cyrilzakka/clinical-trials huggingface dataset:
The Effect of Lipmatte K

This study is conducted to evaluate the safety and the effectiveness of Lipmatte K on lip hydration and brightening. The study duration is 4 weeks and the lip assessment will be carried out at baseline, week 2 and week 4.The main questions this study aims to answer are:

1. The hydration effect of the product on lip.
2. The brightening effect of the product on lip.
3. To observe any adverse effect occurrence with the usage of the product.


Eligibility Criteria:
Inclusion Criteria:

* Malaysia citizen
* Female (age 30-55 years old)
* Lip with mild-to-moderate dryness

Exclusion Criteria:

* Subjects who have history of performing lips-related treatments such as lip augmentation (filler, botox, laser)
* Heavy lips desquamation or chapped lip conditions
Efficacy, Safety And Tolerability Study In Subjects With Parkinson's Disease

The B7441003 study will assess PF-06412562 for motor benefit in Parkinson's disease subjects. Safety, tolerability and PK of PF-06412562 in Parkinson's disease subjects will also be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects with a diagnosis of idiopathic Parkinson's disease.
* Daily L-dopa dose between 300 and 1200 mg.
* MBRS score \>1.

Exclusion Criteria:

* Surgical intervention for Parkinson's disease.
* History of troublesome dyskinesias.
* Any significant AXIS I psychiatric disease.
Measurements of Corneal Biomechanical Properties Using a Dynamic Scheimpflug Analyzer for Young Healthy Adults in South Korea

The human cornea is affected by the magnitude and velocity of both internal and external forces because the cornea has both static and dynamic resistance components. Considering these natures of the human cornea, many investigators have tried to demonstrate corneal biomechanical properties to understand these characteristics of the cornea. Corneal biomechanical properties are known to influence the accuracy of measurements in intraocular pressure (IOP) and are recognized as important factor to explain the susceptibility of development of glaucomatous damage. Until recently, the only instrument which enabled the in vivo measurements of the ocular biomechanical properties was ocular response analyzer (ORA, Reichert Ophthalmic Instruments, Depew, NY, USA).8 The ORA has been used to assess the biomechanical properties of the cornea according to the dynamic bidirectional applanation process. A dynamic Scheimpflug analyzer (corneal visualization Scheimpflug technology \[Corvis ST\], OCULUS, Wetzlar, Germany) has been introduced recently and has become a useful instrument for evaluating corneal biomechanical properties. The dynamic Scheimpflug analyzer captures the dynamic process of corneal deformation caused by an air puff using an ultra-high-speed Scheimpflug camera at a rate of up to 4,330 images per second. Until now, well-organized analysis on the normative data of the corneal biomechanical profiles measured with the dynamic Scheimpflug analyzer for young healthy adults has not been reported yet. Hence, in the present study, we aim to conduct normative data analysis for the corneal biomechanical properties with the dynamic Scheimpflug analyzer in a cohort of young healthy adults in South Korea.


Eligibility Criteria:
Inclusion Criteria:

* Participants will be included in analyses if they are 20 to 40 years of age
* Participants who have myopia with a spherical equivalent (SE) between 0.00 and -11.00 diopters (D)

Exclusion Criteria:

* Participants will be excluded from analyses if they had previous ocular or intraocular surgery, a visual field defect, suspicious optic disc appearance, IOP ≥ 30 mmHg, or presence of corneal abnormalities such as keratoconus and forme fruste keratoconus, corneal scarring that would preclude accurate measurements.
Comparative Utility of Clinical Balance Measures in Traumatic Brain Injury

The purpose of this research study is to investigate how useful three balance tests are in predicting fall risk in the individual with traumatic brain injury (TBI). These tests are the Functional Gait Assessment (FGA), the Berg Balance Scale (BBS), and the mini-Balance Evaluation Systems Test (mini-BESTest).

The purpose of the proposed study is to investigate the reliability and predictive validity of three balance measures, the Berg Balance Scale (BBS), the Functional Gait Assessment (FGA) and the mini-Balance Evaluation Systems Test (mini-BESTest), among individuals with history of traumatic brain injury. Participants will complete a health history questionnaire and six-month fall history. When available, fall history will be corroborated with a family member that resides with the participant. Participants will complete the Montreal Cognitive Assessment. Each participant will then participate in a 45-minute evaluation using the three performance-based outcome measures, with order randomized, with two blinded assessors. Six and 12 month follow-up of number of falls will occur via telephone. Statistical analysis with investigate the inter-rater reliability, predictive validity of fall risk and to determine cut off scores for fallers vs. non fallers in the population.

Eligibility Criteria:
Inclusion Criteria:

* community dwelling
* medically stable
* able to stand at least one minute unsupported (with/without assistive device)
* able to ambulate 20 feet (with/without assistance or assistive device)
* able to follow one step instructions or visual demonstrations.

Exclusion Criteria:

* presence of partial or non-weight bearing on a lower extremity
Temporary Simultaneous Two-arterial Occlusions During Laparoscopic Myomectomy

The aim of this study was to evaluate the efficacy and safety of the temporary simultaneous two-arterial occlusions (TESTO) on operative blood loss during laparoscopic myomectomy.

Significant hemorrhage is major perioperative concern in myomectomy, and can result in need of blood transfusion, conversion to hysterectomy, development of hypovolemic shock and postoperative anemia, and delayed recovery. Therefore, methods to decrease operative blood loss during myomectomy in women wishing to preserve their uterus and fertility are important and must be developed.

Eligibility Criteria:
Inclusion Criteria:

* women with symptomatic myomas such as menorrhagia, pelvic pressure/pain, or infertility
* women who were planning to undergo laparoscopic myomectomy
* women who had ≤ 10 myomas, with the largest myoma ≤ 10 cm
* women with regular menstrual bleeding
* women who were not pregnant at the surgery
* women between 19 and 48 years of age.

Exclusion Criteria:

* women who underwent concomitant complex surgical procedures at the time of laparoscopic myomectomy, such as severe adhesiolysis or resection for severe endometriosis
* women who were in postmenopausal or climacteric status
* women with a history of oophorectomy or salpingo-oophorectomy
* women with any suggestion of malignant uterine or adnexal diseases
* women with major medical comorbidities or psychiatric illnesses, which could affect follow-up and/or compliance
* women who refused to participate or give consent to the procedures
RSPR-007 Mannitol Challenge Trial

This is a double-blind, randomised, placebo-controlled, cross-over, Phase 2 trial evaluating two doses (a low and a high) of CRD007 for the treatment of asthmatic trial subjects with a positive asthma test (mannitol challenge) prior to enrolment.

The present trial will include subjects with diagnosed asthma in a provocation model which mimics assessments of asthma control. Mannitol challenge is an indirect asthma provocation test, which requires the presence of inflammatory cells, particularly mast cells, in the airways.

The trial involved in total 5 subject visits and will last for a maximum of 30 days for each subject from Visit 2 (Randomisation) to Visit 5 (Follow up).

Visit 2,3, and 4 will be treatment visits where Investigational Medicinal Product (IMP) is administrated 3 hours before the Mannitol challenge.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Age ≥18 and \<50 years
* Diagnosis of asthma

Exclusion Criteria:

* Clinical significant comorbidities
* Lower respiratory tract infection \<6 weeks prior to Visit 1
* Others, as specified in the protocol
Mesh Versus Suture Repair for Umbilical Hernias

The purpose of the present study is to investigate whether or not the use of mesh is indicated in the repair of all size umbilical hernias as to reduce the rate of recurrence. This method is regularly used in umbilical hernia reconstruction although most surgeons repair small hernias using suture repair (fascia adaptation). Especially risk factors for hernia recurrence such as hernia size and BMI \> 30 kg/m2 need to be evaluated and correlated to the method of hernia repair.

Purpose The purpose of the present study is to investigate whether or not the use of mesh is indicated in the repair of all size umbilical hernias as to reduce the rate of recurrence. This method is regularly used in umbilical hernia reconstruction although most surgeons repair small hernias using suture repair (fascia adaptation). Especially risk factors for hernia recurrence such as hernia size and BMI \> 30 kg/m2 need to be evaluated and correlated to the method of hernia repair.

Study design Randomised controlled, double blinded, multi-centre trial. 300 consecutive patients with an umbilical hernia will be included in the study. Patients will be randomised in one of two groups of 150 patients each. Group 1 will include patients that will undergo primary (suture) repair; group 2 umbilical hernias will be repaired using a pre-peritoneal, flat polypropylene mesh in a tension free fashion.

Stratification will be utilized for the size of the hernia (1-2 cm or ≥2-4 cm) and the participating centre. Patients will visit the outpatient clinic after 2-3 weeks and after 3, 12 and 24 months.

The cumulative hernia recurrence rate during the 2-years follow-up period will be the primary outcome of the study. Complications, pain and QOL are secondary endpoints.

Statistical analysis All analyses will be performed according to the intention to treat principle and as specified in the protocol.

Financial support None.

Eligibility Criteria:
Inclusion Criteria:

* Primary umbilical hernia
* Signed Informed consent

Exclusion Criteria:

* Umbilical hernia ≥ 4 cm diameter
* Recurrence
* Midline laparotomy
* Ascites/Cirrhosis
* ASA score IV or above
* Incarcerated hernia/emergency procedures
Donor-Derived Ex-Vivo Expanded Natural Killer Cell Infusions in Children and Young Adults With High Risk Acute Myeloid Leukemia Receiving Myeloablative HLA-Haploidentical Hematopoietic Cell Transplant

This is a Phase II pilot study to determine the efficacy of three fixed dose (1 x 108/kg) infusions of ex-vivo expanded human leukocyte antigen (HLA)-haploidentical donor natural killer (NK) cells (haploNK) in children and young adults with high risk acute myeloid leukemia (AML) undergoing HLA-haploidentical hematopoietic cell transplant (haploHCT) with a busulfan and cyclophosphamide-based myeloablative conditioning regimen and post-transplant cyclophosphamide (PTCy) for graft versus host disease (GVHD) prophylaxis. The investigators will also demonstrate the feasibility of performing this trial in a multi-center study.

The investigators hypothesize that the infusion of haploNK in this setting will facilitate immune reconstitution and decrease relapse rates and infectious complications without increasing GVHD, resulting in improved survival as compared to recent historical cohorts of haploHCT without NK cell infusion.


Eligibility Criteria:
Inclusion Criteria:

* Age ≤ 25 years at time of enrollment
* High-risk AML, as defined by one of the following:
* AML in CR1 (defined as \<5% blasts in BM by morphology and flow cytometry) having at least one of these high-risk features:
* Mutations associated with high risk disease (Appendix A). Other high-risk features not explicitly stated in Appendix A can be considered after discussion/approval with the protocol chair/team
* MRD-positive at the end of Induction I chemotherapy (defined as flow cytometry ≥ 0.1% blasts)
* AML in ≥CR2 (defined by \<5% blasts in BM by morphology and flow cytometry)
* Recovery from prior cycle of chemotherapy as defined by an absolute neutrophil count ≥ 500/mm3
* AML secondary to select germline marrow failure disorders (with exception of Fanconi Anemia) may be eligible but require approval from Protocol Chairs prior to enrollment.
* Performance status ≥70% (Lansky for \<16 years; Karnofsky for ≥16 years)
* Adequate major organ system function as demonstrated by:
* Renal: Creatinine clearance (CrCl) ≥60 mL/min/1.73m2 by Cockcroft-Gault formula, Schwartz formula, or nuclear GFR study (Table 3)
* Hepatic: Total bilirubin \<2 mg/dL (unless due to Gilbert syndrome) and ALT and AST \< 5x ULN
* Cardiac: LVEF at rest ≥50% or SF ≥27% (by MUGA or ECHO)
* Pulmonary: DLCO, FEV1, and FVC ≥ 50% of predicted corrected for hemoglobin. For patients \<7 years of age or those unable to perform PFTs: O2 Sat \>92% on room air by pulse oximetry and on no supplemental O2 at rest
* The patient, patient's parent, guardian, or legal representative can provide written informed consent

Exclusion Criteria:

* Active extramedullary disease
* Unresolved/ongoing and serious viral, bacterial, or fungal infection despite appropriate treatment
* Positive pregnancy test in a female of child-bearing potential (FCBP)
* Inability to comply with medical therapy or follow-up
* Prior allogeneic transplant
* Patients with Fanconi Anemia and Down syndrome
Subbrow Blepharoplasty Combined With Double Eyelid Surgery for Upper Eyelid Rejuvenation in Asian Women

Subbrow blepharoplasty combined with double eyelid surgery excising the subbrow skin and the supratarsal upper eyelid skin, lifting and fixing the OOM flap, meanwhile restoring the natural and symmetrical appearance, is a safe, effective, and durable way for treating patients presenting with dermatochalasis.


Eligibility Criteria:
Inclusion Criteria:

* Visual, lacrimal gland and eyelid functions were normal The eyes and eyebrows are aged between 35 and 65 years Informed consent was signed and approved by ethics review

Exclusion Criteria:

* Congenital craniofacial deformity, acquired craniofacial injury Scar constitution, pregnancy Mental illness
Hämeenlinna Metabolic Syndrome Research Program: Surrogate Indicators for Atherosclerosis

Mechanisms that link metabolic syndrome to atherosclerosis are incompletely understood. As a part of Hämeenlinna Metabolic Syndrome Research Program (HMS) surrogate indicators for atherosclerosis are studied in 120 men with metabolic syndrome, 120 men with coronary heart disease and 80 physically active controls and in different settings.

Accumulation of oxidized low-density lipoproteins (LDL) in the intimae of arteries together with risk factors known to enhance atherosclerosis, damage the endothelium of the arterial wall. Dysfunction of the endothelium leads into loss of elasticity of the artery. Surrogate indicators of atherosclerosis might be seen already in the early phase of otherwise subclinical arterial disease.

In this study, we investigate calculated risk of the subjects (SCORE, FINRISK, Framingham score), platelet function and surrogate indicators for atherosclerosis like erectile dysfunction, plasma levels of oxidized LDL, arterial elasticity and biochemical markers for endothelial damage and dysfunction in different settings (case-only and case-control).

Eligibility Criteria:
Inclusion Criteria:

Group 1: Metabolic syndrome

* 120 Finnish men with metabolic syndrome (MetS) defined according to National Cholesterol Education Program (NCEP) Adult Treatment Panel III
* MetS diagnosed in routine health examination and laboratory tests
* Age: 30 to 65 years

Group 2: Coronary heart disease (CHD)

* 120 Finnish men with angiographically proven CHD
* Age: 30 to 65 years

Group 3: Control

* 80 Finnish men
* Exercising physically more than three times a week and more than 30 minutes per exercise on regular basis
* Never been studied or treated because of cardiovascular disease
* Age: 30 to 65 years
Neuroliten MVP System Clinical Observation Study

This is an observational study for data collection from subjects diagnosed with Epilepsy/intractable seizures. The Neuroliten MVP System will not be used for patient management or treatment decisions.

Neuroliten MVP system stores the data obtained from wearables, caregivers, and all audio/video recording of seizure activity that the caregiver captures associated with a seizure episode.

The primary objective of this study is to obtain vital signs and neurological indicators via the Neuroliten MVP System to correlate to the onset of seizures that are detected by the observations of family/caregivers.

The secondary objective is to identify the vital signs and/or neurological indicators that are associated with seizure onset.

Eligibility Criteria:
Inclusion Criteria:

1. An Institutional Review Board (IRB) approved informed consent is signed and dated before any study-related activities.
2. Male and female subjects ages 18 to 75, inclusive.
3. Documented history of at least two (2) seizures per week. Seizures can be generalized and/or focal.
4. Diagnosed with intractable or refractory epilepsy.
5. Have a caregiver/family member who stays with the subject, has the ability to detect seizures, and is willing to provide the information needed for the study.
6. Have implanted vagus nerve stimulation (VNS).
7. Have the ability to understand the requirements of the study and are willing to comply with all study requirements.
8. Must have a working Apple iPhone.

Exclusion Criteria:

1. Women who are either pregnant or breastfeeding.
2. Subjects unable/unwilling to wear the Apple Watch and EEG Wearable for extended periods.
3. Requires the use of a ventilator.
4. Requires the use of supplemental oxygen.
5. Uses a pacemaker or other electronic neurostimulator, except the VNS.
6. Any medical or surgical condition that in the opinion of the investigator may interfere with participation in the study.
One vs Two Weeks Treatment for H.Pylori Eradication A RANDOMIZED NON-INFERIORITY PLACEBO CONTROLLED TRIAL

1. To assess the efficacy of the duration of Vonoprazan based triple regimen (one versus two weeks), in the eradication of H-pylori among patients attending gastroenterology clinics of Karachi, Pakistan.
2. To assess the improvement in the quality of life of patients receiving Vonoprazan as part of the triple regimen.

Introduction: The overall aim of the study is to assess the efficacy of one week of Vonoprazan compared to two weeks of Vonoprazan in eradicating H-Pylori in patients with dyspeptic symptoms.

H. pylori is a pathogenic Gram-negative spiral bacillus that survives in the acid environment of the stomach. It is a leading cause of chronic gastritis, peptic ulcers, non-ulcer dyspepsia, gastric adenocarcinoma and mucosa-associated lymphoid tissue (MALT) lymphoma. It is estimated that up to 50% of the total world population are infected with H. pylori. The prevalence of H. Pylori infection is currently rising in the developing world. Modified one-week triple therapy (two antibiotics for a week and a potassium-competitive acid blocker for 4-8 weeks) represents the most advanced prescribed regimen for H. pylori infection. With current and widely used therapeutic regimens, (such as two antibiotics and a proton pump inhibitor) there is a significant failure rate for the eradication of microorganism. Therefore, interventions that can improve H-pylori eradication along with improving patient's quality of life are highly important.

Vonoprazan is a potassium-competitive acid blocker, which inhibits the H+/K+ pump in the stomach. Unlike proton pump inhibitors, Vonoprazan inhibits the pump in a competitive and reversible manner. Hence, it is expected to be at least as effective as PPIs in the elimination of Helicobacter Pylori. Assessing the duration of Vonoprazan based triple therapy is of great concern.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* H pylori infection confirmed by any of the 3 tests C-urea breath test (UBT), , rapid urease test, and stool H pylori antigen.

Exclusion Criteria:

* acute gastrointestinal disease (e.g., acute diarrhea)
* chronic gastrointestinal disease (e.g., inflammatory bowel disease, celiac disease)
* known renal and/or liver failure
* no known malignancy
* varices bleeding
Spinal Cord Stimulation (SCS) for Amputees

The purpose of this study is to investigate how leg amputee patients can feel sensations with neuromodulation while they are using a prosthetic leg. "Neuromodulation" is the process by which the nervous system can be regulated by targeted delivery of a stimulus, such as electrical stimulation or chemical agents, to specific neurological sites in the body. In this study, the investigators plan to use either electrical stimulation of the spinal cord (Spinal Cord Stimulation) or electrical stimulation of the dorsal root ganglion (DRG stimulation) as methods for neuromodulation.

Participation in this study will involve visiting the K-Lab (Human Performance Laboratory) at Duke's Sports Medicine Institute once prior to trial implant surgery, if feasible, and four times during the two weeks following the implantation of trial stimulation leads to evaluate sensations related to touch and position of the prosthetic leg as they are generated by neuromodulation.


Eligibility Criteria:
Inclusion Criteria:

* Subject is at least 18 years of age
* Subject is able and willing to comply with the schedule and protocol
* Subject is a lower limb amputee who uses a prosthetic leg
* Subject is a good candidate for implantation of a stimulator for their amputation related pain
* Subject has stable neurological/cognitive function in the past 30 days
* Subject is able to provide informed consent

Exclusion Criteria:

* Subject is currently participating in a clinical investigation that includes an active treatment arm
* Subject currently has an active implantable device including an Implantable Cardioverter Defibrillator (ICD), pacemaker, spinal cord stimulator, or intrathecal drug pump
* Subject is a prisoner
* Female subject whom are pregnant
Safety Study of Ophthalmic Solution in Healthy, Normal Volunteers

The purpose of this study is to evaluate the safety of R89674 0.25% ophthalmic solution in healthy normal volunteers


Eligibility Criteria:
Inclusion Criteria:

healthy normal volunteers age \>=3 years with normal ocular health and a best-corrected logMAR score of 0.3 or better

-

Exclusion Criteria:

intraocular surgery and/or ocular surgical intervention within last 3 months, refractive surgery within last 6 months, active ocular disorder other than refractive disorders, breastfeeding women, pregnant female \< 18 years of age -