cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety Study of Botulinum Toxin Type A to Treat Glabellar Lines

The purpose of this study is to test the hypothesis that the efficacy and safety of Meditoxin® are not inferior to Botox®'s in the treatment of glabellar lines.

The allocated subject is injected Investigational Product(Meditoxin® or Botox®) 20U in middle of the forehead. The efficacy and safety are evaluated for 16weeks through 4 follow up visits.

Eligibility Criteria:
Inclusion Criteria:

* Men and women aged between 20 and 65
* Patients attaining ≥grade 2 (moderate) in the investigator's rating of the severity of glabella lines at maximum frown
* Patients who can comply with the study procedures and visit schedule
* Patients who voluntarily sign the informed consent

Exclusion Criteria:

* Patients with medical conditions who may be at greater risk due to the administration of the investigational drugs (e.g.. diseases that may affect the neuromuscular action including Myasthenia Gravis, Lambert-Eaton Syndrome, Amyotrophic Lateral Sclerosis and motor neuropathy)
* Patients with severe internal diseases (cardiovascular, respiratory, endocrine diseases etc.)
* Patients who have bleeding tendency or taking anti-coagulant
* Patients who were injected with botulinum toxin within the past 3 months
* Patients with allergy or hypersensitivity to the investigational drugs or their components
* Female subjects who are pregnant or lactating. Female subjects of childbearing age who have a plan to get pregnant during the study period, or do not use available contraceptive methods (Women of childbearing age should have negative urine pregnancy test results at baseline visit (0 week) prior to the first injection.)
* Patients with the history of facial nerve paralysis or the symptoms of eyelid ptosis
* Patients with skin disorders or infection at the injection site
* Patients who have received other procedures which may affect glabellar and forehead lines within 6 months
* Patients with the history of treatment of glabellar part(including forehead) like face lifting and permanent implant or with scars which may affect the treatment results
* Patients whose glabellar lines cannot be satisfactorily improved with physical method since the lines are not flattened even using hands
* Patients who have a plan to receive facial cosmetic procedures including dermal filler, photorejuvenation, chemical peeling and dermabrasion during the study period
* Patients who are participating in other clinical trials or have participated in other clinical trials 30 days before screening or the five times the half life of a drug which was given to patient during the previous clinical trials
* Patients who are unable to communicate or follow the instructions
* Patients who are not eligible for this study based on the judgment of an investigator
Study Evaluating Levonorgestrel and Ethinyl Estradiol for Oral Contraception

The purpose of this study is to evaluate the contraceptive efficacy and safety of an oral contraceptive containing a combination of LNG 100mcg/EE 20mcg compared to LNG 150mcg/EE 30 mcg.


Eligibility Criteria:
Inclusion Criteria:

* Healthy women,aged 20-35 years who wish to use a contraceptive.
* Women without reproductive system infection complications.
* Willingness to not use other forms of hormonal treatment.
* Three regular menstrual cycles before the study(21-35 days per cycle with 3-7 day's bleeding period, without amenorrhea or irregular bleeding).
* Signed informed consent prior to entry into the trial.

Exclusion Criteria:

* Any contraindication to the use of oral contraceptives.
* Vascular, metabolic, hepatic, renal, oncologic and other diseases.
Investigating the Safety and Performance of a New 2-piece Ostomy Product Compared With SenSura Click 2-piece

The aim of the current investigation is to investigate the performance of a new 2-piece ostomy product

The present investigation aims at testing the performance and safety of a new 2-piece ostomy product.

Eligibility Criteria:
Inclusion Criteria:

* 1.Have given written informed consent and letter of authority (DK only)
* 2.Be at least 18 years of age and have full legal capacity.
* 3.Be able to handle the products her/himself
* 4.Have an ileostomy with a diameter between 10 and 40 mm.
* 5.Have had their ostomy for at least three months.
* 6.Be willing to use minimum 2 base plates every week
* 7.Currently use 2-piece flat mechanical coupling product with open bag 8
* 11.Negative result of a pregnancy test for women of childbearing age (only DK)

Exclusion Criteria:

* 1.Currently receiving or have within the past 2 months received radio- and/or chemotherapy.
* 2.Currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet/injection) treatment.
* 3.Is pregnant or breastfeeding.
* 4.Is participating in other interventional clinical investigations or have previously participated in this investigation
* 5.Has participated in the previous explorative study CP234
* 6.
* 7.Known hypersensitivity towards any of the test products
* 8.Currently suffering from peristomal skin problems (i.e.bleeding or red and broken skin)
Accuracy of Methemoglobin Measurement for Rainbow DCI Sensors

In this study, the level of methemoglobin (HbMet) will be increased in a controlled manner by administering sodium nitrite intravenously in healthy volunteers. The accuracy of a noninvasive HbMet measurement by a DCI pulse oximeter sensor will be assessed by comparison to blood measurements from a laboratory analyzer.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects must understand and consent to be in the study
2. American Society of Anesthesiology Class I (Healthy subjects without any systemic disease at all).

Exclusion Criteria:

1. Subjects who have any systemic disease at all.
2. Subjects who do not understand the study and the risks involved.
3. Current smokers.
4. Subjects who are pregnant.
Genetic Markers and Biomarkers in Patients With Intellectual Disabilities of Genetic Origin

Analyze genetic and biological markers in patients with Intellectual Deficiencies (ID) of genetic origin in order to better understand the mechanisms of modified genes, cellular mechanisms, pathways involved in different disorders , complications and pathologies associated with ID of genetic origin.

Blood and skin samples will be taken from patients coming at the outpatients clinic of the Institut Jérôme Lejeune and who consent to participate to the study. Search and identification of markers will be then done from the collected samples.

Eligibility Criteria:
Inclusion Criteria:

* Patient diagnosed with an intellectual disability of genetic origin
* Patient of all ages coming for consultation at the Institut Jérôme Lejeune
* Patient whose parents or legal representative have received and understood the information document and signed the informed consent for a sample for the research project.
* Patient affiliated to a social security scheme

Exclusion Criteria:

* Parents unable to find out about the constraints related to the study
* Refusal of informed patient participation
* Pregnant, parturient and nursing mothers
* Persons deprived of their liberty by judicial or administrative decision
Multi-center, Open Label, Extension Study of ALN-VSP02 in Cancer Patients Who Have Responded to ALN-VSP02 Treatment

This study provides a mechanism for continued administration of ALN-VSP02 therapy to patients with cancer who completed participation in another ALN-VSP02 clinical study. The primary objective of this study is to collect long term safety data.

Study ALN-VSP02 is an extension study for previously conducted ALN-VSP02 studies. The study is being conducted to allow for continued ALN-VSP02 therapy for patients who completed participation in an ALN-VSP02 clinical study, achieved clinical benefit with ALN-VSP02 (i.e., disease response of stable disease or better), and, in the Investigator's opinion, may benefit from continuation of ALN-VSP02 therapy.

Eligibility Criteria:
Inclusion Criteria:

1. Patient has completed a previous ALN-VSP02 study, and is deemed to have stable disease or better.
2. Patient has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.
3. Patient has adequate hematologic, liver, and renal function.

Exclusion Criteria:

1. Patient is receiving full-dose (therapeutic) anticoagulation therapy and/or aspirin \> 325 mg/day or other platelet inhibitory agents.
2. Patient has clinically significant cardiovascular disease or uncontrolled serious cardiac arrhythmia.
3. Patient has clinically significant cerebrovascular disease.
4. Patient has a seizure disorder not controlled on medication.
The Samsung Medical Center Comprehensive Cancer Center Registry from 2008 to 2023

This is a retrospective cohort study using the Samsung Medical Center Cancer Registry, including cancer patients between 2008 and 2022.

To monitor trends in patient demographics, treatment patterns, and outcomes.

All medical, administrative, and patient information is saved in an EMR system. Age at diagnosis (years), sex, body mass index, region of residence, marital status at diagnosis, employment status at diagnosis, diagnostic pathways (detected by screening, incidentally diagnosed cancer, detected by symptoms), and diagnostic method were obtained from the ERM by trained cancer registrars. Cancer types were classified based on the GLOBOCAN cancer dictionary, and the latter was the taxonomy used in "Cancer Incidence in Five Continents", and the International Association of Cancer Registries provided both of them. In this study, the cancer classification with 24 types of cancer was used for description based on the Korean National Cancer Registry annual report.

The summary staging system developed under the Surveillance, Epidemiology, and End Results (SEER) program (i.e., SEER summary staging) \[12\] was used to categorize the extent of tumor invasion or metastasis. Based on the 7th edition of the American Joint Committee on Cancer Staging Manual, SEER data were markedly enriched with tumor grades, invasion/metastasis status (bone, brain, lung, and liver), site-specific variables, and tumor stages.

For procedures such as genetic testing, surgery, chemotherapy and radiation therapy, clinical trial participation, and supportive care center visits, data were extracted from the DARWIN-C clinical data warehouse of Samsung Medical Center.

Trends of the hospital process included applying clinical pathways, fast track, and multi-disciplinary community were obtained from Enterprise Data Warehouse (EDW). Clinical pathways are tools used to guide evidence-based healthcare. A clinical pathway is a structured multidisciplinary care plan that details the steps in a course of treatment or care in a plan, pathway, algorithm, guideline, protocol, or other inventory of actions. The fast-track treatment system is additional tests for surgery, and decisions about surgery are all done on the first day of the visit for patients diagnosed with cancer who require surgery. Multi-disciplinary community is to bring together a group of healthcare professionals from different fields to determine patients' treatment plans. Survival status and date of death were obtained from the mortality database of the Ministry of the Interior and Safety. Overall survival (OS) was defined as the time from the date of diagnosis to death from any cause.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with cancer
JC-Virus (JCV) Antibody Program

The primary objective is to define the prevalence of serum anti-JCV antibody in relapsing multiple sclerosis (MS) participants receiving Tysabri® (natalizumab) or being considered for such treatment. Secondary objectives are to analytically validate the anti-JCV antibody assay in a plasma matrix and to determine changes in anti-JCV antibody status over time.

This study requires serum, plasma and urine collection at enrollment and every 6 months thereafter for up two years.

Eligibility Criteria:
Key Inclusion Criteria:

* Relapsing multiple sclerosis (MS) patients interested in or considering beginning treatment with Tysabri® (natalizumab).

Key Exclusion Criteria:

* Patients participating in any other Tysabri® (natalizumab) clinical trial or study sponsored by Biogen Idec or Elan may not participate in this study.

NOTE: Other protocol-defined inclusion/exclusion criteria may apply.
Additive Effects of QVAR to (Seretide) on Surrogate Markers of Airway Inflammation in Refractory Asthma

The purpose of this study is to establish whether addition of extra-fine particle steroid inhalers achieve additional suppression of small airways inflammation when added to 'standard' Fluticasone/Salmeterol combination therapy in refractory asthma.


Eligibility Criteria:
Inclusion Criteria:

* Refractory, non-smoking asthmatics with FEV1 les than 80% predicted
* RV greater than 100% predicted and CANO greater than 3ppb when stepped up to 1000µg of fluticasone per day, with or without additional asthma medication.
* Informed consent and ability to perform exhaled nitric oxide assessment.
* Participants must be on greater than 500mcg of fluticasone per day to enter dose ramp run-in.

Exclusion Criteria:

* Recent respiratory infection or oral steroid use.
* Pregnancy or lactation.
* Known or suspected contra-indication to any of the IMP's.
* CANO less than 3ppb, FEV1 greater than 80% or RV less than 100% at post-optimisation visit.
The Construction of Physical ACtivity Enhancement Scheme (PACES) in Hemodialysis Patients

Hemodialysis (HD) is the most commonly used renal replacement therapy in patients with end-stage renal disease (ESRD). More than 553,000 ESRD patients in China are currently receiving HD, but the long-term survival rate is low and the mortality rate is as high as 18%, which is significantly associated with low physical activity (PA). Low PA could decrease cardiopulmonary and muscle function, limit the ability to perform activities of daily living, and increase risk of death. The National Kidney Foundation Disease Outcomes Quality Initiative (K/DOQI) recommends PA as cornerstone of ESRD rehabilitation. However, HD patients still live with inactive lifestyle. The investigators' previous study have demonstrated that enhancing PA benefits physical function in HD patients. Therefore, this study intends to establish Physical ACtivity Enhancement Scheme (PACES), that is, to take PACES (measured by pedometers) as the investigation core and motivate patients to PACES.

This study will consists of three distinct parts: 1, 2 and 3. In Part 1, the investigators will conduct research on the PA of HD patients through pedometer and questionnaire, and understand the participants' attitude to PA through a series of questionnaires. In Part 2, the investigators will conduct a semi-structured interview to understand HD patients' attitudes and habits towards PA, as well as recommendations for PACES. In Part 3, the investigators will take the results of Part 1 and 2 as the initial draft of PACES and modify the initial draft through the Delphi method to form the final PACES.

The study aims to develop PACES from the perspective of patients to address the above cognitive factors, making it easier for HD patients to enhance PA.


Eligibility Criteria:
Inclusion Criteria:

* adult (age≥18) with stable ESRD;
* receiving≥3 months HD;
* receiving HD more than 5 times every two weeks;
* volunteer for participating in this investigation.

Exclusion Criteria:

* are unable to do walk on one's own (severe musculoskeletal pain at rest or with minimal activity precluding walking or stationary cycling; unable to sit, stand or walk unassisted, walking devices such as cane or walker allowed);
* have shortness of breath at rest or with activities of daily living (NYHA Class IV);
* have mental disease, disturbance of consciousness and couldn't cooperate with this investigation.
EUS GUIDED Transduodenal Biopsy Using the 19G Flex

This study evaluates the feasibility, safety and accuracy of a 19 gauge (19G) needle in nitinol in the performance of endoscopic ultrasound (EUS) guided transduodenal biopsy for the acquisition of samples for histologic analysis. Patients with lesions that can be approached only from the duodenum will be prospectively enrolled.

A 19 gauge needle in nitinol (Flex needle) has been recently become available for EUS guided procedure.

The use of nitinol should guarantee a better needle flexibility with a theoretical advantage on the use of this needle for lesions that need to be sampled through the duodenum. Moreover, samples for histologic examination seems to be easy to interpret than cytologic ones allowing evaluate of the overall architecture of the tissue, better performance of immunohistochemical staining, and may be of additional value to perform tissue profiling that in the future will be very important to guide individualized therapies

The existing data on the performance of the Flex needle for EUS-guided transduodenal biopsy are coming form a single study performed in one single center. Thus, the reproducibility of these results is unknown and multicenter prospective studies are warranted to answer this important question.

Eligibility Criteria:
Inclusion Criteria:

A. Age greater than 18 and less than 90. B. Presence of a solid lesion of the gastrointestinal tract adjacent to the duodenum with no previous tissue diagnosis.

C. Absence of an uncorrectable coagulopathy as defined by abnormal prothrombin time (PT) or partial thromboplastin time (PTT) that does not normalize after administration of fresh frozen plasma.

D. Informed consent is obtained.

Exclusion Criteria:

A. Presence of an uncorrectable coagulopathy as defined by abnormal prothrombin time (PT) or partial thromboplastin time (PTT) that does not normalize after administration of fresh frozen plasma.

B. Altered anatomy of the upper gastrointestinal tract due to surgery of the esophagus, stomach and duodenum.

C. They are unable to understand and/or read the consent form.
Bioequivalence Study of Alendronate Sodium Tablets 70 mg of Dr. Reddy's Under Fasting Conditions

The purpose of this study is to determine the bioequivalence of Alendronate Sodium 70 mg of Dr. Reddy's and Fosamax Tablets 70 mg of Merck \& Co.

Open label, balanced, randomized, two-treatment, two-sequence, two-period, single-dose, crossover oral bioequivalence study of Alendronate sodium 70 mg tablets of Dr Reddy's Laboratories Limited, India and Fosamax® tablets of Merck \& Co., Inc., USA, in healthy, adult, human subjects under fasting conditions.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy human subjects aged between 18 and 45 years (including both).
2. Subjects with a BMI between 18.5 - 24.9 Kg/m2 but weight not less than 45 Kgs.
3. Female subjects who are postmenopausal or surgically sterile.
4. Female subjects of child bearing potential practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as condoms, foams, jellies, diaphragm, intrauterine device (IUD) or abstinence.
5. Subjects with normal health as determined by personal medical history, clinical examination, and laboratory examinations and serology tests.
6. Subjects having normal 12-lead electrocardiogram (ECG).
7. Subjects having normal chest X-Ray (P/A view).
8. Subjects able to communicate effectively.
9. Subjects willing to given written informed consent and adhere to all the requirements of this protocol.

Exclusion Criteria:

1. Subjects having contraindications or hypersensitivity to Alendronate sodium or related drugs.
2. History or presence of any medical condition or disease according the opinion of the physician.
3. History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder.
4. History or presence of significant alcoholism or drug abuse in the past one year.
5. History or presence of significant smoking (more than 10 cigarettes or beedi's/day or consumption of tobacco products).
6. Difficulty with donating blood.
7. Difficulty in swallowing solids like tablets or capsules.
8. Systolic blood pressure less than 90 mm Hg or more than 140 mm Hg.
9. Diastolic blood pressure less than 60 mm Hg or more than 90 mm Hg.
10. Pulse rate less than 50/minute or more than 100/minute.
11. Use of any prescribed medication during last two weeks or OTC medical products during the last one week preceding the first dosing.
12. Major illness during 3 months before screening.
13. Participation in a drug research study within past 3 months.
14. Donation of blood in the past 3 months before screening.
15. Female volunteers demonstrating a positive pregnancy screen.
16. Female volunteers who are currently breast-feeding.
17. Female volunteers with child bearing potential using prohibited contraceptive method (Oral, Injectable or Implantable hormonal agents).
Fresh Start Experiment

The investigators are proposing an experiment to help Humana investigate when to launch programs or send messages that are designed to improve customers' engagement. The investigators' past research has shown that certain life events and calendar events (e.g., a job change, a birthday, a holiday, Monday) feel like a "fresh start" to people and have the potential to motivate them to begin pursuing their health goals (e.g., exercising, starting a diet, quitting smoking).

The investigators are proposing an experiment to help Humana investigate when to launch programs or send messages that are designed to improve customers' engagement. The investigators' past research has shown that certain life events and calendar events (e.g., a job change, a birthday, a holiday, Monday) feel like a "fresh start" to people and have the potential to motivate them to begin pursuing their health goals (e.g., exercising, starting a diet, quitting smoking). In this experiment, the investigators will test (a) whether Humana can increase the effectiveness of its messages by sending them to customers around fresh starts moments and (b) whether highlighting a recent fresh start event in Humana's messages can further increase customer engagement.

Eligibility Criteria:
Inclusion Criteria:

* customers of our insurance company partner

Exclusion Criteria:

* none
Test and Treat TB: A Proof of Concept Trial in South Africa

The purpose of this study is (1) to establish the feasibility, yield, and clinical impact of a "Test \& Treat TB" strategy on a mobile HIV screening unit in South Africa and (2) to assess the cost and cost-effectiveness of this mobile, integrated HIV/TB screening strategy for maximizing linkage to TB care and treatment completion.


Eligibility Criteria:
Inclusion Criteria:

* English or Zulu speaking
* presenting for screening at mobile unit
* voluntarily undergoing HIV testing
* able and willing to give informed consent
* willing to share HIV and TB test results
* willing to attend one of six local clinics for treatment
* access to a mobile phone

Exclusion Criteria:

* pregnant