cyrilzakka/clinical-trials huggingface dataset:
A Study of the Excretion Balance of Radiocarbon and the Pharmacokinetics and Metabolic Profile of TRO19622 (Olesoxime)

This Phase I study is designed to determine the excretion balance of radiocarbon, as the sum of carbon-14 (14C)-labeled TRO19622 and its 14C-metabolites, and to investigate the pharmacokinetics and metabolic profile of TRO19622 (olesoxime) in healthy participants.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) 20.0 to 28.0 kilograms per meter-squared (kg/m\^2) and body weight at least 60 kilograms (kg)
* Fitzpatrick skin type less than (\<) 4
* Good health according to medical history, physical examination, laboratory parameters, vital signs, and 12-lead electrocardiogram (ECG)
* Negative urine test for drugs of abuse
* Negative alcohol breath test
* Negative tests for hepatitis or human immunodeficiency virus (HIV)
* Use of effective contraception during and for 3 months beyond study participant, among sexually active non-vasectomized participants with females partners of childbearing potential

Exclusion Criteria:

* Concomitant or recent medication use within 2 weeks prior to Day 1, except for paracetamol
* Use of enzyme-inducing drugs within 2 months prior to Day 1
* Any medical condition that may alter the pharmacokinetics of olesoxime or affect interpretation of study results
* Irregular bowel movements
* Drug addiction or alcoholism
* Use of nicotine products
* Participation in another clinical study within 12 weeks prior to Day 1
* Exposure to ionizing radiation within one year prior to Day 1
MK-5442 in the Treatment of Osteoporosis in Postmenopausal Women Previously Treated With an Oral Bisphosphonate (MK-5442-012)

This study seeks to demonstrate that additional gain in bone mineral density (BMD) can be achieved by switching to MK-5442 from an oral bisphosphonate in participants who have been receiving oral bisphosphonate therapy for at least 3 years.

The study was originally planned for a duration of 2 years and included efficacy analysis of a 15 mg MK-5442 treatment arm. Amendment 1 of the protocol eliminated the 2nd year of the study as well the 15-mg arm. Enrollment into the 15-mg MK-5442 arm was stopped as a result of the amendment and all participants who had been randomly assigned to the MK-5442 15-mg treatment arm were discontinued from the study.

Eligibility Criteria:
Inclusion Criteria:

* Taking oral bisphosphonate treatment for osteoporosis for at least 3 of the past 4 years. At present, and for the past 12 months, treated with alendronate
* Bone Mineral Density (BMD) T-score that is ≤ -1.5 at one or more of the following anatomic sites; lumbar spine, femoral neck, trochanter, and total hip, AND a BMD T-score at all of these sites that is ≥ -4.0, AND a history of at least one fragility fracture, OR, a BMD T-score that is ≤ -2.5 at one or more of the following anatomic sites; lumbar spine, femoral neck, trochanter, and total hip, AND a BMD T-score at all of these sites that is ≥ -4.0
* Postmenopausal for at least 5 years

Exclusion Criteria:

* Obesity (ie, weight greater than 250 pounds) that prohibits the use of dual-emission X-ray absorptiometry (DXA)
* Received intravenous (IV) bisphosphonates, fluoride treatment at a dose \>1 mg/day for more than 2 weeks, strontium, growth hormone, a cathepsin K (CTSK) inhibitor, or a receptor activator of nuclear factor kappa-B ligand (RANKL) inhibitor at any time in the past
* Use of oral bisphosphonates other than alendronate in the last 12 months, parathyroid hormone (PTH) in the last 24 months, cyclosporin for more than 2 weeks in the last 6 months, heparin in the last 2 weeks, or anabolic steroids or glucocorticoids for more than 2 weeks in the past 6 months
* Use of estrogen with or without progestin or a selective estrogen receptor modulator (SERM) in the last 6 months or calcitonin in the last 30 days
* Has used pioglitazone hydrochloride or rosiglitazone hydrochloride in the last 6 months
* Taking more than 10,000 International Units (IU) vitamin A daily or more than 5,000 IU vitamin D daily
* Has had a total thyroidectomy
* History of Paget's disease
* Has human immunodeficiency virus (HIV)
* History of cancer in the last 5 years, except certain skin or cervical cancers
* History of major upper gastrointestinal (GI) mucosal erosive disease
* Unable to adhere to dosing instructions for alendronate in regard to fasting and positioning
* Not ambulatory
Abnormal Placenta Plant Disease Early Diagnosis and Individualized Treatment Research

As the "two-child" policy implementation, caesarean women's clinical pregnancy is a huge problem again, Especially the placenta planting abnormal disease is a serious threat to the maternal health and life. Through this research, the investigators can obtain relevant epidemiological data and provide objective data for the department of public health policy; Predicting an placenta abnormal planting early diagnosis model was constructed, it will fill the blank in this field, and high-risk groups in the early stages of pregnancy will be taken proper disposal, the related complications will be reduced to ensure the safety of maternal.

This study focus on four hands: (1) to investigate different types of gestational sac implantation for pregnancy in caesarean women of childbearing age;(2) to explore the relationship between abnormal placenta planting disease in middle-late pregnancy and the different types of scar pregnancy (3) to explore the the value of ultrasound and serological markers for early diagnosis of placenta planting disease from scar pregnancy; (4) to compare the end and the influence of health economy of different termination method on scar pregnancy.

Eligibility Criteria:
Inclusion Criteria:

* Single pregnancies with once cesarean section history
* see a doctor before gestational 8 weeks in our study center
* will continue to pregnancy, high patient compliance

Exclusion Criteria:

* twins or multiple pregnancies
* hysteromyoma or adenomyoma stripping history
* history of intrauterine adhesions
Effectiveness of Intraoperative Neuromonitoring of External Branch of Superior Laryngeal Nerve During Thyroid Surgery

The paralysis of the external branch of superior laryngeal nerves after thyroid surgery is known to be a common complication resulting in poor quality of life. Aim of this randomized control trial(RCT) is to evaluate effectiveness of neuromonitoring during thyroid surgery for the preservation of these nerves.

The external branch of superior laryngeal nerves(EBSLNs) are important for voice quality. Injury to this nerve during thyroid surgery can manifest as ipsilateral paralysis of the cricothyroid muscle. Clinical symptoms may include: hoarseness, breathy voice, an increase in the rate of throat clearing, vocal fatigue, or diminished vocal frequency range, especially with regards to raising pitch. The amount of EBSLNs identified intraoperatively varies from 10% to 80%, while the rate of EBSLN injury reported in the literature is between 5% and 28%, depending on different evaluation methods. Advances in intraoperative neuromonitoring techniques would allow for EBSLN identification during thyroid surgery. However, there is controversy regarding usefulness in preserving EBSLN function using nerve monitoring system. The aim of the study is to evaluate effectiveness of neuromonitoring during thyroid surgery for the preservation of EBSLNs.

Eligibility Criteria:
Inclusion Criteria:

* planned open thyroidectomy
* acceptable clinical laboratory tests
* understand clinical trials
* no significant past medical history

Exclusion Criteria:

* planned radical neck dissection
* hyperthyroidism history
* history of laryngeal nerve palsy
* laryngeal disease history
* uncontrolled hypertension or diabetes mellitus or heart disease
* anticoagulation or antiplatelet medication
* stroke history
* participated another clinical trials in 30days
The Relationship Between Activity Energy Expenditure and Body Composition in School-age Children

Obesity is increasing rapidly all over the world not only in adults but also among children. As a modifiable component of total energy expenditure (TEE) ,the amount of energy expended during physical activity plays an important role in preventing weight gain. Decreased physical activity, coupled with an over-consumption of calories, lead to the change of body composition by storing energy as fat.Although several studies have simultaneously examined body composition with energy expenditure the independent roles of body composition with activity energy expenditure (AEE) are less firmly established. It's suspected shrewdly that energy expenditure is partly influenced by the body composition. The aim of the study is to examine the relation of AEE with body composition in a population of school-age children.

Body composition (ie. FAT% and FFM) will be evaluated by means of bioelectrical impedance analysis (BIA) with Inbody 720 (Biospace, Seoul, South Korea). Anthropometric dimensions will be recorded for all participants according to standard procedures. Height will be recorded to the nearest 1.0mm by using a field stadiometer (Seca Corporation, Germany). FitMate metabolic system (Cosmed, Rome, Italy) will be used to estimate AEE. Subjects will be tested in a 10-minute submaximal exercise test using the FitMate systems while taking cycling test at 50 Watts on an electrically braked bicycle ergometer. Each subject will be connected to a calibrated respiratory gas analyzer, a portable metabolic analyzer designed for measurement of oxygen consumption during exercise via a face mask. Heart rate will be simultaneously measured with the use of a Cosmed wireless HR monitor to track the participant's heart rate level.

Eligibility Criteria:
Inclusion Criteria:

* Children in Shanghai

Exclusion Criteria:

* cardiovascular disease
* asthma
* severe disease conditions such as cancer and renal failure
* taking steroids (corticosteroids) or antidepressants
A Study of Tildrakizumab in the Treatment of Genital Psoriasis (CZATCH-Genital-PsO)

The main aim of this study is to check the safety and effectiveness of tildrakizumab regarding the alleviation of symptoms in the genital area after administration according to the summary of product characteristics (SmPC) and to access overall treatment safety and quality of life assessed on multiple scales.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of psoriasis, with significant involvement of genital regions, i.e., sPGA-G greater than or equal to (\>=) 3.
* Need for systemic biologic therapy based on the local country specific regulations. Tildrakizumab, in accordance with the SmPC, must be the anti-IL23p19 selected therapy before including the patient in the study.
* Age 18 - 99 years.
* Informed consent in writing in accordance with applicable country regulations
* Patient must have plaque psoriasis affecting a body surface area (BSA) \>= 1% in a non-genital area at baseline.
* Patient willing and able to fill out study questionnaires.

Exclusion Criteria:

* Patient appears to be unwilling or unable to comply with the requirements of the study or who, in the opinion of the investigator, should not participate in the study.
* Patient exposed to any experimental treatment in the past 3 months prior to baseline.
* Any condition preventing prescription of Tildrakizumab according to the SmPC, including but not restricted to any contraindication or history of hypersensitivity or intolerance.
* Patient dependent on the investigator, including but not restricted to employees of the study site.
* Previous treatment with Tildrakizumab.
Effect of Lumbar Stabilization Exercises and Circular Dances in Chronic Non Specific Low Back Pain

Supervised exercises are the first line therapy for patients with chronic low back pain. The lumbar segmental stabilization (LSE) is a specific training for the muscles of the lumbar spine, which aims to improve neuromuscular control, strength and endurance of the muscles that promotes stability to the spine. The circular dance (CD) belongs to the group of complementary and integrative practices entered in Public Health Care in Brazil, and has been used to improve several aspects related to physical and mental states such as flexibility, posture, strength and muscular endurance, awareness or scheme body, pain control and strains. There are few studies evaluating the circular dance effect on back pain. The aim of this study is to compare the effects of lumbar stabilization exercises and circular dance for improvement in non specific low back pain in middle-aged women.

OBJECTIVE: To compare the effect of CD with ESL exercises on pain and functional disability in women with nonspecific chronic low back pain (DLCI). METHOD: Thirty-eight women, aged 35-60 years, were randomly assigned to two groups: 1) Circular Dance group (gDC); 2) Lumbar Stabilization Exercise group (gESL). The primary clinical outcomes were pain, assessed using the Numerical Pain Scale and functional disability by the Roland Morris Disability Questionnaire and the secondary outcomes were: Depression assessed by the Beck Depression Inventory; Anxiety by the Numerical Anxiety Scale; Global Perception with the Global Effect Perception Scale, Signs and Symptoms of Adverse Effects analyzed by the Collective Subject Discourse and Quality of Life method using the Short-Form Health Survey Questionnaire (SF-36). The groups were treated twice a week for 60 minutes for 8 weeks totaling 16 sessions. Each participant was assessed before and after treatment and at follow-up 12 and 24 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Diagnose of non specific low back pain for a period of three months without radiculopathy symptoms
* Seek treatment

Exclusion Criteria:

* Inflammatory disorders of the spine
* Spinal tumors
* Spine surgery
* Unconsolidated fractures or malunion of the spine
* Rheumatologic disease
* Spondylolysis or spondylolisthesis
* Patients who are in labor dispute
* Patients undergoing physical therapy or drug treatment to opioid-based
Pilot Study of Myocardial Effects Following an Endurance Race

Ten healthy subjects perform a baseline computer tomography (CT) of the heart and routine laboratory blood tests for myocardial injury and inflammation.

The same data are collected \<24 hours after an endurance race corresponding to a maraton run (i.e. about 40 km of running and/or about 2.5 hours hard training or more). A third collection of lab tests and CT is done a couple of weeks after the race. Magnetic resonance imaging is also performed in parallell to the CT on occasions 2 and 3 in most subjects, serving as a reference for determination of myocardial blood flow.

Ten healthy subjects perform a baseline computer tomography (CT) of the heart and routine laboratory blood tests (troponin T, hs-CRP, CK-mb etc) for myocardial injury and inflammation.

The same data are collected \<24 hours after an endurance race corresponding to a maraton run (i.e. about 40 km of running and/or about 2.5 hours hard training or more). A third collection of lab tests and CT is done a couple of weeks after the race. Magnetic resonance imaging (MRI) is also performed in parallell to the CT on occasions 2 and 3 in most subjects, serving as a reference for determination of myocardial blood flow. The CT of the heart includes contrast injection and blood flow will be determined by a recently developed based on very powerful computers using "machine learning".

Eligibility Criteria:
Inclusion Criteria:

Healthy subjects, experienced in long distance running

Exclusion Criteria:

Significant renal, kidney, heart, liver or musculoskeletal disease.
Discriminating Ability of the Cirrus High Definition (HD) Optical Coherence Tomography (OCT) for Glaucoma

The Cirrus HD OCT, a new spectral domain optical coherence tomography, has better resolution than the previous OCT. Reproducibility and discriminating ability of the Cirrus HD OCT for glaucoma detection will be studied.

The Cirrus HD OCT is a newly developed imaging device of the spectral domain optical coherence tomography. Even though its resolution and speed are much better than the previous OCT, its reproducibility and diagnostic power for detecting the glaucomatous defect of retinal nerve fiber layer (RNFL) have not known yet. In the present study, we will review the data of RNFL thickness measurement using the Cirrus HD OCT. After assessing the inter-test variability, the discriminating ability of the Cirrus HD OCT for glaucoma diagnosis will be determined by the ROC curves.

Eligibility Criteria:
Inclusion Criteria:

* Cooperative patients
* Repeated OCT data

Exclusion Criteria:

* Intraocular surgeries history
* DM
* High refractive error ( \< -4.00 diopters, or \> + 4.00 diopters)
* Media opacity
Study Of The Safety And Efficacy Video Assisted Submandibular Gland Resection Using A New Two Step Technique

The study addresses a problem that face surgeons who perform key-hole surgery to resect the submandibular salivary gland. The problem is the narrow space available around that gland. This does not allow for a safe operation. The study aims to evaluate a new, two step resection technique, that should overcome this difficulty.

The study included twelve adult patients suffering from chronic submandibular sialadenitis and indicated for sialadenectomy. The following exclusion criteria were adopted: Previous history of surgery or irradiation to the neck; History of abscess formation in the region; Patients having large, hard or fixed submandibular gland and where there was suspicion of malignancy. Laboratory work-up and ultrasound of the neck were obtained.All patients had video assisted submandibular sialadenectomy, using a "two step resection" technique as follows:Step 1: A 15 to 20 mm skin incision was performedThe edges of the wound are protected using a rubber cuff. The dissection is done using the harmonic scalpel in one hand and the suction spatula in the other hand. The anterior part of the gland is then dissected off the mylohyoid muscle. The plane of the dissected anterior pole of the gland is used as a guide. This plane is followed all around the gland until the whole superficial part of the gland is dissected free. Step 2: The retractors are adjusted to elevate the roof of the cavity created by removing the superficial part pf the gland. The scope is inserted into the wound to view the deeper part of the operative field. All nearby important structures are now identified and protected. The deep part of the gland is dissected and removed

Eligibility Criteria:
Inclusion Criteria:

* Adult patient
* Has submandibular sialadenitis

Exclusion Criteria:

* Previous history of surgery or irradiation to the neck
* History of abscess formation in the region
* Patients having large, hard or fixed submandibular gland
* If there was suspicion of malignant submandibular tumour
The Clinical Study for Evaluation of Efficacy and Safety of EGF on Oral Mucositis in Radiation Therapy Patients

The purpose of this Study is to evaluate the efficacy and safety of rhEGF on oral mucositis in patients receiving the radiation therapy or the concurrent chemo-radiotherapy

Radiation therapy causes many side effects especially oral mucositis. The purpose of this Study is to evaluate the efficacy and safety of rhEGF on oral mucositis in patients receiving the radiation therapy or the concurrent chemo-radiotherapy. Head and neck cancer patients who have a plan to receive a minimum of 50 Gy radiation therapy will be enrolled.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, aged at least 18 years

Exclusion Criteria:

* Females who are pregnant, nursing, or planning a pregnancy during the study period or females of childbearing potential
* Have oral mucositis or other oral conditions at study entry
Multimodal Therapeutic Approach in Undernourished Maintenance Hemodialysis Patients (AMERICANO)

The aim of the study is to evaluate a 3 months integrated multimodal therapeutic approach including exercise training program with ergocycle during dialysis sessions, oral nutritional supplementation, omega 3 and androgen, on effort tolerance and quality of life of under-nourish maintenance hemodialysis Chronic Kidney Disease (CKD) patient.

The aim of the study is to evaluate a 3 months integrated multimodal therapeutic approach including exercise training program with ergocycle during dialysis sessions, oral nutritional supplementation, omega 3 and androgen, on effort tolerance and quality of life of under-nourish maintenance hemodialysis Chronic Kidney Disease (CKD) patient.

Eligibility Criteria:
Inclusion Criteria:

* Hemodialysis patient since at least 6 month
* Patient aged 18 years or older
* Written consent to participate in the study
* No acute infection or hospitalization
* Opinion of Cardiologist saying there is no known evidence against the evaluation of the maximum exercise capacity
* Protein-energy wasting diagnosed if at least two of this characteristics are present
* Serum albumin \<3.8 g per 100 ml (Bromcresol Green)
* Serum prealbumin (transthyretin) \<30mg per 100 ml
* Reduce body mass (BMI \<23)
* Unintentional 10% weight loss over 6 months
* Lean body mass index \< 10th percentile

Exclusion Criteria:

* Presence of comorbidity which compromising the survival within 6 month
* Unintentional low DEI \<20 kcal kg_1 day_1
* HIV or HCV positive
* History of hormone dependent cancer
* Suspected or confirmed prostate cancer or breast carcinoma
* Known hypersensitivity for testosterone
* Presence or history of hepatic tumor
* Inability to follow the rehabilitation program
* Inadequate dialysis dosage (\<12 hours / week or Kt/V index\< 1,2) Pregnant or planning pregnancy and lactating women during study period
* Adult patient protected by law
* Patient who don't sign his informed consent
Dermacyd PH_DETINLYN (Lactic Acid) Tangerine Mix - Compatibility

The purpose of this study is to demonstrate the absence of irritation potential (primary dermic irritability and cumulated dermic irritability) and allergy (sensibilization) of the product Dermacyd PHDETINLYN Tangerine Mix.None.


Eligibility Criteria:
Inclusion criteria:

* Phototype Skin I,II, III e IV
* Integral skin test in the region;
* Willingness in following the study procedures and to be present in the clinic at the days and scheduled time for medical evaluations and for application of occlusion;

Exclusion inclusion:

* Lactation or gestation
* Use of Antiinflammatory and/or immunossupression drugs
* Personnel history of atopy;
* History of sensitivity or irritation for topic products;
* Active cutaneous disease;
* Use of new drugs or cosmetics during the study

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Sertraline and Naltrexone for Alcohol Dependence

This study is a double-blind, placebo-controlled outpatient trial to improve, through the addition of sertraline (Zoloft), the abstinence and relapse rates in alcohol- dependent individuals currently taking naltrexone (Revia).


Eligibility Criteria:
Inclusion Criteria:

* Meets the criteria for alcohol dependence.
* Abstinent from alcohol for a period of at least 5 days and not greater than 30 days.
* Able to read English and complete study evaluations.
* A stable residence and a telephone to ensure that subjects can be located during the study.

Exclusion Criteria:

* Currently meets criteria for substance abuse or dependence with the exception of nicotine dependence.
* Current use of disulfiram (Antabuse) or a MAO Inhibitor.
* Psychotic or otherwise severely psychiatrically disabled (i.e., depressed, suicidal, current mania).
* Major depression at the time of assessment.
* Previous treatment with naltrexone (Revia) for alcohol dependence.
* Significant underlying medical conditions such as cerebral, renal, thyroid, or cardiac disease.
* Abstinent longer than 30 days prior to admission to program.
* Hepatocellular disease or elevated bilirubin levels.
* Females who are pregnant, nursing, or not using a reliable method of birth control.