cyrilzakka/clinical-trials huggingface dataset:
Scar-Improvement Efficacy and Safety of a Single Intradermal Injection of Avotermin (Juvista) Administered Following Full-Thickness Skin Incisions

This study was undertaken to investigate the scar-improvement efficacy and safety of a single dose of avotermin (Juvista) injection into skin incisions.


Eligibility Criteria:
Inclusion Criteria:

* Males and females aged 18-85 years who had given written informed consent.
* Subjects with a body mass index within 15 to 35 kg/m2.
* Subjects with clinically acceptable results for the laboratory tests
* Female subjects of child bearing potential who are using acceptable method(s) of contraception.

Exclusion Criteria:

* Subjects with history or evidence of hypertrophic or keloid scarring.
* Subjects with tattoos or previous scars within 3cm of the area to be incised.
* Subjects with prior surgery in the area to be incised within one year of the first dosing day.
* Subjects with a history of a bleeding disorder; receiving anti-coagulant or anti-platelet therapy.
* Subjects with evidence of any past or present clinically significant disease that may affect the endpoints of the trial.
* Subjects with a clinically significant skin disorder that is chronic or currently active.
* Subjects with any clinically significant medical condition or history that would impair wound healing.
* Subjects with a history of drug hypersensitivity to any of the drugs or dressings used in this trial.
* Subjects who are taking, or have taken any investigational product or participated in a clinical trial in the three months prior to first trial dose administration.
* Subjects who are taking regular, continuous, oral corticosteroid therapy.
* Subjects undergoing investigations or changes in management for an existing medical condition.
* Subjects with a history of drug abuse, or with a positive drugs of abuse test for cocaine, amphetamines, metamphetamines, opiates or benzodiazepines during the screening period.
* Subjects who are considered unlikely to complete the trial for whatever reason.
* Subjects with a clinically significant neurological impairment or disease.
* Subjects with any active infection.
* Subjects who are pregnant or lactating.
Relative Bioavailability Study of Bicalutamide 50 mg Tablet and Casodex Following a 50 mg Dose in Healthy Subjects Under Fed Conditions

The purpose of this study is to demonstrate the relative bioavailability of Bicalutamide 50 mg tablet and Casodex following a 50 mg dose in healthy subjects under fed conditions.


Eligibility Criteria:
Inclusion Criteria:

* No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

Exclusion Criteria:

* Positive test results for HIV or hepatitis B or C.
* Treatment for drug or alcohol dependence.
Reducing the Duration of Untreated Psychosis

The study examines the possible effect of a community campaign to decrease the duration of untreated psychosis in persons with their first episode of a psychotic disorder.

The study examines whether a community campaign can reduce over time the duration of untreated psychosis (DUP) among persons with first episode psychosis (FEP). The DUP of mental health patients with FEP who sought services at a public outpatient or an inpatient facility was assessed for a 15 month period prior to the campaign launch. This serves as the baseline or historical control. The DUP will continue to be assessed for another 3 years. The hypothesis being tested is that there will be a significant decrease in DUP between baseline, one-year, two-year and three-year follow-ups. This study is being carried out with Latinos in Los Angeles County because as a group, particularly among Spanish-speaking immigrants, Latinos are at high risk for prolonged DUP.

Eligibility Criteria:
Inclusion Criteria:

* Meet Diagnostic and Statistical Manual-4 criteria for a psychotic disorder
* of Latino origin

Exclusion Criteria:

* has a neurological disorder or suffers from brain trauma
Evaluation of a Human Immunodeficiency Virus (HIV) Blood Screening Assay

To test blood samples from volunteer donors of whole blood and blood components using a new investigational test that detects human immunodeficiency virus (HIV) infection. Results will be compared to the current HIV screening assay.


Eligibility Criteria:
Inclusion Criteria:

* Healthy donors that have consented to study
Effect of Educational Program on Parental Stress of Parents of Children With CHD

Congenital Heart disease accounts for about one third of the all congenital anomalies. In last decades' huge advancements occurred in treatment and diagnosis. More and more surgeries are being done which causes stress in parents and affects their mental health. Some studies have reported that about one third of the parents of children with CHD remain in stress even after surgery is being done. The goal of this trial is to evaluate effect of educational intervention on mental health of parents of children with congenital heart disease undergoing cardiac surgery compared to the parents who get usual care and pamphlets of the same information.

The investigators are including parents of children with CHD who are already diagnosed with CHD and are undergoing cardiac surgery.


Eligibility Criteria:
Inclusion Criteria:

1. Parents of children with congenital heart disease
2. Patient is scheduled for elective cardiac surgery and not had any surgery before.
3. Willing to participate in the study

Exclusion Criteria:

1. Parents of CHD who have other critical conditions along with CHD
2. Parents able to understand local languages (Urdu and Pashto)
Does Oral Baclofen Improve Care and Comfort in Spastic Children in Nursing Homes?

Baclofen is a drug that reduces the muscle stiffness. In disabled children that have very stiff muscles, the stiffness and secondary changes in the joints may cause discomfort and pain. In this study we will check if treatment with Baclofen reduces pain in disabled children with stiff muscles.


Eligibility Criteria:
Inclusion Criteria:

* Cerebral palsy nursing homes children ages 1-18 years spastic quadriplegia

Exclusion Criteria:

* active epilepsy severe truncal hypotonia
Trial of Docetaxel-Samarium in Patients With Hormone-Refractory Advanced Prostate Cancer

This is a prospective phase II trial of docetaxel-samarium in patients with hormone-refractory advanced prostate cancer who achieve a response or a stabilization to docetaxel-estramustine.


Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years and less than 80 years
* Histologically-proven adenocarcinoma of the prostate
* Evidence of bone metastases and progressive, hormone-refractory, disease
* No previous chemotherapy
* No previous radiotherapy, except radiotherapy directed to the prostate and/or to a single bony lesion
* No previous carcinoma, except basal-cell carcinoma of the skin
* Adequate renal function: measured or calculated creatinine clearance \> 60 ml/min
* Absolute granulocyte count ≥ 1,500/mm3, platelets ≥ 100,000 mm3, bilirubin ≤ 1.5 fold the upper normal value
* Signed informed consent.

Exclusion Criteria:

* Patients infected by the Human Immunodeficiency Virus (HIV)
* Patients who do not fit inclusion criteria
Comparison of the Rate of Preoperative Haemoglobin After Administration of Epoetin Alpha Associated With an Oral Medical Supplementation Versus Intravenous Before Surgery of Craniosynostosis at the Child

Oral iron is commonly used in conjunction with EPO preoperatively for hemorrhagic surgeries in children and especially in the surgery of craniosynostosis. The bioavailability of oral iron is low and compliance with treatment is inconsistent. The aim of this study is to evaluate whether the use of ferric carboxymaltose by injection, which has a much better bioavailability, would make it possible to increase the preoperative hemoglobin level more effectively and thus reduce the risk of perioperative blood transfusion .

Prospective study, randomized in two parallel groups (martial treatment versus venous injection) and stratified by center (Montpellier, Nice, Angers).

The number of subjects required is 100 patients, or 50 per group.

Eligibility Criteria:
Inclusion Criteria:

* Craniosynostosis Surgery
* Age: between 4 and 24 months inclusive
* Weight: less than 12kg
* Hemoglobin: 10 g / dl ≤ Hb 14 ≤ g / dl
* Affiliated patients or beneficiaries of a Social Security scheme
* Signature of the consent of the patient's parents

Exclusion Criteria:

* Generalized infection
* Time for consultation of anesthesia with respect to the date of surgery greater than 5 weeks or less than 22 days.
* Initial biological assessment dating more than 3 months before the consultation of anesthesia
* Parents do not understand French
* BMI greater than 20 kg.m-2
* Contraindications to EPO
* Contraindications to ferric carboxymaltose and to ferrous fumarate
RESET-SSc: An Open-Label Study to Evaluate the Safety and Efficacy of CABA-201, a CD19-CAR T Cell Therapy, in Subjects With Systemic Sclerosis

RESET-SSc: A Phase 1/2 Open-Label Study to Evaluate the Safety and Efficacy of CABA-201, a CD19-CAR T cell therapy, in Subjects with Systemic Sclerosis

Systemic sclerosis (SSc), also known as scleroderma , is a rare autoimmune disorder characterized by autoantibody production and abnormal B cell function. Though the cause of SSc is not well understood, it is thought to involve B cells that cause the body to attack different tissues in one's own body, causing skin and organ fibrosis. This study is being conducted to evaluate the safety and efficacy of an investigational therapy, CABA-201, a CD19-CAR T cell therapy, that can be given to patients with SSc who have active disease. A single dose of CABA-201 in combination with cyclophosphamide (CY) and fludarabine (FLU) will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 and ≤75
* A clinical diagnosis of SSc, based on the 2013 American College of Rheumatology and European League Against Rheumatism classification criteria.
* Early active disease
* Evidence of significant skin, pulmonary, renal, or cardiac involvement

Exclusion Criteria:

* Contraindication to leukapheresis
* History of anaphylactic or severe systemic reaction to fludarabine, cyclophosphamide or any of their metabolites
* Active infection requiring medical intervention at screening visit
* Current symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, pulmonary, psychiatric, cardiac, neurological, or cerebral disease, including severe and uncontrolled infections, such as sepsis and opportunistic infections.
* Concomitant medical conditions that, in the opinion of the investigator, might place the subject at unacceptable risk for participation in this study, interfere with the assessment of the effects or safety of the investigational product or with the study procedures
* Severe lung or cardiac impairment
* Previous CAR T cell therapy
* Prior solid organ (heart, liver, kidney, lung) transplant or hematopoietic cell transplant

Other protocol-defined inclusion/exclusion criteria may apply.
Can we Improve Preoxygenation by Using Adjustable Pressure Limiting Valve (APL) ?

The aim of this study is to investigate the effects of setting airway pressure release valve (APL valve) on the anesthesia workstation to 5 cmH2O during spontaneous breathing on preoxygenation. In this prospective study healthy volunteers are randomized in cross-over between spontaneous breathing with the APL valve on spontaneous position or spontaneous breathing with the APL valve on 5 cmH2O or CPAP (continous positive airway pressure) mode with 5 cmH2O PEEP (positive end expiratory pressure).

There are several methods to improve preoxygenation but most of them require advanced anesthesia workstations. Therefore the investigators planned an an experimental study on healthy volunteers to investigate the effects of a simple method on preoxygenation.

Healthy volunteers are randomized in cross-over between spontaneous breathing with the APL valve on spontaneous position or spontaneous breathing with the APL valve on 5 cmH2O or CPAP mode with 5 cmH2O PEEP.

The volunteers will breath through an anesthesia face mask. The fresh gas flow rate is 12 L/min, inspiratory fraction of oxygen is 100%. The exhaled gas (oxygen and carbon dioxide) are monitored. The inspiratory and end expiratory fraction of oxygen will be recorded every 10 seconds.

The primary endpoint is the time to achieve end expiratory fraction of oxygen of 90% or more.The secondary endpoint is the proportion of subject with end expiratory fraction of oxygen of 90% or more after a 3 min period and the end expiratory fraction of oxygen at the third minute.

Eligibility Criteria:
Inclusion Criteria:

* healthy volunteers

Exclusion Criteria:

* any respiratory disease
Transurethral Resection of Bladder Tumor (TURBT) Combined With Adjuvant Intravenous GC Chemotherapy for Non-muscle-invasive Bladder Cancer

It is still a challenge for urologic surgeon to prevent the post transurethral resection of bladder tumor (TURBT) recurrence of moderate-high risk non-muscle invasive bladder tumor. Adjuvant chemotherapy is a standard treatment for local progressive bladder tumor, which contains mainstream GC treatment scheme. It is common to observe clinically moderate-high risk NMIBC recurrence after routine intravesical instillation.Systematic chemotherapy can eliminate remained tumor cells especially those from mucosa basal cells so as to improve the prognosis of patients. Our clinical trial aims to investigate whether the utilization of combination of GC treatment scheme and epirubicin instillation would decrease the recurrence of moderate-high risk NMIBC.

Prevention of the post-transurethral resection of bladder tumor (TURBT) recurrence of moderate-high risk non-muscle invasive bladder cancer(NMIBC) is still a difficult problem. NMIBC was classified as low, moderate and high risk patients. Moderate-high risk NMIBC contained those are multiple, recurrent, II-III grade, tumor diameter \>3cm, invasive to submucosa and associated with carcinoma in situ. For those patients, no matter which treatment was conducted, for example, exchanging instillation drugs, increasing medicine dose, appending adjuvant drugs and prolonging instillation time, would not improve the prognosis of these patients. Adjuvant chemotherapy is a standard treatment for local progressive bladder tumor, which contains mainstream GC treatment scheme. For muscle invasive bladder cancer patients, radical cystectomy with neoadjuvant chemotherapy will improve patients' tumor grade and increase overall survival and disease specific survival rate.Systematic chemotherapy can eliminate remained tumor cells especially those from mucosa basal cells so as to improve the prognosis of patients. Our clinical trial aims to investigate whether the utilization of combination of GC treatment scheme and epirubicin instillation would decrease the recurrence of moderate-high risk NMIBC. In addition, we also would like to investigate the improvement of life quality after TURBT of moderate-high risk NMIBC.

Eligibility Criteria:
Inclusion Criteria:

1. moderate-high risk non-muscle invasive bladder cancer patients: Multiple,recurrent, II-III grade, tumor diameter\>3cm, invasive to submucosa, associated with carcinoma in situ.
2. Normal liver and renal function.

Exclusion Criteria:

1. Liver and renal function deficiency (GFR\<60ml/min\*kg, ALT、AST\>1.5\*normal), lung function deficiency, heart failure, acute myocardial infarction, severe infection and trauma, major surgery and clinical hypotension and anaerobic conditions.
2. Attending other drug experiments.
3. Performance status, Zubrod-ECOG-WHO, ZPS≥2.
4. Pregnant.
5. Bone marrow transplantation, severe leukopenia, associated with severe infection or injury.
Single Session Pain Psychology Treatment: Comparative Efficacy & Mechanisms

This study aims to compare the efficacy of a single session psychological treatment, "Empowered Relief" (ER), with the current standard of care, group Cognitive Behavioral Therapy (CBT) specifically on individuals with chronic low back pain who have pain-specific distress as indexed by pain catastrophizing scores.

This is a randomized 3-arm study comprised of 2 active psychological treatments (ER \& CBT) and a health education (HE) arm that controls for time and attention. Study goals are to provide scientific evidence to demonstrate the efficacy of ER, and also provide a comparison of said efficacy against the current gold standard group treatment for PC -- manualized 8-session pain-CBT.

Eligibility Criteria:
Inclusion Criteria:

* Axial low back pain without radicular symptoms
* Pain duration ≥ 6 months (per recent NIH Task Force on Research Standards for Chronic Low Back Pain based on participant self-report
* Average pain intensity ≥4/10 for the past month at screening visit
* English fluency
* Males and females 18-70 years of age
* Pain Catastrophizing Score (PCS) ≥20

Exclusion Criteria:

* Gross cognitive impairment
* Active suicidal ideation or severe depression
* Previous attendance in the active treatment groups (any ER classes ever taken or CBT in the past 3 years)
* Participating in any interventional research study or completed participation in the last 2 months; enrollment in an observational study is acceptable
* Current substance abuse
* Clear likelihood to disrupt fellow class participants (e.g., personality disorder) at the discretion of the study team
Olmesartan Medoxomil in Diabetes Mellitus

This is a study in diabetic patients with at least one additional cardiovascular risk factor and normoalbuminuria prior to randomization.


Eligibility Criteria:
Inclusion Criteria:

* Diabetes mellitus type 2, defined as fasting blood glucose of greater than or equal to 126 mg/dL;
* Presence of at least one of the following cardiovascular risk factors:

  1. total cholesterol greater than 200 mg/dL or statin treatment,
  2. High density lipoprotein (HDL) less than 40 mg/dL,
  3. triglycerides greater than 150 mg/dL and less than 400 mg/dL,
  4. blood pressure greater than or equal to 130/80 mmHg,
  5. Body mass index (BMI) greater than 28 kg/m2,
  6. waist circumference greater than 102 cm for men and greater than 88 cm for women,
  7. smoking of more than 5 cigarettes a day;
* Normoalbuminuria at screening

Exclusion Criteria:

* Severe uncontrolled hyperlipidemia;
* Documented renal and/or renal-vascular disease;
* Myocardial infarction, stroke or myocardial revascularization within the last 6 months;
* History of alcohol and/or drug abuse;
* Allergic reaction, lack of response or contraindication to angiotensin receptor blockers (ARBs);
* Current treatment with an ARB or angiotensin converting enzyme (ACE) inhibitor
Adductor Canal Nerve Block Following Total Knee Arthroplasty

The purpose of this study is that an adductor canal nerve block (putting numbing medicine near the nerve) has been shown to produce excellent pain relief with less pain medication use after knee replacement surgery.The investigators will be comparing the amount of pain relief following knee replacement surgery when you have a nerve block in place. There will be approximately 66 subjects participating in this study. After surgery subjects will receive numbing medication every 6 hours for 48 hours. Subjects will also receive a morphine PCA (patient controlled analgesia) after surgery and pain medication by mouth every 4 hours around the clock with the option to receive more pain medication if needed. Subjects will participate in the study up to 3 days.


Eligibility Criteria:
Inclusion Criteria:

1. Is the subject undergoing primary unilateral total knee arthroplasty?
2. Is the subject 18 to 99 years of age?
3. Is the subject ASA class 1, 2, or 3?
4. Does the subject have a BMI less than 35?
5. Can the subject consent in the English language?

Exclusion Criteria:

1. Does subject have an allergy to drugs used in this study;
2. Does subject have a daily intake of opiate medications that are considered stronger than hydrocodone?
3. Does subject have a history of alcohol or drug abuse
4. Has subject had a previous total knee arthroplasty?
5. Has subject had any neurologic deficits in the lower extremity being studied?
Prevention of Stimulant-Induced Euphoria With an Opioid Receptor Antagonist

The purpose of this study is to a) assess the efficacy of naltrexone in preventing stimulant-induced euphoria in adults with ADHD, b) assess whether naltrexone will interfere with the clinical efficacy of stimulants in treating adults with ADHD, c) assess whether naltrexone will interfere with the effects of stimulants on neurotransmitter activity. We predict that naltrexone will successfully prevent stimulant-induced euphoria without interfering with the ability of stimulants to effectively treat ADHD in adults. This study will be an 8 -week trial with young adults (18-24) with ADHD.


Eligibility Criteria:
Inclusion

1. Male and female outpatients
2. age 18-30
3. diagnosis of ADHD by DSM-IV, per clinical evaluation and confirmed by structured interview
4. likeability response (\> 5) on Question #2 of the DRQ-S after an initial test dose of 60 mg of IR MPH.
5. Baseline ADHD severity of \> 20 on the Adult ADHD Investigator System Report Scale (AISRS)
6. Able to participate in blood draws and to swallow pills.
7. Subjects must be considered reliable reporters, must understand the nature of the study and must sign an informed consent document

Exclusion

1. Any current (last month), non-ADHD Axis I psychiatric conditions
2. Ham-D \> 16, BDI \> 19, or Ham-A \> 21
3. Any clinically significant chronic medical condition
4. any cardiovascular disease or hypertension
5. Clinically significant abnormal baseline laboratory values
6. I.Q. \< 80)
7. Organic brain disorders
8. Seizures or tics
9. Pregnant or nursing females
10. Clinically unstable psychiatric conditions (i.e. suicidal behaviors, psychosis)
11. Current or recent (within the past year) substance abuse/dependence
12. patients on other psychotropics
13. Current or prior adequate treatment with MPH
14. known hypersensitivity to methylphenidate
15. Current opioid use (by history and urine screen) or potential need for opioid analgesics during the study
16. acute hepatitis or liver failure (baseline blood tests).
Drug Use-Results Survey in Participants Infected With Hepatitis C Virus Genotype 2

The main objective of this study is to evaluate the safety and effectiveness of paritaprevir/ritonavir/ombitasvir with ribavirin used for participants infected with chronic hepatitis C virus (HCV) genotype 2 in daily practice in Japan.


Eligibility Criteria:
Inclusion Criteria:

* HCV genotype 2 participants treated with paritaprevir/ritonavir/ombitasvir plus ribavirin in daily practice.

Exclusion Criteria:

* Participants who have been previously treated with paritaprevir/ritonavir/ombitasvir and ribavirin.
Stimulation of the Efferent Loop Before Loop Ileostomy Closure

The purpose of the study is to determine the impact of the efferent loop stimulation of a loop ileostomy prior to closure on postoperative complications such as ileus and hospital stay

Stimulation was performed 3 weeks prior to the ileostomy closure using 500 cc of a thickening substance (saline and nutritional thickener) through the efferent limb.

Eligibility Criteria:
Inclusion Criteria:

* Patients with loop ileostomy
* Barium transit throught the efferent limb without leaks

Exclusion Criteria:

* Chemotherapy at the moment
* Ileostomy closure at the same admission than the ileostomy creation