outcomes for hospitalised PLHIV, compared to usual care alone.

Our study is a single centre, unblinded, cluster-randomised (by day of admission) trial of DCXR-CAD plus FujiLAM plus usual care vs. usual care alone for screening for TB in unselected adult PLHIV admitted to a district general hospital in Malawi.

The primary outcome is the proportion of people starting TB treatment by the time of death or hospital discharge. The secondary outcomes are all-cause mortality at 56 days from enrolment, proportion of people starting TB treatment within 24 hours from enrolment, and proportion of people with undiagnosed TB. In the CASTLE study we collect a single sputum sample for M. tb culture from participants and undiagnosed TB specifically refers to a person who did not start TB treatment by the time of death or discharge from hospital and has a M. tb cultured from their sputum sample.

Alongside the two trial arms, a third smaller diagnostic cohort arm (1 in 9 of admission days / trial clusters) will explore the range of underlying infectious pathology. The diagnostic cohort does not contribute to trial outcomes.

CASTLE is funded by Wellcome, grant reference 203905/Z/16/Z

Eligibility Criteria:
Inclusion Criteria:

* Requires acute admission to a hospital medical ward at Zomba Central Hospital for any reason
* Is living with HIV (existing or new diagnosis, irrespective of ART status)
* Willing and able to give informed consent

Exclusion Criteria:

* Aged \<18 years
* Has been admitted to a medical ward for longer than 18 hours
* Taking TB treatment before admission or has received treatment for TB within the preceding 6 months.
* Has already been in the study during an earlier hospital admission.
Nutritional Support in Pressure Ulcer Patients

Pressure ulcers are frequently associated with malnutrition. Previous studies have reported that nutritional support can improve the healing rate of pressure ulcers but no attention has been clearly given to the nutritional status of the patient treated. Moreover, other investigators have suggested the additional healing power of some nutrients. Unfortunately, previous results have been unpowered by small sample size, poor monitoring of compliance to treatments and the confounding effect of other nutrients. The investigators aimed to test the effect and additional benefits of several micronutrients delivered through oral nutritional support on the healing rate of pressure ulcers in malnourished patients.


Eligibility Criteria:
Inclusion Criteria:

* patient or legal guardian or caregiver consent
* stage II, III or IV pressure ulcers
* malnutrition (as defined by low body mass index and/or unintentional weight loss and/or low serum albumin and/or reduced food intake \[\<60% of total daily estimated requirements\])
* patients who can drink supplements
* home-care or long-term care

Exclusion Criteria:

* decompensated diabetes (HbA1C \>7%)
* renal failure
* hepatic failure (Child B and C)
* current neoplastic disease
* any organ-failure
* immunosuppressive therapy
* connective tissue disease
* use of steroids
* obesity
* respiratory insufficiency (COPD)
* anemia (haemoglobin \<10g/dL)
* previous neoplastic disease (\<1 year since last treatment CT or RT)
* infected wounds
* cellulitis, sepsis or osteomyelitis
* poor tolerance to sip feeding
Development of Ovarian Tissue Autograft in Order to Restore Ovarian Function

Ovarian cryopreservation is one of the available option for preserving fertility prior to potentially sterilizing treatments. In the absence of other techniques such as in vitro folliculogenesis or injection of isolated ovarian follicles, this tissue can only be re-used by autograft. In France, the first live birth after orthotopic ovarian transplantation, was obtained by Roux et al. in 2009. This clinical trial aims to collect data on the efficiency of the graft in terms of restoration of ovarian function and live births. It will also allow us to carry out the patient follow-up after ovarian tissue cryopreservation and after autograft when achieved. In cases of neoplastic malignancies, minimal residual disease detection will be performed on ovarian tissue, to avoid any risk of cancer re-seeding.


Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent Ovarian tissue cryopreservation
* Premature ovarian failure
* Patients cured of their primary disease
* Women between 18 and 43 years of age
* Patients who have already benefited from ovarian tissue autograft

Exclusion Criteria:

* Patients under trusteeship
* Patients placed in receivers
* Patients under the protection of a conservator
Effect of Indinavir Plus Two Other Anti-HIV Drugs on Blood Clotting in HIV-Positive Males With Hemophilia

The purpose of this study is to see if indinavir plus two other anti-HIV drugs affect blood clotting in HIV-positive patients with hemophilia.

Patients are enrolled in one of two study groups. The treatment group consists of HIV-1 seropositive patients with hemophilia A or B who are protease-inhibitor naive. The laboratory control group consists of HIV-1 seropositive patients with hemophilia A who are on a stable, triple-combination antiretroviral regimen. Patients in the treatment group receive indinavir sulfate plus two of the following NRTIs: zidovudine (ZDV), didanosine (ddI), zalcitabine (ddC), stavudine (d4T), or lamivudine (3TC). Patients in the treatment group preferably are naive to one or both of the NRTIs. Patients in the laboratory control group continue on their stable triple antiretroviral regimen consisting of a protease inhibitor plus two NRTIs. Patients in the control group are not provided antiretroviral medications as part of this study. Patients in the treatment group are evaluated by physical examination, safety laboratory tests, CD4 cell counts, and viral load on Day 1 and at Weeks 2, 4, 8, and 12 and then every 8 weeks through Week 52. Patients in the control group are evaluated by physical examination, safety laboratory tests, CD4 cell counts, and viral load on Day -1 and at Week 12. All patients receive their usual factor concentrate infusion over a 10-minute period on Day -1 and at Week 12 to estimate factor VIII (or IX) recovery and half-life. Blood samples are taken prior to infusion and 30 minutes and 1, 3, 6, 9, 12, and 24 hours after infusion. All patients are required to keep a daily log documenting bleeding episodes and use of factor VIII (or IX) throughout the study.

Eligibility Criteria:
Inclusion Criteria

You may be eligible for this study if you:

* Are an HIV-positive male.
* Have been diagnosed with hemophilia.
* Have been taking clotting factors for hemophilia for at least 6 months.
* Have been taking a combination of one protease inhibitor plus two other anti-HIV drugs for at least 6 months, or have never taken a protease inhibitor.
* Are at least 16 years old (consent of parent or guardian required if under 18).
Effectiveness of a Pictorial Flashcard Regarding Self-care of Peripheral Intravenous Cannula (PIVC) on Its Indwelling Time and Related Complications Among Inpatients

The study title is "A Study to evaluate the Effectiveness of a Pictorial Flashcard regarding Self-Care of Peripheral Intravenous Cannula (PIVC) on its indwelling time and related complications among inpatients at ILBS, New Delhi." and it aim to evaluate the Effectiveness of a Pictorial Flashcard regarding Self-Care of PIVC on its indwelling time and related complications among inpatients.

Objectives of the Study

1. To evaluate the Effectiveness of a Pictorial Flashcard regarding Self-Care of PIVC on its indwelling time and related complications among inpatients.
2. To find out the association between indwelling time of PIVC with selected demographic and clinical variables.
3. To find out the association between PIVC related complications with selected demographic and clinical variables.

Setting of the Study General wards of ILBS, New Delhi

Population Inpatients with PIVC

Sampling Technique Convenient sampling technique.

Data collection Data will be collected from the study subjects as well as from medical records. Subjects were taken from General wards of Institute of Liver and Biliary Sciences, New Delhi.

Methodology Research Approach: Quantitative research approach. Research Design: Quasi Experimental Research design (Post-test only comparison group Design) Sample size: 80 (40 in each group), finalize after power analysis

Data Analysis Method Descriptive statistics: Mean, frequency, percentage distribution and Standard Deviation Inferential Statistics: Chi Square, t- test ANOVA, RM-ANOVA and Man-Whitney U test.

Eligibility Criteria:
Inclusion Criteria

Patients who:

* were conscious \& oriented.
* could understand Hindi or English.
* were between the age group of 18 to 60 years.
* were admitted in general wards and scheduled for PIVC insertion
* received IV infusion and/or medication for at least 3 days (72 hours)

Exclusion Criteria

Patients who:

* were on physical restraints
* were on sedative drugs.
* in whom PIVC was removed for the sole purpose of discharge before 72 hours.
* had short admission period, i.e less than 72 hours
Gene Expression in Samples From Patients With T-Cell Acute Lymphoblastic Leukemia

RATIONALE: Studying samples of blood and tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer. It may also help doctors find better ways to treat cancer.

PURPOSE: This research trial studies gene expression in samples from patients with T-cell acute lymphoblastic leukemia.

OBJECTIVES:

* To test whether the tumor suppressor candidate gene PDLIM2 is downregulated in human cancers such as T-cell acute lymphoblastic leukemia (T-ALL) and to use the human T-lymphotropic virus 1 (HTLV-1)-mediated in vitro transformation of human T cells as control.

OUTLINE: Previously collected cancer and control tissues are analyzed for the expression patterns of PDLIM2 and other control genes. Human T-cells isolated from human blood are also co-cultured with HTLV-1-transformed T-cell lines.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Specimens (e.g., tissue, blood, and bodily fluids) of various cancer cells and or tissues from de-identified patients such as T-cell acute lymphoblastic leukemia (T-ALL)
* Normal control tissue

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified
Gynecological Follow-up of Patients With Dystrophic Epidermolysis Bullosa (EBD)

Dystrophic epidermolysis bullosa is a rare genetic pathology resulting in fragility of the skin and mucous membranes, causing bubbles and wounds following trauma. Scarring is pathological with a tendency to retraction. The gynecological and in particular the vulvovaginal mucous membranes can be affected but no description of any series is available in the literature. Likewise, some of these patients have a sexual and obstetrical life, despite sometimes-severe damage, but again no specific data is available. The investitigator thus wish to carry out a non-interventional multicenter prospective descriptive study. Better knowledge of gynecological semiology in patients with EBD will allow better adaptation of gynecological follow-up, screening for STDs and gynecological cancers, as well as possible specific complications. This study would eventually allow the draw up of recommendations for our gynecologist / obstetrician colleagues.


Eligibility Criteria:
Inclusion Criteria:

* 18 years old or older
* with hereditary dystrophic epidermolysis bullosa (dominant or recessive)
* followed at the Nice University Hospital or at the St Louis Hospital of the APHP.
* not opposed to participation after being informed of the study

Exclusion Criteria:

* men
* age \< 18years old
MISP 60528 Pneumococcal Vaccination

This study aims to use two different blood tests (ELISA and OPA) to study response to pneumococcal vaccination administered as per standard guidelines in patients who are undergoing workup for heart transplant (whether or not they have undergone LVAD implantation or have undergone heart transplant.

The patients will be receiving vaccination consistent with standard of care guidelines, regardless of study participation. The additional risk of study participation would be the risks associated with venipuncture (injury to vessel or nerve, syncope).

Patients will not accrue benefits personally. However, participation will help others by identifying whether current vaccination strategies in this population are adequate.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or over
* Either undergoing evaluation for heart transplant (with or without LVAD receipt), or having received a heart transplant
* Receiving a dose of PCV15 or PPSV23 (or both sequentially) concordant with AST guidelines

Exclusion Criteria:

* Infants and children under age 18
* Subjects without the capacity to consent
* Pregnancy
* Already up to date on pneumococcal vaccination or declining vaccination
Proliferative Effects of Erythropoietin on Human Endometrium

The purpose of this study to assess the proliferative effects of erythropoetin on human endometrium tissue by measuring the endometrial thickness, uterine artery and subendometrial blood flow in postmenopausal women.

20 postmenopausal women who are planned to treat with erythropoietin alpha for their renal conditions will be included to the study. Sample size was calculated with proper power analysis with accepting the difference of 1 mm in endometrial thickness as a significant change. After the informed consent, endometrial thickness (mm), uterine artery and subendometrial blood flow by doppler ultrasonography (RI, S/D) will be measured. Same measurements will be repeated on the 3rd day and 30th day. Patients' age, BMI, co-morbidities, administered erythropoietin doses will be noted. No adverse effect is expected with regard to the ultrasonographic examination. Date of the patients who do not attend for the appointments for repetitive examinations and uninterpretable doppler variables due to the atrophic uterus will be noted as the missing data and will be excluded from the study. Proper statistical analysis will be done.

Eligibility Criteria:
Inclusion Criteria:

* Clinically condition with need for erythropoietin treatment such as anemia due to the renal failure or the need for hemodialysis.
* Must be in postmenopausal period

Exclusion Criteria:

* Patients with any type of malignancy
* Existence of any intracavitary mass which may affect endometrial thickness or blood flow such as endometrial polyps, myomas, intracavitary fluid etc.
* Intrauterine device
* Being on Hormon replacement therapy
* Hysterectomized patients
Myo-inositol in Obese Pregnant Women

Myo-Inositol is classified as a member of the vitamin B complex. It is a constituent of living cells and is widespread in many food. It is involved in a number of biological processes, including insulin signal transduction, resulting in modulating insulin sensitivity. This is a prospective, randomized, double center, placebo-controlled study. Two hundred and twenty obese pregnant women will be included in the trial and, after an informed consent, will assume randomly 2 g of myo-inositol twice a day or placebo from 12-13th weeks gestation until delivery. Then,they will perform an Oral Glucose Tolerance Test (OGTT) at 24-28th weeks gestation. Records about delivery (gestational age, neonatal weight...) will be registered.


Eligibility Criteria:
Inclusion Criteria:

* Obese pregnant women: BMI \> 30 Kg/cm2
* first trimester fast glycaemia \< 126 mg/dl
* single pregnancy

Exclusion Criteria:

* Pregnant women with BMI \< 30 Kg/cm2
* first trimester fast glycaemia \> 126 mg/dl
* previous gestational diabetes
* twin pregnancy
* pregestational diabetes
* associated therapies with corticosteroids