cyrilzakka/clinical-trials huggingface dataset:
The Use of an Engineered Glove for the Assessment and Rehabilitation of Manual Dexterity in People With Stroke.

Stroke often results in impairments of upper extremity, including coordination deficits, reducing of force, weakness and changes in the kinetic and kinematic workspace of fingers with 75% of stroke survivors facing difficulties performing activities of daily living.

The ability to oppose the fingertip of the thumb to each fingertip of the same hand is the basis of grasping objects of various sizes and operating tools and assessing and improving distal upper extremity function is of primary goal in the rehabilitation of stroke survivors. Moreover, repetitive movement practice seems to be crucial for maximizing therapeutic benefits.

Recent studies, proposed an engineered glove to assess motor performance during finger-to-thumb opposition movements and to provide objective and reproducible measures.

The same tool can be integrated with Virtual Reality and serious games to provide repetitive practice of activities improving motivation and adherence with therapy.

the investigators developed a new integrated glove and virtual reality to facilitate the recovery of hand functionality.

The aim of this study is to investigate the feasibility of the engineered glove in the assessment and treatment of hand dysfunction in people with Stroke.


Eligibility Criteria:
Inclusion Criteria:

* a single stroke,
* some movement of the fingers,
* any technical and difficulties with wearing the glove on the paretic hand

Exclusion Criteria:

* visual or cognitive deficits that would prevent them for performing the task
Deprescribing of Symptomatic Medications in Rehabilitative or Subacute Care Patients

Deprescribing is a systematic method of withdrawing potentially inappropriate or unnecessary medications and is warranted in the elderly due to the high prevalence of polypharmacy. In particular, symptomatic control medications, such as acid suppressants, laxatives and painkillers, are frequently prescribed and continued, though such medications are rarely needed on a long-term basis.

Therefore, the study objectives were to determine the cost savings, effects and feasibility of implementing a systematic process of deprescribing medications for symptomatic management, namely, acid suppressants, laxatives, analgesics, and antiemetics.

Deprescribing is a systematic process of identifying and withdrawing drugs, which are potentially or currently causing more harm than benefit to patients, based on each individual patient's condition, treatment goals and level of functioning. Deprescribing needs to be patient-centric with shared decision-making between patients or caregivers and the multidisciplinary care team. Five distinct steps of deprescribing have been elucidated, and they comprise: 1) performing a comprehensive patient medical/medication history; 2) considering the overall risk and appropriateness of drugs; 3) assessing possibility of and planning drug discontinuation; 4) initiating and documenting drug discontinuation; and 5) monitoring effects and providing patient support.

Deprescribing is necessary in elderly aged 65 years and above due to the higher prevalence of polypharmacy and unnecessary and inappropriate medication use, compared to younger age groups. In Singapore, statistics from an acute restructured hospital in 2013 showed that 50 percent or more of inpatients were discharged with at least five chronic medications.

The discontinuation of medications has been trialled in earlier studies without causing significant adverse effects or symptom recurrence. Positive outcomes demonstrated include enhanced cognition, improved health and reduced falls. However, it is necessary to investigate the effects and feasibility of deprescribing in the present local setting, where healthcare perceptions, and associations between medication discontinuation and patient clinical outcomes may be different from other studied populations.

Therefore, this randomized controlled intervention study was conducted in a community hospital in Singapore to determine the cost savings, effects and feasibility of implementing a systematic process of deprescribing medications for symptomatic management, namely, acid suppressants, laxatives, analgesics, and antiemetics.

Eligibility Criteria:
Inclusion Criteria:

* All patients, regardless of age, who were on at least one of the following target symptomatic control medications for deprescribing: acid suppressants/proton pump inhibitors (PPIs), laxatives, analgesics (paracetamol, nonsteroidal anti-inflammatory drugs (NSAIDs), codeine, tramadol) and antiemetics

Exclusion Criteria:

* Patients with terminal illness or cancer and patients with documented clinically significant dementia and had no accompanying caregiver
Transcranial Direct Current Stimulation for Attention Deficit

Infantile hemiplegia due to brain injury is associated with poor attention. Left-sided infantile hemiplegia affects the learning and acquisition of new skills. This study is aiming to improve the Selective visual attention (SVA) through transcranial direct current stimulation (tDCS) in children with Left-sided infantile hemiplegia .

Infantile hemiplegia (IH) refers to brain injuries that occur before or at birth and lead to hemiplegia/ total paralysis of one side of the body, including the face, arm and leg. The IH is quit rare condition and occurs in 1 in 1000 live births. however, the condition is reported to cause functional and cognitive disability. Children with IH suffer from poor attention particularly visual attention, that is essential to be understand the written language. A focused reading is essential in learning and children with IH possess moderate intelligence and attend school.

Transcranial direct current stimulation(tTCS) is a novel intervention that use small amplitude electrical currents to stimulate the essential areas of the brain through surface electrodes placed on the corresponding areas of the brain.

The eligible children were divided into two groups. one group received tDCS with visual attention activities and the second group received sham tDCS with similar activities. The effect will be assessed before and after with Strops-color testing and a academic reading test.

The experiment intends to explore the affect of tTCS on visual attention span among children with Left-sided infantile hemiplegia.

Eligibility Criteria:
Inclusion Criteria:

* Age between 8-15 years
* Left-sided infantile hemiplegia
* lesion to non-dominant hemisphere

Exclusion Criteria:

* History of epilepsy
* second stroke
* color blind
* under medication for psychiatric illness
BAX 802 in CHA With Inhibitors

The purpose of this study is to evaluate the efficacy and safety of BAX 802 in males with congenital hemophilia A (CHA) with inhibitors who are undergoing major or minor elective surgical, dental, or other invasive procedures.


Eligibility Criteria:
Inclusion Criteria

1. Participant requires a major or minor elective surgical, dental or other invasive procedure
2. Participant is male and ≥ 12 to ≤ 75 years old at the time of screening
3. Participant has provided signed informed consent (and assent for adolescent participants, as applicable) in accordance with local regulatory requirements
4. Participant has severe (factor VIII (FVIII) level \< 1%) or moderately severe (FVIII level ≤ 2%) congenital hemophilia A (CHA) with inhibitors to human factor VIII (hFVIII) of ≥ 0.6 Bethesda units (BU), as tested at screening at the central laboratory
5. Participant is not currently receiving or has recently received (\< 30 days) immune tolerance induction (ITI) therapy
6. Participant has a Karnofsky performance score of ≥ 60 at screening
7. Participant is human immunodeficiency virus negative (HIV-); or HIV+ with stable disease and CD4+ count ≥ 200 cells/mm\^3 at screening
8. Participant is hepatitis C virus negative (HCV-) by antibody or polymerase chain reaction (PCR) testing; or HCV+ with chronic stable hepatitis disease. Positive serologies will be confirmed by PCR testing.
9. Participant is willing and able to comply with the requirements of the protocol.

Exclusion Criteria

1. The participant requires emergency surgery
2. Severe chronic liver dysfunction or disease (e.g., ≥ 5 × upper limit of normal \[ULN\] alanine aminotransferase \[ALT\], as confirmed by central laboratory at screening or a documented prothrombin time/international normalized ratio \[PT/INR\] \> 1.5)
3. Clinically symptomatic renal disease (serum creatinine \> 2.0 mg/dL), as confirmed by central laboratory at screening
4. Anti-porcine factor VIII (pFVIII) inhibitor \> 10 BU prior to surgery
5. Platelet count \< 100,000/μL at screening
6. Participant has another active coagulation disorder, other than hemophilia A, as per the medical history
7. Planned use of α-interferon with or without ribavirin for HCV infected patients or planned use of a protease inhibitor for HIV infected patients. Patients currently taking any of these medications for ≥ 30 days are eligible
8. Known hypersensitivity to recombinant porcine factor VIII (rpFVIII), or hamster or murine proteins
9. Participant has an ongoing or recent (within 3 months of screening) thrombo-embolic disease, fibrinolysis or disseminated intravascular coagulation (DIC)
10. Participant has been exposed to an IP within 30 days prior to enrollment or is scheduled to participate in another clinical study involving an investigational product (IP) or investigational device during the course of this study
11. Participant is unable to tolerate quantity of blood to be drawn for protocol procedures
12. Participant is a family member or employee of the Investigator.
Guided Imagery Training and Self-Referential Processing

The purpose of this study is to examine the efficacy of a guided imagery paradigm for reducing negative ways of thinking about the self. There will be at least 60 participants enrolled at the University of Texas at Austin. Participants will be randomly selected to receive one of two types of trainings, each over the course of two weeks. Participants will undergo the training exercises at home. The training exercises will help them to think differently about themselves.

Participants will be able to determine if they are eligible, and then participate, by filling out a screening questionnaire online.

This study uses a randomized controlled trial to compare two types of guided imagery. One intervention is an active intervention; the other is intended to be inert. These interventions were developed based on extensive research indicating the efficacy of using imagery in depression, and a perceived lack of treatments targeting biased self-referential processing.

This protocol aims to develop a novel intervention which can be used on its own or as an adjunct to existing treatments. Common treatments for Major Depressive Disorder (MDD) are diffuse; this paradigm instead aims to specifically target negative self-schema, a part of the cognitive model of MDD. This study focuses on participants with elevated depressive symptoms.

Eligibility Criteria:
Inclusion Criteria:

* willing and able to provide informed consent
* elevated depressive symptoms -- i.e., a score above a 13 on the Center for Epidemiologic Studies Depression Scale (CESD)

Exclusion Criteria:

* N/A
Monitoring Drug-induced Uveitis

Several drugs and chemotherapies seem to induce uveitis. This study investigates reports of uveitis, including the International classification of disease ICD-10 for treatments in the World Health Organization (WHO) global Individual Case Safety Report (ICSR) database (VigiBase).

Several drugs and chemotherapies seem to have an impact on the eyes and are responsible of uveitis. Those are poorly described, due to the modification of the pharmacopeia, and the recent recognition of several of these adverse events. This study investigates the main characteristics of patients affected by uveitis side effect imputed to drugs. A causality assessment according to the WHO-UMC (World Health Organization - Uppsala Monitoring Center) is systematically applied.

Eligibility Criteria:
Inclusion Criteria:

* Case reported in the WHO's pharmacovigilance database till 01/04/2019

Exclusion Criteria:

* Chronology not compatible between the drug and the toxicity
The Danish Childhood Obesity Biobank

The Danish Childhood Obesity Biobank aims to produce a scientific platform for research in obesity: Bio-clinical data are collected from two cohorts - an obesity clinic cohort and a population-based cohort. The biobank thus facilitates translation between research and clinical practice of obesity treatment and related complications.

The Danish Childhood Obesity Biobank collects data from two cohorts - an obesity clinic cohort and a population-based cohort, of which the latter functions as a reference group.

The biobank continuously and longitudinally includes clinical data and biological samples from children and adolescents in obesity treatment. The population-based cohort has been recruited in a cross-sectional manner from Danish schools, high schools, and dentistries.

Data included in the biobank include venous blood samples, stool, urine, saliva, anthropometrics, body composition by dual-energy X-ray absorptiometry, magnetic resonance imaging and spectroscopy, and genetic markers among others. The data are stored in a central secured electronic database and biological materials are stored in -80-degree Celsius freezers until analyses.

To date, the Danish Childhood Obesity Biobank have included data from more than 5250 children, adolescents and adults from the obesity clinic cohort and more than 4200 from the population-based cohort.

Eligibility Criteria:
Inclusion Criteria:

* 2- 100 Years old
* Adipose, BMI \> 90 % percentile
Comparison of 12% Ammonium Lactate and 10% Urea Cream in Geriatric With Xerosis Cutis

This study aims to compare the efficacy and safety between moisturizing cream containing 12% ammonium lactate and 10% urea in geriatric with xerosis cutis. A double-blind randomized controlled trial with matching paired subject was conducted on 40 residents of a nursing home in Jakarta. Specified symptom sum score (SRRC), skin capacitance (SCap), transepidermal water loss (TEWL), and side effects were measured at baseline, week-2 and week-4 after therapy, and week-5 one week after therapy cessation. After a week of preconditioning, each subject received two different moisturizing creams to be applied on separate lower limbs.

Dry skin or xerosis cutis is widely known skin health issue in geriatric population with prevalence rate ranges between 29.5 - 85.5%. One of the internal etiological factors is decreased production of natural moisturizing factor as a humectant. Application of moisturizer is the mainstay treatment. Moisturizer with humectant property, like lactate and urea, could restore skin hydration and barrier dysfunction. This study aims to compare the efficacy and safety between moisturizing cream containing 12% ammonium lactate and 10% urea in geriatric with xerosis cutis.

Eligibility Criteria:
Inclusion Criteria:

* presenting with clinical diagnosis of xerosis cutis or with using the specified symptom sum score (SRRC)
* able to communicate well and perform daily activities independently
* willing to follow the research and sign the informed consent

Exclusion Criteria:

* sensitive to the ingredients in the formulations
* suffer from dermatitis or skin inflammation at the test site
* erythema and fissure values based on SRRC value \>2
Optimal Oral Hypoglycaemic Agents (OHA) for Combination With Insulin Glargine (Sulfonylurea vs. Metformin)

Primary objective:

To find out an optimal regimen of OHA (oral hypoglycaemic agents) in combination with insulin glargine (metformin, glimepiride or metformin+glimepiride) by measuring HbA1c level

Secondary objective:

To compare the incidence of hypoglycemia in each treatment group


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes for at least 6 months
* Treated with maximal, tolerable dose of metformin (≥ 1000mg/day) and sulfonylurea (glimepiride≥ 4 mg/day or equivalent dose of other SU) for at least 3 months prior to the screening visit
* 7.0 \< HbA1c \< 11 %
* Fasting serum C-peptide \> 0.33 nmol/L
* BMI \< 30 kg/m²
* Patients who is willing to monitor BG using SMBG

Exclusion Criteria:

* Type 1 Diabetes
* Clinical evidence of active liver disease, or serum ALT 3 times the upper limit of the normal range
* Serum creatinine: ≥ 1.5 mg/dl for males, ≥ 1.4 mg/dl for females
* Active proliferative diabetic retinopathy, as defined by the application of photocoagulation or surgery, in the 6 months before study entry or any other unstable (rapidly progressing) retinopathy that may require photocoagulation or surgery during the study (an optic fundus examination should have been performed in the 2 years prior to study entry)
* History of alcohol or other substance abuse
* Pregnancy or not using contraceptive in childbearing aged women
* Breast feeding women
* History of hypersensitivity to the study drugs or to drugs with a similar chemical structure
* Treatment with any medication including corticosteroid or herbal medicines that can affect blood glucose level within 3 months prior to study entry except metformin and sulfonylurea.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Does Caffeine Reduce Postoperative Bowel Paralysis After Elective Colectomy?

Postoperative bowel paralysis is common after abdominal operations, including colectomy. As a result, hospitalization may be prolonged leading to increased cost. A recent randomized controlled trial from the University of Heidelberg showed that consumption of regular black coffee after colectomy is safe and associated with a significantly faster resumption of intestinal motility (Müller 2012). The mechanism how coffee stimulates intestinal motility is unknown but caffeine seems to be the most likely stimulating agent.

Thus, this trial addresses the question: Does caffeine reduce postoperative bowel paralysis after elective laparoscopic colectomy?

Patients after laparoscopic colectomy will receive either 100 mg caffeine, 200 mg caffeine, or 250mg corn starch (placebo) 3 times daily in identically looking gelatin capsules.

The study is a randomized, controlled trial, with blinding of physicians, patients and nursing stuff (evaluating the endpoints).

Primary endpoint will be the time to first bowel movement.


Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for elective laparoscopic colectomy (right or left hemicolectomy, segmental resection, extended hemicolectomy, sigmoid resection, upper rectum (anastomosis higher than 7 cm ab ano))
* There will be no upper age limit. If elderly patients are considered fit for surgery, they will be included in the study.
* Informed consent
* Application of epidural analgesia

Exclusion Criteria:

* Participation in another concurrent interventional trial
* Need for a stoma (colostomy or ileostomy) or reversal of a stoma, if the patient had a complete bowel obstruction
* Known hypersensitivity or allergy to caffeine/coffee
* Expected lack of compliance
* American Society of Anesthesiologists (ASA) Physical Status Score of IV or V
* Impaired mental state or language problems
* Alcoholism or drug abuse
* Previous extensive abdominal surgery
* Inflammatory bowel disease
* Clinically significant cardiac arrhythmia
* Cardiac insufficiency
* Pregnancy, lactation, or childbearing potential without using adequate contraception
* Intake of opioid analgesics, or steroids \>5mg/d for ≥7 days before surgery
* Under anti-depressive medication
* Liver cirrhosis or compromised liver function (MELD score \>15)
* Emergency procedure
Single Arm Clinical Trial of Small Molecule Natural Flavonoid Compounds for Intervention in Neurodegenerative Diseases

1. Explore the effects of natural plant flavonoids on the positive intervention mechanism of neurotransmitter transmission physiological indicators changes (EEG) in the brain of the study subjects;
2. Investigate the effects of natural plant flavonoids in positively intervening clinical symptoms of the study subjects.


Eligibility Criteria:
Inclusion Criteria:

1. Age: 25-70 years
2. Patients complaining of sleep disorders, mood disorders (unstable mood, irritability, depression and anxiety) and cognitive decline (people with memory, decreased reaction time, BPSD symptoms) within one month
3. Montreal Cognitive Assessment Scale (MOCA) score ≤26; if MOCA score is not satisfied, then Pittsburgh Sleep Quality Index (PSQI) score \>10 and Hamilton Anxiety Scale (HAMA) score \>14 or Hamilton Depression Scale (HAMD) score ≥8 are required
4. Patients who can understand and communicate in language, and complete aphasia patients are not included;
5. Patients who agree to participate in this clinical observation and sign the informed consent form.

Exclusion Criteria:

1. Patients with severe organ diseases such as heart, kidney, and liver failure, chronic lung diseases such as COPD, and severe diabetes;
2. Patients with severe uncontrolled hypertension;
3. Patients who have taken antipsychotic drugs within the past two weeks;
4. Patients with the core features of Lewy body dementia or significant behavioral variant frontotemporal dementia;
5. Patients with various malignant tumors;
6. Patients with progressive stroke, transient ischemic attack, cerebral hemorrhage after cerebral infarction, and cerebral arteritis;
7. Patients with brain tumors, brain trauma, cerebral parasitic diseases, and other conditions;
8. Pregnant or lactating women;
9. Patients allergic to the known ingredients used in this trial;
10. Patients with active ulcers or bleeding tendencies;
11. Patients with neurodegenerative diseases such as Huntington's disease, amyotrophic lateral sclerosis, and Pick's disease;
12. Other patients who are deemed unsuitable to participate in this trial by the investigators.
Contribution of Auriculotherapy in the Management of Mastectomy With Immediate Reconstruction by Latissimus Dorsi Flap (ATMAGD)

Over the past decade, more and more healthcare professionals are using auriculotherapy as a preventative and effective therapy for pain. This therapy is applied by odontologists, anesthetists, surgeons, etc., to alleviate chronic pain. The effects of auriculotherapy are known in particular in reducing preoperative anxiety, pain in cancer patients and postoperative pain.

The aim of this study is to assess the effectiveness of adding auriculotherapy to the standard global anesthetic protocol, compared to this single reference protocol, on the incidence at 3 months post-intervention of Chronic Post-Surgical Pain, in patients operated for a mastectomy with reconstruction immediate by latissimus dorsi flap.


Eligibility Criteria:
Inclusion Criteria:

* Women patient over 18 years-old
* Patient scheduled for a mastectomy with immediate reconstruction by latissimus dorsi flap with or without symmetrization on the contralateral breast.
* Patient affiliated or beneficiary of a social security scheme.
* Patient who has given her free and informed consent.
* Preoperative blood test showing no contraindication to the operation.

Exclusion Criteria:

* Refusal of the patient.
* No indication for auriculotherapy:
* Patient having a heavy treatment with neuroleptics,
* Or tricyclic antidepressants which interfere with the action of auriculotherapy.
* Patient undergoing long-term morphine treatment for chronic pain.
* Patient with unweaned opioid addiction.
* Chronic painful patient.
* Protected patient: Major under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision; Hospitalized without consent.
* Pregnant, breastfeeding or parturient woman.
* Patient participating in another interventional study.
* Patient who had already participated in this study as part of first breast surgery.
* Patient receiving regular care by auriculotherapy