cyrilzakka/clinical-trials huggingface dataset:
Evaluation of a Parent-Infant Interaction Model

When becoming a parent of a preterm infant there is an increased risk of stress. There are a number of studies showing that parental stress has a negative impact on their engagement with their child. Other studies, on the other hand, show that different intervention programs with the aim to strengthen the relationship can decrease parental stress and hence affect the parent-infant interaction in a positive way. Structured intervention programs for preterm infants have also been successful in improving the infants' cognitive functions.

The investigators have developed a program with the aim to strengthen the parent-infant interaction for late preterm infants. The observational program is called LiMoNid. Our hypothesis is that LiMoNid will strengthen the parents' own parental abilities and give them a deeper understanding of their child. They will hopefully develop more skills on how to communicate with their child; to see, interpret, understand and approach the child, which can lead to an improved parent-child interaction. Parental stress may also be reduced by increased understanding and control. Regarding the child itself, we hypothesize that the psychological development will be affected depending on the communication with the caregiver and depending on the support it has received in expressing its feelings and needs. The emotional regulation should be strengthened by such an intervention.

The aim is to study if LiMoNid can have an impact on cognition, stress, parent-child interaction.

The Design is a randomised controlled study in two groups; intervention group versus standard care. Parents who meet the inclusion criteria are given oral and written information about the study aim and procedure and are asked for participation. If the parents consent they will be randomised to one of two groups. Follow-ups will be conducted at 1 month, 4 months, 10-12 months corrected age and when the child is 4 years.

Eligibility Criteria:
Inclusion Criteria:

* Preterm infants born 30-36 weeks gestational age without known major malformations or complications
* Families living in the county of Ostergotland, Sweden
* Swedish speaking parents
* Single or duplex birth

Exclusion Criteria:

* Complications encountered during hospital stay that are known to affect cognition
Cross-sectional Study to Assess Prevalence and Burden of CKD-associated Pruritus in Hemodialysis Patients

Vifor International Ltd. is seeking real-world evidence (RWE) to better understand the epidemiology, patient characteristics, and management of CKD-aP in the real-world clinical setting.

CKD-aP is a global clinical problem, and finding effective treatment remains a therapeutic challenge because of its complex pathophysiology (Sommer 2007, Weisshaar 2019, Yosipovitch 2013). The association between CKD-aP and clinical features and laboratory data remains unclear (Davison 2021, Manenti 2021). CKD-aP is thought to be associated with several conditions, including vitamin D deficiency, metabolic abnormalities (e.g., abnormal serum calcium or phosphate levels), toxin build-up, peripheral neuropathy, immune system dysregulation, or opioid receptor dysregulation (Jung 2015, Xie 2021, Kremer 2019, Verduzco 2020, Swarna 2019, Manenti 2021).

At present, there is no systematic assessment of CKD-aP in routine clinical practice, and the prevalence of CKD-aP is generally under-reported by patients and therefore underestimated by as much as 69% of healthcare professionals (HCPs) (Rayner 2017). Alleviating the burden of CKD-aP requires proactive identification of patients who suffer from it (Sukul 2020, Davison 2015, Phan 2012).

Eligibility Criteria:
Inclusion Criteria:

* Male or female adult patients with CKD (≥18 years) receiving HD for at least 3 months prior to signing informed consent
* Signed informed consent
* Able and willing to fill in questionnaires

Exclusion Criteria:

* Patients receiving HD at home or both home and site
Prospective Comparison of Metolazone Versus Chlorothiazide for Acute Decompensated Heart Failure With Diuretic Resistance

The primary objective of the study is to compare efficacy of metolazone and chlorothiazide as add-on therapy in patients refractory to loop diuretics with heart failure with a reduced ejection fraction (HFrEF). This will be a single-center randomized pilot study.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years old
* Admitted for acute decompensated HF with left ventricular ejection fraction (LVEF) \<40%
* Refractory fluid overload:
* Unresponsive (\<500 mL net negative over previous 24 hours) AND ineffective diuresis (determined by HF team) to moderate intensity push or low intensity continuous infusion loop diuretic (80 mg IV furosemide or equivalent bumetanide dose of 4 mg)
* English or Spanish-speaking subjects
* Willing and able to comply with study procedures

Exclusion Criteria:

* Baseline thiazide use prior to admission or prior to study enrollment
* Renal replacement therapies (RRT) or glomerular filtration rate (GFR) \<30 mL/min at the time of enrollment
* Pregnant women
* Cognitive impairment
* Prisoners
* Left ventricular assist devices (LVAD) or temporary mechanical circulatory support devices
* History of cardiac transplant
* Reported allergy to thiazides
* No enteral access or unable to take medications enterally
* Palliative diuretics
* Systolic blood pressure (SBP) \<90 mm Hg prior to randomization
* Patients receiving concomitant lithium therapy
Evaluation of Efficacy and Safety of Wishbone HA as Bone Graft Substitute, a Pre-market Clinical Investigation

Evaluation of efficacy and safety of Wishbone HA as bone graft substitute, a pre-market clinical investigation.

Group1: Extraction Socket management Group 2: Sinus lift


Eligibility Criteria:
Inclusion Criteria:

* Subject signed the informed consent form
* Subject is ≥18 and ≤ 80 years old.
* Subject presented in need of:

  1. tooth extraction without estimated need of connective tissue grafting OR
  2. defect in the upper jaw requiring sinus lift with or without lateral augmentation procedure prior to implant placement
* The subject is willing and able to comply with all investigation related procedures (such as exercising oral hygiene and attending all follow-up visits).
* Full-mouth bleeding score (FMBS) lower than 25%
* Full-mouth plaque score (FMPI) lower than 25%
* The subject displays no clinical contraindications for a 2-stage surgical procedure

Exclusion Criteria:

* Less than 2 mm of remaining keratinized mucosa
* Severe vertical resorption of the crest (except internal resorptions, i.e. expanded sinuses)
* Ridge with prior bone augmentation procedure performed (i.e ridge preservation)
* Any disorders in the planned implant area such as previous tumors, chronic bone disease.
* Alcohol or drug abuse as noted in subject records or in subject history.
* Any ongoing application of interfering medication (steroid therapy, bisphosphonate, etc).
* Reason to believe that the treatment might have a negative effect on the subject's overall situation (psychiatric problems), as noted in subject records or history.
* Smoking: \>10 cigarettes per day
Application of Dried Human Amnion Graft to Improve Postprostatectomy Incontinence and Potency

The investigators present a randomized trial of patients undergoing placement of dehydrated human amnion membrane (dHAM) around the neurovascular bundle (NVB) and vesicourethral anastomosis (VUA) during radical retropubic prostatectomy (RRP) in a tertiary center in Germany.

Patients suffer under incontinence and impotence after RRP, improving techniques and studies are missing. The human amniotic membrane includes growth factors and unique immune tolerance which can improve tissue regeneration. The preliminary studies could prove the potential value of dHAM in the reconstruction of the urinary tract and nerve protection. The investigators initially present a randomized trial to improve postoperative continence and potency of patients undergoing placement of dehydrated human amnion membrane (dHAM) around the neurovascular bundle (NVB) and vesicourethral anastomosis (VUA) during RRP for the treatment of prostate cancer. RRP is performed in a standardized way by one experienced surgeon. The patients are randomized 1:1 to dHAM vs. placebo and blinded during the study period. The primary outcome is a postoperative continence measure as 24hrs pad test up to 12mos postoperatively. Secondary outcomes are potency, insufficiency of VUA, postoperative complications and biochemical recurrence. Using the T-test with an alpha of 0.05 and a power of 80% and expecting a drop-out of 20% of the patients, an adjusted sample size per arm of 164 patients is required.

Eligibility Criteria:
Inclusion Criteria:

* patients with localized prostate cancer
* indication for radical prostatectomy
* no other treatment of prostate cancer
* availability to informed consent

Exclusion Criteria:

* preoperative incontinence (24hrs pad-test)
* preoperative erectile dysfunction (IIEF-5 \< 20)
* metastasized or locally advanced prostate cancer in preoperative assessment
* previous radiation of pelvis
* previous prostate cancer therapy
* psychiatric disease
* participation at another study
Placental Transfusion Project for Preterm Infants

The American College of Obstetrics and Gynecology, American Academy of Pediatrics and the World Health Organization have recently published recommendations related to placental transfusions in preterm infants. This project will review outcomes of preterm infants following a quality improvement implementation process in several delivery centers in Indiana. Centers involved in this project are also part of the Indiana Vermont Oxford Network (IRB#1003-84). Data is recorded for that network and the investigators site will be reviewing that data every 3 months from infants who have completed the Vermont Oxford Network collection. This project will specifically look at the incidence of intraventricular hemorrhage, necrotizing entercolitis, periventricular leukomalacia, sepsis and death following the implementation of the ACOG recommendations.

Centers involved in this project are also part of the Indiana Vermont Oxford Network. Data is recorded for that network and the investigators site will be reviewing that data every 3 months from infants who have completed the Vermont Oxford Network collection. This project will specifically look at the incidence of intraventricular hemorrhage, necrotizing entercolitis, periventricular leukomalacia, sepsis and death following the implementation of the ACOG recommendations.

Eligibility Criteria:
Inclusion Criteria:

* Preterm infants born at participating hospital who are less than 30 weeks gestation or less than 1500 grams and/or preterm infants 30 weeks to less than 34 weeks gestation

Exclusion Criteria:

* None
Follow-up of Patients' Physical Activity in Post-hospitalization

Physical exercise has been identified as a major item of many affecting many chronic diseases and stroke rehabilitation. It contributes to an improvement in the quality of life and to a decrease in the current treatment side-effects and mortality. Stroke in association with an inactive lifestyle lead to a decrease in physical capability and causes problems in daily activities. The physical capacity and the tolerance for exercise fall simultaneously leading to vicious circle of less and less mobility. Therefore, physical activity for the health is a valid and relevant way to improve the quality of life and to recover functional capacity. The aim of the study is the assessment of the effects of a incentive program for physical activity on people following/with stroke.


Eligibility Criteria:
Inclusion Criteria:

* Person having stroke (ischemic or hemorrhagic)
* Whatever the area of stroke
* Person supported by HEMIPASS (monitoring team and home support)
* Stroke less than 6 months
* Patient walking with or without technical or human assistance: FCC score

Exclusion Criteria:

* Disability limiting the gait before the stroke
* Age \< 18 years
* Cognitive impairment limiting participation to the program
* Non signature of the consent
* cardiopulmonary pathology which forbid/banned effort
Effective Treatments for Jellyfish Stings

The purpose of the study is to attempt to determine which treatment from commonly used treatments is the best at reducing pain and redness of the skin after a sting from a Portuguese Man of War, Chrysaora chinensis, or Chrysaora fuscescens.

Jellyfish stings are a common occurrence in many parts of the world causing significant morbidity to persons stung by jellyfish while participating in marine activities whether commercial or recreational. Much debate and confusion exist both in the medical literature and the common recommendations regarding how to treat persons stung by jellyfish. Specifically concerning what topical treatments are most efficacious at decreasing envenomation by nematocyst on skin, preventing the firing of un-discharged nematocyst, decreasing inflammation and pain resulting from envenomation by nematocyst. Antidotal recommendations and past studies have referenced numerous different topical treatments for jellyfish stings including but not limited to vinegar, urine, alcohol, distilled spirits, ammonia, bleach, acetone, bicarbonate slurry, lidocaine, meat tenderizer, Coca Cola, old wine, salt water, cold packs, hot water, and commercial products such as Stingose and Stingaid. Conflicting data exists regarding what works and what does not for nematocysts discharge, skin erythema, and pain reaction.

The investigators would like to investigate which treatment is best out of some of the more commonly studied treatments for reducing pain and erythema.

The investigators would like to complete a research study to try to bring some reasonable evidence to the field treatment of jellyfish stings, namely, the decontamination process (e.g., what can you put on a jellyfish sting that will be helpful, based on real data?).

The questions asked are as follows:

* What topical treatments for jellyfish stings actually decrease the amount of inflammation seen on a macroscopic level on the skin of humans?
* What topical treatments for jellyfish stings actually decrease the sensation of pain in humans?
* Do topical chemical treatments cause different outcomes when exposed to the above parameters?
* Do different species of jellyfish nematocysts react differently based on the type of topical chemical treatment used? What is the variation of effects of topical treatments based on the species of jellyfish sting?

Specifically, the investigators will be stinging human subject on both arms with a segment of tentacle for approximately 2 minutes. This will be followed by no treatment on one arm (control arm) and by treatment on the other arm with either: acetic acid (5%), sodium bicarbonate slurry (50%), papain slurry (70%), ammonia (10%), viscous lidocaine (4%), isopropyl alcohol (70%), or hot tap water (40 degrees Celsius). Outcomes measured will include pain and erythema.


Eligibility Criteria:
Inclusion Criteria:

* Ages 18-65 years
* Healthy volunteers

Exclusion Criteria:

* Known history of allergic reaction or anaphylaxis to prior Cnidaria sting of there envenomations
* Family history of anaphylaxis to any sting from either Cnidaria, bee, or wasp
* Pregnancy
Delayed Release (DR) Risedronate Compared to Immediate Release (IR) in Postmenopausal Women

Randomized, multicenter, double-blind, double-dummy, active-controlled, parallel-design study in approximately 201 postmenopausal women. A subset of subjects (approximately 102) will also participate in a pharmacokinetic (PK) component of the study. Each subject will be randomized to 1 of 3 treatment regimens for 3 months.


Eligibility Criteria:
Inclusion Criteria:

* female, 45 to 80 years of age, in good general health
* postmenopausal ≥2 years, surgically or naturally
* body mass index less than or equal to 32 kg/m\^2 at screening

Exclusion Criteria:

* no use within 3 months prior, nor use for more than 1 month at any time within 6 months of: glucocorticoids, anabolic steroids, estrogens, selective estrogen-receptor modulators (SERMs), or estrogen-related drugs, progestins, calcitonin, vitamin D supplements (\>1200 IU per day), calcitriol, calcidiol, or alfacalcidol at any dose, any bisphosphonate. fluoride (≥10 mg/day), strontium (≥50 mg/day), parathyroid hormone, investigational bone active agents.
* allergic or abnormal reactions to bisphosphonates
* history of cancer within 5 years, excluding squamous and basal cell carcinoma with 6 month remission
* positive pregnancy test
* no depot injection \>10,000 IU vitamin D in previous 9 months.
* no history of GI disease that requires medication, or history of Crohn's disease, ulcerative colitis, diverticular disease, polyps, or surgery that could have changed GI structure or motility.
* no history of frequent diarrhea or constipation that requires regular laxative use.
* no history of alcohol or durg abuse, hyperparathyroidism, cancer previous 5 years, major surgery within 1 month prior to screening, diabetes, uncontrolled hypertension, cardiovascular, hepatic, renal or GI disease.
* no active hyperthyroidism, osteomalacia, use of anticonvulsant medication, or allergic reaction to bisphosphonates
Feeding Trial in the Obese Critical Care Population

This study will assess enteral feeding in an obese critically ill population with a higher protein whey based peptide formula.

Assess enteral feeding goal with a higher protein whey based peptide formula in an obese critically ill population.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Surgical or Medical intensive care unit (ICU) patient
* Body mass index (BMI) ≥ 30

Exclusion Criteria:

* pregnant or lactating
* unable to access gastrointestinal (GI) tract for feeding via tube
* other contraindication to tube feeding
* admitted with burns
* severe head trauma
Bortezomib Consolidation Trial

The aim of this trial is to determine whether bortezomib improves response and delays progression for multiple myeloma patients after high dose therapy and autologous stem cell transplant. It will also assess the effect of bortezomib treatment on patient bone health.


Eligibility Criteria:
Inclusion Criteria:

* MM patients who have received high dose Melphalan with ASCT 3-4 months prior to registration and have not progressed
* Age 18 - 70 years
* Life expectancy \> 6 months
* Written informed consent
* Creatinine \< 400µmol/L
* Bilirubin \< 3x upper limit of normal
* WHO performance status 0-2
* Contraceptive precautions where appropriate

Exclusion Criteria:

* Received bortezomib previously
* On, or planned for, steroid therapy
* Poor performance status (ECOG ≥ 3)
* Disease progression at any stage
* Past history of polio, cord compression or other neurological condition resulting in persisting neurological deficit ≥ grade 2
* Severe hepatic impairment, indicated by bilirubin ≥ 3x upper limit of normal, or AST \> 2.5x upper limit of normal
* Pregnant or lactating women
* Allergic reaction attributable to bortezomib or to compounds containing boron or mannitol
* Severe cardiovascular disease
* History of acute infiltrative pulmonary or pericardial disease
* History of hypotension or has decreased blood pressure
* Peripheral neuropathy ≥ grade 2, or neuropathic pain
* Serious medical or psychiatric illness likely to interfere with participation in this clinical study
* Received any drugs or agents that inhibit or induce CYP2C19 or CYP3A4 within 14 days before the first dose of bortezomib
* Need for therapy with concomitant CYP 3A4 or CYP2C19 inhibitors
* Have received an experimental drug or used an experimental medical device within 4 weeks before the planned start of treatment
Study of the Safety of Orencia in Japanese Children and Adolescents With Active Juvenile Arthritis of Unknown Origin

Observational study of abatacept in the treatment of JIA in Japan.


Eligibility Criteria:
Inclusion Criteria:

* All JIA participants who initiate treatment with Orencia in accordance with the prescribing information

Exclusion Criteria:

* Participants receiving Orencia for an off-label indication

Other protocol defined inclusion/exclusion criteria could apply
MEasuring Satisfaction of Treatment With REbif After Initial Treatment of Multiple Sclerosis (MS)

This is a prospective, multicenter, open label, uncontrolled, non-interventional, single arm study to measure treatment satisfaction of relapsing remitting MS (RRMS) participants on Rebif after discontinuing initial first-line treatment.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, 18 to 65 years of age (both inclusive), at the time of informed consent
* Participants diagnosed with RRMS according to McDonald criteria 2010
* Participants have discontinued treatment with dimethyl fumarate (Tecfidera), teriflunomide (Aubagio), glatiramer acetate (Copaxone®), intramuscular IFNβ-1a (Avonex®), pegylated interferon (Plegridy®), subcutaneous IFNβ-1b (Betaferon®) or fingolimod (Gilenya®) within 6 months prior to Visit 1

  * Currently treated with Rebif using RebiSmart 2.0, for a maximum of 6 months prior to Visit 1
  * Participants have a score on the Expanded Disability Status Scale (EDSS) between 0 to 5.0 inclusive
  * Participants willing and able to give informed consent.

Exclusion Criteria:

* Participants have known planned surgical procedures at the time of the informed consent that will prevent adherence to treatment with Rebif through RebiSmart 2.0
* Participants diagnosed with primary progressive, secondary progressive, or progressive relapsing MS
* pregnant or lactating, or planning to become pregnant subjects
* In the opinion of the Investigator has significant renal or hepatic impairment or other significant disease (e.g., cognitive or visual impairment) that would compromise adherence and completion of the study
* Reports any reason that he/she cannot complete the 1 year study
* Participants have a history of hypersensitivity to natural or recombinant interferon, or any other component of the formulation
* Participants who contraindicated for the treatment with subcutaneous IFNβ-1a therapy as per summary of product characteristics or currently approved specific country product information
* Participants have any other factor that in the opinion of the Investigator would make the subject unsuitable for participation in this study
* Participants have significant psychiatric symptoms that, in the opinion of the Investigator, would impact patient ability to comply with treatment recommendations.