cyrilzakka/clinical-trials huggingface dataset:
Parafricta Bootees vs UK Standard Care to Prevent Heel Pressure Ulcers

This randomised study will assess whether Parafricta bootees, when used in addition to normal standard care, can reduce the incidence of heel PUs in patients at very high risk of skin breakdown. The participant group will be hospital inpatients at high risk of PUs (Waterlow score of 20 or more) who are bedbound and do not have existing heel PUs. The participants will be randomised to an intervention arm using Parafricta plus standard care, or a control arm of standard care only. The primary outcome is incidence of heel PUs at day 3. Secondary outcomes are incidence of PUs at day 14, length of stay, severity of PUs, patient acceptability of device, cost-effectiveness.


Eligibility Criteria:
Inclusion Criteria:

The eligibility criteria for this study at the time of recruitment were:

* Adult of age 18 years or over
* Admitted to secondary care in an in-patient hospital (with no specified interval from admission to hospital to study recruitment)
* Bedbound or unable to walk independently and requiring assistance to transfer to a chair
* 'Very high' risk group for pressure ulceration (defined by a Waterlow Score of 20 or more)
* No existing heel pressure ulcers of EPUAP/NPUAP/PPPIA Category 1 or above or any other type of wound on the feet.
* Patient was not being treated with pressure offloading boots.
* Patient was not being treated with a heel cast.

Exclusion Criteria:

• Patients with a single or double lower limb amputation were not eligible to participate in the study.
Zinc for Infection Prevention in Sickle Cell Anemia-2 (ZIPS-2)

A randomized double-blinded placebo-controlled trial of zinc to reduce the incidence of severe or invasive infections in Ugandan children with sickle cell anemia (SCA)

The study will be a randomized, placebo-controlled, double blind clinical trial in which 100 Ugandan children 1.00-4.99 years of age with SCA will receive zinc (20 mg oral dispersible tablet daily) or placebo (identical to zinc in appearance) for 6 months. The primary study outcome will be incidence of infection (all causes).

Eligibility Criteria:
Inclusion Criteria:

* Documented sickle cell anemia (HbSS supported by hemoglobin electrophoresis)
* Age range of 1.00-4.99 years, inclusive, at the time of enrollment
* Weight at least 5.0 kg at the time of enrollment
* Willingness to comply with all study-related treatments, evaluations, and follow-up
* Children whose parents or guardians give full written informed consent

Exclusion Criteria:

* Known other chronic medical condition (e.g., HIV, malignancy, active clinical tuberculosis)
* Severe malnutrition determined by impaired growth parameters as defined by WHO (weight for length/height or height for age z-score \<-3, using WHO growth standards)
* Absolute neutropenia (absolute neutrophil count \<500)
Surgical Stress After Laparoscopic Compared to Open Liver Resection

The purpose of this study is to determine whether the postoperative insulin resistance and cytokine release would be attenuated in laparoscopic compared with open liver resection.


Eligibility Criteria:
Inclusion Criteria:

* ASA 1-2
* left hemihepatectomy(liver resection)
* left lateral sectionectomy(liver resection)

Exclusion Criteria:

* Patients with diabetes mellitus
* drug abuse
* BMI \>24 or \<18
The Color of Itch; Itch Modification by Color Viewing

Itch is the commonest skin-related symptom. There is increasing evidence that itch can be influenced by visual cues. The impact of colors on itch has not yet been studied.

This study investigates Itch modification by color viewing and whether patients can match or counteract their itch with a color.


Eligibility Criteria:
Inclusion Criteria:

* Dermatology in- and outpatients with itch

Exclusion Criteria:

* color blindness
* lack of time
* lack of German language.
Randomized Trial of HIFU vs. Cryo for Prostate Cancer

HIFU has been FDA approved and is widely utilized across the United States and Europe for the treatment of prostate cancer. Despite this, HIFU has not been offered within SCPMG until now due to growing patient demand. We have offered cryoablation. This pilot study will determine the efficacy of HIFU vs. cryoablation focal therapy for early stage prostate cancer within SCPMG. We hope to elucidate whether outcomes are similar between the two modalities.

All men presenting with elevated prostate specific antigen (PSA) will be required to undergo an initial multiparametric MRI (MRI) and 14 core systematic biopsy. Decipher genomic testing will be run on all prostate cancer specimens. 48 men with with unifocal low-intermediate risk prostate cancer (clinical stage T1-T2, Gleason group 1-2) prostate cancer will be offered focal therapy vs. conventional therapy (surgery or radiation) via shared decision making. Those who elect focal therapy (FT) will be enrolled and randomized 1:1 to HIFU or cryoablation. Men with negative biopsy, multifocal disease, or unfavorable intermediate risk or higher disease will be excluded and offered standard therapy (surgery or radiation).

Following treatment, mpMRI and biopsy will be performed at 3mo. Baseline, 3mo, 6mo and 12mo post-treatment PSA will be obtained. In field and out of field cancer recurrence will be determined. Baseline and 3mo American Urologic Association Symptom Score (AUAss) and International Index of Erectile Function (IIEF) will be recorded as well as any treatment related side-effects or complications. SpaceOAR hydrogel will be utilized for all posterior lesions.

Eligibility Criteria:
Inclusion Criteria:

1. All men age 40 or older with Gleason group 1 or 2 prostate cancer involving a single or adjacent sextants
2. PSA \< 10
3. mpMRI without extracapsular extension or seminal vesicle invasion (non-focal MRI or organ confined)
4. mpMRI which is either nonfocal or concordant with biopsy.

Exclusion Criteria:

1. Gleason group 3 or higher
2. Multifocal disease
3. mpMRI with ECE or SVI
4. PSA \> 10
5. Active anorectal disease
6. Age \> 80
Rehabilitation of Post-stroke Aphasia by Targeting Phonological, and Lexico-semantic Deficits With Speech Output Tasks

Aphasia in brain-damaged adult patients refers "to the more or less complete loss of the ability to use language" resulting from acquired brain damage, typically of the left hemisphere. The defective spoken output of persons with aphasia (PWA) has anomia as a main clinical manifestation. Improving anomia is a main goal of any language treatment.

The present randomized controlled study assessed the effectiveness of a novel, two-week, rehabilitation protocol (PHOLEXSEM), focused on PHonological, SEmantic, and LExical deficits, aiming at improving lexical retrieval, and, generally, spoken output.

The effects of the PHOLEXSEM treatment were compared to those of a control treatment, i.e., a Promoting Aphasics Communicative Effectiveness (PACE) protocol.

Finally, we studied the effects of age, education, disease duration, brain lesion volume, and functional independence (Functional Idependence Measure, FIM) on the treatment-induced linguistic improvements.


Eligibility Criteria:
Inclusion Criteria:

* acquired brain-damage
* presence of aphasia

Exclusion Criteria:

* global aphasia
* undergoing another treatment for aphasia
Safety and Efficacy Study of Isolagen TherapyTM in Treatment of Facial Wrinkles and Creases

The purpose of this study is to evaluate the safety profile and the treatment effect of autologous human fibroblasts and placebo when administered to facial wrinkles and creases


Eligibility Criteria:
Inclusion Criteria:

* Male or female, at least 18 years of age
* High Investigator wrinkle severity assessment score
* Subject assessment of dissatisfaction of facial appearance
* Provide written informed consent and comply with the study requirements
* Negative pregnancy test at screening visit
* Healthy, non-scarred skin for biopsy

Exclusion Criteria:

* Low Investigator wrinkle severity assessment score
* Subject assessment of satisfaction of facial appearance
* Physical attributes which prevent the assessment or treatment of the facial wrinkles
* Treatment with an investigational product or procedure within 30 days or plans to participate in another clinical trial
* Previous treatment with Isolagen Therapy
* History of active autoimmune disease or organ transplantation
* Diagnosis of cancer, receiving active treatment
* History of pigmentary disorders which can affect the face
* Active or chronic skin disease
* Known genetic disorders affecting fibroblasts or collagen
* Active systemic infection
* Requires chronic antibiotic or steroidal therapy
* Use of certain cosmetic treatments \& procedures
* Use of systemic agents that increase bleeding or clotting, or disorders equated with these effects
* Pregnant or lactating women or women trying to become pregnant
* Known allergic reaction to components of study treatment and/or study injection procedure
* Excessive exposure to sun or sunburn in the post-auricular area
* Subject has any disorder that may prevent compliance
* Subject who is part of the study staff, a family member or friend
An Extension Study of KPS-0373 in Patients With Spinocerebellar Degeneration (SCD)

The purpose of this study is to evaluate the long-term safety, efficacy, and pharmacokinetics of KPS-0373 in SCD patients.


Eligibility Criteria:
Inclusion Criteria:

* Japanese SCD patients with mild to moderate ataxia (Completion of the KPS1301 study)

Exclusion Criteria:

* Less than 75% of compliance in KPS1301 study
Study to Investigate the Safety, Tolerability, and Pharmacokinetic Profile With Oral AB521 in Healthy Volunteers

This study will evaluate the safety and tolerability, pharmacokinetic, and pharmacodynamic profile, and drug-drug interaction (DDI) of casdatifan in healthy participants.


Eligibility Criteria:
Inclusion Criteria:

* Participants who are healthy volunteers (in the opinion of the investigator) as determined by pre-study medical history, physical examination, vital signs, and 12-lead electrocardiogram (ECG)
* All clinical laboratory tests of blood and urine must be within the normal range or show no clinically relevant excursions from the normal range as judged by Principal Investigator at screening and admission.
* Screening and randomization hemoglobin ≥for males and females is as follows:

  * SAD: male and female hemoglobin level ≥ 12.5 grams/ deciliters (g/dL) (7.7 millimoles/liters \[mmol/L\])
  * MAD and DDI: male hemoglobin level ≥ 14.2 g/dL (8.8 mmol/L) and female hemoglobin level ≥ 12.5 g/dL (7.7 mmol/L).
* Participants should have adequate peripheral venous access.
* Body weight of 45 kilograms (kg) or greater and body mass index within the range of 18 to 32 kg/meters squared (m\^2) (inclusive)
* Male participants must be vasectomized and have been vasectomized for at least 3 months prior to screening visit with confirmed history of azoospermia subsequent to the vasectomy procedure
* Contraceptive use should be consistent with local regulations

Exclusion Criteria:

* Has any (acute or chronic \[including severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection\]) medical or psychiatric condition that, in the opinion of the investigator, could jeopardize or would compromise the study participant's ability to participate in this study
* Has history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, cerebrovascular, neurological, or other major disorders capable of significantly altering the absorption, metabolism, or elimination of investigational drug; constituting a risk when taking the study intervention; or interfering with the interpretation of data in the opinion of the investigator
* Abnormal blood pressure (BP) or pulse measurements at the Screening Visit or Day -2/-1 (Admission) in a supine position after 5 minutes of rest as follows: mean systolic BP ≥139 millimeters of mercury (mm Hg) or mean diastolic BP ≥89 mm Hg; mean pulse \< 40 beats per minute (bpm) or \> 100 bpm.
* Liver enzyme test results: Alanine aminotransferase, aspartate aminotransferase, bilirubin, or alkaline phosphatase \>1.0x the upper limit of normal
* Current or chronic history of liver disease or known hepatic or biliary abnormalities
* Has 12-lead electrocardiogram with changes considered to be clinically significant at the Screening Visit or day of admission
Moyo; strap-on Fetal Heart Rate Monitoring in a Rural Setting

Annually, an estimated 2.6 million still births occur half of which die during labor and delivery (fresh stillbirths). In addition, around 750,000 newborns die shortly after birth due to intrapartum-related hypoxia or birth asphyxia. Almost 99% of these perinatal deaths take place in low-income countries where the provider/patient ratio is low and fetal monitoring is inadequate. Poor intrapartum fetal heart rate monitoring, failure to identify fetal distress, and subsequently intervene, is a common pathway to perinatal deaths in these low-resourced settings. Recently, an innovative fetal heart rate monitoring device, called Moyo, using ultrasound technology, was developed to be strapped on the mother during labour. This project will compare the effectiveness of automatic use of Moyo versus intermittent use of hand-held fetoscope in detection of abnormal fetal heart rate, through a randomized control study, at Haydom Hospital, Tanzania.


Eligibility Criteria:
Inclusion Criteria:

* Women admitted in labor

Exclusion Criteria:

* Women scheduled for elective cesarean section, women with abnormal fetal heart rate on admission, multiples, and critically ill patients with no measurements of fetal heart rate on admission
Relation Between Position of the Uterus (Anteversion or Retroversion Flexion) and Degree of Cesarean Scar Niche

This study aims to determine the association between the size of caesarean scar niche and uterine position in childbearing women.

Research hypothesis: There is a relation between uterine position and degree of cesarean scar niche.

Research question: Is there a relation between uterine position and degree of cesarean scar niche?

It has been noted that the cesarean scar defect in patients with retroflexed uteri appear to be larger than are those in patients with anteverted uteri.

This study will describe the association between position of the uterus whether share in degree of cesarean scar niche or not and associated symptoms.

Primary outcome:

The association between the position of the uterus (Anteverted/Retroverted) and large CSD (the ratio between the depth and adjacent myometrial thickness)

Secondary outcomes:

The association between position of the uterus (Anteverted/Retroverted) and:

* Residual myometrial thickness (RMT).
* Depth, Width, Length of SCD.

The association to the clinical symptoms as:

* Postmenstrual spotting: more than 2 days of intermenstrual spotting, or more than 2 days of brownish discharge after the end of menstruation if bleeding duration exceeds 7 days (discharge is considered normal if bleeding duration is \< 7 days).
* Abnormal uterine bleeding (AUB) as per FIGO guideline.
* Pain as dysmenorrhea, chronic pelvic pain or dyspareunia. If present will be assed using Visual Analogue Scale (VAS).
* Secondary infertility: inability of a couple to conceive after one year of regular, unprotected intercourse.

Eligibility Criteria:
Inclusion Criteria:

* Women in childbearing age.
* At least six months postpartum.
* With cesarean scar niche/defect (CSD) by transvaginal ultrasound that is defined as "indentation at the site in the cesarean section scar with a depth of at least 2 mm" that was agreed upon in 2019 by a European task force

Exclusion Criteria:

* Severely Obese (Body mass index; BMI more than or equal to 35 kg/m2).
* Women with abnormal uterine pathology, observed during the ultrasound examination that may have been responsible for abnormal uterine bleeding, including endometrial hyperplasia, polyps, malignancy or myomas.
* Women with any cause of pelvic pain as pelvic inflammatory diseases, endometriosis or adenomyosis.
* Women with history of classic upper segment cesarean section or hysterotomy.
* Women with history of previous uterine scars rather than cesarean sections as myomectomy.
* Women with bleeding tendency disorders, taking anticoagulants or having chronic medical conditions as liver diseases, or coagulopathies.
Birth Ball Versus Meperidine and Haloperidol Injection for Pain Relief During First Stage of Labour

The study was performed at Gregorio Marañón Hospital birth centre. A Randomised Clinical Trial comparing the two methods of pain relief in the first time of labour was carried out. In this study, 110 women in the first stage of labour were allocated in two study groups by a randomised block design. One of them used the birth ball as a pain relief method,and the other one used pethidine and haloperidol injection.


Eligibility Criteria:
Inclusion Criteria:

* healthy pregnant women
* women in the first stage of labour or women at induction of labour
* fetal head in pelvis or whole amniotic membranes
* must be able to understand spanish

Exclusion Criteria:

* intrapartum meconium
* needed of continuous fetal monitoring
* suspecte/compromise fetal wellbeing
* morbidly obese women
* unaccompanied women
Academic Education of Midwifes in Germany - Teaching in the Field of Maternal and Infant Oral Health

The goal of this study is to learn about teaching of maternal and infant oral health in the recently implemented degree program Midwifery B.Sc. in Germany. The main questions it aims to answer are:

What contents regarding maternal and infant oral health are taught? How is teaching in the field of maternal and infant oral health organized? Study coordinators of all study locations of Midwifery B.Sc. in Germany are asked to participate in an online survey once.


Eligibility Criteria:
Inclusion Criteria:

* Returned questionnaire

Exclusion Criteria:

* Questionnaire not returned
Pre- and Postoperative Cardiopulmonary Rehabilitation Reduces Complications After Coronary Artery Bypass Surgery: A Randomized Trial

Pre- and postoperative cardiopulmonary rehabilitation reduces complications after coronary artery bypass surgery. This study was conducted as a randomized trial to verify this hypothesis in our institution. ICSC


Eligibility Criteria:
Inclusion Criteria:

* All CAB patients

Exclusion Criteria:

* SCA in the previous 24h and incapacity of doing light exercise. Valvular patients
Photodynamic Therapy and Microvesicles

This study is designed to test whether localized photodynamic therapy (PDT) treatment will result in increased skin levels of microvesicle particle (MVP) and if the use of imipramine will counteract PDT generated MVP release. The effects of PDT and ultraviolet B radiation (UVB) on platelet-activating factor (PAF) and MVP production have long been part of the PI's research experience. To test this, the investigator plans to enroll up to enroll up to 12 male subjects whom are aged 21 to age 45. These subjects will be treated with topical 5-aminolevulinic acid gel (Ameluz) to small areas of forearm followed by treatment with blue light. The areas will then be treated with either 4% imipramine cream or cream base as control. Four hours later, the redness of the areas will be measured using a mexameter and MVPs measured in skin biopsies taken from PDT-treated skin.


Eligibility Criteria:
Inclusion Criteria:

* Male adult subjects age 21 to age 45
* Skin type must be "fair", Fitzpatrick type I or II
* Able to understand/complete informed/consent
* Have access to stable transportation

Exclusion Criteria:

* Underlying diseases that could affect wound healing (e.g., diabetes mellitus)
* Taking medications that are known photosensitizers (e.g., doxycycline) or anti- inflammatories (e.g., NSAIDS \[except for low-dose aspirin\] or steroids)
* Have a history of abnormal scarring (e.g., keloids)
* Taking vitamin C or E supplements for past month
* Utilizing imipramine or any other tricyclic antidepressant (oral or cream)
* Utilizing topical anti-inflammatory or systemic agents (eg, prednisone)
* Tanning bed use within last 3 months
* PDT or UVB treatments in past 3 months
TASO-001 in Combination With Recombinant Interleukin-2(Aldesleukin) in Advanced or Metastatic Solid Tumor

To evaluate safety, tolerance and efficacy of TASO(TGF-β2 targeting anti-sense oligonucleotide)-001 in combination with recombinant interleukin-2(Aldesleukin) in advanced or metastatic solid tumor and to find appropriate dose for phase 2 clinical trial.

This clinical trial is conducted by dividing into two cohorts according to the dose of the test drug, starting with Cohort 1, and confirming whether DLT occurs until 14 days after the 2nd cycle of the test drug administration and proceed with Cohort 2 after discussion by DMC. Recruitment of each cohort is applied with a 3+3 design.

Eligibility Criteria:
Inclusion Criteria:

1. Adults over 19 years old on the day of consent
2. Pathologically confirmed solid cancer
3. Patients with advanced or metastatic solid timour failed or tolerable with standard therapy.
4. A person who has a tumor lesion that can safely undergo tissue biopsy during administration of the test drug and can provide tissues stored at the clinical trial agency or tissue obtained from a tissue biopsy conducted before the first administration of the test drug

Exclusion Criteria:

1. Those who have been treated with IL-2 or TGF-β inhibitors other than test drugs (e.g., anti-sense oligonucleotide, antibody, TGF-b receptor inhibitor)
2. Chemotherapy within 21 days or at least 5 half-lives (whichever is shorter) prior to first dose of study treatment.
3. Immunotherapy within 2 weeks prior to first dose of study treatment.
4. Major surgery within 4 weeks prior to first dose of study treatment.
Efficacy of Chronic Disease Self-management Program in People With Schizophrenia

This was a randomized controlled behavioral intervention trial to assess the efficacy of investigating program of chronic disease self-management program in people on schizophrenia patients conditions of depression, activities of daily living, social function, work, and quality of life.

Subjects were randomized to intervention group and control group. The primary outcome included eight measures, Stanford Self-Management Questionnaire, the Beck Depression Inventory-II, the Activities of Daily Living Rating Scale III, the Instrumental Activities of Daily Living Scale, the Participation Measure-3 Domains, 4 Dimensions, the Work Behavior Inventory, and the Schizophrenia-Quality of Life questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of schizophrenia by DSM-5
* age \> 20 years
* Stable mental symptoms
* Willing to sign the subject's consent

Exclusion Criteria:

* History of severe brain injury
* Substance abuse
* Diagnosis of intellectual developmental disorder
* Unable to follow instructions
6-Month Extension Trial of Asenapine With Olanzapine in Negative Symptom Patients Who Completed the Protocol 25543 (25544)(P05777)

This is an extension study to further test

the efficacy and safety of asenapine compared with a

marketed agent (olanzapine) in the treatment of patients with

persistent negative symptoms of schizophrenia.


Eligibility Criteria:
Inclusion Criteria:

* Continue to meet all demographic and procedural

inclusion criteria of the 25543 trial (NCT 00212836; P05817) to enter into

this extension trial.

* Have demonstrated an acceptable

degree of compliance and completed the 25543

trial, and would benefit from continued treatment

according to the investigator.

Exclusion Criteria:

* Have an uncontrolled, unstable clinically significant

medical condition.

* Have been judged to be medically

noncompliant in the management of their disease.