cyrilzakka/clinical-trials huggingface dataset:
Bucillamine Study of Holding Remission After Infliximab Dose-off

Patients with rheumatoid arthritis who have been well controlled with methotrexate plus infliximab may remain in remission or low disease activity without infliximab. And the chance of sustained remission increase by the addition of another DMARD, bucillamine, at the time of discontinuing infliximab. The BuSHIDO trial is the prospective, randomized, controlled study comparing MTX monotherapy and MTX plus bucillamine combination therapy as to the rate of disease flare after discontinuing infliximab.


Eligibility Criteria:
Inclusion Criteria:

* RA according to American College of Radiology (ACR) classification criteria
* Age of 20 or greater
* DAS28-ESR \< 3.2 or DAS28-CRP \< 2.6 for more than 6 months

Exclusion Criteria:

* Previously teated with bucillamine
* Pregnancy or lactation
Circulating Tumor Cell Detection in Hepatocellular Carcinoma

The investigators examined circulating tumor cells (CTC) in the perioperative peripheral blood of hundreds of HCC patients undergoing liver cancer surgery using CellSearch technology between 2013 and 2016. Although the investigators have done a preliminary study of the above data and published some results, the previous study was only a basic analysis. Now the investigators plan to carry out further in-depth analysis of these data, including hospitalization data, follow-up results, surgical tumors and blood specimens, and make full use of biostatistics, molecular biology, pathology and other related techniques to elucidate the association between the levels of CTC or CTC clusters and patients' disease during the perioperative period, and to explore the molecular basis of CTC production in hepatocellular carcinoma.

From 2013 to 2016, CellSearch technology was used to detect the number of circulating tumor cells (CTC) in peripheral blood of hundreds of HCC patients undergoing liver cancer surgery during perioperative period. The analysis results confirmed that the level of CTC before and after surgery were significantly correlated with overall survival (OS) and disease-free survival (DFS) of patients. CTC level changed before and after surgery, but there was no statistical difference. Preoperative CTC was more correlated with patients' disease-related clinical parameters, while postoperative CTC was an independent prognostic indicator of patients after surgery. In addition, the investigators' study found that CTC clusters level can be a new marker of tumor progression in HCC patients.

Based on the above data, the investigators will perform retrospective analysis to compare the relationship between CTC level and clinical indicators of HCC patients. Participants were divided into groups according to pathological type, differentiation degree, clinical stage, invasion degree, recurrence and metastasis of tumors. Combined with immunohistochemistry and quantitative PCR results, the correlation of CTC in tumor genesis, pathological model, degree of differentiation, tumor stage, invasion, metastasis and expression of other tumor markers was studied.

Eligibility Criteria:
Inclusion Criteria:

* The pathological diagnosis was primary liver cancer.
* Undergoing radical surgical treatment
* No preoperative antitumor therapy was received
* Between 18 and 80 years old

Exclusion Criteria:

* With distal metastasis
* With other tumors
* Perioperative death
* Recurrence within one month after surgery
* Lost contact before the first follow-up
Long Term Impact of Induced Abortion

Through prospective observation of the queue, the risks of mid to long term complications for Chinese women caused by surgical and medical abortion, as well as their potential impacts on women's fertility, pregnancy complications/comorbidities, and maternal and infant health, are identified. This provides scientific evidence for the assessment, protection, and preservation of fertility among Chinese women of childbearing age, and decision-making basis for the development and improvement of artificial abortion and fertility policies and guidelines for the country.


Eligibility Criteria:
Inclusion Criteria:

* Women who voluntarily request non-medical abortion surgery, early pregnancy (≤ 10 weeks of gestation); Age range: 20-40 years old (inclusive); Willingness to have another child; No long-term intention to go abroad during the research period; Willing to accept regular postoperative follow-up and voluntarily sign an informed consent form.

Exclusion Criteria:

* Pathological miscarriage such as spontaneous abortion and missed abortion; Difficulty in reading, writing, or understanding; Other situations deemed unsuitable for inclusion by doctors.
Resection And Partial Liver Segmental Transplantation With Delayed Total Hepatectomy

RAPID is an auxiliary liver transplantation where a small liver partial graft (namely left lateral segments from living or cadaveric donors) is implanted orthotopically after a left hepatectomy of the native liver. Subsequently, in order to implement a fast regeneration of the transplanted segments a portal flow diversion is operated in the direction of the future remnant. After obtaining a fast regeneration of the auxiliary future remnant liver the native liver hepatectomy is completed as in a two stage- hepatectomy. Peculiar inclusion criteria will be adopted for patient selection with particular reference to the admission of patients with \<3 lung metastases radically treated before transplantation.


Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 and \<70 years
* Performance status, ECOG 0-1
* Histologically proved adenocarcinoma in colon or rectum
* BRAF wild-type CRC on primary tumor or liver metastases
* High standard oncological surgical resection of the primary tumor
* Liver metastases not eligible for curative liver resection confirmed by the validation committee
* At least one line (3 months) of chemotherapy
* At least 6 months time span from CRC resection and date of being listed on the transplantation list.
* At least 8 weeks of tumor control: stable disease or partial response according to RECIST 1.1 criteria
* No signs of extra hepatic metastatic disease or local recurrence on CT, MRI and Pet-CT except patients may have \<3 lung lesions all\<15mm resected or treated by radiotherapy or metastatic hilar nodes treated by resection and without recurrence at 3 months from resection or radiotherapy.
* Satisfactory blood tests creatinine in normal level, PLT \>60.000/mm3, GB\>2500/mm3
* CEA stable or in decrease
* Signed informed consent and expected cooperation of the patients for the treatment and follow up

Exclusion Criteria:

* Weight loss \>10% the last 6 months
* Patient BMI \> 30
* Participation refusal
* General contraindication to LT
* Other malignancies in the previous 5 years
* Pregnancy or breast feeding
* Any reason why, in the opinion of the investigator, the patient should not participate
Flutiform in Treatment of Patients With Asthma in Daily Clinical Practice.

The objective of the study is to evaluate the effect of frequency of use with a spacer on asthma control in Dutch patients with asthma during their daily clinical practice over 12 weeks treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patients eligible to be prescribed fluticasone/formoterol fixed dose combination as follows:

Patients not adequately controlled in inhaled corticosteriods and "as required" inhaled short acting beta 2 agonist or patients already adequately controlled on both an inhaled corticosteriod and a long-acting beta 2 agonist.

The decision to prescribe fluticasone/formoterol fixed dose combination will precede and be independent of the decision to enroll the patient into the study

Exclusion Criteria:

* There are no specific exclusion criteria as this is an observational study
Study to Evaluate the Therapeutic Action of Tamsulosin and Finasteride in Symptomatic Benign Prostatic Hyperplasia (BPH) Patients

Study to evaluate the therapeutic effect of tamsulosin and finasteride in symptomatic BPH patients, two medications indicated in BPH belonging to two different pharmacological classes, as evaluated from the point of view of patient's perception of his pathological condition and of the impact of the disease on general health and quality of life


Eligibility Criteria:
Inclusion Criteria:

* Male out-patients aged 50-80 years
* IPSS \>= 13 at Visit 1
* Qmax: 4-15 ml/sec at Visit 2
* Residue urinary volume \> 400 ml as evaluated by ultrasonography
* SPI \>= 7 at Visit 2
* Prostate Specific Antigen (PSA) value \< 3 ng/ml at Visit 1, or of 3-10 ng/ml provided that prostate cancer is ruled out on the basis of the usual diagnostic procedures performed at each Centre
* Written informed consent

Exclusion Criteria:

Patients with known history or diagnosis at the time of the screening visit of the following conditions that could influence the end-points of the study:

* Urological disturbances

  * Medical history of pelvic surgery; palpable bladder at the physical examination, or residue urinary volume \> 400 ml; known neurological bladder disorder, bladder neck stenosis, urethral stricture, bladder or prostatic cancer, bladder stone, severe diverticulum of the bladder, symptomatic urinary tract infection during the last month, or recurrent urinary tract infections (more than 2 during the last year); hematuria of unknown origin; diseases that may affect micturition (e.g. diabetes mellitus)
* Cardiovascular diseases - The following cardiovascular diseases if occurred in the last 6 months:

  * Myocardial infarction
  * Unstable angina
  * Clinically significant ventricular arrhythmias
  * Heart failure (NYHA classes III/IV)
  * Orthostatic hypotension
  * Cerebral stroke
* Neurological diseases

  * such as senile dementia, multiple sclerosis, Parkinson's disease, psychiatric disturbances, if their severity could have prevented the correct performance of the trial
* Hepatic or renal insufficiency

  * (Biochemistry values 15% outside normal laboratory ranges and regarded as clinically relevant by investigator)
* Clinically significant abnormalities in the results of hematologic and biochemical tests performed on blood samples drawn at the screening visit
* Patients who are taking or have been taking α-blockers for BPH or for hypertension or phytotherapy for BPH in the previous 6 weeks
* Patients who are taking or have been taking finasteride in the last 6 months
* Patients who require concomitant drugs which could influence the pharmacodynamic or pharmacokinetic properties of tamsulosin. In particular: alpha-blockers and mixed alpha-beta blockers, alpha- agonists, anti-cholinergics
* Patient who are or have been taking part in a clinical study in the previous 3 months
* Patients who have hypersensitivity or allergic reactions to previously prescribed alpha-blocker(s) or to finasteride
* Patients judged by the investigator to be inappropriate for inclusion in the study
Study: Study to Compare Video Miller Device to Direct Laryngoscopy

The purpose of this study is to compare:

the standard pediatric intubation instrument (Miller blade) used as direct laryngoscopy during tracheal intubation to the VideoMiller device (the standard pediatric blade with a camera attached, giving indirect view of the vocal cords in the screen). This intubation device is used to place the tube in the trachea to keep the patient breathing during the surgery procedure.

The anesthesiologist obtains a better view of the vocal cords looking at the screen provided by the VideoMiller.


Eligibility Criteria:
Inclusion Criteria:

1. Patients aged 3 years or younger undergoing anesthesia requiring endotracheal intubation.
2. Obtaining signed the informed consent by their parents or legal guardian.
3. American Society of Anaesthesiologists (ASA) physical status classification I - II or III

Exclusion Criteria:

1. Patients deemed to be at significant airway risk necessitating an awake fiber optic intubation
2. Patients with facial abnormalities, and/or oral-pharyngeal malformation.
3. Emergency operation
Parameter Space of kTMP

The investigators have recently developed a new non-invasive brain stimulation (NIBS) system, kilohertz transcranial magnetic perturbation (kTMP) that opens up a new experimental space for safely modulating neural excitability in targeted areas of the human brain. This project will characterize the broad parameter space of kTMP in terms of tolerability and efficacy in healthy individuals. Following earlier feasibility studies, we are now increasing our number of subjects in order to capture preliminary safety and effectiveness information on a near-final device.

Non-invasive brain stimulation (NIBS) has attracted considerable interest in the cognitive neuroscience community, providing an important basic research tool to study brain function, with emerging clinical applications to enhance function in individuals with neurological disorders.

The investigators have developed a radically new NIBS approach, one in which subthreshold modulation of neural excitability is brought about via oscillating magnetic fields at kilohertz (kHZ) frequencies. This system, referred to kTMP (kHz Transcranial Magnetic Perturbation) significantly increases the range of subthreshold E-field induction, and through modulation of the envelope of the kHz carrier frequency, can impose E-fields at physiological relevant frequencies. The investigators will conduct testing with healthy human participants to assess the tolerability and efficacy of the system in producing changes in cortical physiology.

Eligibility Criteria:
Inclusion Criteria:

Age 18-75

Exclusion Criteria:

* serious medical condition
* had a seizure of any sort
* epilepsy or experienced seizures
* neurological disorder
* head injury
* stroke
* had any form of brain surgery
* history of migraine
* metal implants in your head, excluding the mouth
* pacemaker
* implanted medical devices of any sort
* pregnant
* hearing loss or hearing impairments
* jet lag
* stress
* substance abuse
* highly stressful event over the past 24 hours
* broken or abnormal skin on your scalp
Repository Study of Autosomal Dominant Polycystic Kidney Disease

The design and establishment of the Polycystic Kidney Disease (PKD) Data Repository does not require, and may be constrained by, a narrowly conceived hypothesis. However, the PKD Repository has been designed to include demographic, clinical, biochemical, and genetic data that will further explore the natural history of the disorder and assess the factors that are likely to be associated with the progression of disease and the incidence of complications including renal failure, cardiovascular disease, and stroke.

The goal of this project is to collect data from a large population of patients with PKD. Based upon the estimated prevalence of PKD (1:500 and 1:1000 live births), it is estimated that there may be 10,000 PKD patients in the New York City area. This sample size far exceeds any database established thus far. As many as 40% of affected PKD patients are reportedly unaware of a family history of this disease, in part because many patients may go undiagnosed until they present with a medical complication (e.g., hypertension, kidney failure). Furthermore, this initiative will provide an opportunity to compare data from racially diverse populations.

Eligibility Criteria:
Inclusion Criteria:

* Males and females
* Age 18 years and older
* Previously diagnosed with ADPKD

Exclusion Criteria:

* Inability to provide informed consent
Randomized Evaluation of the 24-Hour Coverage: Efficacy of Rotigotine

The objective of this trial is to assess the effects of transdermal rotigotine on the control of early morning motor function and sleep disorders compared to placebo in subjects with idiopathic Parkinsons´s disease. In addition, effects of rotigotine on specific nocturnal and non-motor symptoms of Parkinson´s disease will be evaluated.

The objective of this trial is to assess the effects of rotigotine on the control of early morning motor function and sleep disorders compared to placebo in subjects with idiopathic Parkinsons´s disease. In addition, effects of rotigotine on specific nocturnal and non-motor symptoms of Parkinson´s disease will be evaluated.

After a Screening Period of up to 28 days subjects will be hospitalized for two nights. After the second overnight stay, subjects will be randomly assigned either to rotigotine patch or placebo patch. Afterwards patients will be titrated to their optimal dose. After subjects have reached their optimal dose (or the highest dose) they will be maintained on this dose for a certain period. At the end of maintenance the subjects will be hospitalized for two nights. Afterwards the doses will be continuously decreased.

Efficacy will be assessed by application of sleep quality scores, motor examination scores, and scores to evaluate non-motor symptoms of Parkinsons. Safety assessments include adverse events, 12-lead electrocardiograms, blood pressure and heart rate assessments, and laboratory checks.

Eligibility Criteria:
Inclusion Criteria:

* Early and advanced Idiopathic Parkinson Disease with early morning motor impairment

Exclusion Criteria:

* Atypical Parkinsonian syndromes
Evaluation of the Safety, Tolerability, and Efficacy of MDGN-002 in Adults With Moderate to Severe Active Crohn's Disease or Ulcerative Colitis

This is a Phase 1b, open-label, dose-escalation, signal-finding, multi-center study. The study will evaluate the safety, tolerability, pharmacokinetics and short-term efficacy of MDGN-002 in adults with moderate to severe, active Crohn's disease or Ulcerative Colitis who have previously failed anti-tumor necrosis factor alpha (anti-TNFα) treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Subject is male or female, ≥ 18 to ≤ 75 years of age.
2. Subject has a documented diagnosis of CD via endoscopy/colonoscopy and histological confirmation, or subject has received a diagnosis of UC for 90 days or greater prior to Visit 1, confirmed by endoscopy during the Screening Period, with exclusion of current infection, dysplasia and/or malignancy.
3. Subject has moderate to severe, active CD as evidenced Simple Endoscopy Score for Crohn's Disease (SES-CD) score of ≥7, and histological confirmation, or subject has moderately to severely active UC, as defined by a Modified Mayo Score (excluding the PGA component) of 5 to 9 points at Visit 1.
4. Subject has failed treatment with an approved therapeutic dose of an anti-TNFα monoclonal antibody treatment.

Exclusion Criteria:

1. Subject has a diagnosis of ulcerative colitis (UC) or indeterminate colitis or subject has a diagnosis of Crohn's disease or indeterminate colitis .
2. Subject with signs or symptoms of bowel obstruction.
3. Subject has short bowel syndrome.
4. Subject has a current functional colostomy or ileostomy.
5. Subject has had a surgical bowel resection within the past 6 months prior to screening or is planning any resection during the study period.
6. Subject is pregnant or a nursing mother.
7. Subject is sexually active and not using effective contraception as defined in the protocol.
Sub Omohyoid Suprascapular Nerve Block Versus Interscalene Nerve Block

Shoulder surgery can be very painful surgery after which the use of opioids is often required. The well-known side-effects of opioids (e.g. respiratory depression, somnolence, nausea, vomiting, and pruritus) limit their use in so called 'fast track' surgery and anaesthesia programmes.

the study aimed to compare the effect of sub omohyoid suprascapular nerve block versus interscalene nerve block in preventing postoperative pain and decreasing analgesic consumption in patients scheduled for shoulder surgery


Eligibility Criteria:
Inclusion Criteria:

1. Aged 18-60 years.
2. ASA I-II.
3. Both sexes.
4. Shoulder surgery.

Exclusion Criteria:

1. Patient refusal
2. Allergy to local anesthetics
3. BMI \>40 kg/m2
4. Bleeding diathesis or history of anticoagulant use.
5. Psychiatric diseases.
6. Infection of the skin at the site of needle punctures area.
Study to Evaluate Diphenhydramine in Children and Adolescents

To characterize the pharmacokinetics of diphenhydramine in two pediatric populations: children, ages 2 to \< 12 years, and adolescents, ages 12 to \< 18 years.

This study has an open-label, single-dose classical pharmacokinetic design with no comparator treatment or group. Twenty-four (24) children, ages 2 to \< 12 years, and 12 adolescents, ages 12 to \< 18 years, with symptoms due to hay fever or other upper respiratory allergies will complete the study. To ensure that younger children are represented, at least 35% (8) of the children enrolled will range from 2 to \< 6 years of age.

Eligibility Criteria:
Inclusion Criteria:

* Male and female children and adolescents, ages 2 to \< 18 years, with a minimum weight of 24 pounds will be eligible to participate. In addition, each subject will be \> 5th percentile and \< 95th percentile for weight based on age and gender.
* Subjects will have a body mass index (BMI) \> 5th percentile and less than or equal to 90th percentile for age and gender.
* Subjects who have a history of allergic rhinitis and who are experiencing symptoms due to hay fever or other upper respiratory allergies will be included.
* Subjects who do not use concurrent medications, except for low-dose inhaled glucocorticosteroids for allergic rhinitis or mild concurrent asthma, if dose is stabilized before entry in the study (ie, dose is not changed for 1 month prior to entry or during the study), and inhaled short-acting beta-2 adrenergic agonists for concomitant asthma, as needed;

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurologic disease.
* Findings from the medical history or physical examination with vital sign measurements that are not within the range of clinical acceptability.
* Have a known sensitivity or allergy to diphenhydramine or EMLA cream.
* Have a known sensitivity or allergy to red dye.
* Have asthma symptoms at the time of study entry or requiring medications other than allowed in Inclusion Criterion 4;
* Took any prescription (other than allowed in Inclusion Criterion 4) or nonprescription medication, within seven days or five half-lives (whichever is longer) before the study's start date.
* Took any herbal supplements or drank grapefruit juice with 28 days of the study's start date.
* Participated in, or completed, another clinical trial within seven weeks before the study's start date.
* Have a history of drug, alcohol, and tobacco use (older children and adolescents)
* Have a history of hepatitis B, a previous positive test for hepatitis B surface antigen, or a previous positive hepatitis C antibody.
* Have a history of HIV infection or previous demonstration of HIV antibodies.
* Pregnant or nursing females; females of childbearing potential who are unwilling or unable to use an acceptable method of contraception from at least three months prior to the first dose of study medication until completion of follow-up procedures.