cyrilzakka/clinical-trials huggingface dataset:
Impact of Maternal Mental Health on the Oral Health Status and Oral Health-related Quality of Life of Their Children

Dental caries is a complex multifactorial disease that is strongly related to and influenced by the children's dietary habits, sugar intake, salivary flow, salivary fluoride level, and preventive behaviors. Based on the literature, other factors can affect child dental caries including the influence of social factors, such as the family environment. To avoid suffering from dental caries, preventive oral hygiene practices beginning in childhood are crucial. However, parents are the primary providers of oral health care for their children and they generally play a pivotal role in the overall health and oral health of both children and adolescents. Therefore, this study aims to investigate the impact of maternal mental health in the form of depression, anxiety, or stress and their perceived social support on the oral health status and OHRQoL of their children.


Eligibility Criteria:
Inclusion Criteria:

* Egyptian mothers.
* Preschool children of both sexes aged (3-5 years who have a full set of primary dentition).
* Healthy children with no long-term medications, and with no physical, learning, or mental disabilities.

Exclusion Criteria:

* Mothers who do not consent to participate in the study (either for themselves or for their children)
* Mothers with any diagnosed mental disorders.
* Pregnant mothers or mothers who delivered within the last year.
* Mothers with any diagnosed physical disabilities.
Acceptability and Feasibility of Finger Foods

This study will investigate the feasibility of using a finger food menu on an acute stroke rehabilitation ward. This study has a mixed methods design, with quantitative, qualitative and economic components which will be used to inform a future randomised control trial.


Eligibility Criteria:
Inclusion Criteria:

* Current patient on stroke rehabilitation ward
* 65 years or older
* Normal textured food

Exclusion Criteria:

* On the end of life pathway
* Partial or full enteral feeding
* Significant food allergies, intolerances or other dietary restrictions that could not be catered for by the finger food menu.
* Unable to give consent or no consultee able to consent on behalf of patient
* In a side room on the ward
Randomized, Double-Blind, Placebo-Controlled, Safety and Tolerability Study of ITI-214 in Patients With Heart Failure

This is a Phase I/II randomized, double-blind, placebo-controlled, single rising dose study in patients with systolic heart failure to evaluate the safety and tolerability of ITI-214.


Eligibility Criteria:
Inclusion Criteria:

* NYHA class II-III heart failure
* Ejection fraction equal to or below 35%
* On stable heart failure drug treatment

Exclusion Criteria:

* Considered medically inappropriate for study participation
Post-surgical Chronic Pain After Retroperitoneal Laparoscopic Living Kidney Donor

This study aimed to determine the relationship between the quadratus lumborum and erector spinae plane block technique and the incidence and severity of chronic post-surgical pain in accordance with Brief Pain Inventory Score (BPI) in retroperitoneal laparoscopic living kidney donor surgery

A minimum of 130 subjects will be recruited and divided into two groups (65 QL block, 65 ESP block). The researcher will use the Brief Pain Inventory (BPI) score to assess the incidence and severity of chronic pain of the living kidney donor who has undergone retroperitoneal laparoscopy with QL or ESP block technique

Eligibility Criteria:
Inclusion Criteria:

* Patient 18-65 years old
* Patient with ASA physical status assessment 1-3
* All patient who have undergone living kidney donor with retroperitoneal laparoscopy at RSUPN Dr. Cipto Mangunkusumo (3 months postoperative)
* The patient and/ or the family are willing to be interviewed about the patient's previous medical history and agree to be the subject of the study.

Exclusion Criteria:

* Patient who have already known the cause of the chronic pain they had
* Patient who have history of major surgery after the donor surgery
* Patient died during the study
Primary Prevention of Intimate Partner Violence in India

The goal of this study is to test and evaluate the feasibility, acceptance, safety, and efficacy of an an intimate partner violence (IPV) intervention in recently-married, low-income husband-wife dyads in Pune, India.

The goal of this study is to test and evaluate the feasibility, acceptance, safety, and efficacy of an an intimate partner violence (IPV) intervention in recently-married, low-income husband-wife dyads in Pune, India conducted over a six week period.

Acceptability and feasibility will be assessed through semi-structured interviews with participants and staff post-intervention. Safety will be gauged through semi-structured interviews with women participants and efficacy will be gauged through change in proximal determinants of IPV in this population (i.e. time spent in the relationship, self-esteem, resilience, communication and conflict management skills, sexual communication, attitudes toward IPV acceptability, and conceptualization of IPV).

Eligibility Criteria:
Inclusion Criteria:

* Recently married (i.e. \<1 year) husband-wife dyads
* First marriage
* Planning to reside in Pune for the majority of the next 6 months
* Marathi fluency
* Lives with partner
* Lives in a slum, slum redevelopment community, or chawl

Exclusion Criteria:

* Pregnant in third trimester of pregnancy
* Women who respond affirmatively to either a physical and/or sexual IPV item on the IFVCS short form
Paracetamol-Tramadol and Paracetamol-caffeine Versus Placebo in the Emergency Discharge Treatment of Renal Colic

This is a prospective, randomized, single-blind study. Patients included in the study after successful treatment of the acute attack were randomized upon discharge from the Emergency Department into three groups: oral paracetamol-tramadol group, oral paracetamol-caffeine group and oral placebo group.

This is a prospective, randomized, single-blind study. Patients included in the study after successful treatment of the acute attack were randomized upon discharge from the Emergency Department into three groups: oral paracetamol-tramadol group, oral paracetamol-caffeine group and oral placebo group.

Different parameters are collected on a standard form prepared for all cases of renal colic included in our study. This sheet essentially contains:

Temperature, systolic and diastolic blood pressure, heart rate, pain intensity assessed by VAS, abdominal tenderness as well as the existence of Giardano signs.

Additional examinations were not systematically carried out for all patients: AUSP, ECBU, renal ultrasound, creatinemia and blood sugar. Their realization depended on the clinical context.

The use of imaging was done following the indications specified in the text of the consensus of the French Society of Emergency Medicine (updated in 2008)

Eligibility Criteria:
Inclusion Criteria:

* -Age \> 18 years old.
* Consent to participate in the study.
* Pain in the flank/lumbar fossa of sudden onset with urine strips and/or imaging corresponding to the diagnosis of renal colic.
* Pain score at discharge \< 30 (visual analog scale - VAS or verbal numerical scale - VAS from 0 to 100).

Exclusion Criteria:

* -Inability to appreciate pain according to the VAS.
* Pregnant or breastfeeding woman.
* Renal insufficiency with creatinine clearance \< 60 ml/min.
Phase 1/2 Lyme Vaccine Study

Section 1:

The purpose of the study is to obtain safety and immunogenicity data of different dose levels of a multivalent recombinant OspA Lyme Borreliosis (mv rOspA LB) Vaccine with and without adjuvant in seronegative healthy adults aged 18 to 70 years. The outcome shall provide the basis for dose/formulation selection for Section 2 of the study.

Section 2:

An additional purpose of the study is to evaluate the safety and immunogenicity of the optimal dose(s)/formulation of the mv rOspA LB Vaccine in a larger population of seronegative and seropositive healthy subjects aged 18 to 70 years.


Eligibility Criteria:
Main Inclusion Criteria:

* Subject is 18 to 70 years old at the time of screening
* Subject has an understanding of the study, agrees to its provisions, and gives written informed consent prior to study entry
* Subject is generally healthy, as determined by the investigator's clinical judgment through collection of medical history and the performance of a physical examination
* If female of childbearing potential, presents with a negative urine pregnancy test, and agrees to employ adequate birth control measures for the duration of the study

Additional inclusion criterion for seropositive subjects in Section 2 only:

- Subject is seropositive for Borrelia burgdorferi sensu lato (s.l.) antibodies at study entry

Main Exclusion Criteria:

* Subject has a physician-diagnosed chronic illness related to Lyme borreliosis (LB) or active LB
* Subject has been treated for LB with antibiotics within 3 months of study entry
* Subject had a tick bite within 3 weeks prior to screening or first vaccination
* Subject has a history or active infection with Babesia microti (babesiosis) or Anaplasma phagocytophilum (ehrlichiosis)
* Subject currently has or has a history of significant cardiovascular, respiratory (including asthma), metabolic, neurological, hepatic, rheumatic, autoimmune, hematological, gastrointestinal or renal disorder
* Subject has clinically significant abnormal laboratory values at screening
* Subject currently has or has a history of immunodeficiency
* Subject tests positive for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV)
* Subject has a disease or is currently undergoing a form of treatment or was undergoing a form of treatment within 30 days prior to study entry that could be expected to influence immune response.
* Subject has a history of anaphylaxis or severe allergic reactions
* Subject has received any live vaccine within 4 weeks or inactivated vaccine within 2 weeks prior to vaccination in this study
* Subject is pregnant or lactating at the time of study enrollment

Additional exclusion criterion for subjects in Section 1 and seronegative subjects in Section 2:

- Subject is seropositive for Borrelia burgdorferi sensu lato (s.l.) antibodies at study entry
Respiratory Microbiome in COPD and Associated Inmune Response.

Hypothesis:

COPD patients with frequent exacerbations have different pulmonary and systemic immune response than COPD patients without frequent exacerbations and this is related to their microbiome.

The objective of this project is to determine the pulmonary microbiome and its relationship with the pulmonary and systemic inmune response in COPD patients with frequent (FE) and non frequent exacerbations (NE).

1. The pulmonary immune response.

   -The role of mucins, antimicrobial peptides (AMPs), Matrix metalloproteinases (MMPs) and Toll-like receptors (TLRs) as lung defense mechanisms and their possible relationship with the microbiome in COPD and FE patients.
2. The systemic immune response. -The pulmonary and blood inflammatory response and circulating bacterial products as markers of the systemic immune response.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of COPD according to national and international guidelines.
2. Clinical stability (8 previous weeks).
3. Signature of informed consent.

Exclusion Criteria:

1. Antibiotic treatment the previous 8 weeks.
2. Other lung diseases.
3. Active neoplasic disease.
4. Terminal concomitant disease.
AssessmenT of smalL Airways involvemeNT In aSthma (ATLANTIS)

Multinational, multicentre, non-pharmacological intervention, cross-sectional and longitudinal study.

Large non pharmacological studies on Small Airways Disease

Eligibility Criteria:
Asthmatic patient inclusion criteria

1. Male or female patients aged ≥ 18 and ≤ 65 years, who have signed an Informed Consent form
2. Clinical diagnosis of asthma f

   1. Positive response to methacholine challenge test
   2. Positive response to a reversibility test or
   3. Peak Flow variability (i.e. highest - lowest PEF over the day/mean value of the two, × 100) \> 20% or
   4. Documented response (defined as ΔFEV1 ≥ 12% and ≥ 200 mL) after a cycle (e.g., 4 weeks) of regular maintenance anti-asthma treatment.
3. Patients with stable asthma.
4. Current smoker, ex-smoker or lifelong non-smoker Healthy subject inclusion criteria

1. Male or female patients aged ≥ 18 and ≤ 65 years 2. No clinical history of asthma or COPD 3. Current smoker, ex-smoker or lifelong non-smokers 4. Normal spirometry 5. Normal airways responsiveness Asthmatic patient exclusion criteria

1. Cigarette smoking \> 10 packyears
2. diagnosis of COPD
3. Asthma exacerbation in the 8 weeks prior to baseline visit
4. Clinical or functional uncontrolled respiratory, haematological, immunologic, renal, neurologic, hepatic, endocrinal or other disease, or any condition that might compromise the results or interpretation of the study.
5. Pregnant or lactating women
6. Participation in an interventional clinical trial \<12 weeks preceding baseline visit
7. Inability to comply with study procedures.
8. Alcohol or drug abuse. Healthy subject exclusion criteria

1. Cigarette smoking history \> 10 packyears 2. Diagnosed upper and/or lower respiratory disease(s). 3. Clinical or functional uncontrolled haematological, immunologic, renal, neurologic, hepatic, endocrinal or other disease, or any condition that mightp compromise the results or interpretation of the study.

4. Pregnant or lactating women 5. Participation in an interventional clinical trial \<12 weeks preceding baseline visit 6. Inability to comply with study procedures. 7. Alcohol or drug abuse.
Nutritional Status of Chinese Residents

In this study, we analyzed the nutritional status of Chinese residents aged above 6y. The indicators such as the hemoglobin, vitamin D, vitamin A and TG, TC and HDLC were also included. Related risk factors (such as age, region type, ethnicity, bodyweight, height, education, season, smoke habit, etc).


Eligibility Criteria:
Inclusion Criteria:

* Participanted in China national nutrition and health survey (CNNHS) 2010-2012; Aged above 6 years old; Had blood taken;

Exclusion Criteria:

* No.
Using Mean Ages on Clothing Size Labels in Revised Advanced Pediatric Life Support Formulas for Weight Estimation

Weight calculation based on age could be performed according to APLS (Advanced Pediatric Life Support) guideline recommendations in children requiring emergency treatment and intervention in the field or during resuscitation with no active weight and height measurements. The aim of the study is to investigate the suitability of weight calculation using mean ages on clothing size labels (ACL) to the actual weight in real emergencies with no known actual age of the patient (AA).

Weight calculation based on age could be performed according to APLS guideline recommendations in children requiring emergency treatment and intervention in the field or during resuscitation with no active weight and height measurements. Age formulas require only knowledge of the actual age of the child and widely used all over the world with being catchy. However, situations in which one has to intervene a child without having any patient data, including information on children's ages, especially in the field or during resuscitation are not uncommon. The objective of this study is to investigate the availability of age information contained in clothing size labels of children in weight calculation according to APLS recommendations. Usability of labels can protect victims from overdose and underdose problems in cases where the actual age is unknown and the measurements cannot be done

Eligibility Criteria:
Inclusion Criteria:

* All patients between 1-12 years of age who presented to the emergency department and agreed to participate in the study were consecutively included in the study

Exclusion Criteria:

* Age under 1 years and over 12.99 years
* No weighing in ED
* No clothing size label information
* Refused to participate
Direct Pulp Capping Agent on Human Pulp Tissue

This in- vivo study was conducted to evaluate the response of human pulp tissue following direct pulp capping using four different pulp capping agents in premolars scheduled for extraction in patients undergoing orthodontic treatment.

For the study 40 premolars from patients in the age group of 15-25 years, undergoing orthodontic treatment, in the Department of Orthodontics, MMCDSR, Mullana, Ambala, who had to get their premolars extracted as per their orthodontic treatment plan will be selected.

Only healthy premolars, with no caries, showing no signs and symptoms of pulpitis or periodontal diseases were selected. Medically compromised patients, or teeth with radiographic findings of external/internal resorption, bone loss, or calcifications in the pulp chamber will be excluded from the study. The selected premolars were then randomly divided into four equal groups namely: GROUP I - Direct pulp capping procedure performed using Biodentine. GROUP II - Direct pulp capping procedure performed using MTA. GROUP III - Direct pulp capping procedure performed using TheraCal LC. GROUP IV - Direct pulp capping procedure performed using Tristrontium aluminate.

The direct pulp capping procedure was carried out under rubber dam. The study protocol included class I cavity preparations on the premolars, followed by iatrogenic exposure of the pulp (0.5mm) using a sterile round bur, placement of the direct pulp capping agent according to the material of allotted to the study group. The teeth were permanently restored on the same visit, except for MTA group were the teeth were temporarily restored using Cavit G, and recalled after 1 day for permanent restoration. The patients were then enquired for any 94 SUMMARY 95 symptoms at 1 day and 7 days post operatively. The teeth were then, atraumatically extracted 3 months after the procedure. The extracted teeth were then put to CBCT as well as histopathological examination. Through CBCT evaluation, the completeness of the dentine bridge was evaluated. Histopathological examination was done to examine the pulpal response and the quality of the dentine bridge formed

Eligibility Criteria:
INCLUSION CRITERIA:

* CARIES-free, undamaged mature maxillary and mandibular premolars that were planned for extraction for orthodontic reasons.
* Teeth that show no reaction to percussion.
* Teeth with no previous restorations.
* Teeth that show vitality, when checked with an electric pulp tester.
* Teeth that show no signs of caries or periapical pathology when examined
* radiographically.
* Fully erupted teeth, that allowed proper application of rubber dam.

EXCLUSION CRITERIA:

* caries are present
* Teeth with signs and symptoms of irreversible pulpitis, such as nighttime severe pain
* or spontaneous pain.
* Teeth that show sensitivity to hot and/or cold.
* Radiographic examination reveals any signs of caries, periapical pathology,
* internal/external root resorption, furcal radiolucency/ inter-radicular bone destruction
* and/or calcifications in the pulp chamber or canals.
* Medically compromised patient.
* Pregnant patient.
Does Treximet Improve Productivity and Patient Satisfaction Due to Sustained Response and Consistency of Response?

Researchers want to learn about work productivity after treatment of a migraine headache with your usual migraine medication as compared to your work productivity after treatment with Treximet.

During this research subjects will take Treximet to treat 3 workday migraine attacks. For a second part of the research subjects will take their usual prescribed medication for 3 workday migraine attacks. The subjects will complete questionnaires after treating each migraine.

A subject who is identified for study participation will participate in the screening and enrollment visit which determines the migraine treatment arm to which the subject will be randomized first. The subject will have a physical exam, vital signs recorded, health and medication questions asked, questionnaires completed and a headache diary explained and dispensed to the subject. If the subject is randomized to the Treximet treatment arm during the first part of the study, Treximet will be dispensed for use in treating workday migraines.

The subject will call the study coordinator after treating a workday migraine and will report information about the migraine to the coordinator. When the subject has treated and reported on 3 migraines, the interim visit will be scheduled. The subject will bring the study diary and Treximet containers (if this was the arm the subject completed)to this visit. The subject will be asked about adverse events and medication changes as well as confirmation and review of the completed questionnaires and diaries from the prior weeks of study participation. The subject will be given new diaries and questionnaires (and Treximet to use if usual prescribed triptan was the treatment in the first arm) and repeat the activities to treat 3 more workday migraines.

When the subject has notified the study coordinator about treating the 3rd workday migraine in this part of the study, the subject will be scheduled for the final study visit. The subject will bring the completed migraine diaries, completed questionnaires (and Treximet bottles if used during this arm) to the study visit. The subject will have the diaries and questionnaires reviewed, be asked about adverse events and medication changes and complete the final study questionnaires at this visit.

Eligibility Criteria:
Inclusion Criteria:

* episodic migraine diagnosis
* age 18 or older
* currently using a triptan as primary migraine monotherapy
* currently employed
* if of childbearing potential, willing to prevent pregnancy during study participation
* able to understand and consent to study participation

Exclusion Criteria:

* younger than age 18
* not having episodic migraine diagnosis
* not using a triptan as primary migraine monotherapy
* not currently employed
* pregnant or nursing or unwilling to prevent pregnancy during study participation
* unable to understand and consent to study participation
Socio-aesthetic Intervention on Body Image and Quality of Life in Women With Breast Cancer.

The aim of this study is to evaluate the impact of a socio-aesthetic intervention on body image and quality of life in post-surgical patients with mastectomy or tumorectomy for breast cancer.Two groups of randomized subjects were constituted. Patients of the experimental group received 2 or 3 aesthetic care during the first post-surgical week, whereas those of the control group not. Body image, quality of life and diverse other personality variables were assessed at three different times: surgical operation day before, exit day before of hospitalization and three months afterwards. Our general hypothesis is that subjects who receive aesthetic care report levels significantly higher of corporal satisfaction and of quality of life at the end of the hospitalization and three months later than patients of the control group.


Eligibility Criteria:
Inclusion criteria:

First diagnosis of cancer and first surgical treatment for cancer Diagnosis of breast cancer

Exclusion criteria:

Psychiatric antecedents Inclusion in another psychosocial research