cyrilzakka/clinical-trials huggingface dataset:
Can Acupuncture Benefit Surgical Patients With Haemorrhagic Stroke?

The purpose is to establish whether acupuncture in addition to conventional rehabilitation programme can improve the functional outcome and quality of life of surgical patients with haemorrhagic stroke, as compared to conventional rehabilitation programme alone.

The investigators aim to recruit 60 patients over a 30 month period. Each patient will have six week of acupuncture treatment (either early within the first six week, or delayed after the first six week of observation and assessment of primary outcome).

Primary outcome measures:

Clinical outcome at the end of week 6 acupuncture treatment: Glasgow Outcome Score extended.

Secondary outcome measures:

Modified Rankin Score, Functional Independence Measure (FIM) score, Modified Aschoff Score, Neurocognitive State Examination (NCSE) score, Barthel index, Modified Rivermead Mobility Index (MRMI), Modified Functional Ambulation Category (MFAC) and motor scores of upper limb and lower limb with Fugl-Meyer Scale at the end of week six acupuncture treatment.

Eligibility Criteria:
Patient inclusion Criteria:

1. Patients after acute hemorrhagic stroke;
2. Within the first month after acute presentation;
3. Premorbid mobility level: Independent Indoor or Outdoor Walker;
4. Co-operative and willing to comply with the rehabilitation program;

Patient exclusion Criteria:

1. Cardiac Pacemaker;
2. Patient who is apprehensive to acupuncture;
3. Clotting abnormality;
4. Poor local skin conditions.
Clinical Trial Comparing Two Protocols Using Intravenous (IV) Hydromorphone

The purpose of this study is to compare two opioid protocols ("H2O" and "1+1") for the treatment of acute severe pain in the emergency department. The investigators primary hypothesis is that the "H2O" protocol will be more efficacious than the "1+1" protocol in Emergency Department patients aged 21-64 years. The primary outcome is the proportion of patients in each arm who choose to forgo additional pain medication at 60 minutes.


Eligibility Criteria:
Inclusion Criteria:

1. Age greater than 21 years and less than 65 years: This is a study of non-elderly adult patients. In addition, patients aged 21 years and younger are automatically triaged to the Children's Emergency Department (ED).
2. Pain with onset within 7 days: Pain within seven days is the definition of acute pain that has been used in ED literature.
3. ED attending physician's judgment that patient's pain warrants intravenous (IV) opioids

Exclusion Criteria:

1. Use of other opioids or tramadol within past 24 hours: to avoid introducing assembly bias related to recent opioid use, since this may affect baseline levels of pain and need for analgesics.
2. Prior adverse reaction to opioids.
3. Chronic pain syndrome: frequently recurrent or daily pain for at least 3 months results in modulation of pain perception which is thought to be due to down-regulation of pain receptors. Examples of chronic pain syndromes include sickle cell anemia, osteoarthritis, fibromyalgia, and peripheral neuropathies.
4. Alcohol intoxication: the presence of alcohol intoxication as judged by the treating physician may alter pain perception.
5. Systolic Blood Pressure \<90 mm Hg: Opioids can produce peripheral vasodilation that may result in orthostatic hypotension.
6. Oxygen saturation \< 95% on room air: For this study, oxygen saturation must be 95% or above on room air in order to be enrolled.
7. Use of monoamine oxidase (MAO) inhibitors in past 30 days: MAO inhibitors have been reported to intensify the effects of at least one opioid drug causing anxiety, confusion and significant respiratory depression or coma.
8. CO2 measurement greater than 46: In accordance with standard protocol, three subsets of patients will have their CO2 measured using a handheld capnometer prior to enrollment in the study. If the CO2 measurement is greater than 46 then the patient will be excluded from the study. The 3 subsets are as follows:

   * All patients who have a history of chronic obstructive pulmonary disease (COPD)
   * All patients who report a history of asthma together with greater than a 20 pack-year smoking history
   * All patients reporting less than a 20 pack-year smoking history who are having an asthma exacerbation
Cold Plasma Therapy for Acceleration of Wound Healing in Diabetic Foot

Diabetic foot is a common complication of diabetes mellitus and requires specialized treatment. Wounds are characterized by persistent infection and chronic inflammatory processes, impeding well directed matrix remodelling and wound closure. Cold plasma applications have demonstrated beneficial effects on wound healing in several case reports. The investigator-initiated "Kaltplasma Wund (KPW)-Trial" was performed to prove beneficial effects of cold plasma in wound healing in a prospective, placebo-controlled, randomized bi-center study.

Diabetic foot (DF) is a major complication in patients with diabetes leading to increased risk of hospitalization, lower limb amputation, and death, as well as a significant decrease in quality of life. During lifetime the risk for developing DF is assumed to be 25%; with 30% of DF resulting in lower limb amputation. If compared to general population people with diabetes have a 20-fold higher risk for amputation. Diabetes mellitus is the leading cause of lower limb amputation. Ulceration and impaired wound healing are commonly associated with common co-morbidities; the increased risk of infection amongst patients with diabetes is driving chronification and accounts for lack of wound healing.

Non-thermal atmospheric pressure plasma has been proposed as a tool for various biological and medical applications relying on its capacity to reduce bacterial load in the wound and to initiate wound healing. Biological plasma effects are largely dependent on plasma-generated reactive species in the gas phase, which subsequently diffuse or react with proteins and lipids in cells or tissues.

Thus, the objective of this placebo-controlled patient-blinded study was to show that application of cold plasma in addition to standard care treatment compared to placebo could accelerate wound healing in terms of more rapid and clinical meaningful wound surface regression. Wound closure progression and microbiological analysis were monitored time dependently to prove the effects. Patient's well-being and subjective perceptions were evaluated during treatment.

Eligibility Criteria:
Inclusion Criteria:

* Type 1 or Type 2 Diabetes mellitus
* HbA1c ≤ 10%
* at least one chronic wound persisting for at least three weeks without healing tendency following standard care wound therapy (Armstrong Wagner Grade Ib or IIb)

Exclusion Criteria:

* concomitant wound treatment with local vacuum therapy or maggot therapy
* dialysis
* use of topical active antibiotics,
* concomitant treatment with platelet rich fibrin,
* presence of critical limb ischemia defined as ankle brachial index below 0.5 or transcutaneous oxygen pressure below 15 mmHg.
* participation in another clinical trial
* women of child bearing potential without effective contraception or active breastfeeding
Immersive Virtual Reality for Stroke Motor Rehabilitation

The present study aims at investigating (i) the feasibility in chronic stroke of using a dedicated virtual reality (VR) based system that embeds real-time 3D motion capture and embodied visual feedback to deliver functional exercises designed for training of impaired upper limb motor skills, (ii) whether chronic stroke survivors improve in functional outcomes in the upper limb when exposed to intensive VR-based therapy, and (iii) safety and tolerance to such a technology. The investigators hypothesize that intensive VR-based rehabilitation may lead to high rehabilitation doses and functional improvement in chronic stroke.


Eligibility Criteria:
Inclusion Criteria:

* Ischemic or hemorrhagic minor-to-moderate (0\<NIHSS\<16) stroke with hemiparesis and experiencing arm motor difficulties
* At least 6 months after stroke incident
* Maximum 4 on the Medical Research Council Scale (MRCS) for shoulder elevation and elbow flexion/extension
* 18 years and older
* First ever stroke

Exclusion Criteria:

* Participating in another movement treatment study at the time of the present study
* Severe cognitive impairment (Mini Mental Status Examination score \< 18 points)
* Orthopedic impairment or visual disorders limiting the treatment
* Unable to give informed consent form
* Risk of epileptic seizures
Real-time Targeted Fluorescence Endoscopy for Detection of the Primary Cancer Lesion in Patients With a Metastasis of Unknown Primary Tumor in the Head and Neck

In current diagnostic work-up of patients with a cancer of unknown primary (CUP), approximately 50% of the primary tumor lesions remains undetected. Identification of the primary tumor site results in minimizing the potential morbidity from treatment by reducing morbidity by omitting the need for a mucosectomy of the bilateral base of tongue and tonsils, reducing the radiation field and better oncologic outcome than those with unidentified primary tumor. Clearly, new endoscopic 'real-time' imaging techniques are needed to visualize mucosal changes associated with head and neck squamous cell carcinoma and increase detection rate of the primary tumor. Targeted fluorescence endoscopy enables the visualization of targeted tumor-specific biomarkers by using fluorescence, thereby enhancing the contrast between normal mucosa and tumor tissue. This could improve the detection of the primary tumor in cases where the primary tumor is not detected with white light endoscopy.


Eligibility Criteria:
Inclusion Criteria:

* Cytology and/or histology-confirmed diagnosis of squamous cell carcinoma most likely originating from the head \& neck area and scheduled to undergo endoscopy of the upper aerodigestive tract as decided by the multidisciplinary head and neck tumor board of the UMCG;
* The primary tumor was not identified during standard diagnostic work-up in the outpatient clinic including physical head and neck examination, fiberoptic laryngoscopy, chest X-ray, CT and PET/CT;
* Age ≥ 18 years;
* Written informed consent;

Exclusion Criteria:

* Medical or psychiatric conditions that compromise the patient's ability to give informed consent;
* Concurrent uncontrolled medical conditions;
* Received an investigational drug within 30 days prior to the dose of cetuximab-800CW;
* History of myocardial infarction, cerebrovascular accident, uncontrolled cardiac heart failure, significant liver disease (ALT \>3X upper limits of normal or increased total bilirubin) or unstable angina within 6 months prior to enrollment;
* Inadequately controlled hypertension with or without current antihypertensive medications;
* History of allergy or infusion reactions cetuximab or other monoclonal antibody therapies;
* Pregnant or lactating women. Documentation of a negative pregnancy test must be available for women of childbearing potential. Moreover, the need to be willing to ensure that she or her partner uses effective contraception during the trial and for 6 months thereafter. Woman of childbearing potential are premenopausal women with intact reproductive organs and women less than two years after menopause;
* Evidence of QT prolongation on pretreatment ECG (greater than 440 ms in males or greater than 450 ms in females)
* Patients receiving Class IA (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents.
* Life expectancy \< 12 weeks;
* Karnofsky performance status \< 70%.
Dose Optimization for Safe and Efficient Fluorescein Angiography (DOSE Study)

This study aims to compare the efficacy and safety of fluorescein angiography using 1mL versus 3mL of 10% fluorescein dye.

The investigators will recruit patients who need fluorescein angiography for their retinal diseases.

The investigators will collect data on image quality and complications.

Eligibility Criteria:
Inclusion Criteria:

* Patients who required an fluorescein angiography for their retinal diseases (eg. diabetic retinopathy, retinal vein occlusion, etc.)

Exclusion Criteria:

* media opacity (corneal opacity, vitreous hemorrhage grade 2 or more, cataract LOCS III grade 3 or more)
* known history of adverse reactions to fluorescein
* dilated pupil diameter less than 5 mm
Ph 1 Study of ADI PEG 20 in Pediatric Subjects Who Are Argininosuccinate Synthetase (ASS) Deficient

This is a phase 1 study of pegylated arginine deiminase (ADI-PEG 20) in pediatric patients who deficient in the expression of tumor argininosuccinate synthetase, and have failed prior treatments. The study hypothesis is that this drug will be safe in pediatric patients.

This phase 1 study will use a classic 3 dose levels by 3 patients per dose level design. Once the maximum tolerated dose is reached, additional patients may be enrolled at that dose level.

Eligibility Criteria:
Inclusion Criteria:

1. Prior diagnosis of failed current standard treatment(s), or AEs associated with prior systemic agent(s) that resulted in discontinuance of that agent(s).
2. Argininosuccinate synthetase deficient tumor.
3. Measurable disease as assessed by \>5% blasts on bone marrow aspirate for patients with leukemia or using RECIST 1.1 criteria for solid tumors.
4. Age 4 to ≤ 18 years.
5. No prior systemic treatment for the tumor in the last 2 weeks for solid tumors and 1 week for leukemia, except hydroxyurea used only to control very high WBC.
6. Fully recovered from any prior surgery and no major surgery within 4 weeks of initiating treatment. Surgery for placement of vascular access devices is acceptable.
7. Female subjects of 10 years and older and male subjects must be asked to use appropriate contraception for both the male and female for the duration of the study.
8. No concurrent investigational studies are allowed.
9. For solid tumor subjects only: Absolute neutrophil count (ANC) \>750/µL.
10. For solid tumor subjects only: Platelets \>50,000/µL.
11. For solid tumor subjects only: Serum uric acid ≤ 8 mg/dL (with or without medication control).
12. Serum creatinine ≤ 1.5 x the upper limit of normal range, or, if serum creatinine \>1.5 x the upper limit of normal range, then the creatinine clearance must be ≥ 60 mL/min.

Exclusion Criteria:

1. Serious infection requiring treatment with systemically administered antibiotics at the time of study entrance.
2. Pregnancy or lactation.
3. Expected non-compliance.
4. Uncontrolled intercurrent illness.
5. Subjects who have had any anticancer treatment prior to entering the study and have not recovered to baseline or ≤ Grade 1 AEs due to agents administered.
6. Subjects who had been treated with ADI-PEG 20 previously.
7. History of seizure disorder not related to underlying cancer.
8. Known HIV positivity.
NPDT Evaluation in Children With CFTR and (PSC)

The investigators hypothesize that PSC in children is associated with mutations and functional changes of the cystic fibrosis (CF) gene.

The purpose of this protocol is to perform Nasal Transepithelial Potential Difference (NTPD) testing to assess the function of the cystic fibrosis gene product, a chloride channel referred to as CFTR, in patients diagnosed with PSC and/or inflammatory bowel disease in childhood and currently 12 years of age and greater.

Dr. Freedman's laboratory has shown that there is an increased prevalence of CFTR abnormalities in adults with PSC as demonstrated by genotype and phenotype analysis. We hypothesize that abnormalities in CFTR based on exhaustive genotype and phenotype assessments are associated with the presence of PSC in children. We would like to enroll patients with inflammatory bowel disease and no PSC to use as a "control group".

Subjects with PSC and/or inflammatory bowel disease diagnosed in childhood, currently aged 12 years and above, will be enrolled in study protocols at Children's Hospital in Boston, which will have received their local IRB approval. The only role for BIDMC will be to perform NTPD testing on these subjects. No other assessment or testing will be performed at our site. We will not be involved in any other aspect of care for these subjects.

Eligibility Criteria:
Inclusion Criteria:

* 12 years of age and older
* Must have diagnosis of primary sclerosing cholangitis and/or inflammatory bowel disease
* Absence of other liver disease, such as viral hepatitis, drug-induced liver disease, and metabolic/hereditary liver disease
* No exclusion based on sex, race, and ethnic background
YAZ Post-marketing Surveillance in Japan

This study is a regulatory post marketing surveillance in Japan, and it is a local prospective and observational study of patients who have received YAZ for dysmenorrhea. The objective of this study is to assess safety and efficacy of using YAZ in clinical practice. A total 3,000 patients will be recruited and followed 3 years since starting YAZ administration.


Eligibility Criteria:
Inclusion Criteria:

* Patients who received YAZ for dysmenorrhea Additional criteria for QOL questionnaire
* Patient informed consent

Exclusion Criteria:

* Patients who are contraindicated based on the product label Additional criteria for QOL questionnaire
* Six months or less after treatment of estrogen or estrogen combination drug
Blood-retinal Barrier Imaging and Neuropsychiatric Sequela in Type 2 Diabetes Mellitus

In Type 2 Diabetes mellitus patients we will:

1. quantify vasculopathy and blood-retinal barrier (BRB) leakage
2. measure blood-brain barrier (BBB) permeability and neuroanatomical changes
3. correlate BRB pathology with BBB breakdown, inflammatory markers and neuropsychiatric sequela


Eligibility Criteria:
Inclusion criteria:

1. T2DM Patient suffering from Non-Proliferative Diabetic Retinopathy (NPDR), Proliferative Diabetic Retinopathy (PDR) and Diabetic Macular Edema (DME) who are in the clinical database of the ophthalmologic department , above 18 years old at the time of diagnosis and underwent FA examination in the past three years
2. Patients which their medical records are available via a computerized data base

Control group:

1. T2DM patients who are in the clinical database of the ophthalmologic department
2. Above 18 years old at the time of diagnosis
3. Underwent FA examination in the past three years and their examination was interpreted as "normal", i.e. without suspected diabetic retinopathy
Bioequivalence of Two Commercial Amoxicillin Suspensions

The aim of the present study was to compare the pharmacokinetic profiles and to evaluate the bioequivalence of two commercial amoxicillin-suspension formulations in healthy Brazilian volunteers.

Under fasting condition, 25 volunteers (13 males and 12 females) were included in this randomized, open-label, two-period crossover (1-week washout interval) bioequivalence study. Blood samples were collected at pre-dose (0h) and 0.5, 1, 1.33, 1.66, 2, 2.5, 3, 4, 6, 8 and 12 hours after drug ingestion. Pharmacokinetic parameters (Cmax, Tmax, T1/2, Area-under-curve0-12h and Area-under-curve0-inf) were calculated from plasma concentrations for both formulations in each subject.

Eligibility Criteria:
Inclusion Criteria:

* negative to HIV, hepatitis B virus, hepatitis C virus, addictive drugs and pregnancy test for women
* age between 19 and 46 years
* weight between 52 and 85 kg and body mass index between 17.6 and 28.4kg/m2
* ability to provide written consent
* laboratory exam results within the normal range for healthy individuals and/or medically acceptable defined by a clinical investigator;
* feeding habits consistent with the standardization of the study

Exclusion Criteria:

* pregnancy
* history of hypersensitivity to penicillins (normal or idiosyncratic drug reaction)
* any evidence of dysfunction or clinically significant deviation from normal
* history of any psychiatric illness that might compromise the ability to provide written consent
* history of gastrointestinal disease, hepatic, renal, pulmonary, cardiovascular, hematological, neurological or diabetes or glaucoma
* active smoker
* consumption of more than 5 cups of coffee or tea per day
* history of drug dependence or abuse of alcohol consumption
* use of enzymatic-inducers drugs within 30 days or any systemic medication (including prescription drugs, such as painkillers, hepatoprotective, influenza, etc) within 14 days before the start of the study
* participation in any clinical study in 9 weeks prior to the study
* have lost or donated more than 350 mL of blood in the last three months
* have been subjected to abnormal diet for any reason (therapeutic, aesthetic, religious, etc.)
* did not have adequate venous access.
Repeated Doses of Misoprostol for Medical Treatment of Missed Miscarriage

Missed abortion is a condition where the fetus has perished but the miscarriage is not expelled. Women often present at a routine ultrasound or with a slight brownish discharge. Traditionally this condition has been treated with curettage or vacuum aspiration. Lately, medical treatment has become more common due to less risk of infection and other complications. The routine medical treatment is 800mcg of misoprostol administered vaginally. We wish to examine of repeated doses of 400mcg misoprostol after the initial 800mcg vaginal misoprostol increases efficacy of the treatment.


Eligibility Criteria:
Inclusion Criteria:

* over 18 years of age healthy no contraindication to medical treatment visible fetal structures such as yolk sac or fetus

Exclusion Criteria:

* empty gestational sac more than sparse bleeding or dilated cervix mental instability after diagnosis contraindication to medical treatment
Anatomical Femoral Stem in Total Hip Arthroplasty

A study that detect the femoral anteversion after total hip arthroplasty using short anatomical femoral stem compared to the contrast side


Eligibility Criteria:
Inclusion Criteria:

* age 18-90
* patients who had THR as an elective surgery
* patients who had THR with short femoral anatomical stem

Exclusion Criteria:

* severe osteoporosis with Dorr C classification
* s/p bilateral hip arthroplasty
* non-complaint patients
* revision surgery
Evaluation of the Long-term Safety, Pharmacodynamics, and Exploratory Efficacy of GZ/SAR402671 in Treatment-Naïve Adult Male Patients With Fabry Disease

Primary Objective:

To assess the long-term safety of GZ/SAR402671 in adult male participants with Fabry disease who previously completed study ACT13739 (NCT02489344).

Secondary Objective:

To assess the long-term effect of GZ/SAR402671 on pharmacodynamic and exploratory efficacy endpoints in adult male participants with Fabry disease who previously completed study ACT13739.

The total duration of this extension study (LTS14116) was up to 31 months (30 months of treatment and one month post-treatment follow-up).

Eligibility Criteria:
Inclusion criteria :

* Male participant with Fabry disease who previously completed study ACT13739.
* Participants, willing and able to provide signed informed consent.
* Sexually active participants, willing to practice true abstinence in line with their preferred and usual lifestyle or using two acceptable effective methods of contraception.

Exclusion criteria :

-Participants, in the opinion of the Investigator, unable to adhere to the requirements of the study.

The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.