cyrilzakka/clinical-trials huggingface dataset:
A Study of a Moisturizing Cream and Baby Wash in the Management of Mild to Moderate Atopic Dermatitis in Infants, Toddlers and Children

The purpose of this study is to evaluate the effectiveness (assessed by clinical evaluation of eczema/atopic dermatitis severity and parent-perceived benefits) and tolerability (assessed by clinical grading and parent-perception) of the investigational cream when used in conjunction with a baby wash in babies, toddlers, and children with mild to moderate atopic dermatitis.


Eligibility Criteria:
Inclusion Criteria:

For Child

* Fitzpatrick skin type I to VI
* Child must have at least 1 target lesion based on the atopic dermatitis severity index (ADSI) with a score of 2-12 and an erythema sub score of at least 2 (moderate)
* Has mild to moderate atopic dermatitis (as per Rajka-Langeland Severity Index; graded as 3.0 to 7.5 inclusive)
* Child must have parent-assessed history of itch
* Has parent-perceived sensitive skin For Parents
* Willing to undergo a 3-day washout period prior to the baseline assessments. During this run-in period, parents will be asked to refrain from using prescription and over-the-counter (OTC) eczema treatments on their child; Acute rescue treatment will be permitted (type of rescue treatment will be determined by principal investigator \[PI\])
* Has signed the informed consent document (ICD), including Health Insurance Portability and Accountability Act (HIPAA) disclosure

Exclusion Criteria:

* Has known allergies or adverse reactions to common topical skincare products or ingredients of the investigational products (IPs)
* Has a history of a confirmed or suspected coronavirus disease 2019 (COVID-19) infection within 30 days prior to Visit 1 For Child
* Presents with a skin condition that may influence the outcome of the study (specifically psoriasis or active skin cancer)
* Severe atopic dermatitis (AD) as determined by the Rajka-Langeland Severity Index For Parent
* Is self-reported to be pregnant or planning to become pregnant during the study
A Trial of Caries Prevention Effect of Fissure Sealants

The purpose of this randomized clinical trial was to compare caries prevention of a conventional resin-based sealant and a glass-ionomer sealant placed on occlusal pits and fissures over a one year period in a high caries children group. Additionally the concentration of Fluoride in saliva was evaluated.


Eligibility Criteria:
Inclusion Criteria:

* 1.Age range of 6 to 10 years 2.Having caries free, fully erupted first permanent molars 3.Deep and/or intermediate pits or fissures 4.dft ≥ 2

Exclusion Criteria:

* 1.Having any systemic disease 2.Topical fluoride was applied last six months 3.dft = 0
Deep Margin Elevation Vs Crown Lengthening

The present clinical trial will be conducted to reject or accept the null hypothesis that in endodontically treated posterior teeth with deeply located proximal margins, will the Deep Margin Elevation will have better results from surgical crown lengthening in terms of biological criteria?


Eligibility Criteria:
Inclusion Criteria:

* Patients underwent endodontic treatment in the posterior region
* 18-40 years
* Male and Females
* Medically free patients
* Patients with healthy periodontium
* Patients with thick biotype.
* Patients having proximal margins violating the biological width

Exclusion Criteria:

* Patients with chronic periodontal disease.
* Patients with persistent poor oral hygiene.
* Patients with unsuccessful root canal treatment.
* Periapical Abscess or Fistula.
* Patients with proximal margins beyond the bone level.
* Patients with developmental dental anomalies.
* Patients undergoing or will start orthodontic treatment
* Patients with removable prosthesis
Dentists' Attitudes Towards Pharmacological Management of Acute Pain in Children and Adolescents - a Follow-up Survey

The aim of this study is to investigate Swedish dentists' attitudes about pain management when treating children and adolescents by assessing 1) dentists' recommendations for the use of pre- and postoperative analgesics, (2) use of local anaesthesia during treatment of primary and permanent teeth, and (3) if the use of these strategies differs between General Dental Practitioners (GDP) and Specialist Paediatric Dentists (SPD).

All Swedish SPDs (including post-graduate dentists in paediatric dentistry), circa 150 in total, and approximately 1,000 GDPs in County Skåne, Sweden will be invited to answer a questionnaire.

This survey study is follow-up to a survey carried out in 2014, addressed to Swedish General Dental Practitioners (GDPs) and Specialist Paediatric Dentists (SPDs). The aim of this study is to investigate Swedish dentists' attitudes about pain management when treating children and adolescents by assessing 1) dentists' recommendations for the use of pre- and postoperative analgesics, 2) use of local anaesthesia during treatment of primary and permanent teeth, and 3) if the use of these strategies differs between GDPs and SPDs.

All SPDs (including post-graduate dentists in paediatric dentistry) in Sweden, circa 150 in total, and approximately 1,000 GDPs, will be invited to answer the questionnaire. To be included GDPs need to have registered addresses in county Skåne, Sweden, and be accredited to provide dental care to children and adolescents by Region Skåne, the regional public health and dental care provider. A questionnaire along with written information about the study and two consent forms will be mailed to presumptive study participants. Those willing to participate in the study are asked to return (postage prepaid) one signed consent form and the completed questionnaire. The questionnaire is adapted from one previously used in Sweden. It contains demographic questions, and questions regarding work situation. These questions are followed by four clinical scenarios, and questions relating to use of pain management practices. Responses are given on a 5-point Likert scale. The final questions are open ended and concern the use of pre- and postoperative analgesics.

Eligibility Criteria:
Inclusion Criteria:

General Dental Practitioners with a civil registration address in County Skåne, Sweden.

Specialist Paediatric Dentists in Sweden.

Exclusion Criteria:

Not accredited to provide dental care to children and adolescents (applies to General Dental Practitioners).

≥ 65 years of age
Misoprostol Versus Uterine Striating by Bladder Filling for Pain Relief During Office Hysteroscopy

The aim of this study is to compare the effectiveness of misoprostol versus uterine straightening by bladder filling for pain relief in menopausal patients undergoing office hysteroscopy.

Several studies revealed that cervical ripening with misoprostol is effective in reducing pain especially in postmenopausal patients. A recent randomized controlled trial revealed that uterine striating by bladder filling prior to office hysteroscopy is associated with reduced pain perception and easier introduction of hysteroscope through the cervix.

The aim of this study is to compare the effectiveness of misoprostol versus uterine straightening by bladder filling for pain relief in menopausal patients undergoing office hysteroscopy.

Eligibility Criteria:
Inclusion Criteria:

* Menopausal patients who have an indication for office hysteroscopy

Exclusion Criteria:

* Nulliparous patients, patients with cervical pathology and previous cesarean section or cervical surgery.
Self-management Interventions for Advanced Breast Cancer

The purpose of this research study is to evaluate whether self-management discussion groups are helpful for women with advanced breast cancer who are experiencing pain. The study is looking at the usefulness of two different types of discussion groups, one of which also includes gentle exercise.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of Stage IV breast cancer or recurrent metatastic breast cancer
* receiving care at Duke Cancer Institute,
* life expectancy ≥9 months as estimated by the treating oncologist,
* speak and read English,
* be at least age 18
* be able to travel to the Duke Cancer Institute

Exclusion Criteria:

* cognitive impairment as assessed by the 6-item Mini-mental Status Exam,
* Karnofsky Performance Rating of \<60 as rated by the oncology provider, an ECOG rating of 0-2
* treatment for serious psychiatric illness (e.g., schizophrenia, severe depression) in the past 6 months,
* currently engaged in yoga practice ≥ 1 day per week
Turning Pattern of Different Body Segments During Turns and Turning Performance

This is a cross-sectional exploratory study. A total of 25 people with PD, 25 young healthy adults, and 25 middle to older adults will be recruited. Axial segment turning pattern and turning performance will be evaluated in two visits using the Vicon 3D motion analysis system, Gaitup, and 3D motion camera. The independent variables are the initiation timing of the head, upper trunk, pelvis, ankle, and foot when turning and the initiation sequence of turning (% turn). The dependent variables are turning performance, including turning velocity, turning steps, turning step length, turning step width), and stance phase (%).

The first aim of the present study is to explore the correlation between axial segment turning pattern and turning performance in people with PD and healthy adults.

The second aim is to verify the validity and reliability of 3D motion camera in turning evaluation.

A total of 25 people with PD, 25 young healthy adults, and 25 middle to older adults will be recruited.

Axial segment turning pattern and turning performance will be evaluated in two visits using the Vicon 3D motion analysis system, Gaitup, and 3D motion camera.

The independent variables are the initiation timing of the head, upper trunk, pelvis, ankle, and foot when turning and the initiation sequence of turning (% turn). The dependent variables are turning performance, including turning velocity, turning steps, turning step length, turning step width), and stance phase (%).

For the data analysis, the Shapiro-Wilk test will be used to check for normal distribution. Pearson's correlation coefficient or Spearman's rank correlation coefficient will be used to examine the correlations between axial segment initiation timing and turning performance. To verify the validity and reliability, Pearson's correlation coefficient will be used for concurrent criterion validity. Intraclass correlation one-way random model will be used for test-retest reliability, showed with intraclass correlation coefficient and 95% confidence interval. A p-value of less than 0.05 is considered statistically significant.

Eligibility Criteria:
Inclusion Criteria:

* Able to walk 5 meters without assistance device
* Able to turn independently

Exclusion Criteria:

* With neurological disorders
* MMSE\< 24
* Any systemic and musculoskeletal disturbances or other causes of walking inability
PDEI Following Mitral Valve Surgery in Patients With Pulmonary Hypertension

A randomized, placebo controlled, single center clinical trial for evaluation of efficacy and safety of Sildenafil administration in the cardiac ICU following Mitral Valve (MV) Surgery in patients with pre-operative Significant Pulmonary Hypertension.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 22
2. Undergoing mitral valve surgery (either repair or replacement) with or without coronary revascularization, aortic valve replacement (AVR) or repair; or tricuspid valve surgery.
3. Pre-operative pulmonary arterial systolic pressure \>50 mm Hg as determined by resting echocardiography and post-operative sPAP \> 45 mmHg as obtained from invasive hemodynamics measurements.
4. Willing and able to give written informed consent prior to the procedure

Exclusion Criteria:

1. Hypersensitivity to study drug
2. Women of child-bearing potential
3. Expected need to administer nitrates that are clinically indicated peri-operatively
4. Post-operative hypotension (systolic blood pressure (BP) \<80) or evidence of shock (postoperative evidence of any kinds of shock)
5. Cardiac or systemic amyloidosis
6. Active malignancy other than BCC (basal cell carcinoma)
7. Stable kidney dysfunction with Creatine clearence (CrCl) \<30 mL/min during the screening period or hepatic failure other than mild
8. Significant anemia (hemoglobin \<8 mg/dl) preoperative.
9. Known drug or alcohol dependence or any other factors which will interfere with the study conduct or interpretation of the results or in the opinion of the investigator are not suitable to participate;
10. Any illness other than cardiac which might reduce life expectancy to less than 1 year from screening
Dextran, a Plasma Expander, Offers New Hope for Patients With Decompensated Liver Cirrhosis and Acute Kidney Injury

A pilot study of Dextran-40 infusion in patients with decompensated cirrhosis presenting with AKI

A pilot study of Dextran-40 infusion in decompensated cirrhotic patients complicating with AKI. Dextran-40® was administered at 1 g/kg/day for two days. AKI reversal was defined when serum creatinine was \< 1.5 mg/dL. Albumin infusion was given if AKI reversal did not occur.

Eligibility Criteria:
Inclusion Criteria:

* Decompensated cirrhosis with acute kidney injury
* Ager over 18 years old

Exclusion Criteria:

* Having chronic kidney disease, severe heart or lung disease, severe sepsis
* Pregnant
* Receiving nephrotoxic agents
* Having history of allergic to Dextran
Retrospective Evaluation of the Impact of Epidural on the Risk of Postpartum Hemorrhage

Postpartum hemorrhage (PPH) is a major complication of childbirth. Epidurals are often implicated in the onset of postpartum hemorrhages. Given the paradoxical data in the literature, the investigators wished to retrospectively evaluate the impact of epidurals on the risk of PPH, instrumental delivery and the occurrence of PPH risk factors.

The investigators retrospectively analyzed 5753 records of patients who gave birth vaginally at Brugmann University Hospital between January 1, 2020 and December 31, 2021. The primary objective was to assess whether epidurals pose a risk of postpartum hemorrhage. Secondly, the investigators assessed whether epidurals pose a greater risk of instrumentation of delivery and emergence of PPH risk factors.


Eligibility Criteria:
Inclusion Criteria:

* Patients who gave birth vaginally at the Brugmann University Hospital Horta site between January 1, 2020 and December 31, 2021.

Exclusion Criteria:

* Patients who gave birth before 25 weeks.
* Patients who gave birth outside of hospital.
* Patients who had recourse to a medical termination of pregnancy (MTP).
* Patients who gave birth by cesarean section.
Nursing Home Team-Care Deprescribing Study

This is a multi-centre study in Singapore nursing homes, investigating the factors that affecting deprescribing, and if a team-care based deprescribing standard practice gives superior health and pharmacoeconomic outcomes over current medication review practice.


Eligibility Criteria:
For interview questionnaire:

Inclusion criteria are:

1. Accepted informed consent,
2. The healthcare professional is practicing in the involved nursing homes.

Exclusion criteria are:

1) Decline/unable to provide consent.

For team-care deprescribing study:

Inclusion criteria are:

1. Accepted informed consent (unless cognitive-impaired, with no or un-contactable next-of-kin),
2. Adult aged 65 years and above,
3. Currently on five or more medications.

Exclusion criteria are:

1. Below the age of 65 years of age,
2. Life expectancy of less than 6 months or respite care.
Effect of Specific Anti-Toxoplasmatic Add-on Medication in Toxoplasma Gondii Seropositive Individuals With Schizophrenia or Major Depression

We investigate whether the add-on specific antitoxoplasmatic medication has positive effects in individuals with schizophrenia or major depression seropositive for Toxoplasma gondii (TG) infection. As TG modulates neurotransmitter metabolism affecting serotonin and dopamine we hypothesize that this chronic persistent infection might play a role for depressive and psychotic symptomatology. Therefore, on the basis of an ex juvantibus approach, specific anti TG medication might further improve psychiatric symptomatology in affected patients. This is investigated in a double-blind, placebo-controlled, randomized treatment trial.


Eligibility Criteria:
Inclusion Criteria:

* Schizophrenia or Major Depression
* Both genders
* Adult
* Patients are able to give informed consent

Exclusion Criteria:

* Additional diagnosis of substance abuse/dependency
* Continuous treatment with medication not compatible with study medication
* Medical status not compatible with study medication
* Any condition that increases study risk considerably
* Pregnancy, nursing
Effects of Blood Flow Restriction (BFR) Therapy on ACL Graft Maturation

This is a study comparing the effects of blood flow restriction (BFR) therapy on the maturation of the Anterior Cruciate Ligament (ACL) graft after reconstruction surgery compared to physical therapy without the use of BFR.

The study will be a randomized controlled trial to compare outcomes between physical therapy with BFR and physical therapy without BFR on the ACL graft maturation following reconstruction surgery. BFR therapy will begin as early as 2 weeks after surgery. The initial 2 weeks after surgery, or prior to initiation of BFR, will consist of the physical therapy following the surgeon's postoperative protocol.

To be considered for participation in this study, patients must be 18 years and older undergoing primary ACL reconstruction. In addition, patients must meet several inclusion/exclusion criteria to be randomized and included in this study.

Eligibility Criteria:
Inclusion Criteria:

* Ages 18 or older, all gender
* Patients receiving any type of ACL graft, either autograft or allograft, and any type of tissue

Exclusion Criteria:

* Patients who do not meet the the comprehensive BFR screening criteria based on predetermined contraindications and precautions
* Patients undergoing any additional concomitant ligament repair or reconstruction at the same surgery
* Revision procedures
* Patients unable to lay still in an MRI scanner
* Patients receiving treatment outside Stanford
* Patients undergoing concomitant meniscus treatment that restricts patients' weight bearing or prolongs their immobilization compared to their surgeons standard postoperative ACL reconstruction protocol
* Patients who are unable to lay still in an MRI scanner
* Patients with a torn ACL or previous ACL reconstruction in the contralateral knee
School-based Physical Activity Intervention for Obesity Among Adolescents With Intellectual Disability in Hong Kong

Considering that children with intellectual disability (ID) might be more vulnerable to obesity than their counterparts in the general population. This study aimed to develop and evaluate the effectiveness of an adapted physical activity (APA) program in reducing weight among adolescents with ID. The hypothesis of the study was the APA program would be able to decrease obesity among adolescents with ID.

Background: Children with intellectual disability (ID) might be more vulnerable to obesity than their counterparts in the general population. This study aimed to evaluate the effectiveness of an adapted physical activity (APA) program in reducing weight among adolescents with ID.

Methods: A 9-month randomized controlled trial of a school-based APA program was conducted in adolescents with ID and overweight/obesity in Hong Kong. The intervention group received the APA program which consisted of endurance and strength-building exercises at a frequency of two sessions per week, while the control group received routine PE classes as usual. Data on obesity-related variables were collected before the intervention, at the midpoint of the intervention and after the intervention. Linear mixed-effect models were used to examine the intervention effects.

Eligibility Criteria:
Inclusion Criteria:

* aged between 12 and 18 years
* overweight and obesity
* mild or moderate intellectual disability

Exclusion Criteria:

* physical disability
* medical predispositions towards obesity (genetic syndrome or drug treatment)
* contraindications (e.g. asthma, heart disease)
* having participated in other exercise programs in the past 6 months.
AdvanTIG-202: Anti-PD-1 Monoclonal Antibody Tislelizumab (BGB-A317) Combined With or Without Anti-TIGIT Monoclonal Antibody Ociperlimab (BGB-A1217) in Participants With Previously Treated Recurrent or Metastatic Cervical Cancer

This study tested how well and how safely the drug tislelizumab, given either alone or with another drug called ociperlimab (BGB-A1217), worked in people with cervical cancer that had come back or spread after previous treatments. The study included two groups and took place at multiple medical centers.


Eligibility Criteria:
Inclusion Criteria:

1. Histologically or cytologically confirmed squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix.
2. Progression on or after one or more lines of chemotherapy for management of recurrent or metastatic disease and is not amenable to curative treatment (eg, systemic chemotherapy, surgery, or radiotherapy).
3. Measurable disease as assessed by RECIST v1.1. Note: A lesion in an area subjected to prior loco-regional therapy, including previous radiotherapy, is not considered measurable unless there has been demonstrated progression in the lesion since the therapy as defined by RECIST v1.1.
4. Participants must submit qualified archival tumor tissue (formalin-fixed paraffin-embedded block containing tumor \[preferred\] or approximately 15 \[at least 6\] unstained slides) with an associated pathology report, or agree to a tumor biopsy for determination of Programmed death-ligand 1 (PD-L1) expression and other biomarker analyses (fresh tumor biopsies are strongly recommended at baseline in participants with readily accessible tumor lesions and who consent to the biopsies).
5. Participant must have adequate organ function as indicated by the screening laboratory values obtained within 7 days before the first study treatment.

Exclusion Criteria:

1. Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, TIGIT or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways.
2. Any active malignancy ≤ 2 years before first dose of study drug except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated curatively (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of breast).
3. Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage (recurrence within 2 weeks of intervention).
4. Any major surgical procedure ≤ 28 days before first dose of study drug. Participants must have recovered adequately from the toxicity and/or complications from the intervention before the first dose of study drug.
5. Has received any chemotherapy, immunotherapy (eg, interleukin, interferon, thymosin, etc.) or any investigational therapies within 14 days or 5 half-lives (whichever is longer) before the first dose of study drug or has received palliative radiation treatment or other local regional therapies within 14 days before the first dose of study drug.

Note: Other protocol defined Inclusion/Exclusion criteria may apply