cyrilzakka/clinical-trials huggingface dataset:
Phase 1 Safety, Tolerability and PK Study of Ondansetron and Hylenex Recombinant in Healthy Volunteers

This is a randomized, open-label Phase 1 pharmacokinetic, tolerability, and safety study of ondansetron and Hylenex given subcutaneously compared to ondansetron given intravenously, intramuscularly, and orally in normal healthy volunteers.

This is a randomized, open label, 4 way crossover Phase 1 study of the pharmacokinetics, safety and tolerability of a 4 mg dose of ondansetron administered subcutaneously with Hylenex recombinant compared to 4 mg doses of ondansetron administered intravenously and intramuscularly and an 8 mg dose of ondansetron administered orally.

Eligibility Criteria:
Inclusion Criteria:

* Male or female volunteers 19-65 years old
* Females must be nonlactating and nonpregnant (negative serum pregnancy test at screening)and agree to practice effective birth control for at least 30 days after study completion
* Nonsmoker or no tobacco/nicotine use in previous 6 months
* Intact normal skin without obscuring tattoos, pigmentation or lesions
* Adequate venous access in upper extremities
* Normal vital signs, ECG, and labs or assessed by the Investigator as NCS
* Serum hemoglobin within site's normal range
* Negative drug and alcohol screen
* Able to make decisions and comply with study requirements

Exclusion Criteria:

* History of drug or alcohol abuse or positive drug and alcohol screen
* Abdominal surgery within the last 30 days
* Phenylketonuria
* Tobacco or nicotine use within previous 6 months
* Hypersensitivity or contraindication to ondansetron or other 5-HT3 receptor agonists
* Received ondansetron within 4 days prior to Day 1
* Known allergy to hyaluronidase or other ingredient in Hylenex recombinant
* Lower extremity edema
* Creatinine clearance \< 60 mL/min
* Dehydration (Grade 2 or higher)
* Hypersensitivity or contraindication to heparin
* Abnormal ECG with clinically significant QT prolongation or history of
* Female who is pregnant or breastfeeding
* Participation in a clinical trial (drug or device) within 30 days of enrollment
* Clinically significant medical history, major systemic disease, intercurrent illness, physical examination finding, or clinical laboratory test result that risks the subject's safety or interfere with interpretation of study results
* Not able to comply with study requirements
Morbidity, Long-term Side Effects and Quality of Life in Germ-cell Tumor Long Survivors Treated with High-dose Chemotherapy and Autologous Stem Cell Transplant

Intensified chemotherapy is an effective treatment in 30-70% of patients with refractory germ cell tumor. Since most cases are diagnosed before the age of 40, survivors can expect to live another 30 to 50 years after being successfully treated. Long-term side effects and physical and emotional consequences can therefore have a significant impact on daily life. To date, no data of this type is available in France. This study will help clinicians better understand the long-term consequences for relapsed patients receiving high-dose chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years at diagnosis
* Treated between 1990 and 2015
* Histologically confirmed diagnosis of germ cell tumor (or high level serum tumor marker-based) and:

Treated for relapse with high-dose of chemotherapy (HDCT) with autologous transplant at Gustave Roussy and relapse-free.

Or Treated by orchiectomy only and no evidence of relapse after a minimum of 3 years.

Or Good or intermediate prognosis metastatic disease according to the IGCCCG, treated by first line cisplatin-based chemotherapy at Gustave Roussy (and surgery of residual masses if needed), with no evidence of relapse.

* Ability to comply with the protocol procedures
* Patient affiliated to a social security system or beneficiary of the same. 6-Who have signed a written informed consent form prior to any study specific procedure.

Exclusion Criteria:

* Diagnosis of second malignancy
* Any other serious or unstable illness, or medical, social, or psychological condition, that could jeopardize the safety of the subject and/or his compliance with study procedures, or may interfere with the subject's participation in the study or evaluation of the study results.
* Patient under guardianship or deprived of his/her liberty by a judicial or administrative decision, or incapable of giving his/her consent.
A Pharmacokinetic Drug Interaction and Tolerance Study of Paracetamol and Nefopam

Pain remains the leading cause of consultation. Despite a wide therapeutic arsenal, a significant percentage of patients disclaim little or no pain relief with common analgesics, specific or not their type of pain. This is especially true in cases of chronic pain, and current treatments are associated with many side effects. A need for therapeutic innovation is needed. Paracetamol is currently the most widely used analgesic worldwide but despite its excellent safety, its analgesic effect is limited from moderate to severe pain. Many analgesic drug combinations include paracetamol, recently the co-administration of paracetamol and nefopam showed a supra-additive antinociceptive effect (Van Elstraete AC et al. 2013). The development of a formulation associating paracetamol and nefopam first requires searching a possible pharmacokinetic interaction between the two active substances and assessing safety of this combination in healthy volunteers. No published studies providing such information.

This is a randomised, cross-over, open label trial assessing drug interaction between paracetamol and nefopam in healthy volunteers.

Eligibility Criteria:
Inclusion Criteria:

* Age over 18
* ALT, AST, PAL, normal GGT, creatinine \<133μmol / L, hematocrit\>38%
* Informed consent to the trial
* Healthy volunteers affiliated to the French Social Security
Safety and Efficacy Study to Evaluate Proellex in the Treatment of Premenopausal Women With Symptomatic Endometriosis

The purpose of this study is to determine whether Proellex is safe and effective for the treatment of symptomatic endometriosis.


Eligibility Criteria:
Inclusion Criteria:

* Premenopausal women aged 18-48 inclusive
* Endometriosis documented by laparoscopic or surgical assessment within the past ten (10) years
* Clinical symptoms of endometriosis for at least the past three (3) months
* Endometriosis symptoms
* Must be sexually active unless sexually inactive for endometriosis-related dyspareunia
* Must have a regular or steady menstrual cycle lasting from 24 to 36 days and a detectable ovulation during the baseline period using an ovulation monitoring kit (for timing of endometrial biopsy)
* Other inclusion criteria may apply

Exclusion Criteria:

* Six (6) months or more without a menstrual period, or
* Prior hysterectomy or
* Prior bilateral oophorectomy
* Diagnosis of osteopenia
* Present history or condition that causes non-endometriosis-related dyspareunia
* Presence of excessive bleeding or menorrhagia
* Abnormal screening endometrial biopsy
* Other exclusion criteria may apply
Analysis of Change of Optic Nerve Sheath Diameter in Robot Assisted Laparoscopic Radical Prostatectomy

In the present study, The investigators evaluated whether anesthetic agents effects on Optic Nerve Sheath Diameter in patients undergoing Robot Assisted Laparoscopic Radical Prostatectomy


Eligibility Criteria:
Inclusion Criteria:

1. Patients undergoing robotic laparoscopic radical prostatectomy
2. Adults 20 to 80 years of age
3. American Society of Anesthesiologists Physical grade 1-2

Exclusion Criteria:

1. Patients who did not agree to participate in the study
2. Patients with ophthalmic diseases
3. Patients with previous history of ophthalmic surgery
4. Patients with neurological disorders
5. Patients with history of head surgery due to neurological disorders
The Effect of High PCO2 Solution on Esophageal Acid Sensation

To determine the effect of intraesophageal high PCO2 solution as compared to acidic and saline solutions on subjects' heartburn sensation using stiumlus-response functions.

Presently, the exact mechanism of GERD and the role of CO2 in pathogenesis of heartburn symptoms is unclear. CO2 conversion to protons may play a key role in the mechanism for heartburn sensation. This is a prospective, randomized study that will help further explore the mechanism for heartburn sensation in GERD patients and can be a prelude for further studies examining the role of new class antireflux agents such as carbonic anhydrase inhibitors in the treatment of patients with heartburn.

Eligibility Criteria:
Inclusion Criteria:

10 Healthy Controls

* Normal EGD, Normal 24-hr pH
* 18-80 Years of age
* Able to read, understand and complete study questionnaires and diary
* Able to understand study procedures and sign informed consent
* Albe to comply with all study requirements

  10 NERD (Non-Erosive Reflux Disease)
* 18-80 Years of age
* Willing to stop PPI/H2 Blocker prior to EGD
* Have heartburn symptoms 2+ times per week for at least 3 months.

Exclusion Criteria:

* Esophageal erosions, Barretts, or peptic stricture on EGD
* Previous esophageal, gastric or duodenal surgery
* underlying co-morbidities
* Diabetes mellitus (requires insulin), scleroderms, or neuromuscular disorder
* Upper airway symptoms
* Tricyclic antidepressants, antispasmodics, selective serotonin receptor inhibitors, thiazides, bile acid-binding agents or prokinetics
* Patients who cannot or are unwilling to sign ICF
Micafungin Versus AmBisome in Invasive Candidiasis and Candidemia

The purpose of this study is to determine the efficacy and safety of micafungin (FK463) versus liposomal amphotericin B (AmBisome) in treating neutropenic and non-neutropenic patients with confirmed invasive candidiasis or candidemia. Enrollment will include adult and pediatric patients.

A phase III, multicenter, double-blind, comparative, parallel, randomized study. Enrollment will include adult and pediatric patients. The adult population is sized to test for non-inferiority. For the pediatric population, descriptive analyses are planned.

Eligibility Criteria:
Inclusion Criteria:

Patients either non-neutropenic with absolute neutrophil counts \>= 500 cells/mm3 or neutropenic with absolute neutrophil counts \< 500 cells/mm3 must have:

* Candidemia or invasive candidiasis,
* Confirmation and typical clinical signs and symptoms by fungal culture and/or histology,
* Positive culture obtained no more than four days prior to the first dose of study medication.

Exclusion Criteria:

* Patient is pregnant or nursing
* Patients with evidence of liver disease as defined by: a) SGOT/AST or SGPT/ALT \> 10 times the upper limit of normal (ULN); or b) Total bilirubin \> 5 times ULN.
* Patients whose sole diagnosis is oropharyngeal and/or esophageal candidiasis and/or with positive cultures of urine specimens, sputum specimens, bronchoalveolar-lavage specimens or samples from indwelling drains.
* Patients who have received prophylactic/empiric therapy with azoles or conventional amphotericin B for more than three days within one week prior to enrollment. Neutropenic patients, however, may have received prophylactic azoles without time restrictions.
Chemoradiotherapy Plus Immunotherapy Followed by Surgery for Esophageal Cancer

Neoadjuvant chemoradiotherapy is recommended as standard therapy for resectable esophageal cancer. The recurrence rate after surgery following neoadjuvant chemoradiotherapy is about 35%. Whether achieving pathological complete response after neoadjuvant chemoradiotherapy is significantly associated with recurrence after surgery. It is reported that immunotherapy combined with chemotherapy improved survival compared with chemotherapy alone in first line therapy of advanced esophageal cancer. We hypothesize that the addition of immunotherapy to neoadjuvant chemoradiotherapy is helpful to improving pathologic complete response and survival.


Eligibility Criteria:
Main Inclusion Criteria:

* Pathologically diagnosed as esophageal squamous cell carcinoma
* Initially diagnosed as thoracic esophageal cancer
* resectable or potantially resectable
* II-IVA according to AJCC 8th edition；
* KPS≥70
* Adequate organ function
Study of the Safety of MRI Scans in People Who Have Breast Tissue Expanders After Mastectomy

The purpose of this study is to find out whether it is safe to perform MRI scans in people who have breast tissue expanders in place.


Eligibility Criteria:
Patients with breast tissue expanders that require an MRI for clinical purposes are eligible for this study. Patients must provide an implant card or surgical report indicated the exact make and model of their implanted tissue expander. Breast tissue expanders marked as "MRI unsafe" will be allowed with exceptions as described in the Participant exclusion criteria. While all types of MRI will be included in this study, including breast MRI, we anticipate that most of the MRI examinations ordered will evaluate the brain or spine for detecting or following metastasis.

Inclusion Criteria:

* Patient ≥ 18 years old on day of signing informed consent
* Has a breast tissue expander implanted \> 28 days ago
* Patients must provide an implant card or surgical report indicated the exact make and model of their implanted tissue expander

Exclusion Criteria:

* Patients with AeroForm Tissue Expanders (manufactured by AirXpanders)
* Anyone who would normally be excluded from undergoing an MRI examination as per the Memorial Hospital for Cancer and Allied Diseases screening policy in the MRI Safety Policy (https://one.mskcc.org/sites/pub/ehs/Policies/ECSE-2009.pdf), aside from having a breast tissue expander
* Patients who are reportedly pregnant, who have a positive urine or serum pregnancy test at the time of imaging, or for which pregnancy cannot be ruled out.
* Patients who are unable to tolerate, comply or complete the MRI exam due to claustrophobia, anxiety, known psychiatric or substance abuse disorder, age, frailty, or medical instability.
Assessment of Severity and Outcome of Addicted Cases.

* Addiction to drugs and alcohol is increasingly becoming a worldwide trend that is prevalent in both rich and poor countries . Substance abuse shows a significant warming to the health, social and economic build of families, communities and nations. Extent of worldwide psychoactive substance use is estimated at 2 billion alcohol users and 185 million drug users .
* Substance abuse (including alcohol and drugs) is an important risk factor for poor health globally due to their intoxicating effects or their toxic effects on organs and tissues that lead to the development of diseases, injuries and other health conditions
* Drug abuse is associated with the increased risk of cardiovascular diseases. A study on the need for hospitalization in approximately 4800 drug users found that 223 of these were admitted to hospital due to cardiovascular diseases .
* The majority of abused substances or their metabolites are excreted through the kidneys and renal complications of drug abuse are very common .The involvement of the kidney due to drug abuse is either attributed to their elimination through the kidney, or a direct nephrotoxic effect. The damage may be acute and reversible, or chronic and can leads to end stage renal failure .
* Addiction is responsible for different types of liver diseases including fatty liver, hepatitis and liver failure. . Intravenous drug addiction by sharing of contaminated needle is very important risk factor for the development of liver diseases, particularly hepatitis B and hepatitis C. Globally, 90% of new hepatitis C infections are attributed to drug injection . In the long run, substance abuse has negative effects on sexual functions and leads to the onset of sexual disorders. .
* Long term use of alcohol was reported to inhibit of hypothalamic-pituitary-adrenal axis and reduces the release of gonadotropins from the pituitary . Morphine administration suppresses LH release and reduces the levels of testosterone, which affects testicular function.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are addicted for at least one year.

Exclusion Criteria:

* Patients who are addicted for less than one year.
* Patients with history of previous renal impairment
* Patients with history of hepatitis B, C or HIV infection
* Patients with history of autoimmune disease.
* Patients with history of heart disease.
A Safety And Efficacy Study Of Alg-1001 In Human Subjects With Symptomatic Focal Vitreomacular Adhesion

Evaluate the safety and efficacy of ophthalmic intravitreal injection of ALG-1001 in human subjects with symptomatic focal vitreomacular adhesion


Eligibility Criteria:
Inclusion Criteria:

1. Symptomatic focal vitreomacular adhesion
2. Vitreomacular traction syndrome
3. Stage 1 and 2 macular holes, ≤ 350 µm
4. BCVA of 20/25 Early Treatment Diabetic Retinopathy Study (ETDRS) or worse in the study eye
5. BCVA of 20/800 ETDRS or better in the fellow eye
6. Male or female subjects, 18 years of age or older
7. Signed Informed Consent

Exclusion Criteria:

1. High myopes \> -8.0 D spherical equivalent
2. History of prior vitrectomy in the study eye
3. History of photocoagulation to the retina in the study eye
4. Macular hole in the study eye \> 350 µm
5. Subjects with epiretinal membranes in the study eye
6. Subjects with broad VMA, defined as VMA of \>1500 µm
7. Subjects with proliferative Diabetic Retinopathy (DR), neovascular Age-related Macular Degeneration (AMD), or retinal vascular occlusion in the study eye
8. Subjects with aphakia in the study eye
9. Subjects with uncontrolled glaucoma
10. Subjects with lenticular or zonular instability
11. Subjects with prior ocular surgery or intravitreal injection in the study eye within 90 days of study enrollment
12. Pregnant or nursing women
Aggressive Squamous Cell Carcinoma in Organ Transplant Recipients

To identify risk factors for aggressiveness in Squamous Cell Carcinoma of the skin in organ transplant recipients.

Squamous Cell Carcinomas (SCC) are one of the most common skin cancers. They belong to the epithelial neoplasm of the skin, which manifest a local aggressive growth and have potential for metastasis. Organ transplant recipients have a hundredfold higher incidence of SCC.

Unfortunately the primary tumor, regional nodes, metastasis (TNM)-Classification for the prognosis of SCC in this group of patient has not yet been established. Therefore there are no standardised criteria for evaluation of local recurrence or prognosis.

The aim of this study is to identify criteria, which permit a risk assessment relating to aggressiveness of SCC.

Eligibility Criteria:
Inclusion Criteria:

Organ transplant recipients with:

* \> 9 SCC in total or
* \> 2 SCC per year (in any one year) or
* any single "index" SCC that has a very poorly differentiated cell morphology or that behaved aggressively in Terms of local recurrence or local/systemic metastasis

Exclusion Criteria:

* Non organ transplant recipients
Intradialytic Pedalling Exercise and Vascular Hemodynamic Parameters Among Prevalent Hemodialysis Population

The purpose of this pilot study is to evaluate 1) the effect of intradialytic pedaling exercise on arterial stiffness and other arterial hemodynamic parameters over 4 months, and 2) the longer-term effect of pedaling on arterial stiffness and other arterial hemodynamic parameters 4 months after finishing the exercise intervention (8 months after study initiation).

The investigators also aim to examine the impact of intradialytic pedaling exercise on general health, anthropometric measures, physical function, and routine laboratory blood markers as secondary outcome measures, as well as to assess feasibility, safety and adverse events associated with the intradialytic pedalling exercise.

Recruitment of more participants in the future will be considered if warranted.


Eligibility Criteria:
Inclusion Criteria:

* Adults with end-stage renal disease (stage 5 CKD), who were on a stable in-center hemodialysis regimen (approximately 4 hours 3 times per week) for ≥ 12 weeks prior to recruitment
* A cardiac evaluation was required within the last year to ensure adequate cardiac function

Exclusion Criteria:

* Any physical or psychological disability that would impact study participation, such as severe cerebrovascular disease (e.g., hemiparesis, cerebellar ataxia, etc.) or dementia
* Serum intact parathyroid hormone(iPTH)\>250 pmol/L within 30 days prior to screening visit
* Dysrhythmia or severe cardiac disease, such as congestive heart failure (CHF) Class III-IV, or unstable cardiovascular disease within 90 days prior to recruitment
* Severe peripheral arterial disease
* Severe hyperkalemia (\>6.5 milliequivalent/L) consistently the last 2 weeks
* Current active cancer (excluding basal cell carcinoma of the skin)
* Poorly controlled hypertension (post-dialytic systolic blood pressure ≥ 160mmHg or diastolic blood pressure≥ 100 mmHg) within 4 weeks prior to recruitment
* Anticipated living donor kidney transplant or any other planned major surgery over the study duration
* History of poor treatment adherence
Study of Subcutaneous Immune Globulin in Patients Requiring IgG Replacement Therapy (EU Extension Study)

This study is a continuation of the study ZLB06_001CR with the objective of assessing efficacy, tolerability, safety of IgPro, as well as long-term health-related quality of life in patients with PID.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with primary humoral immunodeficiency, namely with a diagnosis of Common variable immunodeficiency (CVID) as defined by the Pan-American Group for Immunodeficiency (PAGID) and the European Society for Immunodeficiencies (ESID), or X-linked agammaglobulinemia (XLA) as defined by PAGID and ESID, or autosomal recessive agammaglobulinemia who have participated in the study ZLB06_001CR and who have tolerated IgPro well
* Written informed consent

Exclusion Criteria:

* Hypoalbuminemia, protein-losing enteropathies, and any proteinuria (defined as total urine protein concentration \> 0.2g/L)
* Other significant medical conditions that could increase the risk to the subject
* Females who are pregnant, breast feeding or planning a pregnancy during the course of the study
* Participation in a study with an investigational medicinal product within three months prior to enrollment, except for ZLB06_001CR
* Evidence of uncooperative attitude
* Any condition that is likely to interfere with evaluation of the IMP or satisfactory conduct of the study
* Subjects who are employees at the investigational site, relatives or spouse of the investigator