cyrilzakka/clinical-trials huggingface dataset:
A Study to Evaluate the Safety and Efficacy of AZX100 Drug Product Following Excision of Keloid Scars

The purpose of this study was to determine the safety of AZX100 Drug Product and to determine whether it was effective in preventing or reducing re-growth of surgically removed keloid scars.


Eligibility Criteria:
Inclusion Criteria:

* keloid scar between 1 and 3 cm long, less than 1 cm at its widest point
* willing to undergo keloid scar removal surgery
* healthy adult male or non-pregnant female
* non-diabetic
* Body Mass Index in the range of 18-35
* no clinically significant abnormal values on a full blood safety screen
* non-smoker and non-nicotine user for the previous six months

Exclusion Criteria:

* history or clinical evidence of acute or chronic disease
* history of malignant neoplasm within the last 5 years, except for surgically removed cancers of the skin that are not on the keloid area
* history of anaphylactic shock or anaphylactoid (hypersensitivity) reaction
* allergy to local anesthesia, including lidocaine and epinephrine
* ongoing dermatologic disorders, except for folliculitis and acne
* on therapy with steroids
* on therapy with a drug that would affect collagen synthesis
* positive urine test for nicotine or drugs of abuse
* positive blood test for HIV 1 or 2, hepatitis B or hepatitis C
* positive blood test for anti-AZX100 antibodies
* participation in another study within 60 days prior to enrollment
* donate blood within 7 days before dosing with study drug
* donate plasma within 3 days before dosing with study drug
* have a tattoo within 3 cm of the keloid scar that will be removed
* apply any lotion or cream on or near the keloid scar that will be removed within 14 days before dosing with study drug
* use a tanning bed or tanning light within 3 months before enrollment
* intend to use any scar improving product during the study (one year)
* history of drug addiction or excessive use of alcohol
* previous drug treatment of the keloid scar that will be removed within the last 3 years; any laser, irradiation, or surgery of the keloid scar that will be removed
Tolerability of Rebif® Injection With and Without the Use of Rebiject™Mini in Relapsing-Remitting Multiple Sclerosis Subjects

This is a randomized, multicenter, parallel-group, open-label study comparing the tolerability of Rebif® injections (44 microgram \[mcg\] administered subcutaneously three times a week) with and without Rebiject™Mini, an auto-injection device in relapsing-remitting multiple sclerosis (MS) subjects. Subjects will be randomly assigned to either one of the two Rebif® groups in a 1:1 ratio on Study Day 1 stratified by center. Subjects will receive a minimum of 3 months of treatment with Rebif® 44 mcg three times a week and will be asked to assess their injection site reactions on a weekly basis. Clinic visit will occur at 1 and 3 months after the initiation of treatment.


Eligibility Criteria:
Inclusion Criteria:

* Greater than or equal to 18 years of age
* Has relapsing-remitting MS
* Are willing and able to comply with the protocol for the duration of the study

Exclusion Criteria:

* Has significant leukopenia/lymphopenia (white blood cell count less than (\<) 0.5 times the lower limit of normal)
* Has elevated liver function tests (aspartate aminotransferase \[AST\], Alanine transaminase \[ALT\], or alkaline phosphatase greater than (\>) 2 times the upper limit of normal or total bilirubin \> 1.5 times the upper limit of normal)
* Has an allergy to human serum albumin or mannitol
* Had treatment with an investigational product or procedure within 3 months
* Has the presence of systemic disease or abnormal laboratory findings that might interfere with subject safety, compliance or evaluation of the condition under study
* Has concomitant use of Avonex®, Betaseron®, Copaxone®, or Novantrone®
A Study to Establish the Efficacy of QBX258 in Patients With Moderate to Severe Asthma

This study is designed to investigate the efficacy and safety of QBX258 in subjects with moderate to severe asthma.


Eligibility Criteria:
Inclusion Criteria:

* Patients with atopic asthma \>1 year duration diagnosed according to the GINA guidelines.
* Subjects must weigh at least 50 kg to participate in the study, and must have a body mass index (BMI) within the range of 18 - 39 kg/m2.
* Asthma which is not adequately controlled on current treatment, as demonstrated by an Asthma Control Questionnaire (ACQ) score of \> 1.5.
* FEV1 40 to 90% of predicted.

Exclusion Criteria:

* Diagnosed with COPD as defined by the GOLD guidelines
* Subjects who have had a respiratory tract infection within 4 weeks prior to screening.
* Women of child-bearing potential must use highly effective methods of contraception during dosing and for at least 18 weeks after last study drug administration
GLUCOSAMINE/CHONDROITIN and PHYSICAL THERAPY EFFECTS ON OLDER POPULATION WITH KNEE OSTEOARTHRITIS

to see the effect of glucosamine chondratin sulfate with and without physiotherapy in knee osteoarthritis

it is a randomized control trail to evaluate the effectiveness of glucosamine chondratin sulfate alone and in combination with physiotherapy on knee osteoarthritis

Eligibility Criteria:
Inclusion Criteria:

* age \> 50 years with radiographic evidence of mild to moderate knee OA (Kellgren Lawrence grade II \& III 20) who met the ACR clinical 21,
* radiographic classification criteria or confirmation of mild to moderate radiographic evidence of knee OA from a personal physician
* not currently participating in another intervention study

Exclusion Criteria:

* dementia (Mini-Mental State Examination \[MMSE\]\< 24)
* active cancer other than skin cancer
* anemia (participants with an hematocrit (HCT)\< 32 (or a hemoglobin below10) were excluded due to possible inability to adequately exercise or the increased potential for increased risk for serious adverse cardiovascular events)
* severe renal insufficiency (serum creat\> 2)
* hepatic disease
Repetitive Transcranial Magnetic Stimulation for Tinnitus Treatment

In this study, we perform an open-label rTMS over the left AC on patients with tinnitus. Outcome measures will be evaluated statistically. The results will be instrumental in deciding the efficacy of this technique in a local patient group.

Tinnitus is a subjective auditory perception of sounds or noise not triggered by external auditory stimuli, affecting millions of people worldwide. To date, pharmacological and physical/ behavioural treatments in severe cases are generally unsatisfactory. Functional brain imaging changes associated with tinnitus include hyperactivity of discrete temporoparietal regions, including both the primary auditory cortex (AC) and the secondary, or associative cortex. High-frequency rTMS (10 Hz or more) applied on the scalp overlying the hyperactive left AC produced an intense tinnitus attenuation.

Repetitive TMS consists of 1000 stimulations/ day at 1 Hz and 110% of the motor threshold, for five consecutive days over the left AC. A high number of stimuli/day were applied because of the previously suggested dose dependency of tinnitus alleviation by rTMS. Furthermore, the use of such relatively high intensity assured the stimulation of most of the target region, even in the case of mismatch between the scalp position and the underlying anatomy, which can be expected using the International EEG system as anatomical reference for TMS stimulation.

Upon recruitment, all patients will undergo a 1 week treatment consisting of 5 rTMS sessions. Tinnitus rating will be performed weekly.

Tinnitus is rated by a 0-100 Visual Analogue Scale (VAS), where 0 is wellness and 100 the worst possible tinnitus related discomfort. In addition, our validated Tinnitus Inventory scoring will be administered. Audiometry and otoscopy will be performed at enrolment and at the end of the study. Tinnitus, and acoustic evaluations are then collected by experimenters blind to the type of rTMS applied.

Standard statistical methods (SPSS for Windows) will be used to perform comparisons.

Eligibility Criteria:
Inclusion Criteria:

* All patients with tinnitus

Exclusion Criteria:

* Patients with contraindications to TMS: pacemaker, intracranial surgery, implants and seizures
Evaluating a Mindful Eating Curriculum, "Savor the Flavor"

The overall goal of this study is to conduct a preliminary evaluation of the feasibility and efficacy of the "Savor the Flavor" intervention.

The overall goal of this study is to conduct a preliminary evaluation of the feasibility and efficacy of the "Savor the Flavor" intervention. The goal of this curriculum is to teach children how to savor foods and slow down while eating by focusing on the sensory experience of eating. The intervention will also teach children attention control techniques so that they are better able to delay consumption of high energy, low nutrition foods, when appropriate.The study will also evaluate a modified version of the Eating in the Absence of Hunger task for use in a preschool classroom setting.

Eligibility Criteria:
Child Inclusion Criteria:

* Child must be enrolled in a Head Start preschool center
* Child must be between the ages of 2 and 6 years old

Child Exclusion Criteria:

* Food allergy or restriction to foods included in protocol

Parent Inclusion Criteria:

* Parent or other primary caregiver of a child enrolled in the study
* 18 years of age or older
* English speaking

Parent Exclusion Criteria:

- None

Teacher Inclusion Criteria:

* Actively employed as an early childhood education provider in the Head Start classroom where intervention is delivered
* 18 years of age or older

Teacher Exclusion Criteria:

- None
Evaluation of Performance Characteristics of Capsule Endoscopy With PillCam UGI Capsule Compared to Standard Endoscopy

This study is to examine the benefits of newly designed capsule with enhanced frame rate and wide angle compared to standard endoscopy, which may help enhance detecting esophageal diseases that otherwise may have been out of vision in the standard endoscopy, ultimately decreasing healthcare costs.

This is a pilot, single center, prospective, tandem study. All veteran patients with Barrett's esophagus scheduled for an upper EGD at Veterans Affairs Medical Center (Kansas City, MO, USA) for check-up of BE will be asked to swallow the pillcam prior to an EGD. A member of the research team will approach a potential subject to discuss participation in the study, including background of the proposed study, inclusion and exclusion criteria, benefits and risks of the procedures and follow-up. If this is of interest to the subject, the informed consent form is discussed and presented. The subject must sign the consent form prior to enrollment. This form will have prior approval of the study site's Institutional Review Board (IRB). Failure to obtain informed consent renders the subject ineligible for the study

Eligible subjects at the participating institution who meet the inclusion criteria for this study will be offered the opportunity to participate in this clinical trial. To ensure that subjects are approached for potential study participation without bias, a Subject Screening Log will be maintained. This Log will track the basic demographic information of each subject approached for clinical trial inclusion and the resulting reason for exclusion from the clinical study if applicable.

The duration of the study is expected to be approximately 12 months. Enrollment of Study patients will cease when approximately 20 patients have been enrolled.

Eligibility Criteria:
Inclusion Criteria:

* Patients age: ≥ 18 years
* Patients with BE length ≥ 1cm undergoing upper endoscopy
* Willingness to undergo both unsedated, capsule endoscopy and conventional EGD
* Ability to provide written, informed consent and understand the responsibilities of trial participation

Exclusion Criteria:

* Coagulopathy with INR \> 1.5, thrombocytopenia with platelet counts \< 50,000
* Pregnant or planning a pregnancy during the study period
* Dysphagia
* Known esophageal diverticulum or stricture
* Swallowing disorder
* Known luminal, gastrointestinal stricture
* History of esophageal, gastric surgery
* Esophageal or GI motility disorder
* Subject has a known history of unresolved drug or alcohol dependency that would limit ability to comprehend or follow instructions related to informed consent, post-treatment instructions, or follow-up guidelines
* Known or suspected gastrointestinal obstruction, strictures, or fistulas based on the clinical picture or pre-procedure testing and profile.
* Subjects with cardiac pacemakers or other implanted electromedical devices.
* Anticipated magnetic resonance imaging within 1 week of capsule ingestion
Lenient Rate Control Versus Strict Rate Control for Atrial Fibrillation. The Danish Atrial Fibrillation Randomised Clinical Trial

Atrial fibrillation is the most common heart arrhythmia with a prevalence of approximately 2% in the western world. Atrial fibrillation is associated with an increased risk of death and morbidity. The comparable effects of a lenient rate control strategy and a strict rate control strategy in patients with atrial fibrillation are uncertain and only one trial has assessed this previously in patients with permanent atrial fibrillation.

The investigators will therefore undertake a randomised, superiority trial at four hospitals in Denmark.


Eligibility Criteria:
Inclusion Criteria:

1. Participants with atrial fibrillation (ECG confirmed and diagnosed by the treatment provider) who at inclusion have either persistent (defined as atrial fibrillation for more than 7days) or permanent atrial fibrillation (only rate control is considered going forward).
2. Rate control must be accepted as being the primary management strategy going forward. Consideration towards whether rhythm control is more appropriate must be considered, especially given the results of the Early treatment of Atrial fibrillation for Stroke prevention Trial (EAST).
3. Informed consent.
4. Adult (18 years or older).

Exclusion Criteria:

1. No informed consent.
2. Initial heart rate under 80 bpm at rest (assessed via ECG before randomisation).
3. Less than 3 weeks of anticoagulation with new oral anticoagulants or 4 weeks with efficient warfarin if indicated.
4. If the treating physician deems that the participant is not fit to be randomised into both groups based on an individual assessment. Such a decision will be made before randomisation by the treating physician. This can e.g. be participants dependent on a high ventricular rate to maintain a sufficient cardiac output. Such participants could be participants with heart failure, participants with a hemodynamically significant valve dysfunction, or severely dehydrated participants.
5. Participants who are haemodynamically unstable and therefore require immediate electrical cardioversion
Effect of Vitamin A and Calcium in Patients With Non-alcoholic Fatty Liver Disease

Non-alcoholic fatty liver disease (NAFLD) has become the most common liver disease at a global scale and is strongly associated with the obesity and metabolic syndrome . It is recognized as a hepatic manifestation of the metabolic syndrome, and characterized by lipid infiltration in the hepatocytes. NAFLD comprises a range of diseases from simple steatosis to non-alcoholic steatohepatitis (NASH), fibrosis, cirrhosis, and may progress to hepatocellular carcinoma (HCC) .

The worldwide prevalence of NAFLD is estimated to be 24% while it is reported to have much higher incidence in patients with metabolic syndrome and type 2 diabetes (T2D) (5). The mortality rate and the number of liver transplantations owing to NAFLD and NASH are increasing, making it the second leading cause of liver transplant in the United States .

Tow significant metabolic abnormalities commonly linked to NAFLD are insulin resistance (IR) and increased supply of fatty acids to the liver . Chronic liver diseases (CLD), including NAFLD, are commonly associated with nutrient and vitamins deficiencies such as those of vitamins D and A (8,9).

Almost all studies documenting vitamin A status in metabolic syndrome (MetS) report reductions in serum retinol, retinoic acid, and/or β-carotene that are inversely correlated with MetS features, including obesity, insulin resistance, glucose intolerance, and hypertriglyceridemia . In line with these observations, inadequate serum retinol levels (\<1.05 μmol/L) were found in 11-36% of morbidly obese adults with ultrasonography-proven NAFLD, and a significant association between low retinol levels and insulin resistance (IR) was found . Moreover, serum retinol levels were inversely associated with body mass and serum transaminases in patients with NAFLD, suggesting a link between retinol inadequacy and development of disease.

The liver plays a critical role in lipid metabolism by taking up serum free fatty acids (FFA) that are involved in the synthesis, storage, and transport of lipid metabolites. The accumulation of excess triacylglycerol (TG) within the liver due to the entry of excess FFA from the obese adipose tissue due to increased lipolysis leads to the development of non-alcoholic fatty liver diseases (NAFLD) .


Eligibility Criteria:
Inclusion Criteria:

* NAFLD patients

Exclusion Criteria:

* • Chronic viral hepatitis or other chronic liver diseases.

  * Hepatocellular carcinoma or other malignancies.
  * Chemotherapy or radiotherapy within the last three months.
A Family-based Intervention to Improve Pap Test Screening Among Under-screened Chinese American Immigrant Women

The purpose of this study is to find out the impact of the involvement of an influential person(s) (e.g., spouse, partners, parents, children, friends) on Pap test screening intention and behaviors, Pap test self-efficacy, and perceived benefits and barriers to Pap test screening among Chinese American immigrant women. These data specific to the impact of the involvement of an influential person on Pap test screening could be used to develop successful cancer prevention programs that target the specific needs of Chinese populations.

The importance of the support from family, spouse, friends, or significant others has been noted among Chinese American immigrant women (CAIW), but little attention has been paid to the effects of family-based (FB) interventions, especially for cervical cancer screening. Understanding the role of CAIW's family in promoting Pap screening and other influences can lead to the creation of more culturally appropriate screening interventions. The objective of this study is to test the effects of a FB intervention on Pap test intention and behaviors, Pap test self-efficacy, and perceived benefits and barriers to Pap tests among under-screened CAIW aged 21-65. This pilot test of the FB intervention will be conducted using a randomized controlled design with two groups only, experimental and control groups. Interventions will be delivered by bilingual and bicultural CAIW trained facilitators. Post-test and follow-up telephone surveys will be conducted at 2 weeks and 6 months after the intervention.

Eligibility Criteria:
Inclusion Criteria:

* a first-generation Chinese American
* no previous cervical cancer screening within the past 3 years
* no total hysterectomy
* no history of cervical cancer
* able to read English, Simple Chinese, or Traditional Chinese.

Exclusion Criteria:

* Not a Chinese American immigrant
* Had total hysterectomy
* Had history of cervical cancer
* Not able to read English or Chinese
Subconjunctiva Bupivacaine as Analgesia in Intravitreal Silicone Oil Removal

The study aimed to investigate the effectivity of bupivacaine 0,5% as post-operative analgesia in intravitreal silicone evacutaion surgery

Approval from Ethical Committee of Faculty of Medicine Universitas Indonesia was acquired prior conducting the study. Subjects were given informed consent before enrolling the study and randomized into two groups. Intravenous (IV) cannule with Ringer Lactate fluid, non-invasive blood pressure monitor, electrocardiogram (ECG) and pulse-oxymetry were set on the subjects in the operation room. Co-induction was done with midazolam 0,05 mg/kg and fentanyl 2 mcg/kg. Induction was done with propofol 1-2 mg/kg, followed by Laryngeal Mask insertion facilitated by atracurium 0,5 mg/kg. Maintenance was done with sevoflurane 1-2 vol%, O2:H2O = 1:2, flow 2 liter/minute. Surgery started. After final stitching, Group 1 received subconjunctival bupivacaine 0,5% 2,5ml in between stitches; Group 2 received subconjunctival NaCl 0,9% in between stitches. Both groups received paracetamol 20 mg/kgBW IV as post-operative analgesics. Hemodynamic, pain degree (using Visual Analog Scale / VAS), and nausea/vomiting incidence, and the time for first requested additional analgesia were recorded. Data was analyzed using SPSS (Statistical Package for Social Scientist), for numerical data using unpaired T-test or Mann-Whitney-U test, for categorical data using Chi-square test or Fischer Exact's Test. Data normality was tested by Kolmogorov-Smirnov test. Significant value is p\<0.05.

Eligibility Criteria:
Inclusion Criteria:

* Subjects aged 18-60 years old, with ASA physical status I-II and BMI 18,5-30 kg/m2 who were planned to do intravitreal silicone evacuation surgery.
* Subjects have been explained about the study, have agreed to enroll and have signed the informed consent form

Exclusion Criteria:

* Subjects with history of post-operative chronic pain
* Subjects with history of pre-operative long term use of analgesic
* Subjects with history of local anesthetics allergy, pregnant subjects
* Subjects with ambulation operation
* Subjects with glaucoma or ocular hypertension
* Subjects with cognition dysfunction or communication disturbance
* Subjects with additional surgery other than silicone oil removal

Drop Out criteria:

* Subjects with intraoperative complications (e.g. shock, anaphylactic reaction, seizures, severe respiratory disturbance)
* Subjects with post-operative intraocular pressure \> 22mmHg.
Assessment of the Ionizing Radiation Received During Percutaneous or Conventional Surgery of Hallux Valgus

To assess the average whole body radiation dose received by the surgeon, the operating team and the patient during hallux valgus surgery, depending on whether the surgery is percutaneous or conventional.

Prospective, open, comparative, non-randomized, non-interventional, single-center study, focusing on two surgical strategies. Patients will be managed in accordance with current practice, the choice of surgical strategy being left to the discretion of the investigators.

Patients will be informed of the study during a preoperative visit. The data concerning them will be collected on the day of the surgery. No follow-up over time is necessary.

Passive "ring" and "cornea" dosimeters will be worn by healthcare professionals during procedures for patients included in the study. Their data will be collected each month and at the end of the study, and reported secondarily to the number of operations. Several surgeons, dressers and operating assistants will participate in the operations, their data will be aggregated taking into account their function and not individuals.

Eligibility Criteria:
Inclusion Criteria:

* Patient undergoing percutaneous or conventional hallux valgus surgery;
* Patient capable of understanding the information related to the study, of reading the information leaflet and having expressed his non-opposition to participating in the study.

Exclusion Criteria:

* Pregnant or breastfeeding woman;
* Patient under guardianship or curatorship, or under a regime of deprivation of liberty.