cyrilzakka/clinical-trials huggingface dataset:
A Bioequivalence Study Comparing a Single Oral Intake of an Imported PROBUCOL Tablet(Lorelco) With a Marketed PROBUCOL Tablet(Chang Tai) in Chinese Healthy Volunteers

This study compares the pharmacokinetics characteristics of a single oral intake of an imported PROBUCOL tablet(Lorelco)(1\*250mg/tablet) with a marketed PROBUCOL tablet (Chang Tai)(1\*250mg/tablet) in healthy male volunteers to demonstrate they are bioequivalent.


Eligibility Criteria:
Inclusion Criteria:

* Chinese Male, aged between 18 and 40 years (at time of informed consent), extremes included
* Non-smokers
* Normal weight as defined by a Quetelet body mass index range of 18.0 - 26.0 kg/m2, extremes included
* Subjects judged by the investigator or sub investigator to be healthy based on the physical examination, medical history, vital signs, electrocardiogram (ECG), and the results of clinical laboratory tests
* Provided signed informed consent prior to beginning protocol-specific procedures, indicating that they understood the purpose of this study
* Willing to adhere to the study procedures described in this protocol

Exclusion Criteria:

* History of respiratory system disease, cardiovascular disease, Renal and Urogenital Disease, Gastrointestinal disease, hematological disease, Neuropsychiatric disease, endocrine diseases, hepatic disease or any other disease or physical condition which could have interfered with the interpretation of the study results
* Known hypersensitivity history to any prescription drug or over-the-counter medication
* Use of the following medications or products during the periods specified below:

Any medication within 14 days prior to scheduled study drug administration; Alcohol and caffeine within 7 days prior to scheduled study drug administration; Grapefruit or grapefruit products within 14 days prior to scheduled study drug administration

* Participation in any other clinical trial within 12 weeks prior to scheduled study drug administration, or intention to participate any other clinical trial during the course of the study
* Significant loss or donation of blood or plasma (200 mL) within 30 days prior to the start of the study
* Body weight \<50kg
* History of drug abuse within past 5 years or positive urine drug screen results
* Subjects who test positive in HIV,HCV antibody,HBS antigen
* Otherwise judged by the investigator to be inappropriate for inclusion in the study
Intralesional Injection of Metronidazole for the Management of Cutaneous Leishmaniasis

Aim of the study to evaluate the effectiveness of intralesional metronidazole 0.5% solution as a local injection in treating cutaneous leishmaniasis.

In an open-label single-arm clinical trial, all patients will be given intralesional levofloxacin injections; the patients had cutaneous leishmaniasis lesions. Each lesion will be considered a case in the final analysis. Each lesion will be followed up for 90 days (censor endpoint) or until the lesions are cured.

Intralesional metronidazole (5 mg/ml, 100 ml, Flagyl®, Sanofi, France) will be injected into each lesion based on its size (5 mg/cm2). The infiltration of intralesional dose will be given once weekly for up to 6 weeks. Treatment will be stopped in patients cured before 6 weeks of treatment, and patients will be only asked to come for lesion assessment. A fine insulin needle will be used to infiltrate the lesion.


Eligibility Criteria:
Inclusion Criteria:

* Patients with single or multiple (less than seven lesions) lesions of cutaneous leishmaniasis

Exclusion Criteria:

* Immunocompromised
* Allergic reaction to treatment.
PERsonalized Mood Augmentation Trial for Depressed Mood

The goal of this open-label single-arm study is to test personalized behavioral intervention for depressed mood.

The goal of this open-label single-arm study is to test personalized behavioral intervention for depressed mood. After an initial period (2-4 weeks) of mood and lifestyle monitoring using smartphone and smartwatch data, participants will be assigned to an evidenced-based behavioral plan that target their lifestyle for 6 weeks. The trial will evaluate changes in depressed mood, associated health behaviors and cognition.

Eligibility Criteria:
Inclusion Criteria:

* Mild to moderate depression per PHQ9 symptom ratings

Exclusion Criteria:

* active substance abuse/dependence
* psychotic disorders
* bipolar disorder
* eating disorder
* displaying acutely suicidal behaviors
Treatment of Meibomian Gland Dysfunction

The current study aims to test the efficacy of treatment for a device that utilises a thermal pulsation system, which applies heat from the inner surface of the eyelids (Lipiflow) in patients suffering from meibomian gland dysfunction.

Patients will be asked to undergo a one-time treatment with Lipiflow and the investigators will monitor them for changes in tear film and lipid composition, as well as changes in the anatomy of meibomian glands for over a study period of 12 weeks. Additionally, dry eye symptoms will be documented in form of questionnaires.

The investigators hypothesize that the treatment will be effective in improving clinical signs and will relieve dry eye symptoms for the patient. If this method of managing Meibomian Gland Dysfunction (MGD) is found to be efficacious and safe, it will be made available to patients in Singapore.


Eligibility Criteria:
Inclusion Criteria:

1. Eyelids must present with blocked meibomian gland openings (plugs), at least 1 visible MG plug in the 4 eyelids, or discernable change in consistency of meibum (increased in viscosity or opacity) when MG expressed in upper or lower eyelids.
2. At least one out of 8 questions on dry eye symptoms is answered with often or all the time.
3. Eyes should not show any other ocular surface pathology which required more treatment than eye lubricant and conventional eyelid hygiene.

Exclusion Criteria:

1. Known history of thyroid disorders (diagnosed by physician).
2. No ocular surgery within the previous 6 months and LASIK within the previous 1 year.
3. Any intake of central nervous system and hormonal drugs within last 30 days and inability to withhold such drugs for at least 6 weeks.
4. Active ocular infection or pterygium.
5. Anticipated necessity to wear contact lens in the duration of the study.
6. Living in the same household as another participant of the study.
7. Any other specified reason as determined by clinical investigator, for example, the need to use any treatment or eyedrops not permitted by the study.
Safety and Tolerability of Lixisenatide in Combination With Oral Anti-Diabetic Treatment in Patients With Type 2 Diabetes

Primary Objective:

The primary objective of this study is to assess the overall safety of lixisenatide once daily treatment in combination with background oral anti-diabetic treatment over 52 weeks in patients with type 2 diabetes in Japan.

Secondary Objective:

To assess the effects of lixisenatide in combination with background oral antidiabetic drug (OAD) on:

* HbA1c;
* Fasting plasma glucose;
* Body weight.

54 weeks +/-11 days

Eligibility Criteria:
Inclusion criteria :

* Patients with type 2 diabetes mellitus diagnosed at least 1 year before the screening visit
* Patient treated for at least 3 months prior to screening visit with one of following OADs at a stable dose of at least usual maintenance dose as described in the label

  * a biguanide (metformin hydrochloride);
  * a thiazolidinedione (TZD) (pioglitazone hydrochloride);
  * an alpha-glucosidase inhibitor (alpha-GI) (acarbose, voglibose or miglitol);
  * or a glinide (nateglinide, repaglinide or mitiglinide);
* Signed written informed consent

Exclusion criteria:

* At screening HbA1c \<7% or \>9.5%;
* At screening: fasting plasma glucose \>250 mg/dL (\>13.9 mmol/L);
* Use of any glucose-lowering agent(s) other than the authorized patient's background treatment defined in I02 (as given in inclusion critieria) within 3 months prior to screening;
* Type 1 diabetes mellitus;
* Women of childbearing potential with no effective contraceptive method;
* Pregnancy or lactation;
* Laboratory findings at the time of screening:

  * Amylase and/or lipase \>3 times the upper limit of the normal laboratory range (ULN);
  * ALT \>3 ULN;
* Any contra-indication to the patient's background oral anti-diabetic treatment;
* History of acute or chronic pancreatitis, pancreatectomy, stomach/gastric surgery, inflammatory bowel disease;
* Personal or immediate family history of medullary thyroid cancer (MTC) or genetic conditions that predispose to MTC (eg, multiple endocrine neoplasia syndromes);
* Any previous treatment with lixisenatide (eg, participation in a previous study with lixisenatide) or any other GLP1 receptor agonist.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Uterine Rupture During Labor Among Women With a Prior Cesarean Delivery

Although a rare event, uterine rupture during labour is one of the most serious obstetric complications because of the dramatic maternal-fetal consequences that can result.

Identifying the risk factors associated with uterine rupture would enable gynecologists to provide patients with risks of uterine rupture in the event of attempted vaginal delivery.

The aim of our study is to determine risks factors for uterine rupture during labour in patients with a previous cesarean delivery who have not given birth since and to assess the occurrence of maternal-fetal comply-cations compared to patients with a previous cesarean delivery without uterine rupture.


Eligibility Criteria:
Inclusion criteria:

* Singleton pregnancy \> 24 weeks of gestation
* Second or multiparous with a previous cesarean section without vaginal delivery since
* Cephalic presentation or completed breech
* Uterine rupture during labor

Exclusion criteria:

* Incomplete uterine rupture
* Multiple gestation
* Transverse presentation or complete breech
* Vaginal delivery after cesarean
* Non-low transverse cesarean section
* Placenta praevia
* Antepartum intrauterine fetal death
* History of uterine surgery (myomectomy)
A Common Elements-based Intervention to Improve Maternal Psychological Well-being and Mother-infant Interaction

Background: Millions of children in low resource settings are at high risk of poor development due to factors such as undernutrition, inadequate stimulation and maternal depression. Evidence based interventions to address these risk factors exist, but often as a separate and overlapping packages delivered through disjointed systems, therefore posing problems in scale-up. A common elements approach based intervention that combines evidence-based elements from packages of care addressing early stimulation, responsive feeding and maternal distress have been developed.

Objectives: The current study aims to develop an online training curriculum to train lay health workers in common elements based intervention to improve maternal psychological well-being and improve mother-infant interaction among distressed mothers in low resource rural community settings of Pakistan. The impact of intervention on maternal well-being, infant growth, nutrition and development will be evaluated at 12-months post-partum.

Method: A two arm, single blind, individual randomized controlled trial (RCT) will be carried out in the community settings of the rural sub-district of Gujar Khan in Rawalpindi, Pakistan. 250 Pregnant women in third trimester of pregnancy, screened positive for psychological distress on Self-Reporting Questionnaire (SRQ), cut-off score ≥ 9, will be randomized on 1:1 allocation ratio into intervention (n=125) and Treatment as Usual (TAU) arms (n=125). The participants in the intervention arm will receive 15 monthly sessions of intervention by community volunteers at home. First three sessions will be delivered in the third trimester of pregnancy followed by one monthly session for 12 months. The primary outcome will be caregiver-infant interaction at 12-months post-partum. The maternal secondary outcomes include maternal psychological wellbeing, quality of life, social support and empowerment. Maternal outcomes will be measured at baseline, 6-months and 12-months post-partum. Infant secondary outcomes include growth, nutrition and development and will be measured at 12 months. A mixed-methods process monitoring and evaluation will be conducted to inform the feasibility of intervention delivery.

Discussion: The outcomes of the study will be a common-elements based online training curriculum for training of community volunteers in intervention to improve maternal psychological well-being and mother-infant interaction in low resource rural community settings at-scale.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant with third trimester (28 gestational week)
* Age 18-40 years
* Intent to reside in the study areas until the completion of the study
* Score ≥9 on the SRQ

Exclusion Criteria:

* Women who require immediate or on-going medical or psychiatric care reported.
* Severe previous or current obstetric morbidity including eclampsia and antepartum hemorrhage;
* Medical disorders that require inpatient management (e.g., diabetes, hypertension, thromboembolism, cardiac disease)
Study Comparing Simulect Plus Standard Immunosuppression to Standard Immunosuppression Alone for the Prevention of Acute Rejection and Bronchiolitis Obliterans in Lung Transplant

The study will evaluate the efficacy and safety of basiliximab Vs placebo as induction therapy combined with standard triple immunosuppression therapy, in the prevention of acute rejection episodes and prevention of Bronchiolitis Obliterans Syndrome.

The objective of this study is to evaluate the efficacy and safety of basiluximab for the prevention of acute allograft lung rejection when used in addition to Neoral, corticosteroids and azathioprine. Acute rejection episodes will be evaluated during the first 6 months post-transplant. Bronchiolitis obliterans syndrome (BOS) will be evaluated at the end of 1 year after transplant and at additional follow-up visits at 2 and 3 years after transplant.

Eligibility Criteria:
Inclusion criteria

* Male or female recipients of a first bilateral or single lung or lobar allograft who are suitable to receive Neoral/ corticosteroids/ azathioprine/ and Basiliximab (Simulect).
* Patients greater than 18 years of age.
* Patients capable of understanding the purposes and risks of the study and who have given informed written consent.

Exclusion Criteria:

* Patients who require immunosuppressive therapy other than the study medications.
* Patients participating in another (investigational) drug trial or who have participated in such a study within 30 days prior to transplantation.
* Pregnant mothers, nursing women.
* Women unwilling to use adequate contraception during and for 3 months after receiving study drug.
* Patients receiving or requiring other investigational drugs, except antibiotics.
* Patients with current or past peak panel reactive antibody levels of 25% or greater.
* Patients with malignancy or history of malignancy other than successfully treated non-metastatic basal cell or squamous cell carcinoma of the skin.
* Patients with any form of substance abuse or psychiatric disorder which, in the opinion of the investigator, might invalidate patient communication with the clinician(s).
* Patients who have previously received Simulect.
Attitudes and Technical Maneuvers Regarding Enterostomy Management and Stoma Creation Among Surgeons

This study was aiming to investigate Chinese surgeons' attitudes toward and technical preferences for stoma creation.

The survey comprised five parts: personnel qualification and training, attitude toward stoma-related complications, preoperative siting, process of acquiring ostomy-related surgical skills, and awareness and adoption of relevant techniques (37 items in total). The questionnaire was distributed to Chinese hospitals by Sojump, a professional online platform. Finally, about 401 surgeons had responded including 188 hospitals of different grades across 26 provinces or municipalities directly under the Central Government.

Eligibility Criteria:
Inclusion Criteria: General or gastrointestinal surgeons involved in general surgery, gastrointestinal surgery, surgical oncology, emergency, and others involved in managing enterostomies who had completed their degree and were licensed, or at least resident surgeons were included.

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Exclusion Criteria: Surgeons who did not provide consent to participate in this study were excluded.

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Patient Centered Postpartum Contraception App

This study will evaluate a smart phone-based application ("app") designed to inform pregnant women ages 15-25 about their contraception options. The goal of this research will be to evaluate the usability, feasibility and acceptability of this app.

This study will evaluate a smart phone-based application ("app") designed to inform pregnant women ages 15-25 about their contraception options. The goal of this research will be to evaluate the usability, feasibility and acceptability of this app. Participants will be asked to complete a survey after informed consent and before using the app. After using the app, participants will complete a second survey. This second survey will ask questions about the app including the following topics: Usability, user-friendliness, navigation, user interface, time spent, organization readability; Feasibility, informative, helpful, comprehensible, quality of art, interface, sound; and Acceptability breadth of content, depth of content, engaging and motivating, Innovative utility and value. Women will also rate the degree to which they promote use of the product: would use the app if available, believe the app will support contraceptive use and would recommend the app to peers. Study participation will end once participants are done with the second survey.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant
* Identify as African American or Black
* English as primary language

Exclusion Criteria:

* Not pregnant
* Not identifying as African American or Black
* Language other than English as primary language
The VESPA Pilot Study

Physical activity has been described by the US federal government as a 'best buy' for public health. Unfortunately, most adults in the United States are not sufficiently active, and this worsens with age. Low levels of participation are driven by many challenging barriers, including lack of access, few opportunities for enjoyable activity, and few supportive social relationships, which is especially important given the central role of social connection for lasting behavior change.

A half-century of research in behavioral sciences has generated effective group-based physical activity programs, but these are inaccessible to most as they are often delivered in a few select research centers. Recent advances in telehealth have offered media for extending these interventions more broadly, but the experience of such programs is often hampered by technology that does not allow for a sense of physical and social presence. Fortunately, uptake of virtual reality (VR) is increasing rapidly, and the medium has a high level of potential for advancing the delivery of immersive evidence-based group interventions to those that most need it. Thus our specific aims are:

Specific aim 1: To test the feasibility and acceptability of a group-mediated physical activity intervention delivered fully via modern VR to older adults.

Specific aim 2: To examine the impact of this program on overall physical activity among older adults compared to the current standard-of-care for telehealth: the video conference meeting platform.


Eligibility Criteria:
Inclusion Criteria:

* Age of 45-80 years
* Body mass index between 30-45 kg/m2
* Low-active (30 or more minutes of moderate intensity physical activity on 2 or fewer days per week)
* Have access to home Wi-Fi
* Have regular access to a computer, tablet, or smartphone to receive teleconferencing calls
* Have a clear "VR space" (7'x7' object-free space)
* Have an "Activity buddy" (spouse, child, caregiver, etc.)
* Modified Telephone Interview for Cognitive Status (TICS-M) score of 32 or greater
* Consent from a physician for study participation
* Proficient in the English language
* Willingness to create or use existing personal Facebook account for virtual reality activities.

Exclusion Criteria:

* Current involvement in other physical activity research studies
* Hearing or sight impairments (significant visual or hearing impairment that cannot be corrected and results in the inability to use the telephone or hear normal conversation, colorblindness)
* Dependence on a cane or walker
* More than 1 fall in the past year
* Contraindication to exercise
* Current or recent history within the last 6 months of: symptomatic coronary heart disease, cancer, liver or renal disease, severe pulmonary disease, gross physical impairment, or uncontrolled hypertension; myocardial infarction or cardiovascular procedure within the last 3 months
* History of or diagnosis of photosensitive epilepsy
* Score of "severe" on any question in the Virtual Reality Sickness Questionnaire;
* Unwillingness to use a head-mounted virtual reality system
* Current severe or untreated depression
BIO|CONCEPT.BIOMONITOR III

The objective of the study is to confirm the safety and efficacy of the BIOMONITOR III system. Furthermore, the insertion procedure, the use and handling of the incision and insertion tools and the sensing quality of the BIOMONITOR III will be assessed.


Eligibility Criteria:
Inclusion Criteria:

* Patient is at high risk of developing a clinically important cardiac arrhythmia; or Patient is undergoing investigation for symptoms such as palpitations, pre-syncope or syncope, that are suggestive of an underlying cardiac arrhythmia; or Patient is undergoing investigation for the detection of atrial fibrillation following cryptogenic stroke; or Patient is planned for AF ablative procedure or has already undergone an AF ablative procedure.
* Patient is able to understand the nature of study and has provided written informed consent.
* Patient is willing and able to perform all follow up visits at the study site.
* Patient is willing and able to use the CardioMessenger and accepts the BIOTRONIK Home Monitoring concept.

Exclusion Criteria:

* Patients implanted with ICD or pacemaker.
* Patient is pregnant or breast feeding.
* Patient is less than 18 years old.
* Patient is participating in another interventional clinical investigation
* Patient´s life-expectancy is less than 6 months.