cyrilzakka/clinical-trials huggingface dataset:
Personalized and Automated Digital Coaching in People With Non-specific Chronic Low Back Pain

The investigators hypothesize that a personalized and automated digital coaching could reduce activity limitations in people with chronic low back pain as compared to usual care

Non-specific low back pain (LBP) is the leading cause of years of life lived with disability worldwide and its burden is growing alongside the increasing and ageing population.

LBP is usually treated according to symptoms duration, presence of concomitant radicular pain and of consistent anatomical abnormalities and is defined according to symptoms duration: acute (\< 6 weeks), subacute (6 to 12 weeks) and chronic (\> 12 weeks). The prognosis of acute LBP is excellent, but in 5 to 15% of individuals, LBP becomes chronic. At 6 months, about 10% of individuals with chronic LBP are on sick leave, and at 12 months, 20% report persistent disability.

Unfavourable evolution of chronic LBP is characterized by onset and persistence of spine-specific disability in all individuals and work absenteeism in working age individuals. The probability of returning to work is only 20% after 1 year of sick leave and 0% after 2 years. Multidisciplinary rehabilitation that combines education, physical therapy, cognitive behavioural therapy and rehabilitation is usually offered. However, lack of personalization of these programs could affect their efficacy and systematic evaluation suggests their low cost-effectiveness).

Current management of non-specific chronic low back pain involves a multidisciplinary approach that typically includes non-opioid analgesics, physical exercise and strength training, education, and cognitive behavioural therapies. Therapeutic interventions such as massage, acupuncture, or spinal manipulation may also be beneficial.

The investigators hypothesize that a personalized and automated digital coaching could reduce activity limitations in people with chronic LBP, as compared to usual care.

Participants allocated to the experimental group will be invited to download a smartphone application which will appraise their motivation and automatically propose 1) exercises to be performed at home and adapted to their pain levels; 2) audio recordings for pain management; and 3) educational and coaching content adapted to their motivation. In addition, the smartphone application enables users to plan their home exercises.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18 or over
* Having non-specific chronic LBP
* Participating in the "ComPaRe" e-cohort
* Having provided consent for their data to be used to assess trial eligibility

  * And to be randomized if eligible
  * And to, allow their data to be used to evaluate intervention effectiveness without being notified that they are in the control group, if randomized to usual the control group
* Having a valid email address
* Able to read and write French Having a smartphone functioning with Android acquired after 2020

Exclusion Criteria:

* No exclusion criteria
Testing a Decision Aid for Women With Urogenital Prolapse

Development of a decision aid for women with urogenital prolapse followed by an intervention with use of the decision aid to investigate the effect on the perceived shared decision making in the clinical consultations.

A protocol for a randomized controlled non blinded multicenter trial. A feasibility trial for the protocol.

Objective :

The objective is to develop a decision aid to increase successful patient involvement and increased health care professionals integration of preferences in the clinical consultations with women with urogenital prolapse.

Method:

in the context of consultations an online app solution using a multicriterial analytic approach is developed and tested in order to support shared decision making (SDM). The decision aid is developed involving four national gynecological departments through participatory design. The decision aid is tested in a randomized, controlled multicenter trial in three hospital departments in the Region of Southern Denmark. A feasibility trial for the protocol of a randomized controlled trial will decide for further approach in relations to testing the online app. in a larger scale In the randomized trial patients will either receive consultations as usual (controls) or consultations using the interface (IF) in an app. The IF is generated upon data from a patient survey regarding their preferences for treatment beforehand.

Effect measures are the perceived shared decision making within the consultation (SDM-Q-9 ) and the patientperceived satisfaction with the decision (SWD)

Eligibility Criteria:
Inclusion Criteria:

* urogenital prolaps symptoms
* e boks

Exclusion Criteria:

* complicated pelvic organ prolapse which requires treatment other than dialogue, pessary, cystocele or rectocele surgery, physiotherapy or local hormones
* physical status classification system (ASA) score 3 or above
* not able to understand Danish without interpreter
* recurrent pelvic organ prolapse
Kangaroo Mother Care to Prevent Hypothermia in Preterm Infants

The overall hypothesis is that better adherence to Kangaroo Mother Care (KMC) in combination with existing WHO thermoregulation care will reduce the incidence of moderate hypothermia (32-36 degrees C) or severe hypothermia (\<32.0 degrees C) in preterm infants (32-36 6/7 weeks of gestational age) when compared with routine WHO thermoregulation alone.

The overall hypothesis is that better adherence to Kangaroo Mother Care (KMC) in combination with existing World Health Organization (WHO) thermoregulation care (warm delivery rooms, immediate drying after birth, KMC whenever possible, early and exclusive breastfeeding, postponement of bathing and weighing, appropriate bundling, and use of air incubator, radiant warmer, or heat mattress if the neonate develops hypothermia) will reduce the incidence of moderate hypothermia (32-36 degrees C) or severe hypothermia (\<32.0 degrees C) in preterm infants (32-36 6/7 weeks of gestational age) when compared with routine WHO thermoregulation alone.

Eligibility Criteria:
Inclusion Criteria:

* Estimated gestational age 32-36 6/7 weeks
* Delivery in the hospital

Exclusion Criteria:

* Abdominal wall defect or myelomeningocele
* Major congenital anomalies
* Blistering skin disorder
Deposition of Terbinafine After Iontophoretic Application of ETS Terbinafine Gel in Subjects With Distal Subungual Onychomycosis in the Great Toenail

The purpose of this study is to determine how much terbinafine is delivered to the nail bed after treatment with a number of modifications to a previously studied method for iontophoretic delivery of terbinafine gel. Iontophoretic delivery involves the use of a small electric charge to deliver drug across skin and nails.


Eligibility Criteria:
Inclusion Criteria:

* Positive KOH
* 25-75% involvement of the visible nail.
* Nail plate must be \< 3 mm thick.
* Must have signed informed consent.
* Must agree to avoid any type of pedicure or application of any nail polish product or nail cosmetic to the toenails after the screening visit until Day 28.
* Female subjects of childbearing potential must agree to take measures to avoid pregnancy until the day after Day 28
* Must agree to avoid the use of oral antifungals or topical terbinafine anywhere on the body until the day after Day 28. Topical antifungals other than terbinafine can be used on the body other than the feet after Day 0.

Exclusion Criteria:

* Presence of proximal subungual onychomycosis or white superficial onychomycosis
* Fungal involvement of a majority of the lunula
* Subjects with psoriasis, eczema, or other abnormalities that could result in a clinically abnormal nail
* Presence of dermatophytoma or onychomycotic spikes or exclusively lateral groove involvement
* Traumatized or dystrophic target great toenail.
* Known diabetics
* Subjects with peripheral vascular disease
* Subjects who are immunosuppressed (chronic corticosteroid therapy, solid organ or bone marrow transplantation, cytotoxic chemotherapy within the previous 12 months (or planned within the next 12 months), or HIV infection.
* Use of systemic corticosteroids within 30 days preceding Day 0
* Use of topical antifungals on the feet in the preceding 30 days of Day 0 through Day 28
* Use of topical terbinafine in the 30 days prior to treatment through Day 28
* Use of systemic antifungals in the preceding 120 days of Day 0 through Day 28
* Use of any investigational drug(s) within 30 days (120 days for systemic antifungals) preceding Day 0 through Day 28
* Has previously participated in this study
* Is pregnant or is a nursing mother
* Women of of child bearing potential who are not using an adequate form of contraception (or abstinence)
* Subjects with pacemakers/automatic implantable cardioverter/defibrillators
* Subjects with an implantable electronic device.
* Subjects with a bleeding disorder or who are using warfarin or any other blood coagulation modulator including aspirin in the 14 days prior to treatment through Day 28
Long-Term Study That Measures the Safety and Efficacy of Deucravacitinib (BMS-986165) in Participants With Psoriasis

The main purpose of this study is to characterize the long-term safety and efficacy of the drug Deucravacitinib (BMS-986165) in patients who have been previously enrolled in an applicable Phase 3 psoriasis study.


Eligibility Criteria:
Inclusion Criteria:

* Completion of the protocol-required treatment period in an applicable study of BMS-986165 in moderate-to-severe psoriasis
* Women must not be pregnant, lactating, or breastfeeding

Exclusion Criteria:

* Any disease or medical condition that the investigator feels that would make the patient unsuitable for this study.
* To be eligible for the study, a participant must not have active signs or symptoms of tuberculosis (TB) as judged by the investigator.

Other protocol-defined inclusion/exclusion criteria apply
Patients' Assessment of Satisfaction for Stroke Prevention in Atrial Fibrillation

To describe the treatment perception from patients with non-valvular atrial fibrillation (NVAF) receiving Pradaxa® or VKA for stroke prevention by using the self-estimation questionnaire of PACT-Q during a 6-month study period.


Eligibility Criteria:
Inclusion criteria:

Cohort A (patients switched from VKA to Pradaxa)

* Written informed consent prior to participation.
* Female or male patients ≥ 20 years of age with a diagnosis of non-valvular atrial fibrillation (NVAF).
* At least 3 months of continuous VKA treatment for stroke prevention prior to baseline assessment.
* Patients switched to Pradaxa prior to baseline assessment according to the physician's discretion and the Summary of Product Characteristics (SmPCs)/reimbursement criteria.

OR Cohort B (patients newly initiated Pradaxa or VKA)

* Written informed consent prior to participation.
* Female or male patients ≥ 20 years of age, newly diagnosed with NVAF, and no previous treatment for stroke prevention (no use of any OAC within 1 year prior to enrolment).
* Patients initiated stroke prevention treatment with Pradaxa or VKA according to the physician's discretion and the SmPCs/reimbursement criteria.

Exclusion criteria:

* Contraindication to the use of Pradaxa® or VKA as described in the SmPCs.
* Patients receiving Pradaxa® or VKA for any other condition than stroke prevention in NVAF.
* Current participation in any clinical trial of a drug or device.
* Current participation in an AF-related registry, e.g. the Gloria AF program.
Satiety, Meal Frequency and Nutritional Aspects

In this study, the investigators are interested in assessing the effects of the isocaloric increase of eating frequency on appetite and metabolism. How the consumption of an isocaloric breakfast in four intakes vs. one can modify satiety and appetite control in lean and obese subjects through :

* the physiological consequences : difference in postprandial kinetics of glucose, non esterified fatty acid, triglyceride, the secretion of satiety gut hormone (insulin, ghrelin, leptin and cholescystokinine (CCK), peptide YY (PYY), glucagon-like peptide-1 (GLP-1), nutrients oxidative fate and plasmatic oxidative stress (Malondialdehyde (MDA), glutathion, lipid hydroperoxides)
* eating behavior during an ad libitum buffet test meal


Eligibility Criteria:
Inclusion Criteria:

* No smokers
* BMI 20 to 35 kg/m2
* Moderate physical activity
* Safety during medical consultation
* Feeding behavioural phenotype (Dutch Eating Questionnaire, Three Eating Factor Questionnaire)

Exclusion Criteria:

* Medical history which may affect glucose metabolism (diabetes, renal or hepatic failure, thyroid dysfunction, Cushing syndrome, acromegaly...)
* Medical history which affect nutrient absorption (gastro-intestinal and pancreatic disease, gastrectomy, colectomy...)
* Drug use in the last two months that could affect glucose metabolism (steroids, topical gastric preparation, anorectic drugs...)
* Eating disorders
* Claustrophobic subjects
MyHand 2: An Active Hand Orthosis for Stroke Patients

This study is designed to further develop and test the hardware and software components of the MyHand device based on user feedback and results from our pilot study. The goal is to refine the device so that is more effective and easier for stroke patients to use to increase their hand function.

From previous experimentation with the MyHand device, the investigators have determined that the device can improve the grasping ability of stroke patients. The investigators now aim to make the controls more intuitive and accurate for the users, to enable subjects to grasp a wider array of objects, to make the donning and doffing of the device easier, and to continue to assess the MyHand as it helps subjects in functional tasks.

Eligibility Criteria:
Inclusion Criteria:

* Adults over 18 years old
* History of stroke(s) with most recent stroke at least six months ago
* Upper extremity weakness with impaired ability to complete daily activities with affected hand
* Full passive range of motion in all digits
* Intact cognition to follow directions
* Gross control of proximal upper extremity musculature

Exclusion Criteria:

* Other neurological conditions besides stroke
* Other orthopedic conditions to affected upper extremity
* Significant spasticity in affected upper extremity that impairs device fit
The Prevalence of Urinary Incontinence in Women and Men With Respiratory Diseases: a Questionnaire Survey

Study the prevalence of the urinary incontinence among adults with respiratory diseases.


Eligibility Criteria:
Inclusion Criteria:

* Adults
* Patients with chronic respiratory diseases
* Age: 18-90

Exclusion Criteria:

* Minors
* Patients with cystic fibrosis
* Cognitive disorders
* Patients who do not speak French
Jiangzhuo Prescription ，Fenofibrate and Placebo in the Treatment of Hyperlipidemia (Syndrome of Phlegm Obstruction)Clinical Study (JZF)

Jiangzhuo prescription ,fenofibrate and placebo in the treatment of hyperlipidemia(syndrome of phlegm obstruction), randomized, parallel-controlled, multi-center clinical study

Charged by the five research centers in line with traditional Chinese medicine syndrome of phlegm obstruction 240 cases have hyperlipidemia, and overweight, as well as hypertension or diabetes were randomly divided into Chinese herbal compound Jiangzhuo prescription group and western medicine fenofibrate group and placebo group.The treatment groups were compared 12-week regulation of blood lipids and step-down, blood sugar effect.

Eligibility Criteria:
Inclusion Criteria:

* 1. Consistent with diagnosed hyperlipidemia, TG≥2.26mmol/L and ≤7.0mmol/L. 2. Aged 18-65 years old. 3.BMI ≥ 24kg/m2, but \<35 kg/m2. 4. Waist circumference ≥ 90cm (male) or waist circumference ≥ 80cm (women). 5. Comply with any of the following 3 :bloode pressure elevated levels of:SBP ≥130mmHg or DBP ≥85mmHg; fasting plasma glucose (FPG) increased: FPG ≥ 100mg/dl (5.6mmol / l ), or previously diagnosed type 2 diabetes or have received appropriate treatment.

Exclusion Criteria:

* 1. Has been used to control lipidsdrugs, but use the time for those below the 3 month.

  2.Secondary dyslipidemia, such as nephrotic syndrome, hyperthyroidism, etc. 3.Taking thyroid medications and other drugs that affect lipid metabolism, such as high-dose thiazide diuretics, β-receptor blockers, corticosteroids.

  4.Severe diseases of heart, lung, liver, kidney, brain, blood ,etc. 5.With the treatment of insulin, sulfonylureas, rosiglitazone or metformin. 6.3 months prior to the study of myocardial infarction or unstable angina confirmed.

  7.Uncontrolled blood sugar or after controlling FPG\>7.0mmol/L or 2hPG\>11.1mmol/L 8.Uncontrolled blood pressure or after contraolling blood pressure\>140/90mmHg 9.ALT≥80mmol/L 10.Pregnancy, for pregnancy or breast-feeding women 11.Allergis of fibrates or Chinese medicine 12.Mental illness 13.Cancer patients 14.History of gallbladder disease or cholelithiasis 15.With the treatment of Cyclosporine or coumarin anticoagulants 16.The patient with other clinical studies in the past 3 months 17.History of alcoholism and drug dependence
Blood Flow Stimulation in the Lower Limbs by Application of Different External Devices

In this study, four different devices which stimulate the blood in the lower extremities are used in ten healthy persons while measuring the blood flow with ultrasound. The aim is to study the haemodynamic effects in the lower extremities of each modality and also to compare those effects between the four modalities in order to identify those which most effective than the others.

Three Intermittent Pneumatic Compression (IPC) devices were selected: Foot-IPC, rapid Calf-IPC and a slow, sequential Calf-IPC. A Neuromuscular Electrical Stimulation (NMES) device was also used in the calf. Blood flow measurements in the right popliteal vein of ten healthy individuals were performed using Doppler ultrasound before (control) and while using IPC or NMES. The blood flow parameters measured where: peak systolic velocity (cm/s), time-averaged mean velocity (cm/sec), volume flow (ml/min) and ejected volume per individual stimulus (ml). The tolerability of each device was also assessed using an analogue scale from zero to ten. Differences between modalities regarding the pattern as well as the absolute values of velocity and volume are being assessed. Power calculation: Recent studies showed that the peak venous velocity (PV) at baseline is around 11 cm/s and after applying foot-IPC the PV rises to 50 cm/s with a maximum standard deviation of 15 (Broderick et all, 2014). Thus, three patients per group would be required to detect a difference of 39 cm/s in PV (two-sided type-I error rate = 5%; power = 80%). To reach an even higher power we choose to include 10 patients in study, which resulted in a power of 99.7% for the above calculation.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers

Exclusion Criteria:

* pregnancy
* previous lower limb operation involving the vascular system
* current thromboprophylactic or thrombolytic therapy
* vascular abnormalities in the lower limbs
* cardiorespiratory or renal failure causing pitting oedema
Effects on Growth of an Extensively Hydrolyzed Formula Fed to Term

The purpose of this study is to assess growth in infants who are fed an extensively hydrolyzed formula.


Eligibility Criteria:
Inclusion Criteria:

* At birth:

  * Healthy, term (37-42 weeks) infant
  * Weight for length between the 10th and 90th percentile according to the National Center for Health Statistics (NCHS) growth charts
* At time of enrollment:

  * \< or = 21 days post-natal age
  * Weight for length between the 10th and 90th percentile according to the National Center for Health Statistics (NCHS) growth charts
  * Exclusively formula fed
  * Written informed consent of parent/guardian

Exclusion Criteria:

* At the time of enrollment: partially human-milk fed; fed baby/solid foods
* Conditions requiring feedings other than those specified in the protocol
* Documented or suspected cow's milk allergy and/or soy protein allergies
* Major congenital deformities
* Suspected or documented systemic or congenital infections
* Evidence of cardiac, respiratory, hematological, gastrointestinal, or other systemic diseases
* Participation in any other clinical trial
Treating Avoidant/Restrictive Food Intake Disorder (ARFID) Using Family-Based Treatment

Although Avoidant/Restrictive Food Intake Disorder (ARFID) was formally introduced in DSM-5, no specialized intervention has yet been empirically studied. This randomized controlled crossover trial (RCCT) will test the feasibility and acceptability of a novel intervention, Family-Based Treatment of Avoidant/Restrictive Food Intake Disorder (FBT-ARFID) for patients ages 5-12 years old.

Potential subjects aged 5 years to 12 years, 11 months old with anorexia nervosa (AN) diagnosed with ARFID and their families will be recruited will be recruited through Stanford University, pediatricians, mental health experts, clinics treating EDs, and local parents' groups. Those eligible for the program will be invited to read and sign informed consent forms and complete the baseline assessment. They will then be randomized to the FBT-ARFID program either immediately after their screening or 3 months after assessment (i.e., to a usual care group). FBT-ARFID consists of 22 sessions over a 6-month period.

There will be 3 major assessment time points for those in the FBT-ARFID Arm: Baseline, 3 months into treatment, and EOT. There will be 4 major assessment time points for those in Usual Care: Baseline, transition to treatment (3 months after the usual care period is complete), 3 months into treatment, and EOT. Both the child and the parent will complete measures at these time points. In addition, patients and parents will participate in ongoing qualitative assessments before treatment (BL), throughout treatment (every other session), and at EOT.

Eligibility Criteria:
Inclusion Criteria:

* children meeting DSM-V criteria for ARFID
* children between the ages of 5 to 12 years old

Exclusion Criteria:

* any medical complications or severe mental disorder (psychosis, low-functioning Autism) that may reduce compliance with the study procedures or require more intensive care to manage the symptoms
* a severe parental mental disorder (e.g., psychotic depression, psychosis, substance dependence)
Efficacy of a Probiotic Formulation on Energy Balance in Overweight Subjects

Probiotic administration is associated with health benefits on gut barrier integrity and immunological functions of the gastrointestinal tract. Recently, probiotic consumption was proposed to reduce fat mass and body weight in rodents (Lee HY. et al. 2006; Hamad EM. et al. 2009). Changes in energy metabolism might be involved in the effects of probiotics on weight control.

The objective of this study was to assess the efficacy of the consumption of a probiotic formulation on energy balance in overweight subjects.


Eligibility Criteria:
Inclusion Criteria:

* Body Masss Index (BMI) 25 - 30 kg/m2
* Healthy (determined by medical questionnaire)
* Able to commit to the duration of the study
* Providing consent for participation

Exclusion Criteria:

* History of cardiovascular disease (CVD), diabetes, cancer, renal, thyroid or hepatic disease
* History of gastrointestinal surgery
* History of sleep disorders
* Recent bacterial infection (\< 2 weeks)
* Weight loss \> 5 kg in the last 3 months
* Under antibiotics or treatments (medical or nutritional program) affecting body weight, appetite, energy expenditure lipid-lowering, hypertension or inflammation or glucose control for the last 3 months or taking hormone replacement therapy
* Excessive consumption of products enriched in probiotics (\> 4 servings per week) within the last 4 weeks before the start of the study
* History of drug or alcohol abuse (\> 2 drinks daily)
* Regular smokers (more than 5 cigarettes a day)
* Not eating breakfast regularly or eating breakfast before 6h00.
* Not willing to eat any of the foods to be served in the study for any reason
* Physical activity level \> 150 min of moderate or intense exercise per week
* Concurrent or recent intervention study (within 60 days)