cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy of an Anticholinergic Agent for Treatment of Primary Axillary Hyperhidrosis

This Phase 2 study is designed to evaluate multiple doses of an anticholinergic-containing medication and identify the dose or doses that may effectively reduce axillary sweating in hyperhidrotic subjects. The anticholinergic agent being studied is designated WL8713.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers with primary axillary hyperhidrosis
* Poor quality of life rating on the Hyperhidrosis Disease Severity Scale (score of 3 or 4)
* Has a baseline gravimetric measurement of spontaneous resting sweat production of ≥100 mg/10 min at room at room temperature in at least one axilla
* Meets at least two of the following criteria (self-reported):

  * sweating is bilateral and symmetrical
  * excessive sweating impairs daily activities
  * subject experiences at least one sweating episode per week
  * excessive sweating onset was earlier than age 25 years
  * has a positive family history for excessive sweating
  * cessation of sweating during sleep
High-flow Nasal Oxygenation During Deep Sedation in Pediatric Dental Patients

It is important to choose an appropriate oxygenation technique during intravenous deep sedation in pediatric dental treatment. The study is to evaluate the efficacy and safety of high-flow nasal oxygenation in intravenous deep sedation in pediatric dental patients.


Eligibility Criteria:
Inclusion Criteria:

1. children in need of deep sedation for dental treatment aged 3-7 years.
2. anticipated operation time over 60 mins.

Exclusion Criteria:

1. Conditions which the attending considers to be unfit for elective surgery or tubeless anesthesia.
2. Any contraindications of high flow nasal oxygenation.
3. Any contraindications or allergic history of propofol.
National Study on the Interest of EEG-fMRI in the Presurgical Evaluation of Partial Epilepsies Drug

The main goal of this study is to evaluate the additional value of EEG-fMRI method in the presurgical evaluation of focal intractable epilepsy.

To consider a patient for surgery, the main difficulty is to define accurately the epileptogenic zone. This definition is complex and is often supported by several types of exploration (MRI, FDG PET, neuropsychological testing, video-EEG...). In this study we will evaluate the adding value of the simultaneous recording of EEG and fMRI in the epileptogenic zone definition.


Eligibility Criteria:
Inclusion Criteria:

* \> 8 years old
* intractable focal epilepsy
* presurgical evaluation or "phase 1" planified
* with focal EEG activity : more than 3 EEG interictal epileptic events per hour
* patient and/or legal representant given their written consent for their participation in the study

Exclusion Criteria:

* MRI contraindication
* pregnancy
* uncomfortable prolonged lying position
* frequent primary or secondary generalised seizure with tonic clonic movements (\>2 per week)
* previous epilepsy surgery
* important mental retardation
The Long-term Safety Study of Idursulfase-beta in Hunter Syndrome(Mucopolysaccharidosis II) Patients

The objective of this study is to evaluate the long term safety and efficacy of once weekly dosing of idurasulfase-beta 0.5mg/kg administered in Hunter Syndrome(Mucopolysaccharidosis II) Patients


Eligibility Criteria:
Inclusion Criteria:

* Patients who have a diagnosis of Hunter syndrome(Mucopolysaccharidosis II).
* Patients who are administered idurasulfase-beta or willing to be administered idurasulfase-beta.
* Patient's parent(s), or patient's legal guardian must have given voluntary written consent to participate in the study.

Exclusion Criteria:

* Patients who have participated in any other blind clinical trials.
* Patient who cannot be tracked about safety.
* Patients who are judged disqualified to participate clinical trials by investigator for other causes.
Hepatitis B Antigen Kidney Graft Into Protective Level Hepatitis B Antibody Recipients

To determine the safety of using kidney organ from hepatitis B surface antigen positive donor, the author conducted the single-center, prospective study of the use of these kidneys for recipients who have protective level of hepatitis B surface antibodies.

The kidney transplant registry was conducted in KCMH since the year of 2000 until the present.

The inclusion criterion was:

* All kidney allograft recipients who received at least one month after transplantation.
* All kidney recipients who already had the protective antibody against hepatitis B virus infection defined by anti-HBs titer above 100 mIU/mL at pre-transplantation period.

The exclusion criterion was:

* The recipients with positive hepatitis C virus antibody.
* The recipients who had received a previous or simultaneous non-kidney solid organ transplant.
* The recipients those lost to follow-up.

Study group:

* The recipients who received kidney allograft from the HBsAg(+) donor.

Control group:

* The recipients who received kidney allograft from the HBsAg(-) donor.

According to the Thai Red Cross National Organ Donation and our institute's policy, the HBsAg(+) kidney allografts were distributed to only and informed consent.

Data collection:

* Baseline characteristic data e.g. donor and recipient age, donor and recipient gender, HLA, PRA, anti-HBs titer, immunity against HBV status (both natural and vaccinated),immunosuppressive regimens were collected.
* The recipients were prospective followed up at month 3, 6, 9, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120.
* Clinical data including jaundice, hepatitis, graft rejection were collected
* Laboratory data of HBsAg, anti-HBc, HBV DNA, SGOT, SGOT, eGFR were collected.
* Pathological data of allograft biopsy at month 12 and 24 were retrieved.

Outcomes:

* Primary outcome: hepatitis B transmission rate.
* Secondary outcome: graft survival, patient survival.

Eligibility Criteria:
The inclusion criterion was:

* All kidney allograft recipients who received at least one month after transplantation.
* All kidney recipients who already had the protective antibody against hepatitis B virus infection defined by anti-HBs titer above 100 mIU/mL at pre-transplantation period.

The exclusion criterion was:

* The recipients with positive hepatitis C virus antibody.
* The recipients who had received a previous or simultaneous non-kidney solid organ transplant.
* The recipients those lost to follow-up.
Characterization and Durability of COVID-19 Vaccine Induced Immune Responses in Healthcare/Frontline Workers

Rationale: Early in the covid-19 pandemic, it was unclear whether and how individuals and populations would develop protective and enduring immunity against SARS-CoV-2, either after infection or vaccination. It is still not clear what role might immune cellular responses play in the development of immunity to SARS-CoV-2 infection and what are the implications for vaccines? As T cells recognise and respond to viral antigens they produce many protective reactions and effector molecules. One such molecule is the cytokine interferon γ, secreted by CD4+ and CD8+ T cells and their memory cells. This can be measured means of documenting specific T cell responses to viral antigens. Published studies offered a strong evidence that T cell immune responses are sustained, even in the face of declining or undetectable antibodies, implying that some immunity persists. The evidence from new studies, interim results from phase III vaccine trials, and previous data from phase I and phase II trials support the notion that memory T cell responses to the vaccines, along with B cell antibody responses, should provide good and possibly enduring immunity to SARS-Cov-2. We propose to describe and characterize the humoral, innate and long-term adaptive immune responses and the neutralization potential generated by COVID-19 vaccination (Covaxin, Covishield) among healthcare and frontline workers.

Study objectives i. To estimate the neutralizing antibodies titre against SARS CoV-2 by vaccine type.

ii. To estimate the proportion of vaccine recipients developing effective antibody response for SARS-CoV-2 specific IgG, IgM, and total IgE and IgA antibodies pre- and post-COVID-19 vaccination on day zero, day 28, month 2, 3, 6, 12, 18 and 24 by vaccine type.

iii. To identify and characterize the immune biomarkers for long term innate and adaptive immune response by vaccine type.

iv. To estimate the ratio of immune biomarker levels between pre- and post- COVID-19 vaccination at days 28, month 2, 3, 6, 12, 18 and 24 by vaccine type

Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18-60 years
* Should have been vaccinated with either Covaxin or Covishield
* Willing to provide written informed consent

Exclusion Criteria:

* Participants will be ineligible if they are not vaccinated for either Covaxin or Covishield vaccine
* Not willing to provide written informed consent
Real-life EValuation Of High Dose RosUvastatin in High Risk Patients After TitraTION

To evaluate achievement ratio of treatment target goal in hypercholesterolemia patients with high risk after high dose rosuvastatin(20mg/day) titration


Eligibility Criteria:
Inclusion Criteria:

* High-risk hyperlipidemia patients who are prescribed with rosuvastatin 10mg, based on the physician's clinical decision and fulfill the following criteria

  1. Over 18 years of age
  2. Have history of CHD or CHD risk equivalents, such as peripheral arterial disease, abdominal aortic aneurysm, symptomatic carotid artery disease (TIA or stroke of carotid origin or \>50% obstruction of carotid artery), DM, and 2+ risk factors with 10-year risk CHD\>20%

Exclusion Criteria:

1. Patients already taking other hyperlipidemic agents
2. Patients who do not fulfil the indication criteria for statin therapy
3. Patients who do not have baseline and/or follow-up lipid data to verify the efficacy data
A Placebo-controlled Trial to Evaluate the Safety and Efficacy of Galantamine in the Treatment of Vascular Dementia

This is a trial to evaluate the safety and effectiveness of galantamine in patients with dementia secondary to blood vessel disease in the brain.

In a previous 6-month study in patients with both vascular dementia and Alzheimer's dementia, galantamine demonstrated positive results on thinking, functioning, behavior, speech and overall well being of patients, and prevented the behavior symptoms of dementia from appearing. This combined study consists of two almost identical 26-week studies that examine the same criteria as the previous study, but in a larger patient population (dementia has been identified as having been caused by blood vessel disease without Alzheimer's disease). The study starts with a 4-week period in which current medications for dementia are withdrawn followed by a 26-week double-blind treatment period when patients will receive either placebo or galantamine 8 milligrams or 12 milligrams twice a day. Effectiveness will be measured by changes in scores on the Alzheimer's Disease Assessment Scale cognitive subscale, Alzheimer's Disease Cooperative Study Scale, the Clinician's Interview-Based Impression of Change Plus, and the neuropsychiatric inventory, as well as (in English-speaking countries only) a 10-minute interview of the patient (EXIT-25 scale). Safety will be evaluated throughout the study based on the incidence and severity of unexpected events, laboratory and physical tests, and vital signs. The hypothesis of the study is that galantamine will improve thinking, function, behavior, speech, and overall well being, better than placebo. A voluntary pharmacogenomic study will be incorporated into the study plan to evaluate whether specific genes are related to the dementia or drug response. 8 milligrams (mg) 2 times a day for 8 weeks, then increasing to12 mg, if tolerated. After 12 weeks dose can be reduced to 8 mg or matching placebo

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with vascular dementia per NINDS-AIREN criteria
* Radiologic evidence of VaD on MRI
* Clinical evidence of VaD (ie focal signs)
* Onset of dementia between ages 40 and 90 years
* Ability to read, write, communicate, and understand cognitive testing instructions
* No uncontrolled medical conditions

Exclusion Criteria:

* Presence of other diseases or disorders that could cause loss of mental functioning (such as trauma, cancer, infections, mental retardation)
* Current significant cardiovascular disease that could limit the patient's ability to complete the study
* Major psychiatric diseases
* Peptic ulcer or significant urine outflow obstructions
* Seizures
* Other serious diseases
* History of drug or alcohol abuse within the past year
Effectiveness and Safety Comparison of Lunaphil Ultra (Hyaluronic Acid, by Espad Pharmed Co.) Versus Juvederm Ultra 4® (Hyaluronic Acid, by Allergan Co.) in Nasolabial Folds (NLFs) Management

Rationale and background: Skin aging is a complex process that results in various changes in the skin, including wrinkles, sun spots, and sagging skin. The NLF is a natural change that becomes more prominent with aging and significantly affects the beauty of the facial skin. Dermal fillers, particularly hyaluronic acid (HA) fillers, are commonly used to correct these signs of aging. This study aimed to compare the effectiveness and safety of Lunaphil Ultra with Juvederm Ultra 4® for treating NLFs.

Primary objective: Effectiveness assessment of Lunaphil Ultra Secondary objectives: Effectiveness and safety assessment of Lunaphil Ultra Study design: This is a randomized, double-masked, active controlled, within-subject, and equivalency clinical trial.

Setting: Subjects were treated with Lunaphil Ultra in one NLF and Juvederm Ultra 4® in the opposite NLF.


Eligibility Criteria:
Inclusion Criteria:

* Subjects ≥ 30 years of age
* Visible bilateral NLFs that were approximately symmetrical and had an equal severity ranging from moderate to severe (assessed at the deepest part)
* Able to follow study instructions and likely to complete all required visits
* Signed informed consent

Exclusion Criteria:

* History of bleeding disorders or participants receiving or recently exposed (≤ 3 weeks) to continuous treatment with thrombolytics, anticoagulants, platelet inhibitors, or NSAIDs
* Acute herpetic eruption
* Known susceptibility to keloid formation, hypertrophic scarring or clinically significant skin pigmentation disorders
* Known sensitivity to local anesthetics of the amide type (such as lidocaine), history of hypersensitivity to gram-positive bacterial proteins, history of multiple severe allergies, history of anaphylactic shock
* Known hypersensitivity to any component of the study products or excipients (like hyaluronic acid)
* History of receiving immune therapy or a history of autoimmune disease
* History of active chronic debilitating systemic disease
* History of connective tissue disease, history of malignancy (except for non-melanoma skin cancer) within the last 5 years
* Clinically significant active dermatologic disorders within the last 6 months
* Use of oral retinoids, over-the-counter (OTC) or prescription antiwrinkle treatments, microdermabrasion, or chemical peels in the NLF area within the last 4 weeks or intention to use them during the study
* Any prior cosmetic procedure or tissue augmentation at the NLF injection site within 1 year before study entry (or intent to undergo such a procedure during the study)
* Pregnancy or breastfeeding
Home-based Exercise Training for Lung Cancer Patients Awaiting Surgery

Surgical resection is the only curative treatment in patients diagnosed with lung cancer, the most mortal type of malignancy globally. However, following lung cancer resection, patients experience a substantial deterioration in health-related quality of life and have an increased risk of developing pulmonary complications.

Although current clinical guidelines strongly recommend preoperative exercise training to improve clinical outcomes after lung cancer surgery, inaccessibility to facility-based exercise programs is a major barrier to routine participation, with patients indicating a strong preference to exercise in a home-based environment.

The primary purpose of the present study was to evaluate the feasibility of a home-based exercise program (HBEP) in lung cancer patients awaiting surgical treatment. The secondary purposes were to evaluate the safety of the HBEP and to explore exercise effects on patients' HRQOL and physical performance, either pre-and post-surgery.


Eligibility Criteria:
Inclusion Criteria:

* Scheduled for surgical treatment of suspected or confirmed lung cancer (clinical stage IIIA or less)
* Waiting time for surgery of at least two weeks from baseline assessment
* Medical clearance to exercise.
* Signed informed consent prior to initiation of study-related procedures.

Exclusion Criteria:

* Metastatic cancer
* Presence of physical or mental disabilities that contraindicated exercise training or physical testing
* Unable to communicate in Portuguese or English
* Performing combined aerobic plus resistance training over the past month (self-reported ≥2 days a week, ≥30 minutes each session).
A Pilot Clinical Trial With Tocotrienol on Breast Cancer

Tocotrienol Rich Fraction (TRF) in combination with Tamoxifen will improve breast cancer specific survival and recurrence free survival, in women with early breast cancer and estrogen receptor positive tumors.

We conducted a, double-blinded, placebo controlled trial of TRF plus tamoxifen versus placebo plus tamoxifen in women with primary breast cancer for five years. Both the TRF and placebo drugs were prepared and supplied by Hovid Sdn Bhd, Malaysia. Hovid Sdn. Bhd. absolutely did not have any influence in the trial designing, patient recruitment, data collection, analysis and reporting. The placebo drug which contained soy oil without tocotrienols had similar appearance and taste as the TRF drug. A total of 240 women breast cancer patients were assigned to two groups by minimization method that balanced treatment groups. The intervention group was given TRF plus tamoxifen, (n = 120) while control group was given placebo plus tamoxifen, (n = 120). The primary end point was breast cancer specific survival, defined as the time from minimization to death due to breast cancer. The secondary end points included disease free survival, biochemical parameters, liver function and plasma levels of vitamin E.

Eligibility Criteria:
Inclusion criteria:

1. women with estrogen receptor positive tumors.
2. 40-60 years of age at the start of the tamoxifen therapy.
3. histologically confirmed primary breast cancer.
4. a tumor that was positive for estrogen receptors, progesterone receptors, or both.
5. an Eastern Cooperative Oncology Group performance status of 0,1, or 2 (scored on a scale of 0 to 5, with lower scores indicating better function).

Exclusion criteria:

1. concurrent use of investigational drugs and estrogen receptor status negative or unknown.
The Triglyceride/Glucose Index and SGLT-2 Inhibitors

This study was designed to evaluate the change in triglyceride glucose index, one of the atherosclerotic markers, in patients with type 2 DM followed in the Internal Medicine Clinic of Samsun University, Samsun Training, and Research Hospital.

Methods: The data of the patients who were followed up for at least 3 months by making a retrospective file review will be recorded and analyzed. It is planned to start the study following the ethics committee's approval.

The data of all patients who applied to Samsun Training and Research Hospital Internal Medicine outpatient clinic for 12 months in 2022 and were started on SGLT-2 inhibitor will be examined. According to the inclusion and exclusion criteria stated below, the patients will be evaluated and the data of the patients admitted to the study will be analyzed. The triglyceride glucose index of the patients before starting the SGLT-2 injection and the trig/glucose index at the end of 3 months of treatment will be calculated by the researchers using the data in the system. No additional blood tests or laboratory analyses will be performed on the patients. Triglyceride, glucose, and glycosylated hemoglobin values were checked at the beginning of the treatment and at the 3rd-month follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 DM
* Age \>18 years old
* Dapagliflozin 10 mg or empagliflozin 10 mg or 25 mg
* 3 months follow-up period

Exclusion Criteria:

* Type 1 diabetes
* Gestational diabetes
* Age \< 18 years old
* Insufficient or missed laboratory test results
* Medical treatment for dyslipidemia
* Hypothyroidism
Early Prescription of Radiography Using the Ottawa Ankle Rules by a Nurse in the Management of Isolated Ankle Trauma

The study will be conducted in 2 phases (A and B) using two different groups of patients in order to prove that an early prescription of radiography using the Ottawa Ankle Rules by a nurse practitioner could shorten length of stay of a patient suffering from ankle trauma at the Hospital Center of Saint-Brieuc.

Ankle sprain is an injury very frequently encountered during consultation in hospitals emergency departments. Its mechanism may at times leads to fracture. The Ottawa Ankle Rules (OAR) provide guidelines to clinicians concerning the need to perform radiographic test to verify whether patients with ankle injuries are suffering from fracture. If all clinical and anamnestic criteria are negative in accordance with the OAR, the probability of a fracture being present is about 0% (IC 95%). OAR are validated for adults.

Actually, a meta-analysis has suggested that it may be beneficial to introduce a nurse-initiated radiographic test protocol as a standard practice in emergency departments. However this early prescription is not a standard of care in most of emergency departments in France.

The implementation of OAR decreases irradiation levels of patients and reduces medical expenses. In addition, it allows to reduce patient's duration of stay in already encumbered emergency departments, thus reducing also overcrowding, which is known to be a major factor of non quality of care in such departments.

The study will be conducted in 2 phases of 4 weeks each :

* The first one (Phase A) will occur in the emergency department with the application of OAR only by the physicians (without changing the standard of care)
* The second one (Phase B) will occur after the Phase A, and nurses will apply OAR before physicians, according to the protocol.

Eligibility Criteria:
Inclusion Criteria:

* With closed ankle injury less than 10 days old
* Affiliation to the national health insurance
* Written informed consent must be obtained

Exclusion Criteria:

* Trauma dating more than 10 days
* Patient not affiliated to the national health insurance
* X-ray performed before patient admission
* Other trauma than an isolated trauma of the ankle
* Injury other than ankle injury : calcaneus, toes, and Achilles' tendon
* Paraplegic or quadriplegic patient
* Previous admission to the Emergency Department for the same traumatic event
* Patient already included in the PARIAO study
* Isolated skin injury / isolated superficial injury
* Ankle fracture or obvious deformation
* Neuro-vascular deficit
* Mental disorder
* Adults legally protected (under judicial protection, guardianship, or supervision), persons deprived of their liberty
* Excessive alcoholization or intoxication by other psychoactive substances (physician's decision)
* Uncooperative patient
* Pregnancy in progress