cyrilzakka/clinical-trials huggingface dataset:
Histologic Response to UVA and UVB Exposure During the Use of Sunscreen

Anti-inflammatory and anti-oxidant agents have become the important ingredients in sunscreen. However, there is no histologic study about the effects of anti-inflammatory and anti-oxidative properties of sunscreen to prevent premature aging from UVA and UVB.

Premature aging can be prevented by using sunscreen. Currently, anti-inflammatory and anti-oxidant agents have become the important ingredients in sunscreen. However, there is no histologic study about the effects of anti-inflammatory and anti-oxidative properties of sunscreen to prevent premature aging from UVA and UVB.

Eligibility Criteria:
Inclusion Criteria:

* subjects aged 35-65 years who were scheduled for abdominoplasty
* the excised area should be larger than 18x10 cm2
* no skin diseases or lesions on the excised area
* no topical treatment on excised area more than 1 month prior to this study

Exclusion Criteria:

* pregnancy
* lactation
* have tattoo or striae distensae on abdomen
Study of Indacaterol Dosed in the Evening in Patients With Chronic Obstructive Pulmonary Disease (COPD)

This study was conducted to provide detailed information on the efficacy of indacaterol (in terms of the spirometry assessment forced expiratory volume in 1 second \[FEV1\]) over the full 24-h time period


Eligibility Criteria:
Inclusion criteria:

* Male and female adults aged ≥ 40 years, who have signed an Informed Consent Form prior to initiation of any study-related procedure
* Co-operative outpatients with a diagnosis of chronic obstructive pulmonary disease (COPD) (moderate to severe as classified by the Global initiative for chronic obstructive lung disease (GOLD) Guidelines, 2006) and:
* Smoking history of at least 20 pack years
* Post-bronchodilator FEV1 \< 80% and ≥30% of the predicted normal value
* Post-bronchodilator FEV1/forced vital capacity (FVC) \< 70%

Exclusion criteria:

* Pregnant or lactating females
* Patients who have been hospitalized for a COPD exacerbation in the 6 weeks prior to Visit 1 or during the run-in period
* Patients requiring long term oxygen therapy (\>15 h a day)
* Patient who have had a respiratory tract infection 6 weeks prior to V2 (with further criteria)
* Patients with concomitant pulmonary disease, pulmonary tuberculosis, or clinically significant bronchiectasis
* Patients with history of asthma (with further criteria)
* Patients with Type I or uncontrolled type II diabetes.
* Patients who have clinically relevant laboratory abnormalities or a clinically significant abnormality
* Any patient with active cancer or a history of cancer with less than 5 years disease free survival time
* Patient with a history with long QT syndrome or whose QTc interval is prolonged
* Patients with a hypersensitivity to any of the study drugs or drugs with similar chemical structure
* Patients who have had treatment with an investigational drug (with further criteria)
* Patients who have had live attenuated vaccination within 30 days prior to Visit 2, or during run-in period
* Patients with known history of non compliance to medication
* Patients unable to satisfactorily use a dry powder inhaler device or perform spirometry measurements

Other protocol-defined inclusion/exclusion criteria may apply
Screening Muscle Strength in Arthroscopic Surgery of the Hip

Hypothesis We hypothesise that hip muscle strength can predict the outcome of hip arthroscopy. A relationship between strength and outcome can improve the success of the procedure and avoid unnecessary and potentially harmful surgery.

Objectives The primary objective is to evaluate the relationship between hip muscle strength and outcomes of hip arthroscopy. The secondary objective is to determine a 'threshold strength' above which the operation becomes successful. If this relationship is established, it would launching a randomised control trial with targeted physiotherapy as the intervention.

Background Hip arthroscopy is key-hole surgery to the hip joint which is performed for femoroacetabular impingement; a condition which describes a shape mismatch between the ball-and-socket hip joint. The number of procedures is increasing, however, studies have shown success in only half of patients undergoing the procedure.

Several factors have been linked with outcomes; however, the influence of muscle strength has never been investigated. We performed a systematic review of this topic, revealing that muscles around affected hips are significantly weaker. We also developed a standardised protocol for the measurement of muscle strength.

Plan Patients awaiting hip arthroscopy will undergo muscle strength testing pre- and post-operatively. There will be no deviation of treatment from their NHS care. Validated outcome measure questionnaires will be completed at five months post-operatively. Magnetic resonance imaging and electromyography tests will be performed on a subset of patients post-operatively.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18-45 years with evidence of FAI on MRI scan (the standard method of imaging of the condition in the NHS)
* Competent to consent to study participation

Exclusion Criteria:

* Established osteoarthritis with evidence of osteophytes (Tonnis grade \>2)
* Patient with hip dysplasia (centre-edge-angle \<20 degrees)
* Patients with full thickness cartilage (chondral) lesions
* Previous diagnosis of mental health disorder
* Failure to comply with Addenbrooke's hospital post-operative rehabilitation exercises tailored to hip arthroscopy
Growth Hormone Treatment in Men With High Risk of Developing Type 2 Diabetes Mellitus

The overall aim of this study is to investigate the effects of GH treatment in men with the Metabolic Syndrome and a high risk of developing type 2 DM.

Forty men with abdominal obesity and impaired glucose tolerance will be randomized to two parallel treatment groups with GH and placebo for 12 months.

The subjects will receive treatment with recombinant human GH (Genotropin®) or placebo administered by a daily s.c. injection before bedtime. The initial dose of GH will be 0.4 IU per day increased to 0.8 IU after 2 weeks and to 1.2 IU after 4 weeks of treatment. Thus, the target dose is 1.2 IU per day which resembles approximately 0.015 IU/kg/day. The GH dose will be reduced by half in the event of side-effects. Oral and written instructions in terms of administration and dosage will be given.

The treatment can be discontinued by the patient. The treatment should be discontinued if malignancy is discovered, DM developes, if the subject experience a cerebrovascular disease and in the event of any other side-effects that is considered as serious.

The treatment code for each subject included in the trial will be kept at the Sahlgrenska University Hospital Pharmacy. This code can be broken on the request of the investigator.

Compliance will be assessed by collecting empty vials from the study subjects. The treatment is discontinued at the end of the study.


Eligibility Criteria:
Inclusion Criteria:

* Fasting plasma glucose level ≥ 6.1 and ≤ 7.8 mmol/L (IFG) and/or a plasma glucose 2 hours after a 75g oral glucose load between 6.9-11.0 mmol/L (IGT).
* BMI \> 25 kg/m2.
* Waist/hip ratio \> 0.95

Exclusion Criteria:

* Proliferative diabetic retinopathy.
* Macro-albuminuri and/or serum creatinine \>150mmol/L
* Known ischemic heart disease, previous stroke or claudicatio intermittence.
* Known malignancy.
* Other hormonal therapy.
Risk Factors and Prevention of Severe Pain Upon Cessation of a Peripheral Nerve Block

Risk factors and Prevention of severe Pain upon cessation of a peripheral nerve block. A prospective randomized study in ambulatory patients undergoing upper limb bone surgery under single shot axillary plexus block.

Pain in the course of upper limb bone surgery is a major source of discomfort for patients during postoperative time.

Severe post-operative pain is a risk factor for chronic pain. Use of a well-known molecule, regularly used in anesthesiology. Prospective double-blind study on 120 patients. Pain rebound upon awakening of the axillary plexus during upper limb bone surgery is a frequent phenomenon in post-operative follow-up of patients.

The anti-hyperalgesic properties of ketamine could be a benefit against this effect.

No studies have combined intravenous ketamine with localoregional anesthesia to reduce pain upon its release.

This may improve patients' post-operative comfort. The patients will be randomized in 2 groups and allocated to receive (slow intravenous injection) either 0.3 mg/kg intravenous ketamine diluted into 10mL saline or 10 mL 0.9% saline after the realization of PNB, before tourniquet set up and beginning of surgery.

Eligibility Criteria:
Inclusion Criteria:

* any ambulatory upper limb bone surgery carried out under axillary PNB

Exclusion Criteria:

* Refusal to participate
* Contraindication to the use of ketamine
* Contraindication to regular use of postoperative analgesics like non-steroidal anti-inflammatory drugs and paracetamol
* Pregnant woman
* Diabetic patient
* Vascular patient
* Cognitive disorders
* Inability to answer perioperative questionnaires (language problem)
Intravenous Fluids in Hospitalised Children

The main objective of the trial is to evaluate the risk of hypokalemia following administration of a isotonic solution compared to a hypotonic solution in acutely ill hospitalised children, who need intravenous fluid therapy.

The main objective of the trial is to evaluate the risk of hypokalemia (low plasma potassium concentration) following administration of a Plasmalyte Glucos 50 mg/mL solution compared to a 0.45% saline in 5% dextrose solution in acutely ill hospitalised children, who need intravenous fluid therapy. The secondary objective of the trial is to evaluate the risk of hyponatremia (low plasma sodium concentration) and the risk of hypernatremia (high plasma sodium concentration) following administration of isotonic solution compared to hypotonic solution.

Eligibility Criteria:
Inclusion Criteria:

* Acutely ill hospitalised children
* Need for intravenous fluid therapy

Exclusion Criteria:

* An initial plasma sodium concentration of lower than 130 mmol/L
* An initial plasma sodium concentration of higher than 150 mmol/L
* An initial plasma potassium concentration of lower than 3.0 mmol/L
* Need for 10% glucose solution
* Diabetes
* Diabetes insipidus
* Diabetic ketoacidosis
* Renal disease that needs dialysis
* Protocol-determined chemotherapy hydration
* Severe liver disease
* Inborn errors of metabolism that need protocol-determined fluid therapy
A Trial of Dexmedetomidine Hydrochloride Nasal Spray in Preoperative Sedation of Children

The study is being conducted to evaluate the efficacy, and safety of dexmedetomidine hydrochloride nasal spray for preoperative sedation in children.


Eligibility Criteria:
Inclusion Criteria:

1. Able and willing to provide a written informed consent
2. Male or female
3. Subjects requiring elective general anesthesia surgery
4. Conform to the ASA Physical Status Classification
5. Meet the weight standard

Exclusion Criteria:

1. Not suitable for nasal spray
2. Pediatric populations requiring special care or court/social welfare supervision
3. Subjects who had been under general anesthesia when they were randomized
4. Subjects with a history of mental illness and a history of cognitive impairment epilepsy
5. Subjects with cardiovascular disease
6. Subjects whose hemoglobin is below the lower limit of normal
7. Subjects with a history or possibility of a difficult airway
8. Abnormal liver function and/or abnormal renal function
9. Adrenoceptor agonists or antagonists or analgesics were used before randomization
10. Participated in clinical trials (received experimental drugs)
11. History of hypersensitivity to drug ingredients or components
12. Other circumstances that the investigator judged inappropriate for participation in this clinical trial
Re-Evaluation of the Effects of High PEEP During General Anesthesia For Surgery (REPEAT)

Aiming to understand the isolated impact of high PEEP in patients undergoing mechanical ventilation for general anesthesia for surgery, three appropriately sized international multicentre randomized controlled trials have been performed over recent years: the 'PROtective Ventilation using HIgh versus LOw PEEP trial (PROVHILO), the 'individualized PeRioperative Open-lung Ventilation trial' (iPROVE), and the 'Protective intraoperative ventilation with higher versus lower levels of positive end-expiratory pressure in obese patients trial' (PROBESE). These three trials had several similarities in key areas of their study protocols, inclusion and exclusion criteria, and collected data, and even the primary and secondary outcomes. Of note, the three trials combined high PEEP with recruitment manoeuvres. This allows an individual patient data meta-analysis.


Eligibility Criteria:
Inclusion Criteria:

- Enrolled into one of the three studies (PROVHILO, iPROVE or PROBESE) to either high PEEP or low PEEP
Stimulating Private Sector Malaria Control

Preliminary evidence from ongoing research provides strong indications that protecting farmers from malaria would be profitable for outgrowing agribusinesses in sub-Saharan Africa. The study team invests in experimental research to investigate this conjecture in more detail.

The study evaluates whether the sourcing of insecticide-treated nets and their distribution to smallholder farmers for free would be a profitable investment for a cotton outgrowing agribusiness in Zambia.

The study therefore carries out a major net distribution through the existing distribution channels of a cotton outgrowing agribusiness, evaluates the impact of this distribution on smallholder cotton yields, and values the profitability implications for the outgrowing agribusiness.

Eligibility Criteria:
Inclusion Criteria:

* Farmers who contracted with the participating cotton outgrowing company in the 2010-2011 season
Can Intermittent Fasting Mimic the Metabolic and Cardiovascular and Anti-aging Effects of Calorie Restriction?

The purpose of Intermittent Fasting study is to investigate whether intermittent fasting could decrease the chronic inflammation levels in overweight/obese people.

The primary objective of this study is to determine whether or not IF reduces the level of chronic inflammation as evidenced by a decrease in high sensitive C-reactive protein (hsCRP), as the main outcome measure

Eligibility Criteria:
Inclusion Criteria:

* The participants in this study will be 50 men and women in the 30 to 65 year age range, who have a BMI in the high normal to moderately obese range (i.e. 24 to 35 kg/m2),
* Participants who are eating usual US diets and are sedentary to moderately active (i.e. not exercise trained).

Exclusion Criteria:

* History of any chronic disease process that could interfere with interpretation of results
* Smoking, pregnancy, alcoholism, psychiatric problems, life situations that would interfere with study participation and compliance.
eDoula Feasibility and Acceptability

eDoula is an app that will give patients reading material and videos to watch based on their due date. It also provides helpful postpartum guidance. First, patients without access to the app will be recruited and surveyed on their labor and satisfaction outcomes. Then, recruitment will begin for the intervention arm of the study. Participants will be recruited to use the app and complete a survey during the postpartum period.


Eligibility Criteria:
Inclusion Criteria:

* Nulliparous
* Singleton pregnancy
* English speaking
* Own a smart phone or other device capable of downloading and running the eDoula app
* Delivered at 36 weeks 0 days gestation or later
* Able to labor

Exclusion Criteria:

* Planned cesarean delivery
* Pregnancy complications including placenta accreta spectrum, vasa previa, intrauterine fetal demise, or known major fetal anomaly
* Delivery planned at a location other than Oregon Health and Science University
A Study to Determine the Safety and Tolerability of Dupilumab (REGN668/SAR231893) in Patients Aged ≥6 to <18 Years With Atopic Dermatitis (Eczema)

The primary objective of the study is to characterize the safety and pharmacokinetics (PK) of dupilumab in pediatric patients with moderate-to-severe atopic dermatitis (AD) (for adolescents ≥12 to \<18 years of age) or severe AD (for children ≥6 to \<12 years of age).

The secondary objective of the study is to explore the immunogenicity and efficacy of dupilumab in pediatric patients with moderate-to-severe AD (for adolescents ≥12 to \<18 years of age) or severe AD (for children ≥6 to \<12 years of age).


Eligibility Criteria:
Key Inclusion Criteria:

1. Male or female patients ≥6 to \<18 years of age with a diagnosis of 1. Atopic Dermatitis whose disease cannot be adequately controlled with topical medications
2. Minimum disease severity, as defined by Investigator's Global Assessment (IGA)

   1. IGA = 3 or 4 in adolescents ≥12 to \<18 year of age
   2. IGA = 4 in children ≥6 to \<12 years of age

Key Exclusion Criteria:

1. Recent treatment (within specific time windows before the baseline visit) with systemic immunosuppressive agents for eg. Systemic corticosteroids, live (attenuated) vaccines and other investigational drugs including biologics
2. History of any of the following infections:

   1. Any systemic infection requiring treatment within 4 weeks before the baseline visit
   2. Superficial skin infections within 1 week before the baseline visit
   3. Known history of HIV infection
   4. History of seropositivity to hepatitis B or C screening tests
   5. History of clinical endoparasitosis (ie, helminthic infection) within 12 months before the baseline visit, or high risk of helminthic infection, unless subsequent medical assessments (e.g. stool exam, blood tests, etc.) have ruled out the possibility of parasite infection/infestation
3. History of malignancy within 5 years before the baseline visit
4. Persistent (confirmed by repeated tests ≥2 weeks apart) elevated transaminases (alanine aminotransferase \[ALT\] and/or aspartate aminotransferase \[AST\]) more than 3 times the upper limit of normal (ULN) during the screening period
5. Presence of any severe concomitant illness(es) that, in the investigator's judgment, would adversely affect the patient's participation in the study
6. Presence of skin comorbidities that may interfere with study assessments
7. Females patients who are pregnant or breastfeeding
8. Female patients who are of reproductive potential and are sexually active, who are unwilling to use adequate methods of contraception
Assesment by Ultrasonography of the Perineal-cephalic Distance

The practice of ultrasounds increases in delivery rooms every year. Indeed, this method can help to visualize elements that may not be observable after clinical examination. Moreover, it is known that a fetal head engagement can lead to an instrumental extraction and in case of error, which happens in some cases, fetal and maternal risks are possible.

These elements led to the investigators' hypothesis which is that a trans-perineal ultrasonography may facilitate the evaluation of a clinical fetal head engagement in case of doubt.

It's a monocentric, transversal, clinical trial regarding women giving birth at the GHICL's hospital Saint Vincent de Paul.

Clinical examinations will be done by the midwives following the indications given on the clinical form. A trans-perineal echography will then be done by technical operators following the ultrasonography form.

These examinations will only last a few minutes, no further tests will be done afterwards.

Eligibility Criteria:
Inclusion Criteria:

* Patients of 18 years old or older
* Primiparous
* Complete dilation of the cervix
* Gestational age of 37 weeks or more according to the date of amenorrhea - - Rupture of membranes
* Fetus in cephalic presentation
* Patient who has signed a consent form

Exclusion Criteria

* Patient for whom the fetus has died in uteri
* Patient who's coming for an abortion
* Fetus in breech or transverse presentation
* Gemellary pregnancy for which the fetus present a severe cardiac anomaly
* Patient under trusteeship or guardianship
Impact of Vitamin D Supplementation on Cardiac Structure and Function

The VITamin D and OmegA-3 TriaL (VITAL; NCT 01169259) is a randomized clinical trial in 20,000 U.S. men and women investigating whether taking daily dietary supplements of vitamin D3 (2000 IU) or fish oil (1 gram of omega-3 fatty acids) reduces the risk of developing cancer, heart disease, and stroke in people who do not have a prior history of these illnesses. This ancillary study (VITAL-Echo) is being conducted among participants in VITAL and will examine whether vitamin D compared to placebo: (1) reduces left ventricular (LV) mass in elderly individuals as measured with 2-dimensional echocardiography and (2) improves LV systolic and diastolic function as measured with tissue Doppler echocardiography.

Recognition of the biological effects of vitamin D on cardiovascular function has been growing. The main objective of the parent trial (VITAL) is to evaluate the effects of vitamin D on cardiac events but is focused on atherothrombotic events and does not specifically address vitamin D effects on LV mass. In ambulatory individuals, LV mass is a key cardiac structural feature and increases in LV mass are frequently accompanied by diastolic dysfunction. This study leverages the existing infrastructure of the parent VITAL trial to perform cardiac imaging studies on a subset of subjects who will be randomized to vitamin D3 (n=500) or placebo (n=500). Echocardiography is a noninvasive, widely accessible tool to evaluate cardiac structure and function. Cardiac echo imaging visits will take place at baseline (pre-randomization), and then after 2 years, at the Massachusetts General Hospital (MGH). The acronym VITAL-Echo reflects the link to the parent VITAL trial and an ancillary investigation of vitamin D versus placebo on LV mass and function as measured by echocardiography. The effect of fish oil supplementation on these parameters will be evaluated as a secondary endpoint, thereby taking advantage of the factorial design of the parent trial.

Eligibility Criteria:
Participants in VITAL (NCT 01169259) who meet the following criteria are eligible to participate in this ancillary study:

Inclusion:

* Willingness to participate in ancillary study of VITAL to undergo cardiac echocardiography (baseline and at 3 years) and sign informed consent to participate in the ancillary study
* Live in the greater Boston area (within 60 miles of MGH)

Exclusion:

* Have a pacemaker, prosthetic valve(s), surgical wires or other devices that could alter the echocardiographic image findings.
The Effects of Laughter Therapy on Hemodialysis on Depression

End stage kidney disease is associated with increased depression. Laughter is associated with improvement in depression in chronic disease. The study objective was to measure the effect of intradialytic group laughter therapy on anxiety and depression. Pragmatic randomized controlled trial conducted in 10 hemodialysis centers in Northern California. The intervention group received a once weekly 30-minute long group laughter therapy session for 8 weeks. Primary outcome was depression score as measured using the Patient Health Questionnaire.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of end stage kidney disease (ESKD) and currently undergoing hemodialysis at a Satellite Healthcare Hemodialysis Center
* Ability to understand English

Exclusion Criteria:

* Cognitive impairment