cyrilzakka/clinical-trials huggingface dataset:
Detecting Auricular Points in KOA by a Novel APD

This is a pilot diagnostic accuracy study conducted to assess the diagnostic ability of a novel APD for auricular point detection among patients with knee osteoarthritis (KOA), as compared with an already commercialized device.

The present study is a pilot diagnostic accuracy study conducted to assess the diagnostic ability of a novel APD for auricular point detection among patients with knee osteoarthritis, as compared with an already commercialized device. The investigators will test if the novel APD could provide a more reliable and quantifiable diagnosis than traditional devices currently available in the market; They will also use the APD device to test whether the cutaneous electrical impedance detected from the corresponding auricular points by the novel device is the lowest in the knee and lower limb area in the KOA population. As a pilot study, 12 patients with KOA will be recruited from the Department of Anesthesiology, Queen Mary Hospital, the University of Hong Kong. 12 healthy subjects will be recruited from the university community. Auricular acupoint detection will be accomplished with the new device and a control device. The electrical impedance will be measured and recorded. Patient's condition will also be evaluated by the Knee Injury and Osteoarthritis Outcome Score (KOOS) and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). The specificity and sensitivity of the auricular point detection by the APD device will be calculated. Cohen's kappa coefficient (κ) will be used to test the inter-methods reliability, test-retest reliability, and inter-tester reliability. Moreover, the Pearson Correlation Coefficient will be used to test the correlation between the electrical impedance of the auricular point of knee and the KOOS score and WOMAC score.

Eligibility Criteria:
Inclusion Criteria:

* Average daily knee pain \>=5 point measured by a 10-point VAS scale;
* Diagnosed KOA of any reason;
* The different patient categories;
* Patients with knee osteoarthritis enrolled for knee arthroplasty, osteotomies around the knee, cartilage repair, or anterior cruciate ligament-deficient knees enrolled for anterior cruciate ligament reconstruction;
* Surgical plan in the coming month after inclusion;
* Provide written inform consent;
* Free of any other diagnosed psychological conditions;

Exclusion Criteria:

* with any other diseases such as cardiovascular, renal, neurological, digestive, hepatic, respiratory disease;
* Pregnancy or lactation;
* Participation in a clinical study that may interfere with participation in this study;
* History of or current tobacco, alcohol use;
* Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study;
* Unable to provide written informed consent due to any reason;
Pharmacokinetics and Safety of Roledumab in RhD-negative Pregnant Women Carrying an RhD-positive Foetus

The aim of this study is to assess the pharmacokinetic profile of Roledumab 300μg IM / IV in RhD-negative pregnant women carrying an RhD-positive foetus.

To assess the safety of Roledumab in RhD-negative pregnant women and in RhD-positive fetus and newborns.

In addition the efficacy of Roledumab 300μg IM and IV to prevent RhD alloimmunisation in RhD-negative pregnant women carrying an RhD-positive fetus and the immunogenicity of Roledumab will be assessed.


Eligibility Criteria:
Inclusion Criteria:

* Signed and dated informed consent form provided by the subject prior to proceeding with any study-related procedure,
* At least 18 years old,
* Pregnancy between 12 and 27 weeks gestational age as confirmed by early ultrasound,
* Pregnant RhD-negative woman carrying an RhD-positive fetus confirmed by a non-invasive fetal RhD genotyping test,
* Negative serology: HIV (1 and 2), hepatitis C and hepatitis B, except for positive results due to vaccinations,
* Covered by healthcare insurance in accordance with local requirements.

Exclusion Criteria:

* RhD allo-immunized subject,
* Positive for ADA test,
* Multiple fetuses,
* Occurrence of a documented potential sensitizing event in this pregnancy before the antenatal IMP administration,
* Prior administration of anti-RhD immunoglobulin during the current pregnancy,
* Known clinically relevant maternal or fetal abnormality (e.g., as determined by ultrasound or genetic testing), such as placenta previa,
* History of anaphylactic or severe systemic reaction to immunoglobulin of any origin,
* Current diagnosis of an immune disease which by itself or its treatment could impair the safety and/or efficacy evaluation of Roledumab in this study. These diseases are: All immune deficiencies, particularly those requiring IV-Ig supplementation or other systemic treatment / connective tissue and autoimmune diseases (e.g., systemic lupus erythematosus, antiphospholipid syndrome, Sjögren's syndrome, rheumatoid arthritis, ankylosing spondylarthritis) requiring systemic immunosuppressive treatment / allergic and inflammatory diseases requiring systemic immunosuppressive treatment,
* Clinically significant medical history contraindicating the participation in the study according to the judgment of the Investigator or Sponsor,
* Clinically significant laboratory (hematology, blood chemistry, or urinalysis) parameters,
* For the IM arm only, subject with coagulation disorders contraindicating intramuscular injection (patient will still be considered for the IV arm),
* Transfusion of RhD-positive blood or blood derived products within the 6 months prior to enrolment,
* Anticipated poor compliance with the study procedures,
* Subject within exclusion period further to her participation in a clinical study.
Concentrations of Salmeterol in Blood and Urine

The purpose of the study is to assess the blood and urine concentrations of inhaled salmeterol.

The purpose of the study is to assess the serum and urine concentrations of salmeterol after inhalation of 100 microgram salmeterol in one dose.

Furthermore, to evaluate any difference in three groups: 10 healthy men, 10 male asthmatic subjects and 10 male elite athletes with asthma.

Eligibility Criteria:
Inclusion Criteria:

* Physician-diagnosed asthma with positive reversibility or challenge test.
* Informed consent.
* Age between 18-45 years.
* Sex: male.
* Asthma classified as mild to moderate according to GINA guidelines.
* Used beta-2-agonist in minimum 12 months.

Exclusion Criteria:

* Smokers or ex-smokers with a smoking history of 10 pack years or more.
* Respiratory tract infections within the last 2 weeks prior to study day.
* Subjects with other chronic diseases than asthma and/or allergy.
* Allergy towards the study medicine.
* Use of beta-2-agonist 10 days prior to study day.
Panoramic Presentation and Tolerance Mechanism of Human Endometrium Based on Tiangui Theory

Detailed Description:In the process of women's menstrual cycle, there are different physiology at different time points in a cycle.

Change, investigators select women with a menstrual cycle of 28 days and take samples every 3 days.

Day 4, Day 7, Day 10, Day 13, Day 16, Day 19, Day 22, Day 25, Day 28 days, a total of 10 time points, 20 healthy women were selected, and the transcription, Protein and phosphorylation proteomics, systematically integrated analysis; at the same time, 20 subjects were classified by age group Divide into 4 groups, 21-year-old group, 28-year-old group, 35-year-old group, and 42-year-old group. At the same time, investigators then analyze the differences in the receptivity of the endometrium of different ages.

The experimental design groups are: 21-year-old group, 28-year-old group, 35-year-old group, 42-year-old group, Each group includes D1 group Vs D4 group Vs D7 group Vs D10 group Vs D13 group Vs D16 group Vs D19 group Vs D22 group Vs D25 group Vs D28 group; in phosphorylation modification omics, different time points are compared with each other, Look for transcripts, proteins and phosphorylated proteins that change significantly during the cycle of change. Analyze phosphorylation modification An important role for changing proteins and an important role for cycle changes.

The experiment quantified the proteome and protein acylation modification through TMT (Tandem Mass Tag), and passed GO, KEGG Pathway, Localization, Functional enrichment analysis, Cluster analysis Bioinformatics analysis


Eligibility Criteria:
Inclusion criteria:

1. The subject's infertility factors are only male factors and/or fallopian tube factors;
2. Age: 21/28/35/42/49 years old (calculated according to the birthday month of the Gregorian calendar, no more than 6 months before and after);
3. Body mass index (weight/height square)=23～25kg/m2;
4. The menstrual cycle is 28+/-1 days (that is, the menstruation is 2-3 days in advance of each month), and the consistency of the past 6 consecutive months (not more than 1 day before and after, that is, 27-29 days);
5. Women with a history of pregnancy are preferred;
6. Asexual life during the study period;
7. No IUD is placed in the uterine cavity;
8. Volunteer to participate in the experiment and sign the informed consent form.

Exclusion criteria:

1. Women who have a history of miscarriage;
2. Women during pregnancy and breastfeeding;
3. Mentally ill;
4. Those who have had oral contraceptives or hormonal drugs in the past three months;
5. Combined with serious primary diseases such as cardiovascular, cerebrovascular, liver, kidney and hematopoietic system;
6. Subjects who have participated in other drug clinical trials within six months;
7. Those who have poor compliance and the investigator thinks it is inappropriate to participate in this clinical trial.
Evaluate Efficacy and Safety of XELOX in Potentially Resectable Liver Metastasis From Colorectal Cancer(CRC)

This is a single arm, open-label phase II study to evaluate the efficacy and safety of Capecitabine plus oxaliplatin (XELOX) in the peri-operative treatment of patients with potentially resectable liver metastasis from colorectal cancer.

To investigate the progression free survival (PFS) advantage of Xeloda plus oxaliplatin in the peri-operative treatment of potential resectable metastatic colorectal cancer

Eligibility Criteria:
Inclusion Criteria:

* Age of 18 and 65
* Histologically confirmed colorectal cancer and two methords of imaging detection confirmed liver metastasis
* Potentially curable by resection, as determined by a surgeon with hepatic surgery expertise
* No evidence of extrahepatic disease by chest x-ray or CT scan of the chest, abdomen, and pelvis
* Patients with adequate hepative, renal and bone marrow function
* Signed written informed consent

Exclusion Criteria:

* Pregnant or nursing patients (fertile patients must use effective contraception)
* Other malignancy within the past 5 years except completely resected nonmelanoma skin cancer or carcinoma in situ of the cervix
* Preexisting grade 2 or greater peripheral neuropathy
* Concurrent uncontrolled illness
* Ongoing or active infection
* Psychiatric illness or social situation that would preclude study compliance
* Less than 6 months since prior adjuvant fluorouracil-based chemotherapy
* Prior chemotherapy for liver metastasis
* Prior oxaliplatin for colorectal cancer
* Prior or concurrent hepatic artery infusion chemotherapy for metastatic disease
* Prior or concurrent radiotherapy for metastatic disease
* Prior or concurrent radiofrequency ablation for metastatic disease
* concurrent treatment with any other anti-cancer therapy.
Study on Hypertonic Saline Nasal Spray

Phytosun decongestant nasal spray is a class I medical device registered in the European Union for the treatment of nasal congestion. The spray contains hypertonic seawater and essential oils. The objective of the study is to investigate the effects of a nasal spray, registered as a medical device under the name Phytosun Decongestant in the European Union, on speed of onset of relief of nasal congestion in 50 subjects suffering from nasal congestion associated with common cold.

The study will also include an exploratory assessement of any objective changes in nasal patency by measuring nasal peak inspiratory flow before and after treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Aged18 years and over
2. Has given written informed consent, and received a copy of their signed consent form prior to any study related procedures
3. Subject considers they are suffering from a common cold of no more than 7 days duration (common cold will be self-diagnosed but all patients will be screened by a doctor and nasal examinations will be performed as needed to establish eligibility of patients for study).
4. Subject on entry to the study has a symptom score of 1 or greater for blocked nose on four point ordinal scale

Exclusion Criteria:

1. Have a known hypersensitivity or are allergic to any component of the test product
2. The subject has a clinically significant cardiovascular, endocrinological, neurological, respiratory, gastrointestinal disease or a history or any current disease that is considered by the investigator as a reason for exclusion e.g. current allergic rhinitis, chronic obstructive pulmonary disease
3. The subject has a severe nasal septal deviation or other condition that could cause nasal obstruction such as the presence of nasal polyps.
4. The subject has had nasal or sinus surgery in the past that in the opinion of the investigator may influence symptom scores
5. The subject has a history of alcohol or other substance abuse in previous year
6. The subject is taking any prescribed medication other than for contraception, that is considered by the investigator as a reason for exclusion e.g. systemic steroids, intranasal medicines, antibiotics.
7. The subject has had common cold or flu like symptoms for more than seven days
8. The subject has recently taken a common cold medicine that in the opinion of the investigator may influence baseline symptom scores (such as nasal decongestants)
9. The subject is a current smoker (more than 2 cigarettes, pipes, cigars a day)
10. The subject is related to any study personnel
11. The subject has received any investigational drug or participated in a clinical trial within 4 weeks of entry to this study
12. The subject is pregnant or lactating -
Cancer/Testis Antigen Immunotherapy Phase I Study With 740-CTA Vaccinia Virus

Monocentric open-label phase I/II trial aiming at evaluating, in adjuvant setting, safety (primary outcome), immunological and clinical efficacy (secondary outcomes) of a non replicating recombinant vaccinia virus expressing cancer/testis antigen (CTA) derived epitopes and CD80 and CD40 ligand (CD40L, CD154) costimulatory molecules in patients with CTA expressing tumors.


Eligibility Criteria:
Inclusion Criteria:

* Surgically treated M0 patients with solid tumors
* Tumor expressing at least one of the vaccine targeted antigens Melanoma-associated antigen (MAGE)-A1, -A2,
* A3, -A4, -A6, -A10, -A12 or New York (NY) esophageal squamous cell carcinoma-1 (ESO-1) (NY-ESO-1) (by real-time quantitative PCR (RT-qPCR))
* Patient expressing the targeted Human Leukocyte Antigen (HLA) restriction (A0201 /A0101/ B3501)
* 4 weeks interval following surgical resection of tumor and, if applicable, completion of adjuvant therapy.
* Karnofsky over 70%
* No other concomitant malignancy

Exclusion Criteria:

* History of anaphylaxis or severe allergic reaction
* Severe heart, lung, kidney, liver or psychiatric condition
* Concurrent immunosuppressive therapy or impaired immune system
Trial to Demonstrate the Efficacy and Safety of Conversion to Lacosamide Monotherapy for Partial-onset Seizures

The objective of this historical-controlled trial is to demonstrate the efficacy and safety of conversion to Lacosamide monotherapy in subjects with Partial-onset Seizures who are withdrawn from 1 to 2 marketed antiepileptic drugs.

Sudden unexplained death in epilepsy have been reported in epilepsy patients. A causal relationship with the administration of antiepileptic drugs has not been established. The most important known risk factor for sudden unexplained death in epilepsy (SUDEP) is the occurrence and frequency of generalized tonic-clonic seizures (GTCS). Twenty-seven patients with only GTCS were enrolled in the conversion to monotherapy study. In this study, two patients with only GTCS had SUDEP. Due to the potential increased risk of SUDEP in patients with only GTCS in a trial setting, the 1 remaining patient with only GTCS was withdrawn from this study.

Eligibility Criteria:
Inclusion Criteria:

* Subject has a diagnosis of Epilepsy with Simple Partial Seizures (motor component) and or Complex Partial Seizures (with or without secondary generalization)
* Must be experiencing 2 to 40 seizures per 28-day period
* Stable dose of 1 or 2 marketed antiepileptic drugs
* Second Antiepileptic Drug (AED) must be less than or equal to 50 % of the minimum recommended maintenance dose per USA product label at screening

Exclusion Criteria:

* Subject has a history of primary generalized or unclassified seizures
* Seizure disorder primarily characterized by isolated auras
* History of status epilepticus
* Seizures that are uncountable due to clustering
* Has greater than 5 seizures/day
* Subjects taking Benzodiazepines, Phenobarbital or Primidone
* Subject has Vagus Nerve Stimulation (VNS)
* Significant medical or psychiatric condition
* History of alcohol or drug abuse
* History of Ethosuximide use, Felbamate use after 1994 or Vigabatrin use after 1997
Long-term Outcomes of Patients with Rheumatoid Arthritis in Remission

The goal of this multi-center prospective observational study is to develop knowledge on how to best personalize treatment and follow-up strategies for patients with RA in remission, with the intention to prevent relapse of disease activity and progression of joint damage and at the same time avoid the use of unnecessary treatment and health resources.

The investigators will perform an extensive evaluation of all patients who participated in the ARCTIC REWIND study 10 and 15 years after they achieved sustained remission and received different treatment strategies.

Rheumatoid Arthritis (RA) is a chronic inflammatory disease that affects 0.5 to 1.0% of the population. In case of ineffective treatment, the inflammation can lead to joint destruction and reduced physical function, as well as affecting internal organs. RA is associated with an increased risk of cardiovascular disease and osteoporosis.

The prognosis for RA has improved significantly over the past two decades, with effective treatment strategies and available drugs allowing a significant proportion of patients to achieve the treatment goal of remission (absence of signs of inflammation). RA has thus become a 'controllable' disease, and the large increase in the number of RA patients in remission leaves a need for improved understanding of how to best treat these patients.

A total of 259 RA patients in sustained remission were included in the ARCTIC REWIND trial. They were randomized to either tapering of DMARDs, or to continue stable DMARD medication, and followed for three years. The current study will provide a 10- and 15-year follow-up on the outcome of all these patients.

The results from the project will add knowledge about the long-term consequences of achieving sustained remission, as well as of experiencing a disease activity flare regarding DMARD use, joint damage progression, functional status and work productivity, and the study will provide novel data on cardiovascular health and other comorbidities in this patient group. Further, the patient perspective on flare will be explored. Such information will be valuable for patients and clinicians to improve shared decision on further treatment, and potentially allow more patients to reduce treatments in an evidence-based manner. Results from the study could influence approaches to the management of RA in the future, as selecting patients who can be switched to remote care (reduce the number of visits the patient has to attend physically).

Eligibility Criteria:
Inclusion Criteria:

* Participation in the ARCTIC REWIND trial
* Patients able and willing to give written informed consent and comply with the requirements of the study protocol

Exclusion Criteria:

* Psychiatric or mental disorders, alcohol abuse, other substance abuse, other factors making adherence to the study protocol impossible.
HRIM vs Mucosal Impedance in GERD Participants

Does baseline impedance measured during the landmark phase of esophageal High resolution impedance manometry HRIM correlates with direct mucosal impedance measurement and discriminates GERD from non GERD patients?

Patients referred to the Mayo Clinic Rochester for a clinically indicated high resolution impedance manometry (HRIM), 24 hour impedance pH (MII-pH) study, and esophagogastroduodenoscopy (EGD) will be recruited. Gastroesophageal reflux will be defined as a total 24 hour esophageal acid exposure time ≥5% regardless of concomitant Proton Pump inhibitor (PPI) use. A negative 24 hour MII-pH study will be defined as an acid exposure time ≤2% off PPI therapy or ≤1% if on PPI therapy.

Eligibility Criteria:
Patients being seen at Mayo clinic Rochester having a clinically indicated endoscopy, a high resolution impedance manometry and a 24 hour pH impedance study.

Inclusion criteria:

* Adults ages 18-90
* Patients scheduled for or have completed a HRIM ( within 5 days)
* Patients scheduled for or recently have completed a MII-pH studies ( within 5 days)
* Patients scheduled for EGD

Exclusion criteria:

* Technically limited esophageal HRIM or MII-pH study
* Patients with HRIM and MII-pH studies not performed within 5 days of each other
* Patients with EGD not performed within 30 days of HRIM and MII-pH studies
* Medical conditions such as severe heart or lung disease that preclude safe performance of endoscopy
* Inability to read due to: Blindness, cognitive dysfunction, or English language illiteracy
Effect of Pilocarpine in Patients With Xerostomia

The purpose of this study is to evaluate the effectiveness of a spray the basis of pilocarpine on salivary flow of patients with xerostomia, by radiation therapy, and primary Sjögren's Syndrome treated at the Clinics Hospital of Faculty of Medicine of Ribeirão Preto (HCFMRP-USP), and its impact on quality of life.

There will be two groups: Group 1 (G1) - will use a spray with pilocarpine for three months and after a washout period of a month, use a spray without pilocarpine for another three months; Group 2 (G2) - will use a spray without pilocarpine for three months and after a washout period of a month, use a spray with pilocarpine for another three months (in a randomized, controlled, duble blind and crossover study). Participants will be submitted to OHIP-14, Xerostomia Inventory (XI) and salivary flow measurement before the start of therapy - baseline (T0), one (T2), two (T3) and three (T4) months after starting the use of spray, after washout, crossover occurs and the same parameters are measured for the same periods (T0', T2', T3' and T4'), and is measured one hour after the saliva (T1 and T1') baseline.

Eligibility Criteria:
Inclusion Criteria:

* Age equal or superior to 18 years;
* Both genders;
* Lucid and without diagnosis of any psychiatric disorder;
* Diagnosed with head and neck cancer and treated for a period of up to 5 years with radiotherapy where the major salivary glands (parotid, submandibular and sublingual) were included in the radiation field;
* Primary Sjögren's syndrome with the diagnosis made by the American-European criteria.

Exclusion Criteria:

* Sensitivity to pilocarpine
* Secondary Sjögren's syndrome;
* Type II diabetes mellitus;
* AIDS;
* pregnant or lactating women;
* Glaucoma;
* Uncontrolled asthma;
* Chronic obstructive pulmonary disease;
* Renal diseases;
* Severe cardiovascular diseases;
* Gastrointestinal disorders;
* Hepatic insufficiency.