cyrilzakka/clinical-trials huggingface dataset:
Robot-based Therapy for Upper Limb Sensorimotor Impairments After Stroke

After a stroke, more than two out of three patients experience problems with upper limb movement and sensation. Current evidence on treatment of upper limb sensory impairments is scarce and shows unclear results. Robot-based therapy has been increasingly used to treat upper limb motor impairments, with similar positive results as compared to conventional therapy. This study aims to investigate a novel robot-based therapy program for treatment of upper limb sensory impairments. The therapy program consists of 10 one-hour session spread over 4 weeks and will be evaluated for its effect in 20 chronic stroke patients. The investigators hypothesize that a 4-week robot-based therapy program can improve upper limb sensation and movement.

Up to 70% of stroke survivors show upper limb impairments consisting of motor and/or somatosensory impairments. These impairments often persist well into the chronic stage, and may lead to significant limitations in activities of daily living and may negatively affect quality of life. Different interventions have been investigated to treat upper limb motor impairments, including robot-based therapy, which shows similar positive results as compared to conventional therapy. Evidence on interventions for somatosensory impairments is scarce and often of low quality. This study therefore aims to evaluate the effect of a robot-based therapy program on sensorimotor function of the upper limb in a group of 20 chronic stroke patients.

The robot-based therapy will be provided using the Kinarm End-Point Lab (BKIN Technologies Ltd., Canada) and consists of passive and active therapy tasks for proprioception and sensory processing. The therapy consists of 10 one-hour sessions spread over 4 weeks. Clinical and robot-based motor and somatosensory assessments will be performed at 4 time points: twice at baseline, once at mid intervention, and once after 10 hours of therapy. The investigators hypothesize to find improvement in both upper limb motor and somatosensory function after the therapy program. The results from this pilot study will provide a basis for further research.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years old
* A first-ever unilateral, supratentorial stroke (as defined by WHO)
* In the chronic phase after stroke (i.e. being at least 6 months after stroke)
* Motor deficits of the upper limb (Fugl-Meyer Motor Assessment - Upper Extremity \< 60/66)
* Somatosensory deficits of the upper limb (Erasmus modified Nottingham Sensory Assessment \< 36/40)
* Ability to perform, at least to some extent, active shoulder abduction and wrist extension against gravity
* Ability to perform passive and active sensory processing assessment task (primary outcome measure)

Exclusion Criteria:

* History of previous stroke or TIA
* Any serious musculoskeletal and/or other neurological conditions
* Serious communication or cognitive deficits
* No written informed consent
The Effects of Video-Assisted Breastfeeding Education

The present study was conducted to determine the effects of online video-assisted breastfeeding education on breastfeeding self-efficacy in primiparous pregnant women.

This two-group parallel randomized controlled study was conducted with pregnant women admitted to the pregnancy follow-up outpatient clinics of a university hospital in northern Turkey. The study was completed with 80 pregnant women in their second trimester, 40 pregnant women each in the intervention and control groups. Pregnant women in the intervention group received online video-assisted education which demonstrated first meeting of the mother-baby and first breastfeeding in addition to receiving counselling on breastfeeding. Pregnant women in the control group did not receive any intervention other than routine care. Data were collected face-to-face with the breastfeeding self-efficacy scale at the beginning of the study and two weeks later. In data analysis, chi-square test was used for categorical variables, independent sample t-test was used for continuous variables and intergroup comparison, and paired sample t-test was used for intragroup comparison.

Eligibility Criteria:
Inclusion Criteria:

* Having a primiparous pregnancy
* Pregnant woman in the second trimester
* There is no risk during pregnancy
* Pregnant woman's ability to read and write
* Volunteering to participate in the study

Exclusion Criteria:

* Having auditory problems
* Having visual problems
* Having psychological problems
* Having cognitive problems
* Wanting to leave work
The Effect of Milnacipran on Fatigue and Quality of Life in Lupus Patients

Systemic lupus erythematosus (SLE) is a chronic multi-system autoimmune disease impacting the physical, social, psychological health and quality of life of patients. Fatigue and pain are aspects of SLE patients which affect their health related quality of life (HRQOL). The purpose of this study is to determine the effect of milnacipran on fatigue in SLE patients with widespread pain (WSP) or fibromyalgia syndrome (FMS). A secondary objective will be to determine the effect of milnacipran on pain and quality of life measurements. Fifty SLE male and female patients, 18 years and older, will be recruited for a 15-week study, in which patients will be receive 14 weeks of milnacipran 50-100 mg twice a day or placebo. Measurements of fatigue, pain, and HRQOL will be compared between the milnacipran and placebo groups at the screening visit, baseline visit, week number 6, and week number 14. Milnacipran has been shown to be an effective treatment for pain, fatigue and physical function in FMS patients. To date, no clinical trials have demonstrated efficacy for the treatment of fatigue in SLE patients with concomitant WSP or FMS. The investigators hypothesize, based on FMS studies, that the milnacipran treated patients will have less fatigue than those in the placebo group. In addition, compared to control arm, those treated with the study drug will have less pain and improved quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Female or male age 18 or older.
* Has fulfilled the 1997 classification criteria for SLE.
* Has chronic WSP or FMS.
* Score a 40 or more on the visual analog score (VAS) for fatigue.

Exclusion Criteria:

* Has a chronic inflammatory autoimmune condition other than SLE.
* Has an acute or uncontrolled co-morbid medical condition.
* Uncontrolled narrow angle glaucoma.
* Has been hospitalized in the last four months for a lupus flare.
* Pregnant or breast feeding.
* Has a current or prior major depressive disorder or other DSM IV diagnosis within 2 years of the screening visit.
* The use of antidepressants, MAO inhibitors, antipsychotics or lithium
* The use of pregabalin or milnacipran within 2-4 weeks.
* Has received cyclophosphamide and or rituximab within 4 and 6 months.
* Unable to speak, read, and understand English.
The Effect of Intermittent Theta Burst Stimulation (iTBS) in Patients With Alcohol Use Disorder

The aim of this trial is to investigate the efficacy of left DLPFC iTBS in a population of alcohol use disorder patients, compared with the sham iTBS. Moreover, this trial will conduct follow-up assessments to evaluate whether its efficacy can sustain for a long time if it is effective.

Alcohol abuse and alcohol use disorder are important major health issues in our modern society. However, the treatment of alcohol addiction is currently limited to the treatment of acute withdrawal symptoms, but lacks effective interventions to reduce craving and prevent relapse. In an attempt to improve the treatment of substance dependence, non-invasive neuromodulation has gained attention as a new potential treatment option. The aim of this trial is to investigate the efficacy of left DLPFC iTBS in a population of alcohol use disorder patients, compared with the sham iTBS. Moreover, this trial will conduct follow-up assessments to evaluate whether its efficacy can sustain for a long time if it is effective.

Eligibility Criteria:
Inclusion Criteria:

* a DSM-5 diagnosis of alcohol use disorder
* age between 18 and 65
* can return to the research center for successive visits.

Exclusion Criteria:

* severe cognitive impairment
* current DSM-5 diagnosis of schizophrenia or another psychotic disorder
* current other substance abuse (except nicotine)
* severe organic diseases
* rTMS contraindications (such as a history of epileptic seizures, metal implants near the head).
Assessing the Knowledge and the Willingness to Accept Renal Transplantation As a Treatment Option Among CKD Patients

Assessing the knowledge and the willingness to accept renal transplantation as a treatment option among CKD patients, a cross-sectional study

Kidney transplantation in CKD patient

Eligibility Criteria:
Inclusion Criteria:

* Age \&amp;gt;18 years
* Patients diagnosed to have CKD stage III- stage V (including patients undergoing regular haemodialysis) regardless the duration of the disease

Exclusion Criteria:

* CKD patients of stage I or II of the disease
* Patients with AKI
* Patients refusing to answer the questionnaire
* Patients who are unable to understand the questionnaire
* Patients underwent kidney transplantation
Radiation Therapy for Heterotopic Ossification Prophylaxis Acutely After Elbow Trauma

The investigators hypothesized that radiation therapy could be safely administered acutely after elbow trauma, and it would decrease the number of patients that would require surgical excision of heterotopic ossification.

A multi-institutional, prospective randomized clinical trial will be employed to determine if single dose, limited field radiation therapy (XRT) will prevent post-traumatic heterotopic ossification (HO) after open reduction internal fixation of intra-articular distal humerus fractures and fracture-dislocations of the elbow and to assess function of the elbow after XRT and no XRT. Patients will be randomly assigned to one of the two groups(XRT/treatment or no XRT/control) by a computer-generated randomization schedule. Assignment will be in a ratio of 1:1 in a complete block design of 10. Each clinical site will be provided with a separate randomization assignment for each study participant. The treating surgeon and patient will be blinded to group assignment until after operative treatment. Clinical and radiographic assessments at 6 weeks, 3 months and 6 months post-operatively will be performed. The primary clinical outcome will be the Mayo elbow performance score which measures pain, stability, function and motion. Motion parameters (flexion, extension, pronation and supination) will be performed at each data collection point. Primary radiographic outcome will be the presence of heterotopic ossification by plain radiographs of the elbow in the antero-posterior and lateral planes at 6 weeks, 3 months, and 6 months post-operatively. Further imaging (radiograph or CT) will be obtained past the 6-month interval if deemed necessary by the treating physician,or if fracture union was not achieved at 6 months. The presence of HO will be quantified by radiograph. All adverse events will be documented. The trial will be monitored periodically by the Safety Monitor at least twice a year to ensure protocol compliance and address safety issues.

Eligibility Criteria:
Inclusion Criteria:

* Skeletally mature patients with minimum age of 18 years and maximum age of 65.
* Patients deemed appropriate for operative intervention by the treating physician.
* Distal humerus intra-articular fractures (types 13-C1, C2, and C3), with or without proximal radius/ulna fractures - open or closed.
* Fracture-dislocations of the elbow (ulno-humeral dislocation associated with proximal ulna and/or radius fractures) - open or closed.

Exclusion Criteria:

* Head injury, quantified by Glasgow Coma Score (GCS) \< 13 at time of consent for operative intervention.
* Burns \> 20% Total Body Area (TBA) or involving the operative site.
* Patients with spinal cord injury affecting the upper extremities will be excluded.
* Open fractures which cannot be closed primarily within 72 hours of initial operative intervention.
* Patients with estimated life expectancy of less than one year due to preexisting condition.
A Study of Single and Multiple Ascending Doses of JNJ-61393215 in Healthy Participants

The purpose of this 3 part study are; Part 1: to investigate the pharmacokinetic (PK), safety and tolerability of JNJ-61393215 suspension (ascending dose levels) after single oral dose administration under fasted conditions, Part 2: to evaluate the relative bioavailability of a solid JNJ-61393215 capsule formulation compared to a suspension of JNJ-61393215 under fasted conditions, and the effect of food on the PK of the solid JNJ-61393215 capsule formulation, Part 3: to investigate the PK, safety, and tolerability of JNJ-61393215 suspension (ascending dose levels) after 7 days of once daily dosing in under fasted conditions.


Eligibility Criteria:
Inclusion Criteria:

* Male or female of non-childbearing potential
* Healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) (including QT interval corrected for heart rate according to Fridericia's formula \[QTcF\] less-than or equal to \[\<=\] 450 milliseconds (ms) for males and \<= 470 ms for females) performed at screening
* Before enrollment, female participants must be of non-childbearing potential, defined as: a) Postmenopausal - A postmenopausal state is defined as no menses for 12 months without an alternative medical cause, as documented by medical records or physician's notes; b) Permanently sterile - Permanent sterilization methods include hysterectomy, bilateral salpingectomy, bilateral tubal occlusion/ligation procedures, and bilateral oophorectomy
* Body mass index (BMI) between 18 and 30 kilogram per square meter (kg/m\^2) (inclusive), and body weight \< than 50 kg at screening
* Blood pressure (after the participant is supine for 5 minutes) between 90 and 140 millimeter of mercury (mmHg) systolic, inclusive, and no higher than 90 mmHg diastolic at screening

Exclusion Criteria:

* Clinically significant abnormal values for hematology, biochemistry, or urinalysis at screening as deemed appropriate by the investigator
* Participants has any liver function test (including alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\], gamma-glutamyltransferase \[GGT\], alkaline phosphatase \[ALP\], and bilirubin) at screening more than (\>)1.5\* upper limit of normal (ULN)
* Participants has estimated glomerular filtration rate (eGFR) according to the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation \< 61 milliliter (mL) / minute /1.73 per square meter (m\^2) at screening
* Clinically significant abnormal physical examination, vital signs, or 12 lead ECG at screening as deemed appropriate by the investigator
* Known allergies, hypersensitivity, or intolerance to JNJ-61393215 or its excipients (or lactose)
Trastuzumab and Trastuzumab-MCC-DM1 Administered Intravenously and GDC-0941 Administered Orally to Patients With HER2-Positive Metastatic Breast Cancer Who Have Progressed on Previous Trastuzumab-Based Therapy

This multicenter, Phase Ib study is an open label, dose escalation, three-arm study evaluating the safety, tolerability, pharmacokinetics, and activity of oral (PO) GDC 0941 administered in combination with either intravenous (IV) infusion of T-DM1 or IV infusion of trastuzumab.


Eligibility Criteria:
Inclusion Criteria:

* Histologically documented locally advanced or metastatic breast cancer that has progressed on at least one trastuzumab-based regimen in the metastatic or locally advanced setting
* HER2-positive disease documented by one of the following results using FDA-approved testing methods: FISH-positive, chromogenic in situ hybridization (CISH)-positive, or IHC 3 + by local laboratory assessment
* Life expectancy \>= 90 days
* Agreement to use an effective form of contraception for the duration of the study

Exclusion Criteria:

* History of Grade \>= 3 hypersensitivity reaction to trastuzumab, or Grade \>= 1 with the most recent trastuzumab infusion before study entry, or continued requirement for prolonged trastuzumab infusions to prevent hypersensitivity reactions
* History of intolerance to trastuzumab and/or adverse events related to trastuzumab that resulted in trastuzumab being permanently discontinued
* Prior anti-cancer therapy (e.g., biologic or other targeted therapy, chemotherapy, hormonal therapy) within 2 weeks prior to Day 1
* Prior investigational anti-cancer therapy within 4 weeks prior to Day 1
* Grade \>= 2 peripheral neuropathy
* History of Grade \>= 3 hyperglycemia (fasting)
* History of Type 1 or Type 2 diabetes requiring daily medication
* History of clinically significant cardiac or pulmonary dysfunction
* History of malabsorption syndrome or other condition that would interfere with enteral absorption
* Clinically significant history of liver disease, including cirrhosis, current alcohol abuse, or current known active infection with HIV, hepatitis B virus, or hepatitis C virus
* Any condition requiring anticoagulants, such as warfarin, heparin, or thrombolytic agents
* Any condition requiring \> 2 grams of acetaminophen daily
* Need for current chronic corticosteroid therapy
* Pregnancy, lactation, or breast-feeding
* Current severe, uncontrolled systemic disease (e.g., clinically significant cardiovascular, pulmonary, or metabolic disease)
* Major surgical procedure or significant traumatic injury within 28 days prior to Day 1, or anticipation of the need for major surgery during the course of study treatment
* Symptomatic hypercalcemia requiring continued use of bisphosphonate therapy
* Known brain metastases that are untreated, symptomatic, or require therapy to control symptoms
Administration of Fingolimod in Greek Patients With Multiple Sclerosis.

The goal of this observational study is to evaluate the efficacy of fingolimod through the estimation of the annualized relapse rate (ARR) over a period of 2 years.

Participants who are already taking fingolimod as part of their regular medical care for MS will answer questions about their medical history for the past 1 year and for their status for the next 2 years.

The efficacy of fingolimod will be assessed:

* by calculating the difference in annualized relapse rate (ARR) between the 12-month period prior to study entry and that which will occur during the study at 0, 6, 12, 18 and 24 months of treatment
* by calculating the change in EDSS score between the 12-month period prior to study entry and that which will occur during the study at 0, 6, 12, 18 and 24 months of treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Patients over 18 years of age.
2. Consent and compliance of participants with the treatments and procedures of the study.
3. Patients diagnosed with relapsing-remitting multiple sclerosis (RRMS) according to the revised McDonald 2017 criteria.
4. Patients who are receiving fingolimod, according to the drug's Summary of product Characteristics (SmPC).
5. Patients with available follow-up data for at least 12 months prior to their inclusion in the study, which are sufficient to calculate the annualized relapse rate.

Exclusion Criteria:

1. Patients under 18 years of age.
2. Patients with a contraindication to taking fingolimod according to the drug's Summary of product Characteristics (SmPC).
3. Patients with a history of mental illness, substance abuse, to a degree that may prevent their participation in the study.
4. Patients participating in another research protocol.
Combinatorial Single Cell Strategies for a Crohn's Disease Gut Cell Atlas

Inflammatory bowel disease (IBD), consisting of two major forms, Crohn's disease (CD) and ulcerative colitis, affects more than 1.6 million people in the United States alone. Despite current therapies, remission only occurs in approximately half of patients. The goal of study is to map single-cell spatial relationships across the spectrum of ileum/ascending colon from healthy control patients to uninvolved/quiescent and involved/active CD patients and assess for relationships between single-cell data and patient clinical data.

The investigators will utilize endoscopic mucosal biopsies and surgical resection specimens with rapid transfer of fresh tissue to the single-cell preparation for RNA-sequencing and use of tissues for RNA-fluorescence in situ hybridization and multiplex immunofluorescence. Along with machine learning image analysis and bioinformatics, this will generate a robust/detailed single-cell gut cell atlas (GCA) of ileo-colonic CD at all disease activities versus normal tissues. The study will also compare the results of endoscopic mucosal biopsies to those obtained from full thickness surgical specimens by utilizing the Cooperative Human Tissue Network (CHTN).

The investigators anticipate the GCA data will provide new insights into disease pathogenesis, leading to new therapeutic targets.


Eligibility Criteria:
Inclusion criteria:

* Provision of consent form
* Male or female greater than or equal to 18 years old
* Healthy volunteers without IBD undergoing colonoscopy for colorectal cancer screening or patients with a diagnosis of Crohn's disease (CD) confirmed by endoscopy or radiology assessment undergoing colonoscopy for clinical care

Exclusion criteria:

* Pregnancy
* Coagulopathy or bleeding disorder
* Renal or hepatic impairment
* History of organ transplantation
Mainz Intracoronary Database. The Coronary Slow-flow and Microvascular Diseases Registry

Primary goal of the registry is to collect prospective data on patients undergoing coronary angiography in Mainz. Following amendment of the procol, this study will also include patients who received an Aborb bioresorbable scaffold for the therapy of de novo stenoses.

Patients included in the registry will be contacted by telephone at 3,6,9, 12 months and 2, 5, 10 years after the procedure. In case coronary slow flow is shown at the index procedure, 39ml of blood will be drawn for further studies.

According to the regulations of the Province Rheinland-Pfalz, national law, and with the approval of the Ethic commission of the Landesärztekammer Rheinland Pfalz, patients (n=1000) will also be retrospectively entered in the database in an anonymous way. For these patients, no specific study procedure is foreseen and the MICAT database will be only used as a platform (database of anonymous data collected during routine clinical practice).

Eligibility Criteria:
Inclusion Criteria:

* clinical indication to coronary angiography

Exclusion Criteria:

* none