cyrilzakka/clinical-trials huggingface dataset:
Effectiveness and Safety of Zingiber Officinale Transdermal Patch for Acne Vulgaris; Study of Interleukin 1 and Skin Microbiome

The goal of this clinical trial is to investigate the effectivity and safety of mild to moderate acne vulgaris therapy using Zingiber officinale 5 % transdermal patch. Researcher will compare both half faces (split face); one side as treatment side where patch is used, and another side as control. Patient will be asked to apply tretinoin 0,025% cream nightly. After applying tretinoin 0,025% on whole face, patient will be asked to apply patch on a pustule on one half face, and no patch will be used on another half face.

Total lesion count will be assessed before treatment and 21 days after treatment. Specimen for skin microbiome and interleukin examination will be collected before and 21 days after treatment.

Current acne vulgaris treatment include antibiotic, retinoic acid, and benzoyl peroxide. The use of antibiotic has been linked to antibiotic resistant problem. Research also has shown the association between acne vulgaris and skin microbiome. Therefore, new treatment for acne vulgaris that has good effect on skin microbiome is needed.

Z. officinale is an herb that commonly used in traditional medicine. Researches have shown that it has anti-inflammation activity and antibiotic activity to Cutibacterium acnes. On the other hand, the prebiotic potency of Z. officinale on gut microbiome has also been investigated.

This randomized controlled trial shall include 26 mild to moderate acne vulgaris patients according to inclusion and exclusion criteria. Patches will be given every 5 days as researcher follow up patient condition. Patient photograph will be taken before treatment, on follow up day, and after 21 days treatment. Skin microbiome specimen will be collected using skin swab method. Secret from a chosen pustule will be collected for interleukin examination.

During clinical trial, patient will use non comedogenic sunscreen and soap from researcher. Patient will be asked to report to researcher if there is side effect of treatment.

Eligibility Criteria:
Inclusion Criteria:

* female
* 15-45 years old
* mild to moderate acne vulgaris according to Lehmann criteria
* minimal 3 pustules on face that are distributed on right and left sides

Exclusion Criteria:

* history of allergy to ingredients that is used in research
* history of topical acne medication and steroid in the last 2 weeks
* history of medical aesthetic procedure such as laser and chemical peeling in the last 2 weeks
* history of oral antibiotic therapy in the last 6 weeks
* history of oral isotretinoin therapy in the last 6 months
* history of probiotic consumption in the last 3 weeks
* pregnancy and lactation
Parkinson Progression Marker Initiative Online (PPMI Online)

Parkinson Progression Marker Initiative Online (PPMI Online) is an observational study collecting participant reported information from people with and without Parkinson's disease (PD), for the goal of better understanding risk and predictive factors for PD.

PPMI Online is part of the broader Parkinson Progression Marker Initiative aimed at identifying markers of disease progression for use in clinical trials of therapies to reduce progression of PD disability.

PPMI is a broad program that is expanding the goals of the original PPMI study, and will include this PPMI Online protocol, as well the PPMI Clinical \[NCT04477785\], PPMI Remote, PPMI Digital protocols (with external regulatory oversight). All participants in PPMI may be asked to participate in one or all of these protocols and their enrollment in these studies may occur in varying order. PPMI participants may also be asked to participate in additional PPMI companion studies (as they are developed), which may only involve a subset of PPMI participants based on their cohort designation

Eligibility Criteria:
Inclusion Criteria:

* Parkinson Disease (PD) Participants:

  * Male or female age 18 years or older.
  * Has received a diagnosis of Parkinson's disease

Participants without PD:

* Male or female age 18 years or older.
* Has not received a diagnosis of Parkinson's disease
A Study to See How BIIB122 Works in the Human Body, and to Evaluate it's Safety, and Tolerability in Healthy Adult Japanese, Chinese, and Caucasian Participants

The study will be looking at an investigational drug, BIIB122, in healthy adult Japanese, Chinese, and Caucasian participants. The main goal of the study is to compare the drug level achieved in the body, between the different ethnic groups, after single and multiple doses of BIIB122. Researchers also want to see if single and multiple doses of BIIB122 are safe and if healthy participants can tolerate given doses of BIIB122.


Eligibility Criteria:
Key Inclusion Criteria:

* Have a body mass index (BMI) between 18 and 30 kilograms per square meter (kg/m\^2), inclusive. Body weight (BW) ≥50 kg and ≤100 kg at Screening
* Negative polymerase chain reaction (PCR) test result for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) at Screening and Day -1
* For Japanese healthy volunteers: Participant was born in Japan, and biological parents and grandparents were of Japanese origin; if living outside of Japan for more than 10 years, must not have significantly modified diet since leaving Japan
* For Chinese healthy volunteers: Participant was born in China, and biological parents and grandparents were of Chinese origin; if living outside of China for more than 5 years, must not have had a significantly modified diet since leaving China. Additionally, Chinese healthy volunteers must be of the same gender and have a screening weight within ±15% of their matched Caucasian healthy volunteer
* For Caucasian healthy volunteers: Participant must be a white person of European descent, which may include participants of Hispanic descent. Additionally, Caucasian healthy volunteers must be of the same gender and have a screening weight within ±15% of their matched Japanese healthy volunteer

Key Exclusion Criteria:

* History of any clinically significant cardiac, endocrinologic, hematologic, hepatic, immunologic, infectious, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, and renal, or other major disease, as determined by the Investigator
* History of severe allergic or anaphylactic reactions, or of any allergic reactions that in the opinion of the Investigator are likely to be exacerbated by any component of the study treatment
* Current enrollment in any other drug, biological, device, or clinical study, or treatment with an investigational drug or approved therapy for investigational use within 30 days prior to Day -1, or 5 half-lives, whichever is longer
* Immunization or vaccinations are not allowed from Screening to safety follow-up (SFU)/ early termination (ET) Visit

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Using an iPhone ECG to Monitor the QT Interval on Dofetilide and Sotalol Patients

This study will validate the recording accuracy of a specific electrical interval of the heart, the QT interval, between an iPhone rhythm strip recording and a traditional 12-lead electrocardiogram (ECG). These measurements will occur in hospitalized patients that are starting either sotalol or dofetilide, since both of these medications can prolong the QT interval.

Patients that were already selected to begin either dofetilide or sotalol in the hospital, will be included in the study. Patients will receive an ECG before and 2 hours after each dose of the medication, which is done to monitor the QT interval. In addition, patients that consent to participate in the study will have an iPhone ECG recording taken in lead positions that correspond to leads I,II, and III.

These recordings will be compared and analyzed to assess the accuracy of the QT interval recordings between the two methods.

Eligibility Criteria:
Inclusion Criteria:

* initiation of sotalol or dofetilide
* inpatient at University hospital

Exclusion Criteria:

* none
Olanzapine and 5-HT3 With or Without Dexamethasone to Prevent CINV

Nausea and vomiting caused by chemotherapy are considered by patients as the main side effects of cancer treatment, which affect the quality of treatment and life.At present, NCCN guidelines have recommended three or four drug regimens for highly emetic chemotherapy (HEC) to prevent vomiting, all containing dexamethasone.However, its side effects such as moderate to severe insomnia, hyperglycemia, dyspepsia, upper abdominal discomfort, irritability, increased appetite, weight gain and acne are gathering increasing concerns.For certain patients, the use of dexamethasone should be avoided.Analysis shows that olanzapine can replace the effect of dexamethasone.Hence, the investigators initiated this prospective, multi-center, phase III study to validate the dexamethasone-free protocol: removing dexamethasone from a three drug regimen containing olanzapine, dexamethasone, and 5-HT3RA.


Eligibility Criteria:
Inclusion Criteria:

1. Patients 18 years of age or older with malignant disease；
2. Life expectancy ≥ 3 months;
3. Scheduled to receive highly emetogenic chemotherapy；
4. Had a European Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2

Exclusion Criteria:

1. There are contraindications to chemotherapy(Absolute number of neutrophils ≤ 1,500/uL, hemoglobin ≤ 90g/L, platelet count ≤ 10000/uL, serum creatinine level ≥ 2.0mg/dl (177 μmol/L), ALT and AST ≥ 2.5 times the upper normal limit, bilirubin ≥ 1.5 times the upper normal limit);
2. History of central nervous system disease (e.g., brain metastases or a seizure disorder);
3. Severe cognitive impairment；
4. Treatment with another antipsychotic agent such as risperidone, quetiapine, clozapine, a phenothiazine, or a butyrophenone within 30 days before enrollment or plans for such treatment during the study period;
5. Concurrent use of pharyngeal or abdominal radiotherapy;
6. Concurrent use of quinolone antibiotics;
7. Concurrent use of Amifostine;
8. Chronic alcoholism;
9. Known hypersensitivity to olanzapine;
10. Know arrhythmia, uncontrolled congestive heart failure or acute myocardial infarction within 6 months;
11. Known uncontrolled diabetes mellitus;
12. Vomiting or retching 24 hours before chemotherapy;
13. Use of anti-emesis drugs 48 hours before chemotherapy;
14. Patients who require medication with dexamethasone for pretreatment.
Late Mesh Complications After 3258 Incisional Hernia Operations

The Danish Hernia Database (DHD) registers 37 different perioperative parameters. The aim of present study is to use large-scale data from DHD to uncover risk factors for long-term (30 days postoperative and later) readmission, reoperation, death and reoperation for recurrence after incisional hernia repair with use of a synthetic mesh.

All principal incisional hernias registered in the Danish Hernia Database are included in the study. The included patients have been followed for more than 4 years in order to identify correlation between technical aspects of the hernia repair and postoperative morbidity.

Eligibility Criteria:
Inclusion Criteria:

* Incisional Hernia Repair
Mindfulness During COVID-19

The objective of this study is to provide remote mindfulness session(s) to help during the COVID-19 pandemic.

The objective of this study is to provide remote mindfulness session(s) to help during the COVID-19 pandemic.The investigators are interested in targeting patients with migraine, providers, faculty and staff. The investigators are hopeful that this will positively impact overall well-being at this stressful time. The investigators are interested in assessing feasibility, accessibility, and overall interest of an online mindfulness intervention in these populations at this time.

Eligibility Criteria:
Inclusion Criteria:

* Any person interested in participating in the mindfulness session will be eligible to complete the pre/post surveys and participate in the mindfulness session.

Exclusion Criteria:

* None
Predictors of Driving Performance and Successful Mobility - Rehabilitation in Patients With Medical Eye Condition

There are two diseases in particular that may have serious consequences for driving and mobility due to their potentially severe impact on visual function: glaucoma and diabetic neuropathy. In this project we will develop predictive models of driving for these patients and will train them to use low-vision aids to improve driving mobility. We will determine how best to train patients with hemianopic field loss due to cerebral vascular accidents and identify predictors of long-term success in the use of low-vision aids.

There are two diseases in particular that may have serious consequences for driving and mobility due to their potentially severe impact on visual function: glaucoma and diabetic neuropathy. Both these diseases can potentially result in significant peripheral visual field loss, sometimes coupled with decreased visual acuity. We have previously demonstrated that each of these visual losses alone can have significant impact on driving and mobility performance. In this project we will develop predictive models of driving for these patients and apply our extensive expertise in training patients to use low-vision aids to improve driving mobility. A second question that will be addressed is how to best train scanning patients with hemianopic field loss due to cerebral vascular accidents. We propose to configure the prisms in a bioptic form similar to previously used for amorphic lenses in RP and for bioptic telescopes for patients in macular disease. The third problem that will be addressed is the identification of predictors of long-term success in the use of low-vision aids.

Eligibility Criteria:
Eye impairment
Tranexamic Acid in Major Vascular Surgery

The purpose of this study is to determine whether tranexamic acid is effective in reducing intraoperative blood loss and necessity for haemotransfusion in patients undergoing open abdominal aortic aneurysm repair


Eligibility Criteria:
Inclusion Criteria:

* Age \> 50
* Able to give written informed consent
* Undergoing open abdominal aortic aneurysm repair

Exclusion Criteria:

* Patients participating in a pharmaceutical clinical trial in the last 3 months
* Urgent/emergent surgery
* Allergy/intolerance to tranexamic acid
* History of seizures
* Acute Venous or Arterial Thrombosis
* Fibrinolytic conditions due to consumption coagulopathy
* Disseminated intravascular coagulation
* Haematuria
* Visual disturbances
Xperience™ vs Normal Saline Irrigation Solution for Decreasing Bioburden After Primary Total Hip and Knee Arthroplasty

The purpose of this study is to evaluate the effectiveness of Xperience, a no rinse antimicrobial solution, on joint infection rates in patients undergoing total hip (THA) and total knee (TKA) arthoplasty surgery.


Eligibility Criteria:
Inclusion Criteria:

* Scheduled to undergo primary total hip (via direct anterior approach, press-fit components) or total knee arthroplasty (via manual approach, cemented components).
* Willing to comply with all study-related procedures and be available for the duration of the study.
* Provide signed and dated informed consent.

Exclusion Criteria:

* Unable to provide signed and dated informed consent.
* Unwilling or unable to comply with all study-related procedures.
* Known history of sensitivity or allergic reaction to any of the study products or its components, including any products used for standard of care (such as dressings or any coverings).
* Has underlying condition or state that, in the 'investigator's opinion, would make them too critically ill to complete the day 90 postoperative follow ups.
* Pregnant, planning to become pregnant, or nursing female subjects.
* Subject with any mental impairment or condition that would make them unable to properly consent without use of LAR or additional subject protections.
* Subject is a prisoner and/or part of a vulnerable subject population, which necessitates additional human research subject protections beyond the scope of this protocol.
* Subject with an active infection or systemic antibiotic therapy within 2 weeks prior to surgery with the exception of preoperative antimicrobial prophylaxis.
Assesment of Embryo Viability and Re-expansion After Thawing in Blastocyst Stage Embryos

In this prospective study, the possible effects of embryo viability and degree of blastocele re-expansion on pregnancy outcomes before vitrified/thawed blastocyst transfer will be evaluated.

Thanks to the advances in embryo vitrification technologies in recent years, high embryo viability can be achieved after thawing, and live birth rates increase after the transfer of these embryos.

Embryo morphology is an essential criterion used to predict embryo viability. Blastocysts endure several morphological challenges during vitrification and thawing, including blastocele collapse, cell collapse, and subsequent rehydration. Blastocysts usually collapse immediately after thawing. Because of these morphological changes, cell damage and loss may occur, and morphological integrity may be impaired.

Considering that implantation results may be affected due to supraphysiological high estrogen and progesterone levels due to multi follicular development in the ovaries during fresh embryo transfers, the study is planned to be conducted only in patients who have undergone artificial endometrial preparation with hormone replacement therapy. Only embryos frozen at the blastocyst stage (day 5) will be included in the study.

After embryo thawing, an experienced embryologist will evaluate embryo viability and expansion and record it in the system. Approximately 2 hours after the indicated procedure (just before embryo transfer), embryo viability and degree of re-expansion will be re-evaluated by the 2nd experienced Embryologist. The evaluation results of both embryologists (embryo viability and re-expansion streams) will be known only to the primary clinician (Assoc. Prof. Şafak Olgan). Pregnancy results will be learned nine days after embryo transfer, In ultrasonography evaluation three weeks after a positive pregnancy result, a clinical pregnancy will be considered in patients with fetal heartbeat, and morphological differences between the pregnant and non-pregnant groups will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Women aged 18-40 years
* Frozen- thawed embryo transfer cycles
* Only the cycles prepared artificially with hormone replacement therapy.
* Embryos with Day 5 (1CC and higher quality)

Exclusion Criteria:

* Embryos at the cleavage stage (D3)
* Patients for whom embryo viability and expansion were not evaluated single-blindly by two different embryologists
JMT101 in Combination With Osimertinib, Versus Cisplatin-pemetrexed in Participants With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) Characterized by Epithermal Growth Factor Receptor (EGFR) Exon 20ins Mutations

This is a multicenter, randomized, open-label, parallel-controlled phase 3 study. This study aims to evaluate the efficacy and safety of JMT101 combined with Osimertinib compared with Cisplatin combined with pemetrexed in participants with local advanced or metastatic non-small-cell lung cancer harboured EGFR 20ins mutation without prior systemic therapy.

Primary objective of this study is to assess the efficacy of JMT101 combined with Osimertinib versus Cisplatin combined with pemetrexed using by （Independent Review Center）IRC-assessed Progression Free Survival (PFS) per RECIST 1.1 as primary endpoint. Approximately 398 participants are estimated to be randomized into the study. Participants enrolled will be randomized to JMT101 or Cisplatin chemotherapy in a 1:1 manner, stratified by baseline brain metastasis (with/without) and Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) (0 versus 1).


Eligibility Criteria:
Inclusion Criteria:

1. Age between 18-75 years old.
2. Histologically or cytologically confirmed diagnosis of NSCLC, locally advanced (Stage IIIB and IIIC according to the 8th edition of the IASLC TNM staging criteria) or metastatic (Stage IV), not suitable for curative therapy. For central laboratory confirmation of EGFR exon 20 insertion mutation with tumour tissue/blood sample.
3. At least 1 measurable lesion per RECIST Version 1.1
4. Life expectancy ≥ 12 weeks
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
6. Adequate organ and hematologic function

Exclusion Criteria:

1. Prior treatment with any systemic anti-cancer therapy for locally advanced or metastatic NSCLC.
2. Central nervous system metastasis with associated symptom and signs.
3. Concurrent EGFR mutations: exon 19 deletion, L858R, T790M, G719X, S768I, or L861Q.
4. History of interstitial lung disease, or infectious pneumonitis need heavy antibiotics therapy
5. As judged by the investigator, unsuitable for attending the study.
Providing Rapid Out of Hospital Acute Cardiovascular Treatment (PROACT)

The purpose of this study is to determine if early diagnosis and risk stratification acquired through pre-hospital clinical assessment, 12-lead electrocardiogram and point of care biomarkers will facilitate enhanced triage and treatment in patients with presumed non-ST elevation acute coronary syndromes (NSTEMI).

Utilizing the platform of pre-hospital STEMI research and clinical experience developed over the past decade; we now intend to investigate how best to achieve timely diagnosis and risk stratification of patients that present to pre-hospital emergency medical services with symptoms suspicious for acute NSTEMI through utilization of systematic clinical assessment, pre-hospital 12 lead electrocardiogram and point of care measurement of biomarkers. Additionally, where deemed appropriate these patients will be enrolled in a clinical Chest Pain Protocol utilizing the pre-hospital biomarkers. We hypothesize that establishing a pre-hospital diagnosis in this condition may facilitate efficient triage and -as appropriate- in-hospital disposition. Additionally, the enhanced pre-hospital assessment of this population will facilitate appropriate timely disposition of those patients not found to have acute cardiovascular disease. These processes will facilitate decanting the frequently overcrowded and under resources Emergency Departments.

Eligibility Criteria:
Inclusion Criteria

1. Patient that activates pre-hospital Emergency Medical Services (EMS) for symptoms of acute chest discomfort for which acute cardiovascular disease is deemed to be the most probable diagnosis by EMS personnel.
2. Patient is older than 30 years of age
3. Patient is able to give informed consent

Exclusion Criteria

1. Patient with documented ST elevation on the initial 12 lead ECG
2. Patient with a prior diagnosis that is compatible with another disease i.e. severe asthma, etc.
3. Patient with Central Nervous System symptoms or syncope
4. Patient with cardiac arrest, ventricular tachycardia or atrial fibrillation with heart rate \> 110 bpm