cyrilzakka/clinical-trials huggingface dataset:
Pharmacokinetics, Pharmacodynamics, And Safety Of Maraviroc (UK-427,857) In Patients With Human Immunodeficiency Virus

To investigate the relationship between the pharmacokinetics and pharmacodynamics of UK-427,857 and its antiviral effects in patients with human immunodeficiency virus (HIV).


Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria:

* Male with HIV or surgically sterilized female with HIV showing no symptoms of HIV
* Weight between 50 and 90kg and within the permitted range for their height

Exclusion Criteria:

Exclusion criteria:

* Subjects with a CD4 count less than 250cells/mm3 or HIV viral load of less than 5000 copies/mL
* Subjects with acquired immune deficiency syndrome (AIDS) or a previous AIDS diagnosis
* Subjects whose HIV infection has been diagnosed less than 3 months prior to screening, or for who there is evidence of recent seroconversion
* Subjects who have taken anti-retroviral drugs in the eight weeks prior to the study screening visit
Alveolar Cleft Reconstruction Using Bone Marrow Aspirate Concentrate and Allograft vs Iliac Cancellous Bone.

radiographic and clinical assessment of alveolar cleft grafting using Allograft mixed with BMAC compared to the standard protocol of anterior iliac crest cancellous bone grafting

In the study group BMAC is collected after processing of bone marrow aspirated from anterior iliac crest using a stab incision and a specialized trocar with no surgical intervention at donor site. The BMAC will be mixed with allow graft and used for alveolar cleft grafting

In the control group the standard protocol for alveolar cleft grafting will be used which is surgical exposure of the anterior iliac crest and harvesting of cancellous bone particles.

Eligibility Criteria:
Inclusion Criteria:

* alveolar cleft patients at the mixed dentition phase

Exclusion Criteria:

* patients with previous alveolar grafting intervention
Sodium Imbalance in Traumatic Brain Injury Patients: Prevalence, Predictors and Prognostic Significance in a Tertiary Care Centre

Observational study about prevalence, predictors of sodium imbalance and prognostic significance.


Eligibility Criteria:
Inclusion Criteria:

* adult and paediatric patients with isolated head injury

Exclusion Criteria:

* age more than 80 years, patient admitted after 24 hours of trauma, chronic kidney disease, chronic liver disease, associated chest trauma, abdominal trauma
Iressa as Second Line Therapy in Advanced NSCLC-Asia

This is a randomized, open-label, parallel group, phase III, multicenter, regional study. The total number of patients expected to be exposed to study procedures is approximately 150 patients will be recruited by investigational sites throughout the Asia Pacific region that have expertise in treating patients with NSCLC.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed non-small cell bronchogenic carcinoma: adenocarcinoma (including bronchoalveolar), squamous cell carcinoma, large cell carcinoma or mixed (adenocarcinoma and squamous) or undifferentiated carcinoma.
* WHO Performance status 0-2
* NSCLC - locally advanced (Stage IIIB) or metastatic (stage IV) disease, not amenable to curative surgery or radiotherapy
* Life expectancy of 12 weeks.

Exclusion Criteria:

* ALT/AST: \>2.5x ULRR if no demonstrable liver metastases or greater than 5 x ULRR in the presence of liver.
* Inadequate bone marrow function; Absolute neutrophil count: \<1.5 x 109/L, Platelets: \< 100 x 109/L
* Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma of skin or cervical cancer in situ
A Single Dose Study of KHK6640 in Japanese Patients With Alzheimer's Disease.

The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of KHK6640, given as a single dose in Japanese patients with Mild to Moderate Alzheimer's Disease.


Eligibility Criteria:
Inclusion Criteria:

* Patients with mild to moderate Alzheimer's Disease
* Body weight ≥ 40 kg and \< 100 kg
* Clinical Dementia Rating (CDR) score of 1 or 2
* Mini Mental State Examination (MMSE) score of ≥ 17 amd ≤ 26

Exclusion Criteria:

* Previous active treatment with an Alzheimer's Disease immunotherapy in an investigational study
* Use of another investigational drug within 4 months prior to the enrollment
* Subjects who meet National Institute of Neurological Disorders and Stroke/Association Internationale pour la Recherche et l'Enseignement en Neurosciences (NINDS/AIREN) criteria for vascular dementia
* Subjects with a history of presence of clinically significant seizures, brain trauma, transient ischemic attack, and/or cerebrovascular disease
* Subjects with a presence of a neurological condition that could be contributing to cognitive impairment above and beyond that caused by the subject's Alzheimer's Disease
* Subjects who have evidence of infection, tumor, or other clinically significant lesions that could indicate a dementia diagnosis other than Alzheimer's Disease
Efficiency of Neuromuscular Bite vs Physiotherapy in TMD Patients

Temporomandibular joint dysfunction (TMD) therapy remains an open challenge for modern dentistry. Usually physiotherapy is considered a reliable approach to treatment of TMD patients. Moreover, neuromuscular bites (orthotic) are able to reduce signs and symptoms of TMD. To our knowledge, no specific trials have been designed for the evaluation of the efficiency of physiotherapy vs neuromuscular bites in TMD patients.

The aim of this trial is to evaluate the efficiency in term of cranial muscles electromyography (sEMG), mandibular kinetic (KNG) and subjective pain scores, of orthotic vs manual physiotherapy therapy compared to placebo.


Eligibility Criteria:
Inclusion Criteria:

* myogenous TMD;
* pain duration longer than 3 months;
* presence of complete permanent dentition, with the possible exception of the third molars;
* normal occlusion.

Exclusion Criteria:

Patients were excluded from the study if they met one or more of the following criteria:

* presence of systemic or metabolic diseases;
* eye diseases or visual defects;
* history of local or general trauma;
* neurological or psychiatric disorders;
* muscular diseases;
* cervical pain;
* bruxism, as diagnosed by the presence of parafunctional facets and/or anamnesis of parafunctional tooth clenching and/or grinding;
* pregnancy;
* assumed use of anti-inflammatory, analgesic, anti-depressant, opioid, or myorelaxant - - drugs;
* smoking;
* fixed or removable prostheses;
* fixed restorations that affected the occlusal surfaces;
* and either previous or concurrent orthodontic or orthognathic treatment. For comparison with previous literature, the diagnosis of myofascial-type TMD was provided after clinical examination by a trained clinician according to group 1a and 1b of the Research Diagnostic Criteria for TMD (RDC/TMD), in a blinded manner
Comparison of 1,550 and 755 Laser in a Split-face Trial

Clinical Trial comparing the 1,550-nanometer fractionated photothermolysis system laser to the 755 nanometer picosecond laser using a split-face (Right-Left) comparison. Patients will receive laser treatments at week 0, week 4, and week 8. Photographs will be taken prior to laser treatment at each visit, and at the week 24 follow-up visit. Photographs will be reviewed by blinded assessors to rate each side of the face and change from baseline photos.

This is a Clinical Trial comparing the 1,550-nanometer fractionated photothermolysis system laser to the 755 nanometer picosecond laser using a split-face (Right-Left) comparison. Both of these lasers are currently FDA approved for acne scarring.

Approximately 18 subjects, men and women with Fitzpatrick skin types I through V and facial acne scarring of grades III-IV (moderate to severe) will be enrolled. Both sides of the participants' face should have similar amount and severity of acne scarring. Participants will be over 18 years old. Patients have to be otherwise healthy without a history of skin cancer, keloidal scarring, localized or active infection, immunodeficiency disorders, and light sensitivity.

Patients have to be overall healthy without a history of skin cancer, keloidal scarring, localized or active infection, immunodeficiency disorders, and light sensitivity. Per PI discretion, any serious medical condition that may interfere with the study. In addition, patients who have been taking isotretinoin for a period of 6 months before treatment will be excluded.

Patients will have photographs taken at every visit prior to the laser treatments at week 0, week 4, and week 8. Photographs will also be taken at the week 24 follow-up visit. Photos will then be assessed by qualified blinded reviewers for comparison.

Eligibility Criteria:
Inclusion Criteria:

* Men and women with Fitzpatrick skin types I through V and facial acne scarring of grades III-IV (moderate to severe) will be enrolled. Both sides of the participants' face should have similar amount and severity of acne scarring. Participants will be over 18 years old. Patients have to be otherwise healthy without a history of skin cancer, keloidal scarring, localized or active infection, immunodeficiency disorders, and light sensitivity.

Exclusion Criteria:

* Patients have to be overall healthy without a history of skin cancer, keloidal scarring, localized or active infection, immunodeficiency disorders, and light sensitivity. Per PI discretion, any serious medical condition that may interfere with the study. In addition, patients who have been taking isotretinoin for a period of 6 months before treatment will be excluded.
Study on Prevention and Treatment of Dry Eye in Patients Using Glaucoma Drops

A multicenter randomized controlled trial on prevention and treatment of ocular surface injury and meibomian gland dysfunction in patients using anti-glaucoma eye drops.

1. To compare the efficacy of drug therapy (sodium hyaluronate + sodium bromide) and combined therapy (combined with meibomian gland massage based on drug therapy) on drug-induced dry eye caused by long-term use of anti glaucoma drugs; 2. To evaluate the efficacy of sodium hyaluronate in the prevention of ocular surface and meibomian gland dysfunction and structural damage in the early stage of patients using anti glaucoma eye drops.

Eligibility Criteria:
Inclusion Criteria:

* 18-80 years of age, diagnosed with glaucoma, including primary open-angle glaucoma or primary angle closure glaucoma, require treatment with anti-glaucoma eye drops.
* A group: Patients using glaucoma eye drops longer than 6 months, and in accordance with the diagnostic criteria of dry eye:

  1. Subjective symptoms (required): dryness, foreign body sensation, fatigue and discomfort;
  2. The instability of tear film (required): tear break up time (TBUT);
  3. Lacrimal secretion: Schirmer I test;
  4. The ocular surface damage (strengthen diagnosis): fluorescein staining (FL); in the mentioned in ①+②（TBUT≤5s) or ①+②（TBUT≤10s)+③（\<10mm）/④（FL+）。
* The choice of study eyes: Choose the eye of the patient with low basical intraocular pressure, and if the basal intraocular pressure is the same, choose the right eye for the study.
* Voluntary participation in this clinical study, and signed informed consent.

Exclusion Criteria:

* With metabolic diseases, autoimmune diseases, connective tissue diseases, such as diabetes, rheumatoid arthritis, multiple sclerosis, systemic lupus erythematosus, Sjogren's syndrome eat;
* Combined with cerebrovascular, liver, kidney, hematopoietic serious system desease, atumor diseases and psychosis.
* Using any artificial tears and except any clinical trials of dry eyes within two weeks.
* With drug therapy, embolization and surgical treatment of dry eyes.
* With other eye diseases, such as eyelid defects, hypophasis, pterygium, chronic dacryocystitis, trichiasis, corneal lesions.
All Polyethylene Tibia-VEGA Kiel

Obligatory Post-Marketing Clinical Follow-up (PMCF) as part of the post marketing surveillance plan for the product under investigation For this PMCF only CE-marked medical devices will be used within their intended purpose and no additional invasive or other stressful examinations are to be carried out (acc. to MPG §23b).

This non-interventional clinical study (NIS) is conducted to clinically confirm the safety and performance of the Aesculap® APT VEGA System® PS components under routine conditions. The VEGA System® PS is an established TKA design, and there is a long-lasting experience in the use of PE for TKA in general and for APT components in particular; thus a NIS is thought to be sufficient to give the required confirmation. For this NIS only CE-marked medical devices will be used within their intended purpose and no additional invasive or other stressful examinations are to be carried out (acc. to MPG §23b). As part of the post marketing surveillance plan an obligatory Post-Marketing Clinical Follow-up (PMCF) is required for the product under investigation.

Eligibility Criteria:
Inclusion Criteria:

* Patients requiring primary TKA because of severe knee joint conditions that cannot be treated through other therapies;
* degenerative osteoarthritis;
* rheumatoid arthritis;
* posttraumatic arthritis;
* symptomatic knee instability;
* knee stiffness or deformation of the knee joint;
* Age ≥ 18 years;
* Patient signed informed consent

Exclusion Criteria:

* Age younger than 18 years
* Any prior joint replacement at the index knee
* Unable or unwilling to return for postoperative follow-up
* Patient did not sign informed consent
* Joint conditions that can be treated by reconstructive surgery (e.g. osteotomy)
* Acute or chronic infections near the joint, or systemic infections
* Secondary diseases that could influence joint implant functionality
* Systemic diseases and metabolic disorders
* Severe osteoporosis or osteomalacia
* Severely damaged bone structures that could prevent stable implantation of implant components
* Bone tumors in the region of implant fixation
* Bone malformations, axial misalignments or other bone conditions that rule out implantation of a prosthetic joint
* Expected overload on the joint implant, especially due to high patient weight or intense physical strain and activity
* Dependency on pharmaceutical drugs, drug abuse, or alcoholism
* Fever, infection or inflammation (systemic or local)
* Pregnancy
* Mental illness
* Severe osteopenia (or any other medical or surgical finding) that would preclude any benefit from the implants
* Combination with implant components from other manufacturers
* Inadequate patient compliance
* Foreign body sensitivity to the implant materials
* All cases not listed under indications
Effect of Different Doses of SAR110894 on Cognition in Patients With Mild to Moderate Alzheimer's Disease on Donepezil

Primary Objective:

- To demonstrate the efficacy of at least one dose of SAR110894 (H3 receptor antagonist) in comparison to placebo on cognitive performance in patients with mild to moderate Alzheimer's disease (AD) while on stable donepezil therapy

Secondary Objectives:

* To explore the effect of SAR110894 on functional impairment, global clinical status and behavioral disturbances;
* To assess the safety/tolerability of SAR110894;
* To assess pharmacokinetic (PK) of SAR110894 and concentrations of donepezil;
* To explore caregiver time consumption and distress changes.

The total study duration for each patient is approximatively 36 - 38 weeks broken down as follows:

* Screening period: up to 4 weeks,
* Treatment period: 24 weeks,
* Follow-up period: 10 weeks.

Eligibility Criteria:
Inclusion criteria:

* Patients with diagnosis of Alzheimer's Disease (AD) (Cannot be dementia from strokes or other causes).
* Patient is on stable and well-tolerated donepezil treatment at a dose of either 5 or 10 mg daily for at least 3 months prior to screening visit.

Exclusion criteria:

* Age \<55 years old.
* Psychotic features, agitation, or behavioral problems within the last 3 months.
* Patients unable to comply with ophthalmologic monitoring.
* Lack of consistent and reliable caregiver.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Randomized, Double-blind Study for the Evaluation of the Effect of Losartan Versus Placebo on Aortic Root Dilatation in Patients With Marfan Syndrome Under Treatment With Beta-blockers

To study the effect of losartan (an angiotensin receptor blocker-ARB) on aortic root growth in patients with Marfan syndrome, already treated with beta-blockers (BB). The effect of losartan will be compared to placebo. Losartan or placebo will be added to the treatment regimen in a two-step up-titration scheme over 2 weeks. Start doses of Losartan will be 25 mg for subjects under 50kg of weight and 50mg if the weight is over 50kg. Uptitration will be guided by the tolerance of the drug by the patients. Patients will be contacted by phone call for assessment of side-effects before second step of uptitration.

Daily maximal doses of Losartan will be 50mg for subjects under 50kg of weight and 100mg if the weight is over 50kg


Eligibility Criteria:
Inclusion Criteria:

* Patients \> 10 years
* Diagnosis of MFS, according to the Ghent criteria and/or genetically proven FBN1 mutations or linkage
* Consent obtained (written) either for the patient and for his/her parents (\<18y
* Z-score of the aorta at the level of the sinus of Valsalva ≥2 (BSA adjusted)
* ARB naïve patients

Exclusion Criteria:

* Poor echocardiographic window,limiting the accurate measurement of the aortic root
* Contra-indication for ARB: Bilateral renal artery stenosis, renal function abnormalities (creatinine above normal for age), hyperkalemia
* Intolerance for ARB (eg angioedema)
* Pregnancy or breast feeding women
* Absence of effective contraception
* Liver function abnormalities
* Heart Failure
* Patients included in other clinical trial
Cognitive-Motor Rehabilitation, Stimulant Drugs, and Active Control in the Treatment of ADHD

The investigators administered a randomized controlled trial (RCT) through random assignment of children with ADHD into three different groups to compare the effects of cognitive-motor rehabilitation, immediate release methylphenidate, and an active control on the executive functioning, learning, and behavioral symptoms of children with ADHD.


Eligibility Criteria:
Inclusion Criteria:

* Receiving ADHD diagnosis
* aged between 9 and 12 years
* Intelligence Quotient (IQ)\>90

Exclusion Criteria:

* Severe co-morbid disorders, such as depression, op-positional defiant disorder and conduct disorder
* A history of seizures during past 2 years
* Disability or handicap preventing the child from participating cognitive-motor exercises
* Sever medical conditions requiring immediate medical treatment
Prevalence Study of Iron Deficiency in Patients With Cancer

Despite its high prevalence, a recent study conducted by Prof. Cacoub (unpublished) on the french national health insurance database showed that iron deficiency was an underdiagnosed and under-treated co-morbidity. In inflammatory situations, especially during cancer, the measurement of the transferrin saturation factor is only performed in about 10% of cases whereas this measure is recommended in inflammatory situations including cancer (French Health High Authority 2011)


Eligibility Criteria:
Inclusion Criteria:

* Patient, male or female, over the age of 18
* Patient in an oncology department (any type of tumor, any type of treatment, initiated or not)
* Patient affiliated or beneficiary of a social security system
* Patient with written consent

Exclusion Criteria:

* Protected patient: major under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision
* Patient hospitalized without consent
Physiological Strain in Young Adults During a Simulated Heat Wave

The likelihood of exposure to overheated indoor environments is increasing as climate change is exacerbating the frequency and severity of hot weather and extreme heat events. Prolonged exposure to excessive heat stress can result in a deterioration in physiological function leading to a myriad of pathophysiological conditions (e.g., heat exhaustion, acute kidney injury, adverse cardiovascular events, heat stroke) that if left untreated can lead to death. While the relationship between extreme heat events and human health has been assessed in relation to outdoor exposure to high heat conditions, relatively little is known about the effects of daylong exposures to indoor overheating on the body's physiology.

In this study, investigators will examine the change in physiological responses (i.e., thermal, cardiovascular) in young (18-35 years) adults exposed to successive days and nights of high indoor temperatures typical of conditions recording in dwellings without air conditioning during the 2021 Western Heat Dome. Specifically, study participants will be housed in a large environmental chamber (outfitted with bed, work space, sitting area, kitchen and bathroom) for three successive days (three days and two nights) while exposed to indoor overheating where daytime temperatures will be maintained at 36°C (45% relative humidity; note: 36°C, temperatures experienced in homes without air-conditioning) for a 10-hour daytime exposure period (DAYTIME: defined as the time period from 9:00 to 19:00). For the nighttime exposure period (NIGHTTIME: defined as the time period from 19:00 to 9:00), participants will be exposed to nighttime temperatures fixed at 31°C (45% relative humidity; note: reductions in indoor temperatures during the nighttime in large urban centers range between 4-6°C). Participants will be permitted to move freely throughout the day in the chamber, but will be restricted from performing any physical activity except for the completion of a battery of tests (cardiovascular, cognitive and posture assessments performed prior to (as performed between 7:00 and 9:00) and the end (as performed between 17:00 and 19:00) of the daytime exposure). During the nighttime period, participants will be permitted to move freely until they decide to go to bed.


Eligibility Criteria:
Inclusion Criteria:

* Non-smoking.
* English or French speaking.
* Ability to provide informed consent.

Exclusion Criteria:

* Chronic health conditions.
* Endurance trained
* Regular exposure to heat (e.g., hot baths, sauna, regular exercise in the heat, recent vacation to area with high temperature).
Dupilumab Phase 4 Study

The investigators will monitor for the incidence of adverse-events in a prospective, longitudinal, non-interventional and observational real-world sub-study of adults patients with moderate-to-severe AD who are receiving dupilumab as standard-of-care therapy.

The investigators will conduct a prospective, longitudinal, non-interventional and observational sub-study of patients receiving dupilumab as normal standard-of-care treatment to assess the efficacy (Specific Aim #1) and safety (Specific Aim #2) of dupilumab for the treatment of moderate-to-severe AD, as well as the prevention and/or mitigation of comorbid health conditions (Specific Aim #3). This study will address the hypotheses that dupilumab will lead to improved long-term control and decreased severity of AD, and that long-term monitoring will shed light on the incidence of adverse drug events.

Eligibility Criteria:
Inclusion Criteria:

* Individuals aged 18 and over who have been diagnosed with Atopic Dermatitis and are using dupilumab therapy as part of standard of care.
* Parents of adolescents ages 12 to 17 who have been diagnosed with Atopic Dermatitis and are receiving dupilumab off-label for the management of AD.

Exclusion Criteria:

* Patients not on dupilumab
* Those who do not comply with the study requirements
* Those who do not provide informed consent