cyrilzakka/clinical-trials huggingface dataset:
Microbial Sampling of Carious Dentin

The School of Dentistry is seeking to determine whether viable microorganisms remain within tooth structure after conventional, mechanical removal of areas of tooth decay, prior to placement or replacement of tooth restorations (fillings). The long-term goal of the work is to decrease the failure rate, and therefore increase the longevity, of tooth restorations (fillings) in human patients and populations.

It is proposed that with informed consent, and in a sterile operating environment (controlled, micron level-filtered environmental air flow, in addition to conventional instrument sterilization) dental patient volunteers will have either areas of decayed tooth structure or recurrent caries defective fillings removed using conventional, routine procedures, which will include: local anesthesia; tooth isolation using rubber dam; removal of superficial decay, weakened tooth structure or defective filling materials with rotary tooth cutting instruments; and then removal of softened dentin using sterile sharp spoon excavators, by hand. The limit of dentin removal will be determined by the clinician's estimate of tooth hardness, that is, using present conventional and ethical practice. This last step, removal of tissue guided by estimated hardness, is as described above the universally accepted standard.

Following removal, the exposed dentin surface will be examined visually with an 15X operating microscope to detect any areas of discolored dentin. Any such areas will be micro-sampled using ultra slow-speed, 0.2 mm diameter rotary cutting instruments and removal of resultant dentin flakes with sterile fibers. Each prepared cavity will then be restored using conventional tooth filling materials and techniques.

Immediately after removal each dentin flake will be weighed, placed into bacterial transport medium, then sonicated. The transport medium will be divided in two, and separate samples added to bacterial growth medium under anaerobic and aerobic growth conditions. Any viable microorganisms detected will be identified both by conventional plating techniques using visual identification, and by a commercial laboratory using RNA analysis.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18-99, Male or Female, No significant systemic illness

Exclusion Criteria:

* Diabetic, Hypertensive, Pregnant
Unaffected Hand in Hemiplegia

The primary aim of our study is to evaluate the functional status of the unaffected hand in hemiplegic patients. The secondary aims are to compare the functional states of the unaffected hand between right and left hemiplegias, and to evaluate the relationships between the functional status of the unaffected hand and the healing phase of the hemiplegic side and activities of daily living.

This cross-sectional study included 30 right hemiplegic and 30 left hemiplegic patients with a history of ischemic cerebrovascular accident (CVA) in the last 1 year and 30 healthy volunteers as a control group.

Participants' data on age, gender, height, weight, comorbidities, time after stroke, and affected body half were recorded. In the patient group, the stages for the upper extremity and hand were evaluated according to the Brunnstrom recovery stages. Afterwards, the participants' hand grip strengths were evaluated with a Jamar type hand dynamometer, pinch strengths with a pinchmeter, and hand dexerity with the Nine Hole Peg Test (NHPT). Evaluations were made in the unaffected hand in the patient groups and in both hands in the control group. The Lawton Instrumental Activities of Daily Living Scale (Lawton-IADL) and the Functional Independence Measure (FIM) were applied to the patient groups.


Eligibility Criteria:
Inclusion Criteria:

This cross-sectional study included 30 right hemiplegic and 30 left hemiplegic patients with a history of ischemic cerebrovascular accident (CVA) in the last 1 year and 30 healthy volunteers as a control group. All patients and healthy volunteers were right hand dominant.

Exclusion Criteria:

Patients with a history of CVA in the last 1 month, bilateral hemispheric ischemic lesion, moderate/severe cognitive impairment, aphasia, neglect, and patients/healthy volunteers with severe systemic, inflammatory, degenerative and neurological diseases that may lead to loss of hand functions, a history of surgery or trauma in the upper extremity in the last 3 months, and younger than 18 years of age were excluded.
Topical Rapamycin to Erase Angiofibromas in TSC

The study is a multi-center prospective, randomized, double-blind, placebo-controlled evaluation of the safety and efficacy of a topically applied formulation of rapamycin to cutaneous angiofibromas in subjects with Tuberous Sclerosis Complex (TSC). Subjects will apply either the topical vehicle containing rapamycin or the topical vehicle alone nightly to their angiofibromas for six months.

The primary goal of this study is to evaluate the efficacy of the topical medication for reduction of cutaneous angiofibromas in patients with TSC. The secondary goal of this study is to confirm the safety of the topical medication.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must be willing and able to comply with all trial requirements.
* Subject has a diagnosis of TSC and has visible facial angiofibromas.
* Female subjects of child bearing potential must not be pregnant and must agree to use appropriate contraceptive methods .

Exclusion Criteria:

* Subject is currently receiving therapy with Rapamycin.
* Subject is receiving any form of immunosuppression or has previously experienced immune dysfunction.
* Subject is currently participating in or has participated within the last 30 days in a clinical trial involving an investigational drug.
* Subject has a known hypersensitivity to either the vehicle or Rapamycin.
* Subject is a pregnant or nursing female.
* Subject has other dermatologic conditions that would preclude or prevent adequate assessment of changes to their facial angiofibromas.
* Subject has had laser surgery, cryotherapy, or other dermatologic treatment to their facial angiofibromas within the previous 6 months.
Exploring the Use of myfood24 (an Online Nutritional Assessment Tool) in Clinical Dietetic Practice

Dietary assessment is a key component of the dietetic care process. Assessments usually take place within dietetic consultations using methods such as 24-hour recall and paper food diaries. This study will examine the feasibility of using an online dietary assessment tool, myfood24 as an alternative to current dietary assessment practices and explore the barriers and facilitators to its use within dietetic clinical practice. This will be a mixed method study using questionnaires and semi structures interviews with both dietitians and patients. Dietitians, and patients with a range of clinical conditions referred to an NHS Dietetic Service, will be recruited. Patients will be asked to trial the system to record their food intake prior to their dietetic appointment. This data will then be used for the dietary assessment within the consultation. Following this, patients and dietitians will be interviewed about their experiences. Quantitative data will be statistically analysed, and thematic analysis will be used to analyse qualitative data.


Eligibility Criteria:
Inclusion Criteria:

* Aged over 18 years
* Referred to the STH Dietetic Department
* Willing and able to attend a dietetic out-patient appointment
* Can read and understand English
* Have access to the internet
* Willing to engage in technology as part of their care
* Have or willing to obtain their own email address

Exclusion Criteria:

* Under 18 years
* Unable or unwilling to attend a dietetic out-patient appointment
* Unable to read and understand English
* No access to the internet
* Unwilling to engage in technology as part of their care
* Does not have or unwilling to obtain their own email address
Prenatal Screening of Intestinal Malrotation With a Higher Risk of Volvulus.

Digestive malrotation is an anatomical anomaly of the positionning of the mesenteric vessels and the digestive tract that can lead in some form to a dangerous neonatal complication: intestinal volvulus. This requires emergency surgery with a risk of digestive resection. Visualizing during pregnancy the normal or abnormal anatomical positionning of the mesenteric vessels could make it possible to diagnose this malrotation and prevent the occurrence of this complication.

The aim of the study is to study the neonatal outcome of fetus confirm to have an abnormal positionning of mesenteric vessels


Eligibility Criteria:
Inclusion criteria:

* Pregnant women attending for 2nd trimester ultrasound
* Abnormal positionning of mesenteric vessels
* No other foetal malformation
* Singleton pregnancy
* Age \>18 years

Exclusion criteria:

* Chromosomal abnormality
* polymalformative syndrom
* Foetal malformation changing intestine disposition (gastroschisis, diaphragmatic hernia, heterotaxis...)
Rollover Study of Weekly Paclitaxel (BMS-181339) in Patients With Advanced Breast Cancer

The purpose of this study is to evaluate the safety and efficacy of continued administration of paclitaxel given weekly in subjects considered to need to continue treatment after completion of the preceding "Phase II Clinical Study of Weekly Paclitaxel (BMS-181339) with Advanced Breast Cancer (Protocol No. CA139-371)"


Eligibility Criteria:
Inclusion Criteria:

* Subjects who were confirmed to have a response after receiving at least two courses of weekly paclitaxel therapy and considered to need to continue the therapy by the investigator/subinvestigator among the patients with advanced or recurrent breast cancer who had met the selection criteria and participated in the preceding phase II clinical study
Postoperative Analgesic Effects of Using Dexmedetomidine for Ultrasound Guided Thoracic Paravertebral Block

we aimed postoperative analgesic effects of using bupivacaine alone or added dexmedetomidine for ultrasound guided thoracic paravertebral block in thoracotomy

paravertebral block is commonly used in the treatment for acute and chronic pain.The duration of paravertebral block could theoretically be prolonged with neurolytic agents. Dexmedetomidine ,an alfa-2 adrenoreceptor agonist, is being used and adjuvant capable of prolonging duration of sensory and motor block on nerve blocks.

Eligibility Criteria:
Inclusion Criteria:

* ASA 1-2
* 18-65 aged
* patient undergoing thoracotomy

Exclusion Criteria:

* chronic opioid consumption
* bupivacaine and dexmedetomidine allergies
* coagulopathy
* infection at the needle insertion side
* chronic liver and kidney disease
Effect of Green Tea Extract on Type 2 Diabetes

The purpose of this study is to examine the effect of green tea extract (GTE) on type 2 diabetes and to explore the relationship between GTE and related hormone peptides.

Green tea is one of the most popular beverages in the world. It is believed to have beneficial effects in prevention and treatment of many diseases, one of which is anti-obesity and anti-diabetes.

The benefit effects of green tea are mainly attributed to its polyphenol content, especially the most abundant one-epigallocatechin gallate (EGCG), which might inhibit adipocyte proliferation and differentiation in vitro studies

We hypothesized that GTE would improve insulin resistance in type 2 overweight diabetes and related hormone peptides will be influenced. Thus, we conducted this randomized clinical trial to examine the effect of GTE on type 2 diabetes and to explore the relationship between GTE and related hormone peptides.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes
* Body mass index \>25 kg/mm
* Aged between 20 and 65 years
* Being Chinese

Exclusion Criteria:

* Aminotransferases aspartate or aminotransferases alanine \> 80 IU/L, serum creatinine \> 2.0 mg/dl,
* Prolating or pregnant women, and patients with heart failure, acute myocardiac infarct, stroke and heavy injuries, and
* Any other conditions not suitable for trial as evaluated by the physician.
Could Apnea Induce Hypoalgesia?

A randomized controlled trial (RCT) in healthy subjects will be conducted with the following aims: (1) Explore the effect of low pulmonary volume dynamic apnoea bouts on Pressure Pain Threshold (PPT) and conditioned pain modulation (CPM); (2) analyse whether CPM response correlates with apnoea induced hypoalgesia; (3) examine the association between apnoea bouts, Rate of Perceived Exertion, hypoxemia and Heart Rate changes in PPT.

A randomized controlled trial (RCT) in healthy subjects will be conducted with the following aims: (1) Explore the effect of low pulmonary volume dynamic apnoea bouts on Pressure Pain Threshold (PPT) and conditioned pain modulation (CPM); (2) analyse whether CPM response correlates with apnoea induced hypoalgesia; (3) examine the association between apnoea bouts Rate of Perceived Exertion, hypoxemia and Heart Rate changes in PPT

Eligibility Criteria:
Inclusion Criteria:

* Healthy participants
* 18-30 years
* Currently pain-free
* Basal SpO2 ≥95%

Exclusion Criteria:

* Diabetes diagnosis
* Hypertension or hypotension diagnosis
* Pharmacological treatment
* Frequent pain during last month
* Drug consumption
* Self-harming behaviours
* Pregnant or potentially pregnant
* Cardiac or respiratory pathology
* Splenectomy or spleen disease
* Having performed moderate or high intensity physical activity 24 hours prior to the study
* Not having slept the previous night
* Alcohol intake 24 hours prior to study.
Vascular Responses to High vs Low Repetition Resistance Exercise Training in Young Men

This study evaluates the effects of two types of resistance exercise training (higher-repetition, lower load vs lower-repetition, higher load vs control) on regional and local measures of arterial stiffness in trained young men.


Eligibility Criteria:
Inclusion Criteria:

* Male
* Aged 18-30 years old
* Non-obese (Body mass index less than 30 kg/m2)
* Non-smoker
* Healthy based on questionnaire responses
* Resistance trained (Resistance training \> 2 times per week for 2 years, minimum 1 lower body exercise session per week)

Exclusion Criteria:

* Allergies to milk proteins (whey or casein)
* Any acute or chronic illness, cardiac, pulmonary, liver, or kidney abnormalities, uncontrolled hypertension, insulin- or non-insulin dependent diabetes or other metabolic disorders-all ascertained through medical history screening questionnaires
* Arthritic conditions
* Individuals who consume any analgesic or anti-inflammatory drug(s), prescription or non- prescription, chronically will be excluded
* A history of neuromuscular problems
* Individuals on any medications known to affect protein metabolism (i.e. corticosteroids, non-steroidal anti-inflammatories, or prescription strength acne medications).
Determination of Glycaemic Index and Insulinaemic Index Values of 6 Food Products in 3 Separate Research Centers

The purpose of this study is to determine and compare the glycaemic index values and response parameters of 6 food products between 3 laboratories.

This study will be performed at 3 centers and 15 subjects will be recruited at each center.

Eligibility Criteria:
Inclusion Criteria:

1. Aged 18-35 years inclusive.
2. Non-smoker.
3. BMI 19.0-25.0 kg/m2 inclusive.
4. Healthy subjects with:

   * Fasting plasma glucose \< 5,6 mM (ADA criteria,2011)
   * Insulin resistance index based on homeostasis model assessment (HOMA-IR) \<1.70
   * Fasting lipids: triglyceride \<1.70mmol/L, LDL-cholesterol\<5.00 mmol/L and HDL-cholesterol \>1.03mmol/L for males or \>1.29mmol/L for females (IDF criteria for metabolic syndrome, 2006)
   * Gamma-GT, AST and ALT \<1.5 times the upper limit of normal (ULN)
   * Complete blood count: Normal full blood count according to the investigator
   * Systolic blood pressure \<130 mmHg
   * Diastolic blood pressure \<85 mmHg
   * Resting heart rate 50-90 beats per minutes (after 3 minutes rest).
5. Stable dietary habits; normal eating patterns; no history of eating disorders or strict dieting.
6. Moderate level of physical activity (from basic daily activity to a high level of physical activity (regular physical activity at least 3 times per week))
7. Able to fast for at least 10 hours the night before each test session.
8. Able to refrain from eating legumes and drinking alcohol the day before each test session.
9. Subject covered by social security or covered by a similar system
10. Subject not taking any treatment for anorexia, weight loss, or any form of treatment likely to interfere with metabolism or dietary habits
11. Subject having given written consent to take part in the study

Exclusion Criteria:

1. Following a restrictive or specific diet.
2. Suffering from any inflammatory or metabolic diseases
3. Suffering from mental illness.
4. Suffering from any food allergies or hypersensitivities (wheat, milk, egg, nuts, etc).
5. Taking any regular prescription medication at the time of inclusion that should interfere with carbohydrate metabolism (except regular oral contraception medication, thyroid replacement therapy)
6. Female who is pregnant (positive test results), lactating, planning pregnancy or not using acceptable contraceptive.
7. Subject having taken part in another clinical trial within the last week.
8. Subject currently taking part in another clinical trial or being in the exclusion period of another clinical trial.
9. Subject undergoing general anaesthesia in the month prior to inclusion.
10. Subject in a situation which in the investigator's opinion could interfere with optimal participation in the present study or could constitute a special risk for the subject.
Acoustic Structures Crying of Infants From 1 to 4 Months and Their Signification

Crying is a survival mechanism for babies and their almost exclusive means of expression until the age of 4 months. Babies 'cry is mostly related to pain, a feeling of hunger, discomfort or separation following the departure of a parent around. Crying is a complex but essential means of communication and information between a baby and his parents that raises the question of their meaning.

The cry phenomenon consists of complex acoustic signals produced by the vocal cords and filtered by the vocal tract. The vibrations frequency determines the fundamental frequency, itself responsible for the perception of the cry tone (pitch). The frequency spectrum of a cry is modified during the passage through the upper airways forming broad bands called "resonance frequency" or "formants".

From the specificity of a crying sequence, it is possible to extract dynamic information and relate it to the perception that the adult has of it. Thus dynamic crying is often perceived by the adult as an imminent need of the baby.

Some studies have shown that a child's crying may change according to his degree of discomfort, suggesting that crying was a "graduated signal" whose frequency and timbre could vary along a continuum. These changes would explain why adult listeners would be able to dissociate crying babies of different intensities.

Conversely, an inappropriate response to crying could gradually generate disorders of the relationship between the baby and the parent.

However, despite their potential neuro-ethological interest, knowledge of information transmitted by babies's cry remains superficial. This could be related to the relatively obsolete techniques of recording or due to the lack of objective physiological data on babies 'cry. Finally, the perception and reactions of adults when they hear crying babies are not fully understood.

The objective of this study is to evaluate acoustic structures crying of infants from 1 to 4 months for to study individual acoustic signature.

Eligibility Criteria:
Inclusion Criteria:

* any safe term infants (\> 37SA)
* eutrophic and in good health
* infants sleeping in bed with bars without baby nest
* form signed by the holder of parental authority.
* Parents affiliated to a social security scheme
* Parents who to live in cities of Saint-Etienne, Villars, Saint Priest-en-Jarez, Etrat and Saint Jean-Bonnefonds, France

Exclusion Criteria:

* inter-uterine growth restriction
* antenatal neurological pathologies or at birth
* perinatal asphyxial encephalopathy
* antenatal pathologies (e.g. trisomy 21, hydrocephalus...)
* multiple pregnancy
ChloraPrep Versus Betadine for Elective Knee Replacement Surgery

This study will enroll patients who will be receiving primary total knee replacements. Subjects will be randomized into two groups: Betadine surgical scrub preparation and ChloraPrep preparation prior to total knee replacements.

Study hypothesis: When used as a surgical scrub preparation prior to primary total knee arthroplasties, ChloraPrep (2% chlorhexadine gluconate and 70% isopropyl alcohol) is superior to Betadine (10% povidone iodine) in reducing incision site bacterial colony counts.

Swabs will be taken over the operative knee by study personnel for a bacterial colony count immediately before surgical site preparation is started, after the surgery prep is complete, and 24 hours post surgery prep. Swabs will be sent to the lab for quantitative colony counts and all 3 measurements will be compared and analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled to undergo primary total knee arthroplasty
* Age 18 or over

Exclusion Criteria:

* Inability to provide informed consent or to comply with study assessments due to cognitive impairment or geographic distance
* Age 17 or younger
* Allergies to chlorhexadine gluconate or povidone iodine
* Topical antimicrobial use within 14 days of surgery
* Any active dermatoses or open wounds over the operative site
* Any condition requiring antibiotics 14 days prior to arriving for surgery
* Patients with chronic immunosuppression (such as HIV/AIDS)
* Unable to adhere to follow up schedule and treatment
Effects of Dietary Fibre on Glucose Metabolism and Satiety

The experimental model is a semi-acute study where the purpose of the study is to evaluate food factors related to colonially derived regulation of glucose metabolism (and related parameters) and satiety in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Normal fasting blood glucose, BMI 19-25 kg/m2

Exclusion Criteria:

* Gastrointestinal diseases or food allergies e.g. lactose-, gluten intolerance, metabolic disorders e.g. diabetes, tobacco/snuff users. Antibiotic or probiotic usage within two weeks, and during study. Vegetarians.