cyrilzakka/clinical-trials huggingface dataset:
Residential Cognitive and Interpersonal Therapy for Social Phobia

The purpose of this study is twofold: (1) to compare the effectiveness of two promising treatments for social phobia, a new cognitive therapy model (Clark \& Wells, 1995; Borge et al., 2001) and interpersonal therapy (Lipsitz, Markowitz, \& Cherry, 1997), adapted for inpatient groups; and (2) to study the empirical change processes in these therapies and compare them with the cognitive and interpersonal models of change.

Social phobia typically leads to severe impairment in work and other social life, and - without treatment - it can persist for decades. Given its prevalence, severity, and chronicity, effective treatment methods are strongly needed. However, traditional psychological and pharmacological treatments have had statistically significant, but clinically limited effects (Taylor, 1996).

Based on an empirical analysis of the cognitive processes in social phobia, Clark and Wells (1995) have developed a new cognitive model. Cognitive therapy (CT) derived from this model has been found to be superior to a combination of fluoxetine and self-exposure (Clark et al., 2003).

Social phobic symptoms may be viewed as a result of more general interpersonal difficulties and interpersonal psychotherapy (IPT) can be a reasonable alternative for social phobia (Lipsitz \& Markowitz, 1996). A clinical case series indicates that social phobic patients improve during interpersonal psychotherapy for social phobia (IPT-SP; Lipsitz et al., 1999.

Eligibility Criteria:
Inclusion Criteria:

* DSM-IV criteria for social phobia
* the patient consider social phobia as the main current problem
* willingness to suspend use of psychotropic medication, alcohol and other substances
* acceptance of random allocation
* ability to speak Norwegian
* age 18-65 years.

Exclusion Criteria:

* a history of recurrent major depression currently treated sucessfully with antidepressant medications
* has immediate need for additional treatment
* current psychotic disorder or substance abuse
* organic mental disorder
* previously treated with similar models
Gender-specific Associations Between Quality of Life and Leukocyte Telomere Length

Quality of life (QoL) is an important factor for successful aging. Telomere length is an indicator of cellular aging and cumulative biological stress and is thus related to health status and survival. However, the relationship between QoL and telomere length has not yet been examined. In this study we investigated the relationship between leukocyte telomere length (LTL) and QoL.

However, the relationship between overall QoL and LTL has not previously been investigated. Therefore, this study was conducted to examine the relationship between LTL and QoL. QoL was measured by the Korean version of the 36-item short-form health survey (SF-36), which is a multidimensional scale consisting of subjective evaluation.


Eligibility Criteria:
Inclusion Criteria:

* married couple
* apparently healthy subjects above 55 years

Exclusion Criteria:

* Subjects who had experienced hormone therapy
* Subjects who had been diagnosed with dementia, Parkinson's disease, stroke, ischemic heart disease, congestive heart failure, arrhythmia, depression, cancer, thyroid disorders, or chronic renal disease
Treatment of Perianal Fistulas by Endorectal Advancement Flap Associated With Adipose Tissue Injection

The study aims to evaluate effectiveness of the association of endorectal advancement flap technique with local injection of autologous and micro-fragmented adipose tissue, obtained with the Lipogems® system, in patients with complex Perianal Fistulas not related to Crohn's Disease.

Treatment of anal fistula pursues permanent healing and preservation of anal continence, not always easy goals in complex anal fistulas.

In patients with Crohn's disease, simple surgery (ligation of the path and suturing of the internal orifice) associated with injections of stem cells derived from autologous or allogeneic adipose tissue has been shown to cure up to 70%. of the cases. Similar results have been obtained in small series of patients with fistulas of cryptoglandular origin and also in rectourethral and rectovaginal fistulas of other etiologies. Unfortunately, this treatment is time consuming and extremely expensive.

Fresh adipose tissue is an alternative source of mesenchymal stem cells (MSC) with regenerative capabilities, immunomodulatory angiogenic and anti-inflammatory effects. The injection of fresh adipose tissue, obtained by liposuction from the same patient, is currently a therapeutic alternative used in regenerative medicine, plastic and orthopedic surgery indications, as well in other fields. Beneficial effects of fresh adipose tissue on anus fistulas and fecal incontinence have also been reported.

The aim of the present study is to evaluate the effectiveness of the injection of autologous, microfragmented and minimally manipulated adipose tissue, associated with a surgical technique that obtains by itself up to 70% cure in order to add the benefits of surgery with those in regenerative medicine hoping that the beneficial effects of MSC will aid in the healing and repair process.

A prospective study is proposed in 12 patients with non-Crohn's-related complex anals fistulas. Whenever possible, the endorectal advancement flap technique will be applied; in blind fistulas and special cases, in which the flap is not indicated, alternative techniques will be used. In all cases, autologous, micro-fragmented and minimally manipulated adipose tissue, obtained with a standardized procedure, previously validated and authorized, will be injected. This procedure uses the "Lipogems ®" device (Lipogems International SpA, Milan, Italy), with which a well-characterized adipose tissue is obtained with the maximum safety guarantees.

Eligibility Criteria:
Inclusion Criteria:

* Patients of both genders, aged over 18 years old.
* Diagnosis, confirmed by standard methods (magnetic resonance and/or trans-anal ultrasound), of complex fistula (trans-sphincteric unsuitable for treatment lay-open).
* Seton placed at least 4-6 weeks previously.
* No limitations to a periodic follow-up lasting for a total of 12 months
* Informed consent form signed.

Exclusion Criteria:

* Active septic process.
* Patients unable to follow the pathway required by the protocol.
* Pregnant women.
* Failure to sign the informed consent form
Desipramine Hydrochloride and Filgrastim For Stem Cell Mobilization in Patients With Multiple Myeloma Undergoing Stem Cell Transplant

This pilot clinical trial studied how well desipramine hydrochloride and filgrastim worked for stem cell mobilization in participants with multiple myeloma (MM) undergoing stem cell transplant. Giving colony-stimulating factors, such as filgrastim, and other drugs, such as desipramine hydrochloride, helps stem cells move from the participant's bone marrow to the blood so they can be collected and stored.

PRIMARY OBJECTIVES:

I. To study efficacy, safety, harvest kinetics and engraftment kinetics of participants undergoing autologous stem cell mobilization, mobilized with a combination of granulocyte colony-stimulating factor (GCSF) (filgrastim) with desipramine (desipramine hydrochloride) (G+D).

II. To analyze polymorphisms of adrenergic receptor beta 2 (ADRB2) and adrenergic receptor beta 3 (ADRB3) genes that correlate with mobilization efficiency.

OUTLINE:

Participants received desipramine hydrochloride orally (PO) daily on days -3 to +4 and filgrastim PO twice daily (BID) on days 1-4. Stem cell collection began on day 6.

After completion of study treatment, participants were followed up to 1 week after completion of stem cell collection.

Eligibility Criteria:
Inclusion Criteria:

* Patients eligible for autologous stem cell transplant for multiple myeloma; planned use of filgrastim (GCSF) for stem cell mobilization
* Ability to give informed consent
* Glomerular filtration rate (GFR) \> 30 ml/minute
* Liver function tests \< 2.5 x upper limit of normal (ULN)
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 2 or less
* Based on prior therapy patients will be classified into two categories:

  * Initial mobilizers with no exposure to alkylators
  * Remobilizers or with prior exposure to alkylators or with greater than 5 cycles of lenalidomide therapy prior to mobilization

Exclusion Criteria:

* Use of a monoamine oxidase inhibitor (MAO-I) during or within 2 weeks of desipramine therapy
* Concomitant therapy with any drugs shown to have major interactions with desipramine
* Concurrent use of drugs that are contraindicated with desipramine
* Myocardial infarction in preceding 4 weeks; history of uncontrolled cardiac arrhythmias or family history of sudden cardiac death; baseline corrected QT (QTc) \> 460 msec
* Active alcohol abuse
* Bipolar disorder
* Untreated active major depression
* History of seizures in the past 3 years
* Pregnancy and lactation; refusal to use adequate contraception
* Uncontrolled thyroid disease
* GCSF or pegfilgrastim use within 14 days prior to enrollment
* Bortezomib, Revlimid or thalidomide use within 7 days of enrollment
* Patients with sickle cell disease
Prenatal DHA and Neurofunctional Development

The purpose of this study is to learn how much DHA to give to mothers in order to provide enough to the baby. Researchers will also learn if there are differences in development of the baby up to 12 months after birth.

Docosahexaenoic acid (DHA) is an essential nutrient. Our bodies make DHA from the foods we eat. If we eat foods with a lot of DHA, like fatty ocean fish, we have more DHA in our bodies. DHA is found in all cells of the body but is especially high in nerve cells of the brain and eye. Babies get DHA from the mother when they're in the womb. After birth, they can get DHA from breast milk or infant formulas.

This study will enroll pregnant women and follow them and their baby until the baby is 12 months old. Changes in the development of the baby will be tracked. Half of the participants in this study will receive 200mg of DHA to take daily. The other half of participants will receive 800mg of DHA to take daily. Participants, along with the researchers, will not know which dose of DHA they are receiving.

Eligibility Criteria:
Inclusion Criteria:

* Women in their 12th to 20th week of gestation
* Participants agree to consume the study capsules from enrollment to delivery
* Healthy weight, overweight and obese women (determined by body mass index; BMI) are eligible
* Must be available by telephone

Exclusion Criteria:

* Underweight women and women who exceed 250 lbs at enrollment
* Women with serious systemic infection, cancer, major organ disease or systemic lupus erythematosus
* Women with multiple infants or fetal diagnosis of congenital cardiac structural or conduction defects or brain malformations
* Diagnosis of Type I diabetes, and/or hypertension
* Reported drug and/or alcohol abuse
* Unwilling to take capsules, or be contacted by phone
* Do not understand English
New Non-Hormonal Treatment by Radiofrequency for Vulvo-Vaginal Atrophy

Vulvo-Vaginal Atrophy (VVA) or Genitourinary Syndrome of Menopause (GSM) is a common and under-reported condition associated with decreased estrogenization of the vaginal tissue The aim of this study is to evaluate safety and efficacy of " Dynamic Quadripolar Radio-frequency" thermal treatment with Vaginal Dynamic Radio-frequency (VDR™) and Radio-frequency Safety System (RSS™) for the treatment of VVA and GSM in postmenopausal women who either present contra-indication for menopause hormone therapy, or are not willing to use Menopause Hormone Therapy (MHT) or have failed to be helped using MHT.


Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women suffering of Vulvo-Vaginal atrophy (VVA), included Breast Cancer survivors defined as having self-identified at least one mild to severe of the following symptoms:

  1. Vaginal dryness (none, mild, moderate or severe),
  2. Vaginal and/or vulvar irritation/itching (none, mild, moderate or severe),
  3. Vaginal pain associated with sexual activity (none, mild, moderate or severe)
* Postmenopausal women with VVA confirmed by at least one of the following criteria:

  1. A proportion of superficial cells ≤ 5% in the vaginal smear using a "Maturation Index"
  2. A vaginal pH \> 5
* Postmenopausal women between 40 and 75 years of age (non hysterectomized or hysterectomized). Menopause will be assessed either by amenorrhea of \> 1 year and / or by Follicle Stimulating Hormone (FSH) \> 30 UI/L and estradiol (E2) \< 20 pg/ml
* They must have either a contraindication to hormonal therapies, a failure of previous use of hormonal therapies (either systemic and/or local) or must have refused to take hormonal therapy.
* Willing to participate in the study and sign an informed consent.

Exclusion Criteria:

* Undiagnosed abnormal genital bleeding.
* The administration of any investigational drug within 30 days of screening visit.
* Endometrial hyperplasia at biopsy performed at screening or endometrial cancer.
* Use of estrogens/progestins products (vaginal, oral, pellet, transdermal....) in the 4 weeks to months (depending on the product used) prior study entry.
* Presence of severe medical disease or neurological disease or important co-morbidities.
* Other gynaecological malignancies.
* Recent vaginal surgery .
* A clinically relevant prolapse (Pelvic Organ Prolapse-Quantification System (POP-Q) ≤ 2)
* Current urinary tract or vaginal infection or recent sexually transmitted disease
* Anticoagulant treatment
* People with pacemakers and/or other implanted electrodes (Intra-Uterine Device (IUD) and surgical pelvic implants for sterilization are not considered as contraindication)
* Disabled people unable to communicate
NovoLet® Acceptance Study Within the Hospital Practise in Indonesia

This study is conducted in Asia. The aim of this study is to evaluate the overall acceptance of healthcare professionals (nurses and doctors) to the NovoLet® system used in a hospital environment.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes
* Type 2 diabetes
* Likely to be hospitalised and require insulin therapy
Validation of the Aktiia SA PulseWatch OBPM Device at the Wrist Against Invasive Blood Pressure Measurements

Single-centre intervention study to validate the performance of the Aktiia SA optical blood pressure monitoring (OBPM) device at the wrist against invasive blood pressure measurements with arterial line.

Aktiia SA PulseWatch is an investigational device for the optical measurement of blood pressure that uses only optical sensors at the wrist. HNE is interested in exploring the potential of the device and technology (OBPM), and aims at benchmarking its performances against gold standard measurements of blood pressure.

The goal of this study is thus to assess whether i) PulseWatch allows to capture blood pressure variations, and ii) the measured blood pressure values remain stable in time.

The proposed study plans to include patients that are already scheduled for arterial catheterization at HNE. For these patients, the study will only require the placement of the safe optical device on the wrist to non-invasively record hemodynamic fluctuations. Therefore, no additional risk for the patient is to be foreseen.

By demonstrating that the Aktiia SA OBPM technology is reliable, HNE aims to make one step further in improving blood pressure monitoring in general, and in particular in advancing the deployment of technologies that have the potential to be used in the ambulatory setting. The diagnosis and treatment of hypertension are expected to largely benefit from these advancements.

Eligibility Criteria:
Inclusion criteria:

* Age ≥ 18 years
* No significant non-invasive systolic blood pressure difference between left arm and right arm (difference \<20mmHg in systolic arterial pressure)
* Patient requires continuous monitoring of diastolic and systolic blood pressure continuously via a radial arterial line;
* Patient information and informed consent is obtained following the procedures described in CIP

Exclusion criteria:

* Arrythmias: tachycardia (resting heart rate \> 120/min) at time of study inclusion
* Atrial fibrillation
* Psychomotor agitation
* Significant bruises or trauma on forearm
* Intravenous canula around the wrist with impossibility to place the device (Aktiia OBPM PulseWatch) around the wrist
Personalized Back Rx Exercise Program as a Treatment for Discogenic Low Back Pain

The prevalence and disability associated with discogenic low back pain are significant, and there is a general lack of widely accepted conservative treatments for the condition. A majority of previous studies that have assessed the efficacy of self-directed exercise-based rehabilitation programs did not include comprehensive metrics to confirm whether participants actually participated in the exercises prescribed. In this pilot study, the investigators hope to determine whether proxies of compliance with a daily, self-directed rehabilitation program for discogenic low back pain are correlated with participant-reported improvements in pain and function. The feasibility of a mobile interface designed to help patients with chronic low back pain track the daily management of their conditions will also be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Low back pain with predominantly axial symptoms (axial pain \> leg pain) that are exacerbated with sitting and alleviated with walking
* Persistence of symptoms for at least 3 months
* Lumbar intervertebral disc pathology evident on magnetic resonance imaging
* 18 to 65 years old
* Computer literate; have smartphone (iPhone 5S or up, Android 2.3 or up)
* English speaking

Exclusion Criteria:

* Concurrent pathology that may contribute to patients' axial low back symptoms (e.g., spondylolysis, spondylolisthesis, facet arthropathy)
* Severe lumbar disc degeneration prior to beginning Back Rx exercise program
* History of lumbar spine surgery or other interventions prior to beginning Back Rx exercise program
* History of trauma
* Cases involving workers' compensation or other legal claims
* Non-English speaking
Effect of Fluconazole on the Levels of ASCA After Surgical Resection for Crohn's Disease.

This was prospective study randomized in two controlled parallel groups verum versus placebo. The objectives were to assess the influence of antifungal treatment with Fluconazole (FCZ) on the rate of ASCA and endoscopic recurrence at 6 months. The rational was based on our previous research having established i) a link between intestinal inflammation and the opportunistic fungal pathogen C. albicans -a yeast colonizing the human digestive tract- ii) the demonstration that this yeast species could be at the origin of ASCA, a prominent serological marker of CD. It was therefore hypothesized that the FCZ could lower the rate of ASCA and/or reduce the occurrence of recurrences.


Eligibility Criteria:
Inclusion Criteria:

1. Crohn disease patients with a small intestine localisation (ileum or ileocecal)
2. Ileal or ileocecal resection in the month before inclusion (resection of all macroscopic lesions). If resection with temporary stoma, the patient may be included at the time of surgery to restore the continuity
3. Patient with low risk of recurrence according to the following criteria:

   (i) Total length of the resection(s) of the small intestine less than 100 cm (ii) Segmental colectomy leaving in place at least another colonic segment as the rectum
4. Preoperative rate of ASCA\> 70 arbitrary units (+/- 10%)
5. Informed consent signed to be involved in the study

Exclusion Criteria:

1. Pregnant women or without adequate contraception
2. Total length of the resection(s) of the small intestine more than 1 meter
3. Subtotal colic resection
4. Preoperative rate of ASCA\<63 arbitrary units (+/- 10%)
5. Known hypersensitivity to fluconazole or other azoles
6. Known liver disease or transaminase levels \>1.5 the normal rate
7. Patient with renal failure
8. Inability to read and sign the informed consent
ParisK: Correlation of Imaging Techniques With Histology

The possibility to identify the risk of rupture of a carotid plaque will have tremendous impact in clinical decision making. A vulnerable plaque is considered to have a large lipid rich necrotic core (LRNC), a thin fibrous cap, the presence of inflammatory cells, intraplaque haemorrhage and/or neovascularisation (vasa vasorum). The investigators aim to validate imaging of plaque vulnerability with histology. Previous studies have evaluated the use of imaging to assess carotid plaque vulnerability, mostly showing a good correlation between imaging and histology and/or clinical characteristics. However, they have focused on single modalities, (magnetic resonance imaging \[MRI\], multidetector-row computed tomography (MDCT), ultrasonography (US) or transcranial Doppler (TCD), and have used relatively small cohorts

The primary goal of this study is to investigate whether there is a correlation between neovascularisation in the carotid atherosclerotic plaque as observed with 3.0 Tesla dynamic contrast-enhanced MRI and histology. Moreover, the investigators aim to investigate the correlation between the volume of the LRNC as determined by dual-energy CT and histology.

Secondly, the investigators will investigate the correlation between the volume of the LRNC, the fibrous cap status and the volume of the calcifications determined by MRI versus histology, the correlation between number of microembolisms and fibrous cap status and the correlation between the deformation pattern seen with ultrasound and the volume of the LRNC.

The imaging parameters showing good correlation with plaque vulnerability characteristics can be used for further analysis in assessing the vulnerable plaque


Eligibility Criteria:
Inclusion Criteria:

* Patients with a carotid artery stenosis, who are scheduled for carotid endarterectomy
* Age 18 years or older (no maximum age)
* Informed consent by signing informed consent form regarding this study
* Inclusion criteria for carotid endarterectomy

  1. Symptomatic carotid artery stenosis 70-99% within 3 months of neurological symptoms
  2. Symptomatic carotid artery stenosis 50-99% in man within 2 weeks of neurological symptoms
  3. Asymptomatic carotid artery stenosis 70-99% with contralateral occlusion

Exclusion Criteria:

* Severe co-morbidity, dementia or pregnancy
* Standard contra-indications for MRI (ferromagnetic implants like pacemakers or other electronic implants, metallic eye fragments, vascular clips, claustrophobia, etc.)
* Patients who have a documented allergy to MRI or CT contrast media
* Patients with a renal clearance \<30 ml/min are not eligible to undergo contrast-enhanced MRI
* Patients with a renal clearance \<60 ml/min are not eligible to undergo CT
* Surgery planned within 4 days of inclusion
Prevalance of Cesarean Section Niche in Patients With Abnormal Uterine Bleeding

Prevalance of Cesarean section niche in patients with abnormal uterine bleeding


Eligibility Criteria:
Inclusion Criteria:

Age between 20-40 years old. Non pregnant women. Previous cesarean section (one or more). Presence of abnormal uterine bleeding

Exclusion Criteria:

Virgins Pregnant women. Patients with vaginal delivery. Patients with uterine bleeding with known cause.