cyrilzakka/clinical-trials huggingface dataset:
The Relationship Between Fat Free Mass and Toxicity of Cytostatics in Cancer Patients

An observational study of the relationship between fat free mass and toxicity of cytostatics in cancer patients, at the department of Clinical Oncology at Zealand University Hospital, Roskilde, Denmark. Fat free mass will be measured by bio impedance spectroscopy and data on toxicity will be obtained from medical records and interviews/questionnaires with the patients.

With a prospective observational design, this study will examine whether there is a correlation between the total dose of cytostatics per measured fat-free mass (FFM) (mg cytostatic agent/kg FFM) and toxicity of cytostatics among cancer patients. The study will include patients with a primary diagnosis of any stage colorectal or pancreatic cancer.

The hypothesis is, that a higher total dose of cytostatics per FFM will correlate to more frequent and/or more severe toxicity than a lower total dose. In extension to this, we hypothesize that a loss of FFM during treatment, and thereby an increased total dose of cytostatics per FFM, will lead to more frequent and severe toxicity.

Recruitment and data collection will take place at the department of Clinical Oncology at Zealand University Hospital, Roskilde over about a five month period. Each patient will be included for two-four cycles of cytostatic treatment. FFM will be measured by bio impedance spectroscopy as close to the first day of each cycle of cytostatic treatment as possible. Information about toxicity will be obtained from patient records and through interviews with the patients. Interviews will be conducted at day 5 (4-6) of each cycle and at the end of each cycle. The interviews include questionnaires about specific toxicities, using National Cancer Institute (NCI) Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE), and overall health and quality of life, and 24-hour recall of dietary intake and questions about physical activity level.

In short, relevant outcomes are change in FFM, hematology, grade 3/4 hematological toxicity as defined by NCI CTCAE, dose-limiting toxicity, hospitalization, patient-reported adverse events, overall health and quality of life, and nutritional intake.

Eligibility Criteria:
Inclusion Criteria:

* Authorized individuals
* Understands, speaks and reads Danish
* Patients referred for or who receives cytostatic treatment, and have a primary diagnosis of colorectal- or pancreatic cancer (diagnoses classified by International Classification of Diseases-10 as C18-21 and C25)
* Have the possibility of contact by telephone

Exclusion Criteria:

* Pregnancy
* Breastfeeding
* Dementia
* Contraindications for BIS measuring (pacemaker)
Botulinum Toxin-A for Hidradenitis Suppurativa

The purpose of this research study is to determine if the medication Botulinum Toxin-A (BTX-A) is effective in treating hidradenitis suppurativa (HS)

Hidradenitis suppurativa (HS) is an auto-inflammatory disorder of apocrine sweat glands which results in painful, draining nodules within hair-bearing skin of the axillae, groin, and perineum. There is no consensus for treatment of HS and neither a medical nor surgical cure exists. Several case reports show potential efficacy of Botulinum Toxin-A (BTX-A) in inducing remission of HS however, these studies are underpowered. The objective of this study is to determine if Botulinum Toxin- A induces regression, remission, or relapse of hidradenitis suppurativa lesions.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with active axillary hidradenitis suppurativa of the same severity bilaterally. regimen
* For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation
* Agreement to forego other treatments for hidradenitis for the duration of the study

Exclusion Criteria:

* Current use of antibiotics, hormonal therapies, steroids, and/or biologics
* Presence of cardiac pacemaker
* Pregnancy or lactation
* Known neuromuscular disorder
* Known hyperhidrosis
* Febrile illness within one month
* Treatment with another investigational drug or other intervention within three months
* Patients without active axillary hidradenitis suppurativa
S1P1 Receptor Subtype (S1PR1) Axis in Patients With Interstitial Cystitis (IC) Pain

For each patient in the study, blood, and pain scores will be collected to look for markers for pain, at the start of treatment and 6 months after surgery of treatment.

The study is investigator-initiated, prospective, study. There will be no change in care.

Patients who have had a diagnosis of IC made by cystoscopy and hydrodistension and still have pain will be recruited for this study.

Patients will have blood samples taken at the visit they sign the consent form and 6 months later.

The study staff will call and remind the patient of their 6 month visit.

Eligibility Criteria:
Inclusion Criteria:

* 18-70 years of age
* Patients must be able to provide written informed consent.
* Diagnosis of Interstitial Cystitis documented by provider

Exclusion Criteria:

* age \<18 or \>70 years of age
* pregnant
Customized Foot Orthoses on Muscle Activity During Standing and Gait in Plantar Heel Pain

The present study will use a randomized controlled trial (RCT) to determine the effectiveness of customized foot orthosis (CFO) for the treatment of patients with PHP. Three treatment groups including the CFO without wedge, the CFO with wedge type 1 (W1), and the CFO with wedge type 2 (W2) will be randomly assigned to each participant by a computer-generated randomization. The opaque-sealed envelopes will be used to allocate the groups of participant.

Participants will be allocated to the control (CFO without wedge) or experimental (CFO with W1 or W2) groups according to the seal-envelop randomization technique. Then, they will be assessed all outcomes for the baseline including pain intensity, foot function, lower-extremity muscle activity during gait and standing by the 2nd physical therapist. And the participants will receive the assigned treatment by the 1st physical therapist.

All participants will be asked to use the CFO in daily life during weight-bearing activities, and logbook, chat LINE, or phone call will be used to monitor the participants during the treatment program. They will be asked about activity they done in daily and a number of hour they used CFO per day in diary book. At least 4 hours per day of wearing CFO will be required to each participant. After 3 months of the CFO use, all outcomes will be re-assessed by the 2nd physical therapist. And such outcomes will be then statistically analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Reaching the specific criteria of PHP including

  * A complaint of tenderness from the palpation of the medial calcaneal tubercle and the medial aspect of the proximal portion of the plantar fascia, or pain along the plantar fascia at medial longitudinal arch side
  * The presence of heel pain immediately during the first few steps of walking in the morning or after a prolonged period of inactivity; and gradually decreased throughout the day with ordinary walking, and worsened with prolonged activity
* Having the symptom of heel pain for at least 6 weeks, indicates the chronic condition
* Having the maximum level of pain intensity during last week using the visual analog scale (VAS) at least 3 out of a full 10 scores

Exclusion Criteria:

* Having positive sciatica test, indicating the L5-S1 nerve root irritation
* Having a history of lower extremity fracture
* Having a history of lower extremity surgery
* Having been diagnosed with gout, diabetic neuropathy, rheumatoid arthritis, systemic lupus erythematosus (SLE), cancer, infectious disease, and tumor
SPD489 in Adults With Persistent Executive Function Impairments (EFI) and Partial or Full Remission of Recurrent Major Depressive Disorder

To evaluate the efficacy of SPD489 for the treatment of executive function impairments (EFI) when used as an adjunct to stable, standard therapy in the setting of partial or full remission from recurrent Major Depressive Disorder (MDD) as measured by the Global Executive Composite (GEC) T-score of the Behavioral Rating Inventory of Executive Functioning - Adult Version (BRIEF-A).


Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18-55 with a primary diagnosis of nonpsychotic uni-polar depression

Exclusion Criteria:

* Current co-morbid psychiatric disorder
Effect of Intraoperative Taping on the Control of Edema Resulting From Stripping

The aim of the study is to evaluate the effects of the Contensive Taping technique on the control of edema of patients submitted to Phleboextraction Surgery including Saphenectomy.

Edema is a common complication after stripping surgery, so measures that can help the resolution of the condition are important for the recovery in the post operative. The aim of the study is to evaluate the effects of the Contensive Taping technique on the control of edema of patients submitted to phleboextraction surgery including saphenectomy. Therefore, 60 patients of both sexes will be invited to participate in the study, undergoing saphenectomy surgery, divided into two homogeneous groups, determined by the sample calculation. The intervention group (IG) will be composed of patients undergoing phleboextraction with saphenectomy and intervention with contensive taping, in intraoperative period associated with compression with elastic stockings. The control group (CG) will be composed of patients undergoing the same surgical procedure, and standard treatment consisting only of compression by elastic stockings. The procedures for evaluation will be applied before and after seven days of therapeutic intervention. For data analysis, the normality test will be performed and distribution, in addition to a suitable statistical test for the appropriate intra and intergroups, with a significance level of 5%.

Eligibility Criteria:
Inclusion Criteria:

* young adults, aged from 25 to 59 years old, submitted to stripping and saphenectomy.

Exclusion Criteria:

* allergies
* skin lesions
* ulcers.
Urine VEGF Levels in Very Low Birth Weight (VLBW) Infants

VLBW infants are at risk of developing retinopathy of prematurity (ROP). In the first phase of ROP there is a down-regulation of retinal VEGF-expression because of postnatal relative hyperoxia, followed by an upregulation of VEGF mediated through retinal hypoxia, which leads to pathologic vessel formation. VEGF acts through binding to the specific receptor FLT-1, the soluble form sFLT-1 is a specific antagonist of VEGF action. Erythropoietin, given to VLBW infants to prevent anemia, may stimulate VEGF-production in neuronal cells. Currently, there are no data published about VEGF urine-levels in VLBW infants and it is not known, if urine VEGF-levels may serve as a non-invasive marker of ROP-risk. Further shall be investigated, if erythropoietin-therapy increases urine VEGF-levels and if there is a correlation with ROP-development.


Eligibility Criteria:
Inclusion Criteria:

* gestational age \< 32 weeks
* birth weight \<1500g

Exclusion Criteria:

* absent written consent by parents
* connatal eye malformation
A Clinical Trial Study to Evaluate the Pharmacokinetic Interaction and Safety Between BR1019-1 and BR1019-2 in Healthy Adult Subjects

The purpose of this study is to evaluate the pharmacokinetic interaction and safety between BR1019-1 and BR1019-2 in healthy adult subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adults aged 19 to 55 years at screening
* Those who voluntarily decide to participate in the study and provide written consent to follow the study directions after listening to and fully understanding the detailed explanation on this study

Exclusion Criteria:

* Those who have clinically significant diseases associated with the cardiovascular system, respiratory system, liver, kidney, nervous system, endocrine system, blood/tumor, psychiatric disorders, or urinary system, as well as drug abuse, or a history thereof.
* Those who took any prescription drugs or herbal medicines within 14 days prior to the first day of administration or any over-the-counter (OTC) drugs within 7 days prior to the first day of administration (however, if other conditions are appropriate according to the judgment of the investigator, they may participate in the clinical study.)
* Those who took drugs inducing and inhibiting drug-metabolizing enzymes, such as barbiturates, within 30 days prior to the study initiation.
* Those who have been on a diet (especially grapefruit juice or its products) that may affect the absorption, distribution, metabolism, and excretion of the drug within 7 days prior to the first day of administration.
* Pregnant women, potentially pregnant women, or breast-feeding women Those who do not agree to rule out the possibility of their and their spouses' or sexual partners' pregnancy by using medically acceptable methods of contraception\* throughout the entire period from the date of the first administration of the investigational product to the end of the clinical study

  * Medically acceptable methods of contraception: Combined use of intrauterine device, vasectomy, tubal ligation, and barrier methods (male condom, female condom, cervical cap, diaphragm, sponge, etc.) or combined use of two or more barrier methods if spermicide is used
* Those who are unwilling or unable to comply with the dietary and lifestyle guidelines required for the clinical study
* Those who have clinically significant abnormalities in the results of other clinical laboratory tests or who have been determined by the investigator to be ineligible to participate in the clinical study due to other reasons (e.g., non-compliance with instructions, uncooperative attitude, etc.)
Clinical Outcomes of MICROPURE and PodEye Monofocal Intraocular Lenses

Prospective, non-randomised, open, controlled, single-center post-market clinical follow study about Micropure 1.2.3. and PODEYE intraocular lenses.

This clinical investigation is a prospective, non-randomised, open, controlled, single-center post-market clinical follow whereby study patients undergoing routine cataract surgery will have implantation of monofocal intraocular lens Micropure 1.2.3. (PhysIOL, Liège, Belgium) in one eye and implantation of monofocal intraocular lens PODEYE (PhysIOL, Liège, Belgium) in the contralateral eye of the same patient.

The study purpose is to obtain clinical data on visual acuity and contrast sensitivity on patients implanted with Micropure 1.2.3. and PODEYE

The devices under investigation (Micropure 1.2.3. and PODEYE) are a monofocal glistening-free hydrophobic acrylic intraocular lenses (IOLs) manufactured by the sponsor of this study PhysIOL sa/nv. The optical properties of the lenses are very comparable. The main difference is the mechanical design of the haptics, that is not expected to have an influence on the clinical outcomes.

The IOLs will be implanted as part of the routine cataract surgery on patients suffering from cataract development.

In total 76 patients will be recruited for this clinical study and receive the implantation of Micropure 1.2.3. and POPDEYE intraocular lenses.

Subjects participating in the trial will attend study visits over a period of 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Cataractous eyes with no comorbidity
* Availability, willingness and sufficient cognitive awareness to comply with examination procedures
* Clear intraocular media other than cataract;
* Signed informed consent

Exclusion Criteria:

* Age of patient \< 45 years;
* Irregular astigmatism;
* Regular corneal astigmatism \>0.75 dioptres by an automatic keratometer or biometer or \>1.0 dioptres if the steep axis of cylinder is between 90° and 120°;
* Difficulty for cooperation (distance from their home, general health condition);
* Previous intraocular or corneal surgery;
* Traumatic cataract;
* Any ocular comorbidity;
* Instability of keratometry or biometry measurements.
Gut Microbiota of Preterm Infants and Full-term Infants at Early Life

The aim of this study is to obtain a longitudinal view of the gut microbial establishment of a cohort of 51 preterm (PT) infants compared to 50 full-term (FT) infants from birth to 90 days of age, and to identify key clinical factors that affect the establishment of neonatal microbiome.

The hypothesis of the investigators is that the gut microbiota progression of PT group and FT group is different in diversity and composition. Antibiotics and its usage duration is likely the main factor disturbing the colonization and development of the gut microbiome of PT infants.

Premature birth is a global clinical problem. Early colonization and development of the neonatal gut microbiome is critically important with a profound impact on the host lifelong health. V3-V4 region of 16S rRNA amplicons of 581 stool DNA will be sequenced from a cohort of 51 PT infants and 50 FT infants to examine the microbial profiles. A random-effects generalized least square regression model is used to compare the difference in the main bacterial groups over time with the adjustment for multiple variables including gestational age and use of antibiotics .

Eligibility Criteria:
Inclusion Criteria:

Preterm infants

1. gestational age \<37 weeks;
2. no gastrointestinal tract disorders, metabolic diseases, or viral hepatitis;
3. hospital stay \> 7 days;

Exclusion criteria:

1. NICU stay less than 7 days
2. Necrotizing enterocolitis infant

Control group:

1. Full-term healthy infants;
2. gestational age \>37 weeks;
3. vaginally born;
4. no gastrointestinal tract disorders, metabolic diseases, or viral hepatitis.
Microcirculation in Spontaneous Breathing Trial

Weaning ventilator support in critically ill patients is crucial. Both delayed extubation and unexpected early reintubation are harmful to the patients. Weaning parameters and spontaneous breathing trial are used to investigate the indication and predict the successful extubation. Hemodynamic stability and physical reserve are important indicators as well. Microcirculation parameters are known to be more sensitive to the change of hemodynamic status than macrocirculation parameters. We hypothesize that the change of sublingual microcirculation before and after spontaneous breathing trial is different between the the patients with successful extubation and the patients with failed extubation. Thus, this study measures sublingual microcirculation in patients receiving spontaneous breathing trial and record the extubation status (successful or failed). The microcirculation parameters before and after spontaneous breathing trial are compared between the the patients with successful extubation and the patients with failed extubation.


Eligibility Criteria:
Inclusion Criteria:

* critically ill patients received ventilator longer than 12 hours
* ready for spontaneous breathing trial
* GCS coma score equal or higher than 8

Exclusion Criteria:

* aged less than 20 years
* patient with tracheostomy
* patient and patients' relatives are non-native speakers
Evaluation of Tomosynthesis for Characterization and the Management of Breast Lesions

Tomosynthesis is an innovative technique developed in digital mammography for obtaining a sectional image of the breast. Mammography has the main disadvantage of being an imaging projection that creates overlays, which eliminates tomosynthesis.

The objective of this study is to evaluate if the BI-RADS classification obtained by tomosynthesis with synthetic mammography is superior to that obtained by conventional mammography in terms of specificity while not inferior in terms of sensitivity.


Eligibility Criteria:
Inclusion Criteria:

* Patient having clinical or breast imaging abnormalities classified as BiRads 3, 4, 5 (Table 1). (5)
* Patient over 18 years old
* Signed informed consent

Exclusion Criteria:

* Patients at high risk of breast cancer, mutations BRCA 1 (BReast CAncer gene 1) or BRCA 2 (BReast CAncer gene 2) carriers, Li Fraumeni, or history of thoracic radiation will be excluded because of their greater sensitivity to ionizing radiation.
* Patient unable to give informed consent for physical, mental, or legal reasons.
* Patient not affiliated with French Social Security Insurance.
* Patient under treatment for breast cancer.
* When mammography is not recommended according to good practice by the French Health Authority (HAS).
* Pregnant patient.
Vibration Training and Muscle Strength Development

Introduction:

Vibration has been used to enhance muscle strength development during resistance training.

Aim:

To assess the effect of adding vibration to a regular resistance training program, using free weights, on muscle strength and everyday functioning of upper limbs in untrained adults

Methods:

60 healthy untrained adults, 30-65 yrs, will divide into two groups: experiment and control. Training program will include 24 sessions, over a course of 8 weeks. The experiment group will use a 1 kg vibrating weights and the control group will use a standard 1 kg free weights. Every session will include 10-15 min of 3-5 standard resistant exercises for upper limbs. Each subject will perform an Isokinetic evaluation of muscular performance, for upper limbs, in 3 occasions: before starting the program, immediately after completing the 8-weeks training program and 4 weeks afterwards, to check the chronic effect of each training regime. Each subject will complete a DASH (Disabilities of the arm, shoulder and hand) questionnaire at 4 occasions- as mentioned above and one more time, when completing the first 4 weeks of the training program, to reject any development of negative effects of the training program, such as pain or inflammation of the joints .


Eligibility Criteria:
Inclusion Criteria:

* healthy adults, ages 30-65
* not participating in resistance training for upper limbs regularly

Exclusion Criteria:

* unbalanced hypertension
* cardiovascular disfunction or disease
* pain and or/ inflammation of the neck, shoulders and arms
* pregnant women
Brain State-dependent PCMS in Chronic Stroke

After stroke, people often have difficulty using their hands. Combined brain and nerve stimulation can strengthen the neural pathways that control hand function. In this study, we will deliver combined brain and nerve stimulation during specific time windows that increase activation of neural pathways underlying hand function. We will compare the effects of combined brain and nerve stimulation during these optimal time windows to the effects of combined brain and nerve stimulation applied during random time windows on post-stroke hand function.


Eligibility Criteria:
Inclusion Criteria:

* History of stroke \> 6 months ago
* Presence of residual upper extremity hemiparesis
* Willingness to participate
* Ability to provide informed consent
* Upper extremity Fugl-Meyer score \< 66
* Mini Mental State Exam score \> 24
* Discernible and reliable motor-evoked potential (MEP) elicited following single-pulse TMS to the lesioned hemisphere

Exclusion Criteria:

* History of neurological disease other than stroke
* Presence of contraindications to transcranial magnetic stimulation (TMS) or peripheral nerve stimulation (PNS), including: history of adverse reactions to TMS or PNS metal in head, eyes, neck, chest/trunk, or arms, including but not limited to shrapnel, surgical clips, fragments from metalworking, fragments from welding, implanted device, history of frequent and severe headaches or migraines, immediate family history of seizure or epilepsy, personal history of seizure or epilepsy, current, suspected, or planned pregnancy, current or recent (within the last 3 months) use of medications acting on the central nervous system other than selective serotonin reuptake inhibitors (SSRIs), including but not limited to antipsychotic drugs, benzodiazepines, prescription stimulants.
* Upper extremity Fugl-Meyer score ≥ 66 (66 is the maximum on this scale)
* Mini Mental State Exam score \<= 24
* No discernible and reliable MEP elicited following single-pulse TMS to the lesioned hemisphere