cyrilzakka/clinical-trials huggingface dataset:
STA-21 Topical Efficacy on Psoriasis

The clinical assessment of patients with plaque-type psoriasis is performed by open, intrapatient comparison of 0.2% STA-21 with vehicle(Vaseline) alone within a 2 week period.

Two discrete psoriatic lesions with a similar size (approximately coin-sized) and clinical severity are selected in each patient. Clinical assessment of psoriatic lesion severity is performed at the baseline and at 1 and 2 (end of treatment) using the scores of erythema, induration, scaling on a scale of 0-4 by two observers. Since STA-21 inhibits Stat3 activation, which is essential for disease activity of psoriasis, topical application of 0.2% STA-21 in Vaseline should improve psoriasis in two weeks.

Eligibility Criteria:
Inclusion Criteria:

* A history of plaque psoriasis for a minimum of 2 years.
* In good general health, as evidenced by blood, renal function, and liver function tests conducted before commencing the study.
* Patients of childbearing age who agreed to continue using birth control for the duration of the study.
* Men or women between 20 and 80 years old.

Exclusion Criteria:

* Chronic plaque psoriasis involving \>40% of the body surface.
* Pustular or generalized erythrodermic psoriasis.
* Use of medications that might affect the psoriasis during the study
* Systemic therapy for psoriasis within 60 d of baseline.
* UV therapy within 21 d of baseline.
* Topical therapy within 14 d of baseline.
* Positive for HIV, hepatitis B, or hepatitis C.
* Clinically significant laboratory abnormality in blood, renal function, or liver function.
* Lactating, pregnant, or planning to become pregnant.
* Participation in another clinical trial in the last 30 d.
* Unwillingness to comply with the study protocol.
* Any other condition that in the opinion of the investigators could compromise the study.
A Study of LY3074828 in Healthy Participants

The purpose of this study is to look at the amount of the study drug, LY3074828, that gets into the blood stream and how long it takes the body to get rid of LY3074828, when given as a solution formulation in different devices. The tolerability of LY3074828 will also be evaluated and information about any side effects experienced will be collected.

Screening is required within 28 days prior to the start of the study. For each participant, the total duration of the clinical trial will be approximately 13 weeks, not including screening.


Eligibility Criteria:
Inclusion Criteria:

- Must be healthy male or female

Exclusion Criteria:

* Must not have an average weekly alcohol intake that exceeds 21 units/week (males) and 14 units/week (females)
* Must not show evidence of active or latent tuberculosis (TB)
* Must not have received live vaccine(s) (including attenuated live vaccines and those administered intranasally) within 1 month of screening, or intend to during the study
* Must not have been treated with steroids within 1 month of screening, or intend to during the study
* Must not be immunocompromised
* Must not have received treatment with biologic agents (e.g. monoclonal antibodies, including marketed drugs) within 3 months or 5 half-lives (whichever is longer) prior to Day 1
* Must not have significant allergies to humanised monoclonal antibodies
* Must not have clinically significant multiple or severe drug allergies, or intolerance to topical corticosteroids, or sever post treatment hypersensitivity reactions
* Must not have had lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years
* Must not have had breast cancer within the past 10 years
Factors Associated With the Absence of Contraception at Women Seeking a Voluntary Termination of Pregnancy

The study will be offered to all women who are consultant for an abortion plan are seen in consultation at the orthogeny center where the study will be conducted. Of these 700 women, about 10% will not agree to participate in the study and 10% will not meet the inclusion criteria. Thus it's plane to include 560 patients in the study.

In 1967, the Neuwirth law allowed women to control their fertility by establishing the right to contraception as a principle. Since then, they have continued to take ownership of the various contraceptive methods, which are regularly renewed.

Contraceptive coverage is important in France as it is estimated that 92% of women of childbearing age use a contraceptive method. The pill remains the most widely used method of contraception (36.5%), ahead of the intrauterine device (25.6%) condoms (15.5%) Several laws have been introduced from 1967 to today to facilitate access to sexual health care: screening for sexually transmitted infections, free provision of emergency contraception to minors, non-prescription delivery of emergency contraception, free consultation at a family planning and education center, voluntary termination of pregnancy 100%, reimbursement of condoms by social security.

Despite all the measures put in place, it is now clear that the number of unplanted pregnancies is decreasing slightly and the number of abortion has remained stable since 2001.

According to the latest literature data, several socio-demographic factors appear to play a role in the rate of use of voluntary termination of pregnancy., including age, socio-cultural level, marital and economic status and ethnic origin. All the more striking, it appears that while voluntary termination of pregnancy are mainly related to contraceptive failures, one third of them involve women who do not have contraception. According to the latest Ined survey, and in accordance with other data from the literature, the factors associated with the absence of contraceptive use are multiple: ignorance about fertility, family or cultural context, cost of contraceptive methods or lack of information related to them.

While these studies have looked at the reasons given by women for the lack of contraception, with little data on the characteristics of these women, particularly socio-demographics and their reproductive history and in particular in the context of unwanted pregnancy. This finding leads us to question the factors associated with the absence of contraception among women in demand of a voluntary termination of pregnancy.

Eligibility Criteria:
Inclusion Criteria:

* woman of 18 years of age or older;
* Being French-speaking;
* request for a medical or instrumental voluntary termination of pregnancy
* No opposition to participation in the protocol
* Be affiliated with a social security plan

Exclusion Criteria:

* desired pregnancy
PRospective Observation of Aortic reGuRgitation aftEr TAVI and progreSS Over Time: PROGRESS PVL Registry

The purpose of this post-market registry is to collect and monitor ongoing safety and performance clinical data of the ACURATE neo™ Aortic Bioprosthesis, and the ACURATE TF™ Transferral Delivery System, when used as per IFU.

The primary objective of this post-market registry is to further evaluate the safety and performance of the ACURATE neo™ Aortic Bioprosthesis and the ACURATE TF™ Transferral Delivery System in 500 consented patients with severe aortic stenosis and treated according to the instructions for use (IFU).

Examinations to evaluate the aortic valve regurgitation performed as standard of care in patients undergoing transcatheter aortic valve replacement will be analyzed by an external Core Laboratory. These examinations are limited to echocardiography and/or contrast aortography assessments.

The secondary objective is to collect adverse events and evaluate them according to the VARC-2 consensus document.

Eligibility Criteria:
Inclusion Criteria:

1. Patient is included in the registry if eligible for transcatheter treatment of severe aortic stenosis with the ACURATE neo™ Aortic Bioprosthesis and ACURATE TF™ Transfemoral Delivery System as per the Instructions for Use (Patients which are included but treated outside of the approved indication will be followed for safety reasons).
2. Patient is willing to participate in the study, provides signed Informed Consent/Data Authorization Form and authorizes the sharing of data in the registry. Patient agrees that anonymized imaging data will be sent to and analyzed by an external Core Laboratory.
3. The treating physician should ensure the subject will return for all required post procedure follow-up visits.

Exclusion Criteria:

1. Patients are excluded from the registry if they are not eligible for transcatheter treatment of severe aortic stenosis with the ACURATE neo™ Aortic Bioprosthesis and ACURATE TF™ Transfemoral Delivery System as per the Instructions For Use.
Multi-institutional Study on the Assessment of Robotic Surgery for Gastric Cancer

Minimally invasive surgery revolutionized the field of gastric cancer surgery. The surgical robot was introduced to alleviate the difficulty of laparoscopic surgery. Although many studies have reported successful outcomes for robotic surgery, there is no multicenter prospective analysis regarding the advantage of the robotic gastrectomy. The aim of this study is to analyze the surgical outcomes of the robotic gastrectomy focusing on the learning curve, cost-effectiveness, quality of life, and acute-inflammatory reaction in comparison with laparoscopic gastrectomy.


Eligibility Criteria:
Inclusion Criteria for prospective study participants

* Patients must have documented diagnosis of gastric cancer
* Patients receiving laparoscopic gastric cancer surgery without preoperative evidence of serosal invasion and distant lymph node metastasis as determined by preoperative CT-scan, upper endoscopy, and endoscopic ultrasound.
* Patients who have received comprehensive explanation about the planned study, understand and accept all the terms of the study and willingly give consent to participate in all the required elements of the study

Inclusion Criteria for retrospective study participants

- Any patients who underwent robotic gastrectomy in Korea

Exclusion Criteria for prospective study participants

* Patients without mental competence
* Patients who are illiterate
* Patients who are pregnant
* Patients \< 20 years old

Exclusion Criteria for retrospective study participants
A Study to Evaluate the Efficacy and Safety of TL118 in Solid Tumors Patients

The main objective of the study will be to evaluate the efficacy of TL118 in participants with solid tumors harboring NTRK gene fusions

TL118 is an orally active inhibitor of the tropomyosin receptor kinase (Trk) family consists of TrkA, TrkB, and TrkC. These receptors are encoded by the NTRK1, NTRK2 and NTRK3 genes, and oncogenic fusions of NTRK may cause cancer cells to grow and spread in the body. The purpose of this study is to explore how effective TL118 is for the treatment of patients with solid tumors harboring NTRK gene fusions.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years old and above, male or female
2. Histologically or cytologically confirmed diagnosis of locally advanced or metastatic solid tumor that harbors an NTRK1/2/3 gene fusion that is predicted to translate into a fusion protein with a functional tropomyosin receptor kinase (TRK)A/B/C kinase domain, without a concomitant second onco-driver
3. Patients must have had disease progression during or after prior treatment for their tumor, or would be unlikely to tolerate or derive clinical benefit from appropriate standard of care therapy or are not suitable - in the opinion of the Investigator - to receive standard of care therapy; prior treatment with approved or investigational TRK inhibitors is not allowed, except for prior TRK treatment for less than 28 days due to intolerable toxicity)
4. At least one measurable lesion
5. Eastern Cooperative Oncology Group (ECOG) score of 0, 1, or 2
6. A minimum life expectancy of \> 3 months
7. Adequate bone marrow reserve, hepatic, renal, and coagulation function

Other inclusion criteria apply for participating in the Study

Exclusion Criteria:

1. Any systemic anti-tumor therapy such as chemotherapy and radiation therapy (including curative radiotherapy or spinal radiotherapy portion \> 30%) used within 3 weeks prior to enrollment; immunotherapy within 4 weeks; any palliative radiotherapy for non-target lesions used to relieve symptoms and traditional Chinese medicines (TCMs) indicated for the tumor (including Chinese patent medicine) within 2 weeks prior to enrollment
2. Participation in another interventional clinical trial 2 weeks prior to enrollment or within 5 half-lives from the last dose of IP (whichever is shorter)
3. Any unresolved toxicities from prior therapy greater than Grade 1, at the time of screening with the exception of toxicities posing no safety risk in the opinion of the Investigator
4. Active central nervous system metastases
5. Any other primary malignant tumors within 3 years (except for cured skin basal cell carcinoma and carcinoma in situ of cervix, low-risk cancer
6. Any active infection which has not been controlled at screening

Other exclusion criteria apply for participating in the Study
Efficacy and Safety of Semaglutide Ingection in Subjects With Type 2 Diabetes

To evaluate the similarity of the efficacy and safety of semaglutide injection (QLG2065) vs. Ozempic® in patients with type 2 diabetes mellitus (T2DM) with poor blood glucose control after metformin treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female, age ≥ 18 years and ≤75 years old at the time of screening.
2. Subjects diagnosed with type 2 diabetes for at least 6 months (WHO, 1999)
3. Within 60 days before screening, subjects received stable treatment with only metformin ≥ 1500 mg/day (or maximum tolerated dose ≥ 1000 mg/day), or receive combination metformin (dose ≥ 750 mg/day) and another OAD (alpha-glucosidase inhibitors, sulfonylureas, glinides, SGLT-2i or thiazolidinedione), stable treatment is defined as unchanged medication and daily doses;
4. At the time of screening, for those who have previously been treated with metformin alone, HbA1c ≥ 7.0% and ≤ 11.0%（local lab）; for those who have previously used metformin in combination with another OAD treatment, HbA1c ≥ 7.0% and ≤10.0%（local lab）;
5. BMI≥18.5kg/m2 and ≤35 kg/m2
6. Subjects voluntarily participate in this research, can communicate well with researchers, are willing to maintain the same diet and exercise habits throughout the study, and sign an informed consent form (ICF) .
7. At baseline，HbAlc ≥ 7.0% and ≤ 11.0%（cental lab）

Exclusion Criteria:

1. Known or suspected hypersensitivity to any GLP-1RA or related products, or allergic constitution
2. Treatment with GLP-1RA, DPP-4 inhibitor, or insulin in a period of 60 days before screening. An exception is short-term insulin therapy (≤7 days in total).
3. History of chronic or acute pancreatitis
4. Screening calcitonin value ≥ 50 ng/L (pg/mL)
5. Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN 2)
6. Have a history of major cardiovascular and cerebrovascular diseases within 90 days before screening.
7. Known proliferative retinopathy or maculopathy
Study to Find the Percentage of Cases Retaining COVID-19 IgG Antibodies 45-65 After They Have Tested Positive

As a serosurveillance measure asymptomatic employees of an industrial workforce Jamshedpur (India) were tested for COVID-19 IgG antibodies. Of the tested employees who were positive for COVID-19 IgG antibodies the study aimed to find the percentage of cases who retained their COVID-19 IgG antibodies 45-65 days after initially testing positive.

As a serosurveillance measure, 3296 asymptomatic employees of an industrial workforce Jamshedpur (India) were tested for COVID-19 IgG antibodies specific for the spike subunit antigen by the ErbaLisa COVID-19, Erba Corporate Services (United Kingdom) between 28th June and 15th July 2020.

The cases who tested positive for COVID-19 IgG antibodies were repeat tested for the presence of COVID-19 IgG at 45-65 days after initially testing positive. This was done with the aim of finding out the percentage of cases retaining their IgG antibodies at 45-65 days of initially testing positive.

Eligibility Criteria:
Inclusion Criteria:

SARS-CoV-2 IgG antibody positive between 28th June and 15th July 2020

Exclusion Criteria:

SARS-CoV-2 IgG antibody negative between 28th June and 15th July 2020
Study to Confirm the Safety and Efficacy of Tegoprazan in Patients With Healed Erosive Esophagitis

This study is designed to confirm the non-inferiority of Tegoprazan 25mg, compared to Lansoprazole 15mg as maintenance therapy in patients with healed erosive esophagitis confirmed by endoscopy following oral administration once daily(QD) for 6 months.

This is a double blind, randomized, active-controlled, phase 3 study. Subjects will be randomly assigned to one of the two treatment groups (tegoprazan 25mg, lansoprazole 15mg).

Eligibility Criteria:
Inclusion Criteria:

1. Erosive eshophagitis(LA classification Grades A to D) within 12 weeks prior to Randomization
2. Healed erosive esophagitis within 7 days prior to Randomization
3. No heartburn and regurgitation within 7 days prior to Randomization

Exclusion Criteria:

1. Unable to undergo upper GI endoscopy
2. Presence of esophageal stricture, ulcerated stricture, gastroesophageal varix, long segment Barrett's esophagus with \>3 cm length(LSBE), active digestive ulcer, gastric bleeding or malignant tumors on an upper GI endoscopy
3. Diagnosed with primary esophageal motility disorder, irritable bowel syndome(IBS) or inflammatory bowel disease(IBD)
4. History of acid-suppressive, esophageal or gastric surgeries
Anti-fibrinolytic and Anti-inflammatory Effects of Local Infiltration of Tranexamic Acid in Patients With Calcaneal Fractures

Background. Consensus is lacking regarding the use of tranexamic acid (TXA) in calcaneal fracture surgery. This study aims to investigate the hypothesis that local infiltration of TXA in the post-operation would maintain hemoglobin (Hb) level, reduce incision drainage volume and risk of infection in patients with displaced intra-articular calcaneal fractures. Methods. A total of 120 patients with displaced intra-articular calcaneal fractures who received extensible lateral L-shaped approach were included in this trial and equally randomized to receive one single dose of 1g TXA or 1g normal saline after closing incision. The demographic data and fracture characteristics, intra-operative indicators, laboratory tests and Visual Analogue Scale (VAS) scores, incision drainage volume, and incision-related complications were collected and compared between the two groups.


Eligibility Criteria:
Inclusion Criteria:

* adult patients with age of eighteen years or older;
* diagnosis of closed and unilateral displaced intra-articular calcaneal fracture;
* agreement to receive one of the two treatment strategies;
* agreement to participate in regular follow-up after surgery

Exclusion Criteria:

* open calcaneal fractures;
* polytrauma of the ipsilateral lower limb;
* systemic inflammatory or infectious diseases;
* previous history of calcaneal fracture or bone tumor;
* allergies to drugs used, or refused to accept the specified treatment strategy.
Myelin Imaging Changes In Patients With Neurosurgical Diseases

Investigate myelin alterations in patients with neurosurgical diseases

While a number of advanced imaging techniques, notably magnetization transfer, diffusion tensor and quantitative T1 and T2 imaging (MTI, DTI, qT1 and qT2, respectively), have been used previously to study white matter in neurosurgical diseases, these methods provide only indirect, non-specific information related to myelin content. For example, these modalities can tell when there is swelling that is affecting the movement of water, which may be indicative of a process that would affect myelin, but they cannot tell us specific information about the amount of myelin surrounding a nerve.

The investigators propose using a MRI sequence, mcDESPOT (multicomponent driven equilibrium potential of T1 and T2) that utilizes a computer model that takes T1 and T2 sequences and derives a quantitative value for the myelin content in the myelin sheath.

In the present program, the investigators propose adding the mcDESPOT sequence to the MRI scanner in accordance with the MRI manufacturer's technical requirements. When this sequence is added, the normal sequences are done first and mcDESPOT is done last. Although the sequences obtained for mcDESPOT are sequences used in clinical practice, the flip-angles are changed so that they cannot be read like a traditional image. Rather, the data have to be post-processed by a computer in order to be able to derive myelin information.

McDESPOT is a 10 minute sequence that can be added to any MRI scanner. It is a obtained from standard T1 and T2 sequences.

Eligibility Criteria:
Inclusion Criteria:

1. Patient age range: 0-19
2. Patients who have an MRI ordered clinically and have one of the following conditions: epilepsy, hydrocephalus, craniosynostosis or mild traumatic brain injury. Epilepsy, hydrocephalus and craniosynostosis patients will be both newly diagnosed and chronic. MTBI patients will be acute and chronic and defined as a glascow coma score (GCS) of 13-15.
3. Patients or their proxy should be capable of giving informed consent

Exclusion Criteria:

1. Unable to tolerate an extra 10 minutes of MRI scan
Identifying Factors Underlying the Discontinuation of Triptans

The objective of this study is to identify reasons migraine patients stop using triptan medications for abortive headache treatment. It is hypothesized that inadequate education of the patient at the time of prescribing the triptan is positively associated with triptan discontinuation.


Eligibility Criteria:
Triptan User Inclusion Criteria:

* Episodic Migraine or Chronic Migraine
* Have used a triptan medication in the prior 3 months
* Have used triptan medications for at least 1 year

Triptan Discontinuation Inclusion Criteria:

* Episodic Migraine or Chronic Migraine
* Used any triptan medication in the last 2 years
* Have not used a triptan medication in the last 6 months
TENS in Post-operative Total Knee Arthroplasty Recovery and Intra-venous Analgesics Requirement

Total knee arthroplasty (TKA) is among the major advancements for the treatment of knee pain and improvement of physical function when conservative management fails to comply with. The success of this arthoplasty results in more functional mobility and better quality of life. However, management of pain after TKA in post-operative period is a big challenge to deal.

Transcutaneous electrical nerve stimulation is a cost effective, non-invasive electrotherapeutic modality used in alleviating pain in both acute and chronic conditions affecting neuromusculoskeletal system of the body.

Eligibility Criteria:
Inclusion Criteria:

1. Both male and female
2. Aged between 31-70 years
3. Total Knee Arthoplasty, who had been diagnosed with knee osteoarthritis, inflammatory arthritis, trauma, fracture result in total knee arthoplasty.

Exclusion Criteria:

1. Any allergic condition of skin
2. Chronic consumption of opioids
3. History of dysplasia or malignancy to knee joint
4. Any major bone operation of lower limb
5. BMI higher than 35 kg m-2
6. History of mental disorder
7. Neurological illness e.g. Alzheimer which might interfere with assessment process.
Treadmill Training With Functional Electric Stimulation After Stroke

The purpose of this study was to investigate the effects of the treadmill training with functional electric stimulation on sensorimotor cortical reorganization and functional improvement in subjects with chronic stroke.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of unilateral hemiparesis secondary to cerebrovascular accident with post-onset duration of more than 6 months
* ability to walk independently for at least 6 meters with or without use of walking aids
* ability to follow simple verbal commands or instructions

Exclusion Criteria:

* unstable medical conditions
* history of other diseases known to interfere with participation in the study
* past history of a seizure
* history of skin allergy to electrode
* use of a cardiac pacemaker