cyrilzakka/clinical-trials huggingface dataset:
Functional Urodynamic Changes in Chronic Kidney Disease Patients and Does Insertion of Urinary Catheter Delay the Need for Kidney Dialysis

The aim of the investigators work is to describe the urodynamic results in the CKD (chronic kidney disease) grade 4 patients and to verify observations that urinary catheter may improve kidney function in those patients.

100 patients with CKD grade 4 will do urodynamic examination.

All patients will be randomized into two groups / the intervention group that will be inserted urinary catheter for 2 weeks and the follow up group. Kidney function will be monitored by creatinin values and the investigators will measure the time to dialysis in the two groups.


Eligibility Criteria:
Inclusion Criteria:

* age \> 18
* chronic kidney disease grade 4-5 (eGFR (estimated glomerular filtration rate) \<30)
* eligible to sign a consent form

Exclusion Criteria:

* non controlled Diabetes Melitus (HbA1C\>10%)
* not controlled HTN (Hypertension)
* cardiovascular event requiring cardiac stenting
* renal hydronephrosis or post void rest \> 200CC according to US (Ultrasound)
* acute renal failure
* not eligible for urodynamics for any reason
* constant urinary catheter for any reason
Real-world CANadian CUvitru Non-Interventional Study in Subjects Transitioning From Subcutaneous Immunoglobulin (CANCUN)

This study will provide insights on the infusion parameters, dosing, and experience of participants transitioning to CUVITRU in a real-world setting.


Eligibility Criteria:
Inclusion Criteria (The participant will not be considered eligible for the study without meeting all of the criteria below):

* Voluntarily provide written, signed, and dated (personally or via a legally authorized representative) informed consent or assent as applicable to participate in the study;
* Participant \> 2 years of age with a documented diagnosis of PID or SID requiring IgG replacement therapy, as defined by the International Union of Immunological Societies Scientific Committee 2009 and by diagnostic criteria according to Conley et al., 1999;
* Participant has received subcutaneous immunoglobulin (SCIG) therapy previous to CUVITRU for at least 3 months; and
* Participant has received CUVITRU in line with the product specification (CUVITRU Product Monograph (Baxalta Canada Corporation, 2018) at start of study

Exclusion Criteria (Participants are excluded from the study if any of the following criteria are met):

* Participation in any interventional clinical study within the last 30 days
* Participant participates in a clinical study in parallel during the observation period; and
* Participant had a dose change 30 days prior to transition to CUVITRU for Cohort 1
Effect of a Fortified Balanced Energy-Protein Supplement on Birth Outcome and Child Growth in Houndé District, Burkina Faso.

The 2016 WHO antenatal care guidelines stated that pregnant women in undernourished populations should receive fortified balanced energy-protein (BEP) supplements to reduce the risk of stillbirth and small-for-gestational-age birth. However, acceptable supplements and delivery channels must be determined for different contexts.

The present proposal therefore will 1) perform a formative study to identify the most suitable (acceptability and utilization) BEP supplement for pregnant women in rural Burkina Faso (phase 1) and 2) evaluate the efficacy of this supplement to improve birth weight, fetal and infant growth (phase 2). The nutritional composition of the BEP supplement was established during an expert convening at the BMGF in September 2016. Private sector partners will prepare the supplements in the selected forms with the recommended nutrient composition.

Pregnancy remains a challenging period in the life of many women in low- and middle-income countries. Maternal mortality remains high and many newborns suffer from premature delivery and /or gestational growth retardation both in length and in weight accumulation.

The 2016 WHO antenatal care guidelines stated that pregnant women in undernourished populations should receive fortified balanced energy-protein (BEP) supplements to reduce the risk of stillbirth and small-for-gestational-age birth. However, acceptable supplements and delivery channels must be determined for different contexts.

The purpose of this study is to assess the efficacy of a fortified BEP supplement for pregnant and lactating women to improve birth weight, fetal and infant growth.

This research includes 2 phases:

* Phase 1 - part 1: Formative research to identify preferred product types of a fortified BEP supplement;
* Phase 1 - part 2: Formative research with a 10-week home-feeding trial to determine the acceptability of a fortified BEP supplement for longer-term consumption.
* Phase 2: A community-based, individually randomized efficacy trial of the fortified BEP food supplement including 1,776 pregnant and lactating women aimed at testing 2 hypothesis: supplementing pregnant and lactating women with a fortified BEP supplement will improve fetal growth; improving fetal growth will have a positive effect on health and growth during infancy.

Eligibility Criteria:
Inclusion Criteria:

* Participant age (15-40 years).
* Pregnant as determined by a pregnancy test and confirmed by ultrasound.
* Women who signed the informed consent form (in case of minors the parents or husband signs)

Exclusion Criteria:

* Women planning to leave the area before delivery.
* Women who plan to deliver outside the area.
* Pregnancies with a gestational age \> 20 weeks at study inclusion.
* Women with multi-fetal gestation (exclusion from analysis).
* Women who are allergic to peanuts.
Study Dosed With (123I-mIBG) for Identifying Subjects With Heart Failure Who Will Experience an Adverse Cardiac Event

The study was designed to study the utility of meta-iodobenzylguanidine (123I-mIBG) imaging to identify those participants with heart failure who would experience an adverse cardiac event during 24 months of follow-up from the administration date of 123I-mIBG in previous studies MBG311 or MBG312.


Eligibility Criteria:
Inclusion Criteria:

* The subject was a Heart Failure subject who signed informed consent for MBG311, MBG312, or MBG312C.
* The subject was administered 123I-mIBG in MBG311, MBG312, or MBG312C.
* The subject completed the late planar imaging assessments (at a minimum) required by the protocols for MBG311, MBG312, or MBG312C.
* The subject agreed to allow the investigator access to medical records, including those relating to subject death should this occur.

Exclusion Criteria:

* The subject withdrew or was withdrawn from MBG311, MBG312, or MBG312C.
* The subject was considered lost-to-follow-up (6 months without contact) in MBG311, MBG312, or MBG312C.
Multidirectional Yoga for Cognition

Older individuals, 60-90, will be provided regular or cognitively based yoga training. They will then be evaluated using standard cognitive testing devices.

Reductions in executive function are common with age. Along with these declines come reductions in simple functional patterns of daily living such as crossing a street, walking in a crowded area, or performing any functions that occurs in an open (changing) environment. This study will use a newly developed yoga program incorporating multi-directional movements, cognitive challenges and visuomotor disturbances to improve executive function and associated movements in persons over 60 years of age.

Eligibility Criteria:
Inclusion Criteria:

* 60-90 years of age
* Capable of walking 50 feet with or without a walking aid-

Exclusion Criteria:

* Regularly participating in yoga or other balance training program
* Currently participating in another exercise study
* Unable to commit to study duration
* Uncontrolled neuromuscular or cardiovascular disease that prevents participation in an exercise study
* Advised not to exercise by their physician
Chest Wall Motion Analysis in Disease

Breathing movements, called chest wall motion, are very complex. The investigators are studying how movement of the abdomen, ribs and diaphragm contribute to breathing and how this differs with different diseases in the chest. Breathing movements may help with diagnosis, assessment of severity or assessing the impact of treatments for chest conditions. The investigators are following people who have a chest disease, measuring their chest wall motion and comparing it to their diagnosis and and how their treatment works.

Chest wall motion can be measured in different ways at rest and whilst exercising. Small stickers on the chest can be used to reflect infra red light or visible squares of light can be shone onto the chest without using stickers.

Optoelectronic plethysmography (OEP) is based on the analysis during breathing of the trajectories of a series of markers positioned on the thoracic-abdominal surface of the patient. The positions in space of these markers are recorded and processed with mathematical models and algorithms by a computing unit that can accurately measure not only volume variations of the whole thoracic-abdominal wall, but also the variations of the various compartments. This detects, for example, asymmetries in the action of respiratory muscles. The system can accurately measure current volume, vital capacity, respiratory frequency, duration of the phases of inspiration and exhalation, the average inspiration and exhalation flux and the volume variations at the end of exhalation.

Structured Light Plethysmography (SLP) also assesses regional chest wall excursion but does not require markers to be placed on the patient. The system uses visible light shone onto the chest wall in a checkerboard pattern and reflected back by the patient's skin or a tight T shirt.

Images from 4 Microsoft Kinnect Motion Cameras can be used to create a 3D representation of the patient's torso. This system has been shown to correlate well with chest wall measurements recorded by OEP.

These systems are innovative examination instruments, non-invasive, accurate, easy to use and unlike traditional plethysmographic technologies, are not affected by humidity and temperature variations and can easily be used to perform measurements for extended periods of time. They accurately measure the dynamics of the volume variations that occur during breathing in the various sections of the thoracic-abdominal walls (upper, lower and abdominal thoracic area). This data, which is otherwise undetectable, is a useful contribution to the evaluation of patients. We will apply chest wall motion analysis to understanding the physiology of thoracic disease processes as well as assessing potential diagnostic and prognostic (response to treatment) markers that could be used in future clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* Aged 16 or over
* Have thoracic disease or healthy control

Exclusion Criteria:

* Unable to provide valid informed consent
Safety and Efficacy of AEB071 in Metastatic Uveal Melanoma Patients

This study has two parts, dose escalation and dose expansion. For dose escalation, the primary objective is to estimate the maximum tolerated dose (MTD) of AEB071 in patients with uveal melanoma. For dose expansion, the primary objective is to characterize the safety and tolerability of the MTD of AEB071 in patients with uveal melanoma.


Eligibility Criteria:
Inclusion Criteria:

* Uveal melanoma with biopsy proven metastatic disease
* Males and females ≥ 18 years of age
* Consent to biopsy of tumor
* Measurable disease according to RECIST version 1.1
* WHO performance status of ≤ 1

Exclusion Criteria:

* Patients with abnormal laboratory values as defined by the protocol
* Patients who are receiving treatment with strong inducers or inhibitors of cytochrome P450 3A4 (CYP3A4) that cannot be discontinued prior to study entry
* Patients with impaired cardiac function or clinically significant cardiac diseases as defined by the protocol
* Patients with another malignancy that was treated within the last three years with the exceptions of localized basal cell carcinoma and cervical carcinoma
* Patients with impairment of gastrointestinal function or disease
* Patients with severe systemic infections
* Patients who are known to be HIV positive and/or have active hepatitis B or C infection
* Time since last therapy for treatment of underlying malignancy:

  * Cytotoxic chemotherapy: ≤ duration of the most recent cycle of the previous regimen (a minimum of 2 weeks for all)
  * Nitrosurea: ≤ 6 weeks
  * Biologic therapy: ≤ 4 weeks
  * ≤ 5 x PK half-life of a small molecule therapeutic not otherwise defined above
* Patients having undergone major surgery less than 4 weeks prior to enrollment or have not fully recovered from prior surgery
* Women of child-bearing potential unless they are using highly effective methods of contraception during the dosing and for at least 36 hours after last dose. Highly effective contraception as defined in the protocol.
* Patients with primary central nervous system tumors or brain metastases.
* Pregnant or nursing (lactating) women.

Other protocol-defined inclusion/exclusion criteria may apply
Safety and Efficacy of a FAAH-Inhibitor to Treat Cannabis Withdrawal

Cannabis dependence is associated with changes in the brain's cannabinoid system. When cannabis dependent individuals try to quit using cannabis, some of them experience problems that make it difficult for them to achieve and maintain abstinence. Therefore, reducing the problems related to quitting cannabis may facilitate abstinence. One way to do this is by harnessing the brain's capacity to make its own cannabis-like substances - endocannabinoids. One of the main endocannabinoids is anandamide. The study is based on the hypothesis that the problems related to quitting cannabis use will be reduced by increasing the brain levels of anandamide. Furthermore, by reducing the problems related to quitting cannabis, people will be less likely to relapse. Brain anandamide levels will be increased by blocking the breakdown of anandamide using a fatty acid amide hydrolase inhibitor (FAAH-I). The effects of a novel FAAH-I cannabis withdrawal and relapse in cannabis dependent subjects will be studied in a double-blind, randomized, controlled, proof-of-concept study. Cannabis-dependent subjects will receive placebo or the FAAH-inhibitor PF-04457845 in a 2:1 randomization. The trial consists of a 1 week inpatient stay to achieve abstinence, a 3 week outpatient treatment phase. Cannabis withdrawal will be measured during the inpatient phase. Cannabis use and urinary THC-COOH levels will be measured during the entire study. The treatment phase will be followed by a safety follow up phase of 8 weeks.


Eligibility Criteria:
Inclusion Criteria:

1. Male
2. Ages 18-55 (inclusive)
3. Cannabis Dependence

Exclusion Criteria:

1. Allergies or intolerance to FAAH-Inhibitors
2. Current significant medical or other comorbidities
The Sleep-pain Relationship in Women with Endometriosis

The goal of this study is to examine the sleep-pain relationship in women diagnosed with endometriosis, by monitoring different symptoms of endometriosis and sleep through an experience sample method study (ESM).The main question it aims to answer is:

How does sleep impact cyclic and chronic pain and vice versa in women with endometriosis?

Participants will be asked to fill in a 6-item diary (twice a day) over the course of 2 months.


Eligibility Criteria:
Inclusion Criteria:

* Adult premenopausal women with a laparoscopic and histopathological diagnosis of endometriosis, without a history of hysterectomy, experiencing cyclic or chronic pelvic pain for 3 months or longer, with pain intensity of at least 3 out of 10 over the past 3 months, experiencing non-restorative sleep (defined as a subjective feeling of being unrefreshed up-on awakening) for 3 months or longer, in the absence of elevated risk for intrinsic sleep disorders (such as sleep apnea or restless leg syndrome), and having sufficient knowledge of either French, Dutch, or English

Exclusion Criteria:

* Participants younger than 18 years old, without laparoscopic and histopathological diagnosis of endometriosis, participants with a hysterectomy or pain intensity lower than 3/10, with restorative sleep or sleep apnea and restless leg syndrome, shift work and insufficient knowledge of either French, Dutch or English.
Effects of HMOs on Faecal Microbiota, Gastrointestinal Symptoms, Mucosal Immunity and Barrier Function in IBS Patients

The study is a randomised, placebo-controlled, double-blind parallel study in IBS patients. A total of 60 adult patients diagnosed with IBS-C, -D or -A/M according to Rome IV criteria will be included. The participants will be randomized into one of three groups consuming either HMO (two groups) or placebo (one group).

The primary objective of the study is to establish the effect of HMOs on the faecal microbiota in IBS patients. Secondary objectives are to assess the effect on gastrointestinal symptoms, mucosal immunity, gut barrier function, quality of life, and anxiety and depression.


Eligibility Criteria:
Inclusion Criteria:

1. Signed written informed consent
2. Age between 18 and 75 years at visit 2
3. Fulfills definition of IBS-D, IBS-C or IBS-A/M according to Rome IV criteria
4. Have a global IBS-SSS score of \>174 during the 2 weeks run-in period
5. Read, speak and understand Swedish
6. Ability and willingness to understand and comply with the study procedures

Exclusion Criteria:

1. Participation in a clinical intervention trial one month prior to screening visit and throughout the study.
2. Any known gastrointestinal disease(s) that may cause symptoms or may interfere with the trial outcome, as judged by the investigator; in particular

   * lactose intolerance
   * coeliac disease
3. Other severe disease(s) such as malignancy, diabetes, severe coronary disease, kidney disease or neurological disease, as judged by the investigator.
4. Severe psychiatric disease and/or psychological disturbance, as judged by the investigator.
5. Use of highly dosed probiotic supplements (yoghurt allowed) one month prior to the study and throughout the study. Excluded products are (i) probiotic supplements in the form of capsules, tablets, and powders in sachets, and (ii) probiotic food and drink products which contain high doses of probiotics. The excluded food and drink products are available in the form of yoghurts, drinking yoghurts, shots and drinks under brands such as Proviva, Actimel, Activia, Wellness, and Verum.
6. Consumption of antibiotic drugs one month prior to screening and throughout the study. Antibiotic use within the last three months prior to screening will be registered.
7. Consumption on a regular basis of medication that might interfere with symptom evaluation (as judged by the investigator) two weeks prior to screening and throughout the study. Specifically excluded drugs are opioids, NSAIDs on a weekly basis, regular use of laxatives and anti-diarrhoeal drugs, any drugs indicated for IBS symptoms.
8. Diagnosed with and treated for IBS for more than 10 years
9. Pregnant or lactating or wish to become pregnant during the period of the study.
10. Lack of suitability for participation in the study for any reason as judged by the investigator.
The Effectiveness of Bilateral Alternating Tactile Stimulation for Improving Sleep in Children

The investigators hypothesize that wearing bilateral therapeutic vibrating devices before bed will result in positive changes in outcome measures related to sleep (e.g., sleep efficiency) in children who are sensitive to stimuli in their environment (aka sensory over responsiveness or SOR).

The purpose of this research study is determine if providing bilateral alternating stimulation to the extremities is effective for improving sleep in children with sensory processing difficulties. The investigators will use Touchpoints to deliver the intervention. The Touchpoints look like a regular watch, and vibrate at different low level frequencies to produce a calming effect on the body. More information about Touchpoints can be found here: https://thetouchpointsolution.com/pages/shop-touchpoints. The investigators hypothesize that these types of wearable vibrating devices may help children fall asleep faster and possibly stay asleep longer. This study will allow the research team to test these assumptions.

In this study, each child will be asked to do the following things:

1. Wear an activity tracker watch on their wrist before bed and through the night for 10 days consecutively (Baseline)
2. Wear both the activity tracker watch (wrist) and the Touchpoints (both ankles) before bed and during sleep for 10 days straight. (Intervention)
3. Wear the activity tracker watch on their wrist before bed and through the night for 10 additional days (post-test)

During the study, the parents will be asked to fill out a brief sleep diary.

Eligibility Criteria:
Inclusion Criteria:

* Scores "more than others" in either sensation avoiding or sensory over-responsive on the Short Sensory Profile
* Has identified sleep difficulties on the Children's Sleep Wake Scale (any sub-scale scores outside of normative range)

Exclusion Criteria:

* Diagnosed seizure disorder or history of seizures
* Rubber or latex allergy (will not be able to wear wrist band)
* Significant motor impairments (e.g. cerebral palsy)
* Children who are wards of the state
Survey of People With Diabetes, Caregivers of People With Diabetes Parents of Children and Young People With Diabetes

A survey of people with diabetes and caregivers of people with diabetes and parents of children and young people with diabetes in Denmark in order to assess perceived diabetes related health and wellbeing and perceived access to and gaps in medical care, support and other financial and support services.

A questionnaire survey was designed for online completion by people with diabetes and caregivers of people with diabetes and parents of children and young people with diabetes in Denmark in order to assess their perceived diabetes related health and wellbeing and perceived access to and gaps in medical care, support and other financial and support services. The aim is for the survey to provide a cross-sectional assessment of present access to health, wellbeing and care for people with diabetes and caregivers in Denmark and to establish a survey tool suitable for ongoing long-term monitoring of well-being, care and support to people with diabetes and caregivers in Denmark.

Eligibility Criteria:
Inclusion Criteria:

* Age over 18

Exclusion Criteria:

* Not able to complete online questionnaire
A Retrospective Chart Review Study of the Outcomes of 2nd Line Therapy With LEn/Dex in Greek Patients With R/R Multiple MyEloma and the Treatment PatterNs Following Progressive Disease

This non-interventional retrospective chart review study aims to evaluate the clinical outcomes of patients with RRMM receiving lenalidomide/dexamethasone (Len/Dex) treatment at 1st relapse and the treatment patterns following progressive disease as part of the routine clinical practice in Greece.


Eligibility Criteria:
Inclusion Criteria:

Subjects must fulfill ALL of the following criteria:

* Subjects of both genders, aged 18 years or older
* Subjects must have a relapsed or refractory MM diagnosis according to IMWG or EBMT criteria
* Subjects must have initiated second-line therapy with lenalidomide/dexamethasone according to the approved products' Summary of Product Characteristics (SmPC) between 01 January 2009 and 01 March 2014
* Subjects must have available medical files/records and detailed historical data on their disease course and clinical management
* Provision of signed ICF for collecting and analyzing medical data pertinent to the objectives of this study

Exclusion Criteria:

For the candidate subjects NONE of the following criteria should apply:

* Prior malignancy (within the 3 years preceding initial diagnosis of MM)
* Concurrent administration of anti-cancer regimens for malignancies other than MM between the time of initial MM diagnosis and time of second relapse
* Subject participation in an interventional study