cyrilzakka/clinical-trials huggingface dataset:
Fertility Study of Women Who Received Organ Transplantation

In terms of immunity, pregnancy can be considered a semi-allogeneic transplant. There are several immunological mechanisms for implantation and maintenance of pregnancy by induction of tolerance without induction of immunosuppression.

This study wants to evaluate the impact of immunodepression on women's fertility by studying the fertility of transplanted cardiac, renal, hepatic and pulmonary women.

A study of HIV-positive immunocompromised patients in medically assisted procreation, published in January 2016, found lower rates of implantation, clinical pregnancy, and newborn babies in these patients compared to HIV-negative patients.

Studying the fertility of transplanted immunocompromised women would provide adequate information on fertility and pregnancy possibilities for these patients, study their fertility on a larger scale and finally better understand the role of immunodepression in fertility.

Pregnancy is considered an allogeneic semi-graft, one can question the fertility of these patients under long-term immunosuppressive treatment. In particular, is there an impact on embryo implantation and on the development of pregnancy? To try to answer this problematic, we propose a retrospective non-interventional study to evaluate the birth rate after spontaneous or induced pregnancy in women who have tried to procreate after transplantation.The data will be collected using questionnaires submitted to the women present in the list of patients transplanted from the Organ Transplant Unit (OTU) of Toulouse University Hospital who have agreed to participate. This will make it possible to retrospectively study fertility data in these patients and to carry out, with the necessary hindsight, statistics on pregnancy rates.

The primary outcome measure: birth rate after spontaneous or induced pregnancy in liver, heart, lung or kidney transplant patients who have attempted to procreate post-transplant is a good primary endpoint because it is a unique clinical criterion. relevant to the purpose of the study, specific and objective.

Eligibility Criteria:
Inclusion Criteria:

* Major patient
* Patient who has had a heart, kidney, liver, pancreatic or pulmonary transplant for at least 5 years
* Patients under 40 at the time of transplant
* Patient having given her no opposition to her participation in research

Exclusion Criteria:

* Minor patients
* Patients over 40 at the time of the transplant
* Menopausal patients during organ transplantation
Evaluation of the Deep TMS H-Coil in the Treatment of Major Depression- Augmentation of Antidepressant Medication

Evaluation of the novel deep TMS H-Coil design as an augmentation measure in the treatment of medication resistant major depression. Stimulation is administered with and without cognitive-emotional provocation.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed as suffering from treatment resistant major depression
* Right laterality

Exclusion Criteria:

* other major axis I diagnosis
* severe axis II diagnosis
* risk factors to convulsions
* history of drug abuse in the past year
The Role of Melatonin in the Effective Attainment of Sleep Electroencephalograms (EEG) in Children

This study aims to determine the safety and effectiveness of oral melatonin as natural inducer of sleep to acquire useful EEGs in South African children following its introduction as the main agent used in the Neurophysiology department at Red Cross Children's Hospital. This is an observational retrospective study.


Eligibility Criteria:
Inclusion Criteria:

* All children who were referred to the neurophysiology department who were either unable to keep still for their EEG, or required a sleep EEG as part of their epilepsy "work-up" and whose caregivers agreed to the administering of sedation with melatonin.

Exclusion Criteria:

* Those children undergoing prolonged EEG monitoring (telemetry) or within 24 hours of status epilepticus (prolonged or cluster of seizures).
* Those children are not sedated as natural sleep is always attained with the prolonged monitoring studies, and for those with status epilepticus, there is usually evidence on the EEG of alteration secondary to the effects of status, and the medications administered to control the presenting event.
* Any child deemed to unwell to undergo a non-emergency procedure.
* Any child already receiving anticoagulant medications.
* Any caregiver who deferred sedation for their child was also excluded from the study and in the unit the procedure attempted without sedation.
Dynasplint for Distal Radius Fracture

The purpose of this study was to examine the efficacy of dynamic splinting as a therapeutic modality in reducing contracture following surgical treatment of distal radius fractures.


Eligibility Criteria:
Inclusion Criteria:

* Distal radius fracture treated with surgical management and wrist flexion contracture upon follow up

Exclusion Criteria:

* Carpal Fractures (Scaphoid, Lunate, Hamate, and Trapezium)
* Radial nerve entrapment
* Arthrodesis
* Traumatic dislocation of the distal ulna
The Effect of Probiotic Supplementation on Cognitive and Emotional Functions in Healthy Elderly Subjects

This study evaluates the cognitive and emotional effects of probiotics in healthy elderly patients.

Gut microbiota (GM) has focused as an important target for emotional and cognitive diseases, moreover in a population that show an altered GM such as elderly population as age-related changes. Several studies have shown that ageing alter GM, both in diversity and integrity.

Probiotics have demonstrated that correct or prevent age-related dysbiosis, in order to reduce or prevent intestinal permeability and associated inflammation, inhibit the generation of harmful and/or toxic metabolites, as well as promote the production of beneficial bacterial components.

The aim of this study is to assess the effectiveness of a multiprobiotic formulation as a therapeutic strategy to attenuate the emotional and cognitive decline associated with ageing in healthy adults over 55 years of age. The hypothesis is that administration of a multi-species probiotic for 10 weeks will slow and/or ameliorate the decline in emotional and cognitive function inherent to senescence.

Eligibility Criteria:
Inclusion Criteria:

* be aged 55 years or over,
* voluntarily agree to participate in the study in accordance with the Helsinki declaration,
* not be participating in another study that could interfere with the results.

Exclusion Criteria:

* suffer from any serious mental illness other than depression and anxiety,
* score below 10 on the Mini-Mental State Examination (MMSE) (severe cognitive impairment)
* be using medications that affect cognition,
* taking anti-inflammatory drugs, antipsychotics, antibiotics and/or anxiolytics,
* have a serious illness (e.g. cancer, Parkinson's or Alzheimer's).
Safety of Rabeprazole in Patients Under Multiple Treatments

The purpose of this study is to evaluate the safety of rabeprazole 20mg/day in polymedicated patients and to examine the necessity of adjusted dosage in both therapies (rabeprazole and concomitant drug). Proton pump inhibitors (PPI) act in the final step of the gastric secretion. PPI's block ATP-ase H+/K+ in gastric parietals cells. It has been described that inhibition of acid secretion has produced the recovery of the gastroesophageal pathology in a high percentage of the patients resistant to conventional drugs. In this context, the objective of the study is to evaluate the safety of rabeprazole as a concomitant treatment and examine the clinical practice the interaction with drugs whose absorption has gastric pH dependence.

Rabeprazole is a new proton pump inhibitor (PPI) with potent anti-secretion action and dose-dependence activity. Rabeprazole is rapidly eliminated by hepatic metabolism and renal clearance. In previous studies in healthy volunteers, interactions between sodium rabeprazole and drugs such as warfarin, theophyline, diazepam and phenytoin have not been found. The objective of the study is to evaluate the safety of rabeprazole as concomitant treatment and examine the clinical practice of the interaction with drugs whose absorption has a gastric pH dependence. This is an observational, multicenter, open and prospective study. It is expected to enroll 500 patients receiving rabeprazole and a concomitant drug (one or more). All data collected will be prospective and will include the following: demographic data, adherence and compliance with treatment, lifestyle (smoking and alcohol consumption) and dose of rabeprazole. Safety analysis will be based on adverse events. Observational Study: For patients with duodenal or gastric ulcer: rabeprazole 20mg per day, orally, for 4-6 weeks; For patients with erosive or ulcerate gastroesophagic reflux: rabeprazole orally 20mg/ per day, 4-8 weeks; For patients with gastroesophagic reflux requiring prolonged treatment: rabeprazole orally 10 or 20 mg per day; For patients with H. Pylori: rabeprazole orally 20mg twice per day , Clarithromycin orally 500mg 2 times per day and Amoxicillin 1gram orally twice daily for 1 week.

Eligibility Criteria:
Inclusion Criteria:

* Patients receiving Rabeprazole and a concomitant drug (one or more) such a non-steroidal anti-inflammatory drugs (NSAID), benzodiazepines or corticoids

Exclusion Criteria:

* Pregnant or lactating patients
* Other severe concomitant pathologies
* History or drug or alcohol abuse
HFS-guided Renal Ablation for Improving Outcome of Renal Denervation Procedure

To increase the number of responders using HFS-guided renal artery denervation (RDN) in patients with resistant and moderate resistant hypertension


Eligibility Criteria:
Inclusion Criteria:

* Office-based systolic blood pressure of ≥140/90 mm Hg and \<160/100 mm Hg (moderate resistant hypertension) or ≥160/100 mm Hg (severe resistant hypertension), despite treatment with 3 antihypertensive drugs (including a diuretic).
* A glomerular filtration rate ≥45 mL/min/1⋅73 m2, with modification of diet using a renal disease formula.

Exclusion Criteria:

* Secondary causes of hypertension
* Severe renal artery stenosis or dual renal arteries
* Congestive heart failure
* Left ventricular ejection fraction \<35%
* Previous renal artery stenting or angioplasty
* Type 1 diabetes mellitus
Obstetric Anesthesia and Analgesia and Multiple Sclerosis

Aim of the retrospective study was to evaluate the influence of the labour on the clinical course of the parturients with MS in selected 6 month follow-up interval and to evaluate to possible influence of the different anesthesia/analgesia types on the course of MS.

The role of anesthesia in multiple sclerosis (MS) progression remains unclear in spite of few foreign studies. The most frequently afflicted patients by MS are women of childbearing age and influence of anesthesia or obstetric epidural analgesia has only not been investigated in Czech Republic. The study aims to retrospectively compare the further course of the disease of MS in patients who labor between 2004 and 2013 in University Hospital Brno either by caesarean section or vaginally with epidural analgesia , with patients who gave birth spontaneously without anesthesia.The aim of the study was to evaluate the influence of the labour on the clinical course of MS and further evaluate the possible influence of the type of anesthesia/analgesia in the peripartal period on the MS progression.

Eligibility Criteria:
Inclusion Criteria:

* Parturients with multiple sclerosis
* Possible follow up - neurologic examination available after 10 month from delivery

Exclusion Criteria:

* probable or no multiple sclerosis at time of labor
* unknown neurology history
* unknown data on neurology outcome 6 months after labour
* Incomplete data
* Follow-up not possible
Controlled Internal Convection in Low Flow Hemodialysis of Dialysate: Removal of Beta-2-microglobulin

Since 2013 daily home hemodialysis allows low volumes of convection. This study is a prospective cross-over trial testing the efficiency of internal convection on Beta2-microglobulin in daily home hemodialysis.

Daily home hemodialysis with low dialysate volume system does not normally allow convection. Middle molecular weight toxins clearance is therefore lower. Beta2-microglobulin is considered representative of these middle molecules and contributes to the uremic toxic state.

Since 2013 daily home hemodialysis allows low volumes of convection ranging from 0 to 9L per session. This technology is called "push pulls" and uses internal convection.

This study is a prospective cross-over trial testing the efficiency of internal convection on Beta2-microglobulin in daily home hemodialysis.

Intradialytic fall of B2m levels is compared in 16 patients treated by one session of dialysis with 9L internal convection and one usual session with free internal convection.

The Kt/V of urea, the phosphorus and sodium removal, the plasma fall of myoglobin, prolactin, kappa and lambda free light chains, intradialytic fall of orosomucoid will be compared between the two session as secondary objectives.

Eligibility Criteria:
Inclusion Criteria:

* home hemodialysis since at least 2 weeks
* hemodialysis since at least 3 months
AL-SENSE 1-Step - Determination of Product Specificity

Clinical diagnosis of amniotic fluid leak will be determined, according the hospital standard procedure, using pooling test and/or sterile speculum examination and /or pH test, and AmniSure, N-Dia, Inc. (immunoassay for diagnosis of ruptured fetal membranes (ROM)). Amniotic fluid leak test, using the AL- SENSE 1-Step device, will be considered positive in case of presence of a blue or green or grey stain on a yellow background of the AL-SENSE 1-Step, as observed by the patient and the clinician (positive/negative).

Pregnant women arriving at the hospital and reporting unidentified wetness (undetermined whether they sense amniotic fluid leakage or urinary incontinence) will receive a single AL-SENSE 1-Step to use up to 12 hours or until they notice any wetness. The clinician will explain the proper use and handling of the AL-SENSE 1-Step and how to read the result.

In each case, the subject and the clinician/midwife (non bias to the hospital standard procedure results) will be required to read and record any occurrence of color change of the AL-SENSE 1-Step immediately after removing the test to mark if it changes color to blue or to green or to grey on the designated form.

The non bias physician, who is not aware to the AL-SENSE 1-Step result (other than the clinician/midwife who records the AL-SENSE 1-Step results) will perform a diagnosis tests for amniotic fluid leak detection, according to the hospital standard procedure.

The investigator will compare the AL-SENSE 1-Step results reading of the patient to the clinical diagnosis.

Eligibility Criteria:
Inclusion Criteria:

1. AgE 18 years OR GREATER.
2. Subject who will sign the informed consent form.
3. Subject who arrive at the obstetric department reporting a feeling of vaginal wetness feeling (undetermined whether she sense amniotic fluid leakage or urinary incontinence).

Exclusion Criteria:

1. Subjects that have had sexual relations within the last 12 hours.
2. Subject is unable or unwilling to cooperate with study procedures.
3. Subject is currently participating in another clinical study
Open-Label Extension of a Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Lovaza® and Simvastatin Therapy in Hypertriglyceridemic Subjects

In a previous trial (LOV111858/OM6), subjects received in a double-blind fashion either 4 g/day of Lovaza® (omega-3-ethyl esters) \[formerly known as Omacor\] co-administered with simvastatin 40 mg/day or placebo co-administered with simvastatin 40 mg/day for 8 weeks. This extension trial, LOV111818/OM6X assessed the continued efficacy and safety of Lovaza® (omega-3-ethyl esters) co-administered with simvastatin 40 mg vs. switching from simvastatin plus placebo to simvastatin plus Lovaza® for lowering non-High Density Lipoprotein-Cholesterol (non-HDL-C) levels at 4 months (primary endpoint) and additionally at 12 and 24 months.

Two studies comprise this OM6 Program. Study LOV111858/OM6 (double-blind study) which is outlined in NCT00246701 and Study LOV111818/OM6X (open-label extension) outlined in this posting.

Eligibility Criteria:
For LOV111818/OM6X - Subjects were included in the study if they had met all relevant inclusion/exclusion criteria prior to and throughout the double-blind Study LOV111858/OM6 and completed Study LOV111858/OM6 to Week 8.

FYI - entry criteria for LOV111818/OM6 (double-blind study)

Inclusion Criteria:

* Men and women ages 18-79 years, inclusive
* Current therapy with a statin drug
* Triglyceride levels between 200 and 499 mg/dL
* Normally active and in good health on the basis of medical history, brief physical examination, electrocardiogram, and routine laboratory tests
* Provide written informed consent and authorization for protected health information disclosure

Exclusion Criteria:

* Sensitivity to statin drugs or omega-3 fatty acids
* Lipoprotein lipase impairment or apo C-2 deficiency or type III hyperlipidemia
* Unexplained muscle pain or weakness
* History of pancreatitis
* Recent history of certain heart, kidney, liver, lung, or gastrointestinal diseases, or cancer (except non-melanoma skin cancer)
* Poorly controlled diabetes, or receiving insulin therapy
* Pregnant or lactating females. Women of childbearing potential who are not using a medically approved method of contraception.
* Use of certain types of hormones, anticonvulsant drugs, immunologic drugs, antibiotic, antifungal and antiviral drugs, and cardiac drugs
* Use of warfarin (Coumadin)
Patient Perspective on Remote Monitoring of Cardiovascular Implantable Electronic Devices

A relatively new and promising development in the area of cardiovascular implantable electronic device therapy is remote patient monitoring (RPM). RPM systems can interrogate the device automatically and send the data from the patients' home to the physician, thereby reducing in-clinic follow-ups.

The purpose of this study is to evaluate the effect of RPM + in-clinic follow-up versus in-clinic follow-up only on patient-reported health status and device-acceptance after implantation with an implantable cardioverter defibrillator (ICD) or cardiac resynchronization defibrillator (CRT-D).

Secondary objectives are (1) to identify subgroups of patients who prefer RPM over in-clinic visits or vice versa due to specific clinical and psychological factors and (2) To investigate the cost-effectiveness of RPM + in-clinic follow-up compared to in-clinic follow-up only.


Eligibility Criteria:
Inclusion Criteria:

* first time ICD/CRT-D implanted at one of the participating centers
* left ventricular ejection fraction \<35%
* NYHA functional class II or III symptoms
* ICD/CRT-D device compatible with the LATITUDE(r) RPM system from Boston Scientific

Exclusion Criteria:

* On the waiting list for heart transplantation
* History of psychiatric illness others than affective/anxiety disorders
* Cognitive impairments
* Insufficient knowledge of the language to fill in the questionnaires
Electrical Vestibular Nerve Stimulation (VeNS) as a Treatment for Insomnia

Insomnia is known to be one of the most common health concerns in in the general population and has been associated with several health consequences. Medications are known to be effective, and currently serve as the primary treatment for insomnia but their use is limited due to the risk of adverse events. Cognitive Behavioral Therapy (CBT-1) has also been shown to be effective and safer in the treatment of insomnia but presents its own limitations such as the time, cost, and training required. The relationship between vestibular stimulation and sleep continues to be explored, however its usefulness in the treatment of insomnia is still unknown. Vestibular stimulation itself has been shown to be safe across multiple populations. If vestibular stimulation is shown to be effective in the treatment of insomnia, it could serve as a safer alternative to medications. It could also require less cost, time, and training than CBT-1, providing a treatment option that is not only safe and effective, but broadly available to the general population. Consequently this trial seeks to evaluate the efficacy of non-invasive electrical vestibular nerve stimulation as a method of improving sleep quality and quantity, as compared to a sham control, in patients newly diagnosed with insomnia.


Eligibility Criteria:
Inclusion Criteria

1. Signed informed consent
2. Diagnosed insomnia with ISI of 15 or greater at screening
3. Males or females
4. 18-80 years of age inclusive on starting the study
5. Ability and willingness to complete all study visits and procedures; in particular an agreement to engage with trying to use the device on a daily basis
6. Agreement not to use prescription, or over the counter, sleep medications for the duration of the trial
7. Agreement not to use sleep trackers for the duration of the study (e.g sleep app smart watches)
8. Access to Wi-Fi (to connect iPod to internet)

Exclusion Criteria

1. History of skin breakdown, eczema or other dermatological condition (e.g. psoriasis) affecting the skin behind the ears (image from participant required).
2. Previous diagnosis of HIV infection or AIDS (HIV is known to cause a vestibular neuropathy which would prevent VeNS from working)
3. Medication for insomnia (unless regime stable for last 3 months).
4. A history of stroke or severe head injury (as defined by a head injury that required a craniotomy or endotracheal intubation). (In case this damaged the neurological pathways involved in vestibular stimulation).
5. Presence of permanently implanted battery powered medical device or stimulator (e.g., pacemaker, implanted defibrillator, deep brain stimulator, vagal nerve stimulator etc.).
6. Pregnancy.
7. Previous use of any VeNS device
8. Participation in other clinical trials sponsored by Neurovalens
9. Have a member of the same household who is currently participating in this study.
10. History of vestibular dysfunction or other inner ear disease as indicated by the following screening questions: