cyrilzakka/clinical-trials huggingface dataset:
Study of Methotrexate Given to Juvenile Idiopathic Arthritis Patients Based on Pharmacogenomics and Pharmacometrics

This study will integrate Pharmacogenomics and Pharmacometrics, to explore an effective concentration of MTXPGn for JIA pediatric patients, and set up a Population Pharmacokinetics model to provide reference for individual administration on JIA pediatric patients.

In order to find out "The critical reasons for individual variances in MTX of JIA pediatric patients and quantize the influence of these factors", based on early research, this study will integrate Pharmacogenomics and Pharmacometrics, to explore an effective concentration of MTXPGn for JIA pediatric patients, and set up a Population Pharmacokinetics model to provide reference for individual administration on JIA pediatric patients.

Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients with Juvenile Idiopathic Arthritis
* 7.5-10mg/m2 per week per dose of methotrexate
* all patients have been treated with methotrexate at least for 3 months

Exclusion Criteria:

* co-treated other drugs which can interact with methotrexate
Gender-sensitive Enhancement of Common Weight Loss Strategies for Overweight and Obesity

The major aim of the proposed study is to develop a gender-sensitive individually tailored add-on intervention that focusses on improving individual gender-specific SIRs (subjective illness representations) in obese or overweight individuals. We will investigate whether this will improve compliance with and long-term success of common weight loss interventions. The effectiveness of this intervention in every-day-life with regard to weight-related behavioral changes and weight loss will be evaluated within a randomized controlled setting.To enhance the applicability of the intervention in every-day-life and its dissemination we plan to develop a smart-phone-based intervention.


Eligibility Criteria:
Inclusion Criteria:

1. Obesity class I or II with subjectively experienced weight-related impairment and a current will to lose weight.
2. Overweight (i.e. BMI between 25 and 29.9 kg/m²) with weight-related health problems and/or visceral adipose tissue and/or high psychosocial weight-related distress with a current will to lose weight.

Exclusion Criteria:

1. Obesity Class III (i.e. BMI \>39.9 kg/m²).
2. Current (or within the last 12 months) involvement in a structured weight loss intervention.
3. Insulin-dependent type 1 diabetes.
4. Previous or intended bariatric surgery.
5. Current psychotherapeutic treatment of weight-related health problems.
6. Weight-enhancing drugs.
7. Drugs which promote weight-loss (e.g. anti-obesity drugs).
8. Weight-enhancing health problems which are not yet treated.
9. Cancerous disease within the last five years.
10. Current substance-use disorders, depression, psychosis, suicidal tendency or pregnancy.
11. Severe cognitive impairments.
12. Insufficient knowledge of the german language.
13. Binge-Eating Disorder or Bulimia nervosa.
Physiotherapy in Lumbar Disc Pathologies

The aim of this study is to compare the effectiveness of four physical therapy treatment approaches for lumbar region pathologies. Eighty volunteers who have back pain will be included in the study. Subjects will be randomly divided into four groups; Group 1: Soft tissue mobilisation techniques and stabilization exercises (n=20), Group 2: Kinesiotape and stabilization exercise (n=20), Group 3: Stabilization exercises (n=20), Group 4: Reflexology and stabilization exercises (n=20).

All patients will be measured with visual analog scale for pain level, goniometric measurement for range of motion, hamstring tension and sit and reach for flexibility, isokinetic evaluation for strength in 60degree/ sec, Side plank position test for trunk stabilization.

Function will be measured with Oswestry Disability Index. Manual muscle testing for flexion, extension, lateral flexion of back, flexion, extension, abduction of hip, flexion, extension of knee and inversion, eversion of ankle will be assessed. Group 1, 2 and 4 will be started to treatment twice a week for 4 weeks after first evaluation. Group 3 will be had home exercise programme after first evaluation.

Groups will be assessed again at 4th and 8th weeks after treatment. Multiway variant analysis will bee done within each group before the treatment and at follow-up. When differences observed, Tukey test will be used to find out the group that caused the differences.

Eligibility Criteria:
Inclusion Criteria:

* The participants between the ages of 25 and 55 years,
* Having a minimum pain level (at activity) of 3 out of 10 on visual analog scale
* Having low back pain for at least 3 months with lumbar disc pathology (bulging or protrusion) diagnosed by clinical tests and magnetic resonance imaging.

Exclusion criteria:

* sacroiliac and lumbar degenerative pathologies,
* another pathology related to neurological deficits,
* physiotherapy previously received for at least 12 months,
* any surgery affecting the lumbar region.
The Active by Choice Today (ACT) Trial to Increase Physical Activity

The increasing prevalence of obesity in U.S. children and adolescents is a major health threat to our society, especially among minority and low social economic status (SES) populations. During adolescence physical activity (PA) decreases and is likely an important contributor to the increasing trend in childhood obesity rates. Little evidence suggests that school-based curriculum interventions lead to increases in overall PA. Thus, this proposal will evaluate the efficacy of an innovative motivational and behavioral skills after-school program for promoting increases PA among underserved adolescents (e.g., minorities, low SES). The motivational plus behavioral skills intervention is consistent with Self-Determination (Motivation) Theory and Social Cognitive Theory in that it emphasizes increasing intrinsic motivation and behavioral skills for PA. Adolescents in the intervention take part in developing the program, selecting physical activities that generate fun and interest, and generating their own coping strategies for making effective PA changes during a videotaped session. Preliminary data from our group demonstrates the feasibility of the motivational plus behavioral skills PA program for increasing moderate-to-vigorous PA (MVPA) in underserved adolescents in South Carolina. The proposed project will use a school-based nested cohort design to evaluate efficacy of a 17-week motivational plus behavioral skills program versus typical after-school program (general health education only) on increasing PA in underserved adolescents. Twenty-four middle schools (70 6th graders per school; N=1,680), located in South Carolina will be randomly assigned to one of two after-school programs. The study employs a nested cohort design, with schools, rather than individuals assigned to condition and will be analyzed using repeated measures analysis of covariance techniques as outlined by Murray. We will also examine psychosocial variables (PA self-efficacy, self-concept, motivation, social support, and enjoyment) as potential mediators of the intervention on changes in MVPA using regression and structural equation modeling techniques. This study will address an important public health problem that will have implications for decreasing obesity in underserved adolescents.


Eligibility Criteria:
Inclusion Criteria:

* parental consent
* agree to random assignment
* 6th grade student

Exclusion Criteria:

* medical condition that interfered with physical activity
* developmentally delayed such that the intervention materials were not cognitively appropriate
* currently in treatment for a psychiatric disorder
Tissue Resistivity in Breast Cancer Patients

The resistivity measurements will be done by introducing a needle-probe into fresh healthy, peritumoral, and tumoral ex vivo tissues.

Patients affected by breast cancer will have their tissue analysed immediately following their surgical excision for the treatment of breast cancer. Two probes will be used: a linear probe of 4 needle-electrodes positioned in a row that is able to perform Electrical Impedance Spectroscopy (EIS) measurements and a circular probe of 8 needle-electrodes arranged into a circular pattern that is able to generate cross sectional images (Electrical Impedance Tomography maps). Firstly, the linear probe will be inserted in the tumor parenchyma at a penetration depth of about 2 mm and the tissue impedance measurement will be performed along a broad spectrum of frequencies for few minutes. Approximately 10 seconds for each measurement will be needed. Subsequently, if the size of the tissue will allow it, the circular probe will be inserted in the tumor parenchyma at the same penetration depth and 10 cross sectional maps will be generated (approximately 30 seconds in total). Both information obtained using the linear and the circular probes will be integrated for a full characterization of the tissue under examination.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* First radiological diagnosis of breast adenocarcinoma needing a histological confirmation
* Written Informed Consent

Exclusion Criteria:

* Tumor mass diameter \< 1 cm
* Surgical specimen (harbouring tumoral + peritumoral tissue) diameter \< 2 cm
Comparative Analysis of Analgesic Efficacy and Maternal Satisfaction: by Single Shot Intrathecal Analgesia (SSSA) in Normal Labor

the goal of this randomized control trial is to compare the effect of adding fentanyl v.s dexmedetomidine to bupivacaine in single shot spinal analgesia in achievement of analgesia by decreasing visual analogue scale, onset and increasing duration of analgesia in normal labor.

on arrival to the operating room, the demographic and baseline data will be collected, which include sections about age, height, weight, primigravida or multigravida, cervical dilation at the time of performing labor analgesia, fetus presentation, presence of rupture of membrane, baseline pain scores will be assessed using a 10-cm VAS (0 = no pain and 10 = worst imaginable pain) before SSSA. Intravenous access will be achieved in all patients loading will be undertaken using 500 ml Ringer's solution, baseline values of pulse rate (PR), respiratory rate (RR), hemoglobin oxygen saturation (SpO2), and arterial blood pressure (ABP) will be recorded. SSSA will be performed with the parturient in the sitting position under complete aseptic precautions at the L3-L4 level using a 25-gauge spinal needles. The correct positioning of the needle tip in the intrathecal space will be confirmed by the observation of a free flow of cerebrospinal fluid, and then the prefilled study drug will be injected intrathecally which is 2.5 mg bupivacaine plus 25 mic fentanyl or 5 mic dexmedetomidine or 0.5 ml saline according to different groups.

parturient will then turn to the supine position, and a wedge will be placed under the right buttocks to prevent aortocaval compression. VAS will be evaluated every 5 min for the first 30 min, followed by every 20 min for 3 hours then every 30 min for next 3 hours. If VAS 8 or more the instigators will give the patient 50 mg intramuscular pethidine and the patient will be excluded.

Maternal blood pressure, heart rate, respiratory rate, and oxygen saturation will be measured and recorded noninvasively every 5 min for the first half hour, followed by every 20 min for 3 hours, then every 1 h for next 3 hours. the investigators will give 5 mg ephedrine if there is hypotension ( decrease in ABP more than 25% of the baseline ABP) and .5 mg atropine if there is bradycardia (HR less than 50 beats per minute). Side effects such as hypotension, nausea, vomiting, bradycardia, shivering, pruritus, and tachycardia will be recorded. The first- and fifth-minute Apgar scores will also be recorded. The onset, duration of analgesia, and obstetric and neonatal outcomes will be compared. Maternal satisfaction questionnaire will be done after delivery to assess maternal satisfaction.

Eligibility Criteria:
Inclusion Criteria:

* ASA I-II.
* Uncomplicated pregnancy.
* At term \& singleton fetus.
* Cervical dilatation \> 5cm
* Cephalic presentations

Exclusion Criteria:

* Patient refusal.
* Bleeding disorders and patients on anticoagulant drugs.
* Infection at site of injection.
* Spine deformity.
* Allergy to any of study medications.
Clinical Study to Evaluate Safety and Efficacy of KAM1403 Gel to Treat Radiation Dermatitis

The main purpose of this study is to demonstrate the safety and efficacy of KAM1403 GEL in reducing the symptoms of mild to moderate Radiation Dermatitis. Efficacy will be evaluated by comparing symptoms assessment during and post radiotherapy: erythema, desquamation, edema, moist desquamation and ulceration in the KAM1403 Gel treated group versus a group of subjects treated with the Aloe vera Gel (the control group). In addition, a comparison will be made between subjects' self evaluation in the treatment group versus the control group. Safety will be determined by the number and severity of Adverse Events Device-Related.


Eligibility Criteria:
Inclusion Criteria:

* Female above 18 years of age
* Diagnosed with breast cancer and scheduled to receive postoperative radiotherapy
* Treatment of regional lymph nodes (i.e. axillary, supraclavicular, or internal mammary) is allowed.
* Schedule for breast radiotherapy (RT) to a dose of 50 Gy in 2 Gy/fx, for 5 weeks and then a boost to the lumpectomy cavity.
* Minimum of 3 weeks from chemotherapy to start of radiation therapy.
* Patient agrees to use only the test products during the study period

Exclusion Criteria:

* Tumor involvement of the skin
* Patient has another dermatological disease/condition that could interfere with clinical evaluation including infected atopic dermatitis lesions
* Patient has a previous history of allergy to the ingredients of the tested formulations
* Paget's disease of the nipple.
* Pregnant or lactating females
Comparıson Of Electromyography Results Before And After Vıtamın D Treatment In Patıents Wıth Carpal Tunnel Syndrome

Therefore, we aimed to evaluate the effectiveness of vitamin D replacement therapy on pain, electrophysiological parameters, ultrasonographic measurement results and functional status scales in CTS patients with low serum vitamin D levels.

Introduction: Apart from its effect on bone health, vitamin D is also known to have beneficial effects on the neurological system. In studies, vitamin D levels were found to be low in patients with Carpal Tunnel Syndrome (CTS). However, studies examining the effects of vitamin D replacement on CTS are limited. Therefore, we aimed to evaluate the effectiveness of vitamin D replacement therapy on pain, electrophysiological parameters, ultrasonographic measurement results and functional status scales in CTS patients with low serum vitamin D levels. Materials and Methods: Our study was planned as an observational and analytical prospective. Vitamin D loading therapy was given to patients with serum vitamin D levels below 20ng/ml and mild-moderate CTS detected by electroneuromyography (ENMG). Patients with vitamin D levels above 20 ng/ml after 8 weeks were included in the study. Each patient was given a rest splint and exercise program. Patients were evaluated before and 3 months after treatment with electrophysiological, ultrasonographic, VAS, pinch-grip strength, two-point discrimination, monofilament test and Boston symptom severity scale.

Eligibility Criteria:
Inclusion Criteria:

* 18-70 years old male or female gender
* Those with mild to moderate CTS according to ENMG,
* Vitamin D level \<20.

Exclusion Criteria:

* Severe CTS according to ENMG
* Thenar region atrophy
* diabetes mellitus,
* rheumatoid arthritis,
* hyperthyroidism,
* hypothyroidism
* Traumatic nerve injury, history of surgery
* Polyneuropathy
* Pregnancy
* Severe psychiatric illness
* Poor orientation and cooperation,
* Injection (corticosteroid, ozone, stem cell...) applied for CTS treatment within 3 months
A Study of XW001 in Healthy Adult Subjects

This is the first-in-human, single-center, randomized, double-blinded, placebocontrolled, single-dose and multiple-dose escalation Phase Ia study

Single ascending dose (SAD), healthy participants will be randomized to receive a single inhalational dose of either XW001 or placebo in each of the planned SAD cohorts. Multiple ascending dose (MAD), healthy participants will be randomized to receive inhalational doses of XW001 or placebo in each of the planned MAD cohorts.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy subjects aged 18-45 years (including both ends), male or female;
2. Body mass index (BMI) of 19.0-28.0 kg/m2 (including both ends);
3. Subjects who fully understand the trial objectives, have a basic understanding of the pharmacological effects and possible risks of the investigational drug, and voluntarily sign an informed consent form;
4. Subjects who can communicate well with the investigators, and understand and abide by the requirements of this study.

Exclusion Criteria:

1. (Screening period) Subjects participated in any drug clinical trial or used the investigational drug within 3 months prior to the trial;
2. (Screening period/admission) Subjects with a medical history of diseases in cardiovascular system, digestive system, endocrine system, urinary system, nervous system, hematological, immunological (including personal or family history of hereditary immunodeficiency), or metabolic abnormalities, etc., that are still considered as clinically significantly by the investigators.
3. (Screening period) Subjects with previously diagnosed chronic obstructive pulmonary disease (COPD), asthma, or other clinically significant lung diseases, or with a medical history of acute upper and lower respiratory infection requiring intravenous injection of antimicrobial drugs or other hospitalization treatment within the past 3 months;
4. (Screening period/admission) Subjects who had underwent a surgery that is considered affecting the pharmacokinetics(PK) behaviors of the drug by the investigator within 6 months prior to the trial;
5. Patients with positive endogenous interleukin 29 (IL-29) level (i.e., the test result in the screening period is higher than the lower limit of quantification);
6. Subjects with lung function abnormality (measured forced expiratory volume in one second #FEV1)/predicted FEV1 ≤ 80% or measured forced vital capacity (FVC)/predicted FVC ≤ 80%);
7. Subjects who are unable to complete the study for other reasons or are not suitable to participate in the trial as judged by the investigators.
A Study to Assess the Efficacy of Intravenous/Oral Bondronat (Ibandronate) in Patients With Metastatic Bone Disease Experiencing Moderate to Severe Pain

This 2 arm study will compare the efficacy of a regimen of intravenous (iv) and oral Bondronat with that of zoledronic acid in patients with malignant bone disease experiencing moderate to severe pain. Patients will be randomized to receive either Bondronat (6mg iv on days 1, 2 and 3 followed by Bondronat 5Omg po daily from day 22 to week 24) or zoledronic acid (4mg iv on day 1, and then every 3-4 weeks). The anticipated time of study treatment is 6-12 months, and the target sample size is 100-500 individuals.


Eligibility Criteria:
Inclusion Criteria:

* patients with malignant bone disease;
* patients with moderate to severe pain.

Exclusion Criteria:

* patients who have received a bisphosphonate within 3 weeks from the signing of informed consent;
* patients receiving concurrent investigational therapy, or who have received investigational therapy within 30 days of the first scheduled day of dosing;
* untreated esophagitis or gastric ulcers;
* recent or pre-scheduled radiotherapy to bone;
* patients who are pregnant or breast-feeding.
Discard the Curative Causes of Late Onset Epilepsy: the Role of Brain 18F-FDG PET

Etiology and cognitive prognosis in late onset epilepsy differ from young adults epilepsy. At the epilepsy onset, this is crucial to detect potential curative/treatable brain disorders. After classical investigation including morphological brain imaging, EEG, clinical assessment, which added value may have brain FDG PET in the diagnosis and prognosis evaluation?


Eligibility Criteria:
Inclusion Criteria:

* late onset épilepsy patients without lesion
* epilepsy followed at the CHRU Nancy france

Exclusion Criteria:

* epilepsy explained by cortical lesion
* severe psychiatric disorders
* severe addiction (alcool, drugs)
* no FDG TEP performed
* no neuropsychological assessement after 2 years epilepsy onset
A Study to Evaluate the Long Term Safety and Efficacy of Bimekizumab in Subjects With Ankylosing Spondylitis

This is a study to assess the long term safety and tolerability of bimekizumab in subjects with ankylosing spondylitis


Eligibility Criteria:
Inclusion Criteria:

* In the opinion of the Investigator, the subject is expected to benefit from participation in an Open Label Extension (OLE) study
* Subject completed AS0008 without meeting any withdrawal criteria
* Female subjects must be postmenopausal, permanently sterilized or, if of childbearing potential, must be willing to use a highly effective method of contraception
* Male subjects with a partner of childbearing potential must be willing to use a condom when sexually active

Exclusion Criteria:

* Female subjects who plan to become pregnant during the study or within 20 weeks following the last dose of investigational medicinal product (IMP). Male subjects who are planning a partner pregnancy during the study or within 20 weeks following the last dose
* Subjects with any current sign or symptom that may indicate a medically significant active infection (except for the common cold) or has had an infection requiring systemic antibiotics within 2 weeks of study entry
* Subjects who meet any withdrawal criteria in AS0008. For any subject with an ongoing Serious Adverse Event, or a history of serious infections (including hospitalizations) in the lead-in study, the Medical Monitor must be consulted prior to the subject's entry into AS0009
Aliskiren in Combination With Losartan Compared to Losartan on the Regression of Left Ventricular Hypertrophy in Overweight Patients With Essential Hypertension

To compare the efficacy and safety of aliskiren in combination with losartan compared to losartan on the regression of the increased size of the left ventricle in overweight patients with high blood pressure.


Eligibility Criteria:
Inclusion Criteria:

* Patients with essential hypertension
* Patients with a BMI \> 25 kg/m2
* Patients with LVH (LVWT ≥ 1.3 cm) confirmed by the ECHO

Exclusion Criteria:

* Patients treated with an ACE or an ARB within 3 months of study entry (Study Visit 1) who are unable or unwilling to undergo the 3 month washout period.
* Patients treated with an ACE and ARB combination at study entry.
* Known secondary hypertension of any etiology (e.g., uncorrected renal artery stenosis).

Other protocol related inclusion/exclusion criteria applied to the study.
Correlation Between Clinical Deterioration in Schizophrenic Patients and Hair Cortisol Levels

The importance of stress as a possible deteriorating factor for schizophrenic patients is well documented. However, this notion is based on subjective experience and retrospective psychological analysis.

A novel method of measuring cortisol using hair has a proven correlation to subjective stress in non-clinical as well as psychiatric clinical populations.

This pilot study will attempt to assess the use of cortisol hair level, as a marker of stress, to predict clinical deterioration in schizophrenic patients.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-50
* Diagnosis of schizophrenia or schizoaffective disorder, made by a senior psychiatrist.
* Signing an informed consent.

Exclusion Criteria:

* Additional psychiatric diagnosis
* Boldness or hair shorter than 1cm
* Physiological disturbance in the HPA or the use of steroidal medication
* Neurological disease (past or present) or neurosurgery.
* Pregnancy
* Substantial chronic physical diseases/