cyrilzakka/clinical-trials huggingface dataset:
A 21 Day Irritation Study in Healthy Volunteers With Diacerein 1% Ointment

Single center, randomized, controlled, evaluator blinded, within-subject study to evaluate the irritation potential of diacerein1% ointment on normal skin of healthy volunteers, using a cumulative irritancy patch test (CIPT) procedure.

This study was designed to assess the cumulative irritation potential of diacerein 1% ointment in comparison with vehicle ointment, 0.2% sodium lauryl sulfate (SLS) (positive control), and 0.9% saline (negative control) on normal skin of healthy volunteers using a cumulative irritancy patch test (CIPT) procedure applied once daily for 21 days.

Eligibility Criteria:
Key Inclusion Criteria:

* Is a healthy male or female (to be confirmed by medical history);
* Is 18 years of age or older;
* In the case of a female of childbearing potential, is using two acceptable forms of birth control;
* In the case of a female of childbearing potential, has a negative urine pregnancy test (UPT) on Day 1 prior to randomization and are willing to submit to a UPT at the end of study (EOS);
* Is free of any systemic or dermatological disorder, which, in the opinion of the Investigator, will interfere with the study results or increase the risk of AEs;
* Is of any Fitzpatrick Skin Type or race, providing the skin pigmentation will allow discernment of erythema

Key Exclusion Criteria:

* Has any visible skin disease at the application site which, in the opinion of the Investigator, will interfere with the evaluation of the test site reaction;
* Is using systemic/topical corticosteroids within 3 weeks prior to and/or during the study, or systemic/topical antihistamines 72 hours prior to and during the study;
* Is not willing to refrain from using systemic/topical anti-inflammatory analgesics such as aspirin, (occasional use of acetaminophen will be permitted);
* Is using medication which, in the opinion of the Investigator, will interfere with the study results;
* Is unwilling or unable to refrain from the use of sunscreens, cosmetics, creams, ointments, lotions or similar products on the back during the study;
* Has psoriasis and/or active atopic dermatitis/eczema;
* Has a known sensitivity or allergy to constituents of the materials being evaluated including diacerein, mineral oil, petrolatum, cetyl alcohol, D\&C Yellow #10 and/or ethyl paraben;
* Has damaged skin in or around the test sites, including sunburn, excessively deep tans, uneven skin tones, tattoos, scars, excessive hair, numerous freckles, or other disfigurations of the test site;
* Has received treatment for any type of internal cancer within 5 years prior to study entry;
* Has any known sensitivity to adhesives; and/or
* Has received any investigational drug(s) within 4 weeks prior to study entry
Sedentary Screen Time Activities on Food Intake

The purpose is to investigate the effect of sedentary screen time activities on food intake and subjective appetite in 9- to 14-year old normal weight and overweight/obese girls. The investigators hypothesize that pre-meal exposure to screen time activities for 45 minutes increases subjective appetite and food intake at the next meal. Food intake will be measured immediately following screen-time exposure, and subjective appetite measured throughout the study period at 0, 15, 30, 45 and 75 minutes.


Eligibility Criteria:
Inclusion Criteria:

* healthy girls with no emotional, behavioral or learning problems

Exclusion Criteria:

* boys
Preventing Mental Health Problems After Childhood Severe Malaria

This is a randomized trial in which caregivers of children suffering from malaria will be assigned to two treatment conditions to prevent mental health problems in the children. A psycho-education arm (control) and a behavioral arm (intervention). Pre- and post-intervention assessments for behavioral problems in the child and mother will be carried out.

This study is designed to prevent mental health problems in children after an episode of severe malaria. The effect of the intervention on the mother's psychological wellbeing will also be assessed. Both caregivers and children will be assessed on the ward before being randomly assigned to the treatment arms. The interventions in both arms will be done in three phases with the third phase being done at home after discharge. Post-intervention assessments will be done on both the caregivers and mothers 6 months after discharge.

Eligibility Criteria:
Inclusion Criteria:

* aged 1.5 to 4 years
* admitted with severe malaria necessitating admission and intravenous treatment
* signed informed consent from the caregiver. Severe malaria in this study will include; cerebral malaria, severe malarial anemia, malaria with impaired consciousness (but not in coma or CM) and malaria with multiple seizures.

Exclusion Criteria:

* Living more than 50km from the hospital
* pre-existing developmental delays based on the Ten Questions Questionnaire
Study to Investigate the Pharmacokinetics & Safety Following One Application of 3 Different Doses 0.5,0.75,& 1.25 gm,a Transdermal Estradiol Cream (VML-0203), in Comparison to a Single Dose of EstroGel 1.25 gm to Healthy Post-menopausal Women.

This study is a Phase I, Randomized, Open-Label, Single Center, Cross-over Study to Investigate the Pharmacokinetics and Safety following a Single Application of Three Different Doses 0.5 gm (0.5 mg estradiol), 0.75 gm (0.75 mg estradiol) and 1.25 gm (1.25 mg estradiol), a Transdermal Estradiol Cream (VML-0203), in comparison to a single dose of EstroGelTM 1.25 gm (1 unit/0.75 mg of estradiol) to healthy post-menopausal women.


Eligibility Criteria:
Inclusion Criteria:

* Healthy post-menopausal (surgical or natural) female defined as:
* No menstrual period within the past year before study entry.
* Serum estradiol levels between 0-20 pg/ml.
* FSH levels greater than 25.8 mIU/ml.
* Greater than 45 years of age or if surgical menopausal, \> 30 yrs. of age.
* Have a body mass index (BMI) between 18 and 30 kg/m2. Have had a normal PAP smear test result in line with the following guidelines:

  * aged 30 to 49 - within the last 3 years
  * aged 50 to 65 - within the last 5 years

Exclusion Criteria:

* Is pregnant (urine pregnancy test at screening) or lactating.
* Has evidence of drug or alcohol abuse.
* Have used hormonal replacement or vaginal hormonal therapy within the past three months before study entry.
* Have used estrogen pellet therapy or progestin injectable drug therapy within the past three months before study entry.
* Has contraindications to HRT use, including: unexplained vaginal bleeding, liver disease, breast or endometrial cancer, venous thromboembolic events.
* Any subjects with an obvious presence of skin conditions, excessive hair at the application sites (no shaving), scar tissue, tattoo, or coloration that would interfere with application of IMP, skin assessment, or reactions to drug.
* Presence of open sores at the application sites.
* Any subjects with a history of significant skin disorder.
* Smoker.
Effect of Social Media Support and Financial Incentives on PrEP Adherence

The purpose of this study is to determine if social media support and financial incentives improve adherence to Truvada as PrEP in African American, Latino and Asian MSM aged 18 to 24 living in the Washington, DC area who are at high risk for HIV acquisition.


Eligibility Criteria:
Inclusion Criteria:

* Male assigned at birth (regardless of current gender identity)
* Age 18-24
* Black/African American, Latino or Asian
* HIV negative
* History of unprotected anal sex with a man in the last 6 months
* Living within the DC metropolitan statistical area and anticipate remaining within the DC area for the next 6 months
* Not enrolled in any other HIV prevention trial
* Interested in taking PrEP
* Not a current PrEP user and have not taken PrEP in the last 30 days
* Able to provide informed consent

Exclusion Criteria:

* Female sex at birth
* Age younger than 18 or older than 24
* Caucasian
* HIV positive
* Actively taking PrEP or having taken PrEP within 30 days of enrollment
* Chronic hepatitis B infection
* Known renal insufficiency
* On probation or parole
* Any other conditions that the Principal Investigator may consider a contraindication to enrolling in the study
Prevalence of Sarcopenia Among Elderly Living in Care Facilities in Klang Valley, Malaysia

The primary aim of this study was to investigate the prevalence of age-related progressive decline in muscle mass and strength (Sarcopenia) among Malaysian elderly residing in long-term care facilities. It is a very important condition to study as it is associated with high incidence of fall, hospitalization and mortality.

Over the past few decades, one condition that prominently affects the muscular system, known as sarcopenia, has captured the attention of healthcare experts and researchers. Sarcopenia is a geriatric syndrome characterized by the involuntary, gradual and generalized deterioration of skeletal muscle mass and strength with advancing age. It is to be noted that while sarcopenia is predominantly a syndrome of the elderly, its development may also be observed in various conditions such as disuse, malnutrition and cachexia, all of which are not exclusive only to the elderly. As of now, there are still ongoing research on an international scale with regards to its epidemiology, risk factors, causative factors, adverse clinical complications, prevention and treatment.

Beginning in 1st of October, 2016, Centres for Disease Control and Prevention (CDC) has finally officialised an International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10- CM) code for sarcopenia after its final proposal since April 2015. This establishment has enabled comprehensible clinical guidelines for diagnosis and treatment of sarcopenia, as well as separate reporting and data collection for sarcopenia in the medical community.

In essence, sarcopenia appears to be one of the most important causes of functional impairment, physical disability and loss of independence in older adults and a prevalence study will help to estimate the deleterious effects of this condition on the elderly living in the care facility, who happen to be the less privileged group as compared to their counterparts dwelling in the community.

Eligibility Criteria:
Inclusion Criteria:

* Currently residing in a long-term care facility
* Ability to walk, with or without the use of any walking aid
* Citizen of Malaysia

Exclusion Criteria:

* Inability to stand for height, weight and gait speed assessments
* Presence of cardiac pacemaker
* Presence of artificial limbs / prosthesis / metal implants
* Difficult or dangerous behaviours
* Severe cardiac, pulmonary, or musculoskeletal disorders
* Severe cognitive impairment or any disability that makes communication impossible
* Presence of terminal illness
* Co-morbidities associated with high risk of falls (e.g. Parkinson's disease or CVA) or that may directly influence affect gait speed
Denture Adhesive is a Patient Advantageous or Prosthetic Failure During Adaption Period: Randomized Control

Introduction: the complete denture wearers mainly complain of decrease of denture retention which affects on patient's quality of life Objective: to evaluate oral health-related quality of life (OHRQoL) of denture adhesive for completely edentulous denture wearers.

Material and methods : 32 patients(new denture wearers) were selected form prosthdontic clinic in three dental faculties in various region in Egypt, there were 22 females (68%) and 10 males (46%) were distributed in two groups: conventional group without adhesive and adhesive group with adhesive application n = 16;, in a cross over study. evaluation by Oral Health Impact Profile in Edentulous Adults (OHIP-EDENT) inventory at 1, 2 and 3 months after the insertion of new complete dentures. Data were analyzed using 2-way ANOVA test and Generalized Estimating Equations (GEEs), α = 0.05.

32 patients(new denture wearers) were selected form prosthdontic clinic in three dental faculties in various region in Egypt, there were 22 females (68%) and 10 males (46%) were distributed in two groups: conventional group without adhesive and adhesive group with adhesive application n = 16;, in a cross over study. evaluation by Oral Health Impact Profile in Edentulous Adults (OHIP-EDENT) inventory at 1, 2 and 3 months after the insertion of new complete dentures. Data were analyzed using 2-way ANOVA test and Generalized Estimating Equations (GEEs), α = 0.05.

Eligibility Criteria:
Inclusion Criteria:

* completely edentulous

Exclusion Criteria:

* no
Total Versus Robotic Assisted Unicompartmental Knee Replacement

The purpose of this research is to compare the functional outcomes of patients with end stage medial compartment OA of the knee undergoing a conventional mTKA to those undergoing rUKA and to assess the associated cost economics of such technology.

Unicompartmental knee arthroplasty (UKA) is an accepted surgical alternative to total knee arthroplasty (TKA) for patients with isolated medial compartmental joint disease with the potential advantages of accelerated recovery, improved functional outcomes and retention of anatomical knee kinematics. However, some surgeons continue to favour TKA over UKA due to a lower revision rate. The higher revision rates associated with UKA are thought to be primarily due to component malpositioning and postoperative limb malalignment.

Robotic-arm assisted (r)UKA offers a greater level of precision of component positioning compared to manual UKA and more recently the survivorship of rUKA has been shown to be greater than manual UKA. Early functional outcomes following robotic UKA appear to be better than those observed after manual TKA. Therefore, the benefits of UKA could potentially be enjoyed by the patient without the increased risk of revision when compared to TKA for those with medical compartment disease.

The primary aim of this study is to compare the early knee specific functional outcome of rUKA with manually performed (m)TKA when performed for patients with medial compartment osteoarthritis of the knee.

A single centre randomised control trial will be carried out powered to the Oxford knee score.

Eligibility Criteria:
Inclusion Criteria:

* Listed for elective primary TKA for end stage medial compartment osteoarthritis
* Intact anterior cruciate ligament
* Full thickness and good quality lateral cartilage
* Correctable intra-articular varus deformity and intact medial collateral ligament
* American Society of Anesthesiologists (ASA) grades 1 and 2
* Male or female, age 50 - 75 at the time of listing for surgery
* Suitable candidate for a cruciate retaining TKA (Triathlon prosthesis) and a UKA

Exclusion Criteria:

* Varus deformity of \> 20 degrees
* Fixed flexion of \>10 degrees
* Patient is unable to comply with the study protocol (incl. refusal for CT scan) or functional assessments
* Female participants who are pregnant, lactating or planning pregnancy during the course of the study
* Requires patella resurfacing or lateral compartment has significant OA
* Inability to understand the patient information for the study, provide written informed consent or answer study questionnaires for cognitive or language reasons
* Inflammatory disorder e.g. rheumatoid arthritis
* Symptomatic foot, hip or spine pathology
* Prior surgery (other than arthroscopy) or septic arthritis of the knee
* Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study,
Developing Breast (Cancer) Organoids

Currently, only a few validated biomarkers and models exist guiding or predicting treatment response for specific patient groups. Therefore, a patient-tailored clinical model needs to be developed to address tumour heterogeneity and thereby guide treatment selection on an individualized level. Organoids are patient-derived aggregates that grow in 3D and maintain self- renewal pluripotency and lineage-specific differentiation. Therefore, in contrast with conventional cell lines, they are thought to sustain patient heterogeneity and characteristics and are consequently already in use for drug response screening.

This now offers the opportunity to investigate if the primary patient breast cancer organoid platform reflects disease progression, treatment response and relapse in patients with different clinical breast cancer subtypes.

Goal: To develop a living biobank from prospective patient-derived breast cancer tissue. The questions we will address are:

1. Do patient-derived breast cancer organoids retain the clinical behaviour and characteristics of the primary patient tumour?
2. Can BC organoids be used to derive prognostic and predictive biomarkers to inform treatment decisions?
3. Can the investigators utilize BC organoids to discover novel actionable targets and combination treatments for therapeutic intervention for breast cancer patients?
4. Can BC organoids be used to discover mechanisms of treatment resistance and relapse?

The investigators will select patients with a diagnosis of breast cancer who undergo breast surgery. Patients will be asked informed consent for the use of a small (0,2-1 cm3) sample of the excised breast tumour and the collection of a blood sample (6ml)for whole-exome sequencing (WES) to compare the genetic profile of the patients with the organoids and the patient biopsy. The patients will not undergo any additional treatment or procedure in addition to the planned routine procedure for the surgical resection of their primary breast tumour.

Patient will undergo standard diagnostic procedures and treatment according to the Dutch breast cancer surgery guidelines. After surgery, the pathologist will provide -after pathological diagnosis- rest (tumour) tissue from the resection to the lab. This material will then be used to develop breast cancer organoids. As part of the routine surgical procedure, 6 ml of blood will be collected. Participation in this study does not lead to additional actions other than reading the patient information and signing the informed consent. Therefore, participation does not change the patient's treatment or outcome.

Eligibility Criteria:
Inclusion Criteria:

* Female,
* \>18 years,
* Family Anamneses
* Breast cancer (proven by histopathology), Included subtypes; (ER-,PR- HER2-); (ER+, PR+, HER2-); (ER+, PR+ HER2+).
* Primary surgery (lumpectomy or mastectomy)

Exclusion Criteria:

- Physically or mentally incapable or incompetent to sign informed consent
Dose Response Study of Dexmedetomidine in Orthopaedic Spine Surgery Patients

To study the multimodal protocol combining adjunct dexmedetomidine with oxycodone in intravenous patient-controlled analgesia bolus dosing and effects in patients scheduled for posterolateral lumbar spine fusion with bilateral transpedicular screw instrumentation.


Eligibility Criteria:
Inclusion Criteria:

* Scheduled for elective posterolateral lumbar spine fusion with bilateral transpedicular screw instrumentation under general anaesthesia.
* Written informed consent from the participating subject

Exclusion Criteria:

* A previous history of intolerance to the study drug or related compounds and additives
* Concomitant drug therapy with oxycodone or buprenorphine.
* History of ischemic heart disease or conduction disturbance
* BMI \> 35
* Existing significant haematological, endocrine, metabolic or gastrointestinal disease
* History of alcoholism, drug abuse, psychological or other emotional problems that are likely to invalidate informed consent
* Allergy to dexmedetomidine or oxycodone
* Blood loss exceeding 1500 ml during operation
Nutritional Status and Intake in Patients With Non-cystic Fibrosis Bronchiectasis (NCFB)

The aim of this study was to characterise nutritional status and dietary intake in a population of individuals living with bronchiectasis from a regional clinic. Participants underwent usual assessment as per their standard pathway of care and in addition, body composition through skinfold measures, Handgrip strength and information on dietary intake over 3 days via 24 hour multiple pass recalls was also collected. This was to establish baseline measures and knowledge in support of understanding the impact of nutritional status within this group.


Eligibility Criteria:
Inclusion Criteria:

* People who have a confirmed diagnosis of NCFB
* people with NCFB who are clinically stable (not requiring acute admission to hospital)
* people who attend the regional clinic

Exclusion Criteria:

* People who are pregnant
* people with existing comorbidities such as malignancy
Phase I/II Clinical Study of Pralatrexate in Japanese Patients With Relapsed or Refractory Peripheral T-cell Lymphoma

Phase I portion:

To evaluate the safety and tolerability of pralatrexate with concurrent vitamin B12 and folic acid supplementation in Japanese patients with relapsed or refractory PTCL and to determine the recommended dosage. Also, to evaluate pharmacokinetics.

Phase II portion:

To evaluate the efficacy, safety, and pharmacokinetics of the recommended dosage regimen determined in the phase I portion. The primary efficacy endpoint shall be objective response rate (ORR).


Eligibility Criteria:
Inclusion Criteria:

* Japanese patients at least 20 years of age.
* Patients histologically diagnosed with peripheral T-cell lymphoma by pathological diagnosis of biopsied lesion.
* Relapsed or refractory patients with a treatment history of at least one regimen.
* Patients with an enlarged lymph node or extranodal mass lesion clearly measurable in two perpendicular directions and greater than 1.5 cm in maximum diameter on computed tomography performed.
* Patients expected to survive for at least 3 months.
* ECOG PS 0-2.
* Patients with adequate hemopoietic efficacy, liver and kidney function.
* Patients from whom written consent has been obtained prior to study initiation.

Exclusion Criteria:

* Patients who received a chemotherapy agent or a high dose of a systemic adrenocorticosteroid within 21 days prior to initial administration of the study drug.
* Patients who received radiation therapy, phototherapy, or electron beam therapy within 21 days prior to initial administration of the study drug.
* Patients who received another study drug within 28 days prior to initial administration of the study drug.
* Patients who received antibody therapy within 100 days prior to initial administration of the study drug.
* Patients with a history of allogeneic hematopoietic stem cell transplantation. Or patients with a history of autologous hematopoietic stem cell transplantation within 100 days prior to initial administration of the study drug.
* Patients with cerebral metastasis or central nervous system lesion or a past history.
* Patients with active multiple primary cancer. Or patients with a history of a malignant neoplasm other than peripheral T-cell lymphoma within the past 5 years.
* Patients with severe cardiovascular disease.
* Patients positive for HBs antigen, HCV antibody or HIV antibody on immunological investigation. Or patients positive for either HBc antibody or HBs antibody, and showing DNA more than sensitivity in HBV-DNA assay.
* Patients positive for CMV antigen on immunological investigation.
* Patients with infectious disease requiring treatment consisting of intravenous administration of antibacterial agent, fungicide, or antiviral drug.
* Patients with interstitial pneumonia or pulmonary fibrosis, or patients judged to have insufficient pulmonary function.