cyrilzakka/clinical-trials huggingface dataset:
Correlation OF Hemodynamics in Pulmonary Hypertension With Perfusion Lung Scans

The goal of our study is to correlate data from non-invasive tests such as perfusion lung scans with hemodynamic measurements from right heart catherizations.

Data collected from PAH patients who have had non-invasive Ventilation/Perfusion testing, Echocardiography, Chest CT Scan, Pulmonary Function Testing and the correlation of those results to the hemodynamic parameters Right Heart Catherization results and the various biomarkers.

Eligibility Criteria:
Inclusion Criteria:

* Pulmonary Arterial Hypertension

Exclusion Criteria:

* Non-Pulmonary Arterial Hypertension
Escitalopram Treatment of Patients With Agitated Dementia

The purpose of this study is to determine the safety and efficacy of escitalopram (Lexapro) using 10 or 20 mg daily in patients with Alzheimer's disease who are also experiencing agitation.

This study is designed for men and women over 60 who have an established diagnosis of mild to severe Alzheimer's disease and who also present behaviors of agitation such as restlessness, physical aggression, yelling and socially inappropriate interactions. While nonpharmacologic interventions are preferable, many times they are not effective alone. Each consented subject will be enrolled in a 12 week study with escitalopram, 10 or 20 mg per day. Each subject will be evaluated using rating scales designed for symptoms of Alzheimer's and agitated behavior. Each subject will also undergo physical and neurological examinations, laboratory tests and monitoring of side effects of escitalopram.

Eligibility Criteria:
Inclusion Criteria:

* Dementia of Alzheimer's type with behavioral disturbance
* Mild to severe cognitive impairment
* Age over 60
* Medically stable
* Agitation present both at screening and baseline
* Agitation not responsive to simple nonpharmacologic interventions and lasting at least 2 weeks prior to enrollment.
* Available Health Care Proxy or other legal representative to give informed consent, and patient assent.
* No planned change in environment for duration of study
* At least one reliable caregiver

Exclusion Criteria:

* Any intercurrent medical problem that could explain the agitation
* History of major depression or bipolar preceding the onset of dementia
* Other major psychiatric illness preceding the onset of dementia or mental retardation
* Other dementias
* History of alcohol abuse or dependence in the last 2 years
* Delirium (or history of delirium in the last 8 weeks)
* Treatment with other psychotropic drugs except those permitted in the protocol. Patients already treated for agitation with psychotropic medication must be able to successfully discontinue it and tolerate a washout period of no less than 1 week.
* Treatment with non-psychotropic, centrally active drugs believed to contribute to patient's agitation.
* Severe psychiatric symptoms requiring psychiatric hospitalization or suicidal, homicidal potential.
* History of intolerance to citalopram
* Noncompliance with oral medication or inability to take oral medication
* Modified Hachinski score of 4 or greater
A Study of the Efficacy and Safety of MK2578 for the Treatment of Anemia in Patients With Kidney Disease (MK2578-003-AM03-EXT12)

This study will evaluate the efficacy and safety of intravenous MK2578, given as maintenance treatment for renal anemia in chronic kidney disease patients on dialysis who were previously receiving erythropoietin stimulating agents.

This study consists of a 12-week base study (MK2578-003-AM03) and an optional 40-week extension study (MK2578-003-EXT12). Participants who complete 12 weeks of treatment in the base study will enter the extension on the most recent dose administered in the base study or a newly adjusted dose, if adjustment is required to bring Hg levels within range. Participants' doses of MK2578 will be adjusted upward or downward during the extension study to maintain Hb in the range of 10-12 g/dL.

Eligibility Criteria:
Inclusion Criteria:

Base Study:

* Patient is male or is a female who either cannot have children or who agrees to use appropriate contraceptive measures
* Patient has been on hemodialysis for at least 6 months when informed consent is signed
* Patient has received intravenous epoetin alfa or epoetin beta for a least 6 months when the informed consent is signed

Extension Study:

* Patient completed the base study through Week 12
* Patient tolerated MK2578 and demonstrated compliance with study procedures

Exclusion Criteria:

* Patient has a life expectancy of less than 6 months
* Patient is scheduled for a kidney transplant within the next 6 months
* Patient has had a blood transfusion within 12 weeks of screening
* Patient has had major surgery within 12 weeks of screening or plans to have surgery
* Patient has Human Immunodeficiency Virus (HIV)
* Patient has history of blood dyscrasia, hematologic disorders or any other disease known to cause anemia
* Patient has severe congestive heart failure (CHF)
* Patient has a history of malignant cancer, except certain skin or cervical cancers
* Patient has a history of grand mal seizures within the last 6 months
TSN2898-201 Safety and Efficacy of TSN2898 in the Treatment of Acne Vulgaris

The purpose of this study is to determine the safety and effectiveness of TSN 2898 topical gel in the treatment of moderate to severe acne.

TSN2898 is an inhibitor of stearoyl-CoA desaturase-1 (SCD-1), an enzyme present in sebaceous glands and a key regulatory enzyme in lipogenesis. This study will assess the safety and efficacy of TSN2898 topical gel and matched gel vehicle, applied daily on the face for the treatment of moderate to severe acne vulgaris.

Eligibility Criteria:
Inclusion Criteria:

* Healthy males or females, 16 to 55 years of age
* Must be diagnosed as having moderate or severe acne vulgaris
* ≥ 20 inflammatory lesions on the face
* ≥ 20 non-inflammatory lesions on the face
* ≤ 3 nodule/cyst acne lesions
* Medically healthy
* Females must be of non-childbearing potential

Exclusion Criteria:

* Systemic therapy with retinoids within six (6) months prior to study start
* Topical use of prescription retinoids within four (4) weeks prior to study start
* Oral antibiotics within four (4) weeks prior to study start
* Topical dapsone, sulfacetamide, benzoyl peroxide, α-hydroxy/glycolic acid and retinol/retinaldehyde-containing products, and topical antibiotics, anti-inflammatory medications and corticosteroids on the face within two (2) weeks prior to study start
* Facial procedures, including lasers, peels, and dermabrasion, within two (2) months prior to study start
IL-1RA, Acute Exercise, and Beta-cell Function

Subjects (N=48) with poorly-controlled type 2 diabetes (HbA1c\>7%) will be assigned to one of the 4 following interventions in a randomised, parallel group design: \[I\] Control (placebo injection; no exercise), \[II\] Anakinra (100 mg subcutaneous injection of human recombinant interleukin-1 receptor antagonist), \[III\] Exercise (1 h cycle ergometry at 75% VO2max), \[IV\] Anakinra + Exercise. Pancreatic beta-cell function (plasma insulin responses) will be measured before and after each intervention using a hyperglycemic clamp (5.4 mM above basal glucose) combined with GLP-1 infusion (0.5 pmol/kg/min) and arginine injection (5 g bolus).


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes with HbA1c \>7%

Exclusion Criteria:

* HbA1c \>7%
* Age \<30 or \>80 y
* BMI \<25 or \>40 kg/m2
* Pregnancy
* Evidence of chronic haematological/renal/hepatic/pulmonary/heart disease
* \>2kg weight change in prior 6 months
* Alcohol consumption (men: \>14 drinks/week; women: \>7 drinks/week)
* Smoking
* Physical activity of \>150 min/week
* Contraindication to exercise
* Contraindication to use of anakinra
Tandem High-dose Chemotherapy and Autologous Stem Cell Rescue in Patients With High-risk Neuroblastoma

The purpose of this study is to evaluate the efficacy and toxicity of tandem HDCT/ASCR in children with high-risk neuroblastoma. In the present study, a single arm trial of tandem HDCT/ASCR will be carried out. In the present study, the investigators will investigate whether tandem HDCT/ASCR might improve the survival of patients with high-risk neuroblastoma with acceptable toxicity.

The prognosis of high-risk neuroblastoma after conventional chemoradiotherapy is generally poor. Therefore, a strategy using high-dose chemotherapy and autologous stem cell rescue (HDCT/ASCR) has been explored to improve the prognosis of patients with high-risk neuroblastoma. This strategy is based on the hypothesis that dose escalation might improve the survival of children with high-risk neuroblastoma. The results of randomized trials comparing HDCT/ASCR with chemotherapy alone showed a better event-free survival (EFS) in the HDCT/ASCR arm than in the continuous chemotherapy arm. However, the overall EFS was unsatisfactory.

In this context, investigators have examined the efficacy of double or triple tandem HDCT/ASCR to further improve the outcome of high-risk neuroblastoma patients. George et al. carried out a single arm trial of tandem transplantation as consolidation therapy, and reported improved long-term survival (5-year progression-free survival 47%) with acceptable toxicity. Kletzel et al. also conducted a single arm trial of triple tandem transplantation and reported improved survival (3-year EFS 57%). They demonstrated that further dose escalation using sequential HDCT/ASCR might result in further improvements in the survival of patients with high-risk neuroblastoma.

Investigators in the present study also carried out tandem transplantation as consolidation therapy, and reported improved long-term survival (5-year progression-free survival 62%) with acceptable toxicity. However, throughout our previous study, multiple modifications were made in the treatment plan, which resulted in significant variability over time between patients. This variability may create doubt as to whether tandem HDCT/ASCR itself resulted in the improved outcome. In addition, toxic death rate was relatively high (15.4%), although final survival rate was very high (best survival rate ever reported). Therefore, prospective study is needed to evaluate the efficacy and toxicity of tandem HDCT/ASCR.

Eligibility Criteria:
Inclusion Criteria:

* Patients with high-risk neuroblastoma
* Patients with intermediate-risk neuroblastoma if gross tumor remained after surgery

Exclusion Criteria:

* Patients with progressive disease before high-dose chemotherapy
* Patients whose parents want to stop or change the planned treatment
* Patients with organ toxicities of NCI grade \>2 before high-dose chemotherapy
MorbiMortality Amelioration in Preeclamptic Primiparas Study. MoMA Pre Prim Study

The purpose of this study is to determine whether close monitoring of patients with a high sFlt1 plasma level between 25 and 28 weeks of gestation (i.e. at high risk of subsequent preeclampsia) improves maternal and fetal outcomes. The investigator hypothesize that 1/ early screening for preeclampsia by plasmatic sFlt1 will reduce maternal and fetal mortality and morbidity and 2/ a simple urinary PlGF screening will be effective.

We will measure plasmatic sFlt-1 level between 25 and 28 weeks of gestation and flow velocity of uterine arteries by Doppler (22 - 26 weeks of gestation) in primipara. Patients will be stratified according to the results of the uterine artery Doppler measurement, and then randomized in two groups A and B. In group A, sFlt-1 concentration will be communicated to the obstetrician (+ or -): the threshold of abnormally high plasmatic concentration of sFlt-1 is 957 ng/mL. In patients with a high plasmatic concentration of sFlt-1 (+), the pregnancy will be closely monitored including repeated clinical, biological, and ultrasound examinations. Patients with sFlt-1 plasmatic concentration below 957 ng/mL (-) will be routinely followed-up.In group B, the result of sFlt-1 measurement will not be communicated and the pregnancy will be routinely monitored.Abnormal Doppler recordings in either group will result in a close monitoring as per our usual local practice. Urinary PlGF (expressed as a ratio PlGF/creatininemia) will also be measured and the results will be analyzed at the end of the study. Beside sFlt-1, we will store the plasmatic samples to measure other biomarkers that could be relevant in the future (no DNA analysis will be done without a new patient consent).

Eligibility Criteria:
Inclusion Criteria:

* Pregnant womenAge ≥ 18 years
* Followed in our center before the 28th week of gestation
* Under social security coverage
* Signed informed consent

Exclusion Criteria:

* Age \< 18 years
* Followed in our center after the 28th week of gestation
* No social security coverage
* Refusal to be included
Evaluation of Soft Tissue Response to Titanium Healing Abutments Treated by Erbium: YAG Laser or Plasma Spray

The attachment of peri implant soft tissue to the implant serves as a biological seal that can prevent the development of inflammatory peri-implant diseases. Presence of contaminants has been suggested to be associated with tissue damaging inflammation and titanium wear microparticles were demonstrated to activate osteoclastic action. Er: YAG laser has been extensively investigated clinically for applications for treating periimplantitis either independently or in combination with other techniques, showing favorable outcomes. Plasma spray treatment can decontaminate surfaces without modifying their topography. It is also able to increase the surface energy by obtaining more hydrophilic surfaces, which may increase the capacity of the titanium oxide layer to interact with cells and proteins of surrounding tissue improving cell adhesion to the treated surface.

This study was conducted on 24 patients seeking implant placement. A total number of 33 healing abutments were included in this study, they were divided into 3 groups. Group 1 (Laser group): 8 patients in this group received 11 healing abutments treated with Er:YAG laser, group 2 (Plasma group): 8 patients in this group received 11 healing abutments treated with plasma sprayand group 3 (control group): 8 patients in this group received 11 healing abutments with no surface treatment.Three months after implants placement, patients included in the study were randomly assigned to one of the three study groups, second stage surgery was performed and patients received healing abutments without surface treatment in control group, surface treatment was performed in plasma and laser groups. After two weeks, clinical assessment was done using PI and GI before taking biopsies from peri-implant soft tissue for histological assessment. H\&E stain was used for measuring inflammatory cells count and Masson's Trichrome stains for measuring collagen fibers area fraction. Analysis of the abutments surface was done using SEM.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients with age range from 20 to 45 years old.
* Patients need placement of fixed implant-supported prosthesis in maxillary arch.
* Patients who are medically free from any systemic diseases as evidenced by the health questionnaire, using modified Cornell medical index (Pendleton et al., 2004).
* patients with good oral hygiene (Plaque Index and bleeding on probing less than or equal to grade 1).
* Absence of any local conditions affecting bone-implant osseointegration (e.g., infection and poor bone density).
* The presence of sufficient bone width and height that permit the placement of implant with minimum diameter 3.5 mm and 8.5 mm length.

Exclusion Criteria:

* Presence of acute infections.
* Smokers.
* Pregnancy and lactation.
* Patients with a history of bisphosphonates therapy.
Impact of Intermittent Hypoxia on Neutrophil Extracellular Traps

This prospective observational study will enroll 60 moderate-to-severe OSA patients (AHI≧15/hour, 30 obese \[BMI\>=27\] \& 30 non-obese \[BMI\<27\]) and 40 age-, gender-, BMI-matched controls without OSA. Venous blood 10 ml will be collected to isolate neutrophils, which are later tested for their ability to produce neutrophil extracellular traps (NETs) under the effect of PMA (phorbol 12-myristate 13-acetate). The test will be repeated if OSA patients receive CPAP therapy (continous positive airway pressure therapy).

Obstructive sleep apnea (OSA) is a common disease, affecting around one billion people worldwide. This disorder is characterized by repetitive upper airway collapse during sleep, thereby leading to intermittent hypoxia (IH). The severity of OSA is gauged by AHI(apnea-hypopnea index), which can be determined by a sleep test, polysomnography. Literature revealed OSA confers a higher risk for incident pneumonia and sepsis-related adverse outcomes, suggestive of defective immunity in those patients. CPAP therapy (continous positive airway pressure therapy) is the mainstay treatment for OSA. This research is aimed to investigate the impact of IH on the ability of neutrophils to produce neutrophil extracellular traps (NETs). We will enroll 60 moderate-to-severe OSA patients (AHI≧15/hour, 30 obese \[BMI\>=27\] \& 30 non-obese \[BMI\<27\]) and 40 age-, gender-, BMI-matched controls without OSA. Venous blood 10 ml will be collected to isolate neutrophils, which are later tested for their ability to produce NETs under the effect of PMA (phorbol 12-myristate 13-acetate).

Eligibility Criteria:
Inclusion Criteria

* Adults with clinical diagnosis of moderate or severe OSA (AHI \>=15/hour)
* Must be willing to participate in this study and sign permit

Exclusion Criteria

* Not willing to participate in this study
* Ever treated with continous positive airway pressure (CPAP) or other therapy for OSA
* Age \< 20 years
* Have comorbid disease or condition, which could impact immunity (such as malignancy, chemotherapy, immune disease, diabetes etc)
Prolutex in Frozen Embryo Transfer Cycles At the Blastocyst Stage (PROGEX)

The objective of this proof of concept clinical trial is to evaluate the impact of two different progesterone treatments for endometrial preparation (25 mg/twice-a-day, subcutaneous injection, and 200 mg/three times a day, vaginal administration) on the clinical pregnancy rate in women undergoing frozen embryo transfer (FET) at blastocyst stage.


Eligibility Criteria:
Inclusion Criteria:

* Women attending the clinics to undergo a frozen blastocyst embryo transfer, having given written informed consent, with the following characteristics:
* 18-49 years of age for subjects undergoing ET with donated oocytes (both inclusive);
* 18-37 years of age for subjects undergoing ET with autologous oocytes (both inclusive);
* BMI \<32 kg/m2;
* Adequate endometrium preparation (Endometrial thickness \> 7 mm) and E2 levels ( \>100 pg/ml) on the day progesterone treatment is started;
* P4 levels \<1.5 ng/ml on the day progesterone treatment is started;
* Transfer of 1 or 2 frozen embryos at blastocyst stage
* Transfer of frozen embryos of quality A and/or B according to Gardner criteria1;
* Semen from ejaculation either from the partner or from a bank
* ≤ 3 previous ET (frozen and fresh) with no pregnancy
* Normal uterine cavity (i.e. no polyp or protruding sub-mucosal fibroid).

Exclusion Criteria:

* Presence of functional follicles \> 10 mm of diameter on the day progesterone treatment is started;
* Intramural uterine fibroids that distort the uterine cavity or polyps \>1 cm;
* Stage III or IV endometriosis (endometriomas);
* Hydrosalpinx;
* Pregnancy or lactation
* Malformations of the sexual organs incompatible with pregnancy;
* Patients affected by pathologies associated with any contraindication of being pregnant;
* Known allergy to progesterone preparations or their excipients;
* Uncontrolled adrenal or thyroid dysfunction;
* Undiagnosed vaginal haemorrhage;
* History of, or current arterial disease;
* Patients with hepatic impairment;
* HIV, Hepatitis B Virus or Hepatitis C Virus seropositive;
* Neoplasias (current) or history of neoplasia that may be responsive to progesterone;
* High grade cervical dysplasia;
* Active thrombophlebitis or thromboembolic disorders, or a history of hormone-associated thrombophlebitis or thromboembolic disorders;
* Currently dependent on alcohol, drugs or psychotropic drugs
* History of recurrent pregnancy loss defined as 3 or more spontaneous miscarriages wherein pregnancy developed to a minimum of a gestational sac on transvaginal ultrasonography;
* Participation in a concurrent clinical trial or another trial within the past 2 months;
* Use of concomitant medications that might interfere with the study evaluation: hormonal treatments other than those used in the study, except thyroid hormones.
Single Incision Laparoscopic Surgery (SILS) Versus Conventional Laparoscopic Hysterectomy

Multi-center prospective randomized trial of single port laparoscopic surgery (SILS) versus conventional 3-4 ports laparoscopic hysterectomy. Hypothesis is that conversion rate of SILS is not inferior to that of conventional approach.


Eligibility Criteria:
Inclusion Criteria:

* Symptomatic (dysmenorrhea, palpable mass, pelvic pain or discomfort urinary symptom, increasing size, menorrhagia) myomas or adenomyomas
* Uterine size \< gestational age of 14 weeks
* Informed consent

Exclusion Criteria:

* Medical diseases such as heart failure, renal insufficiency, liver cirrhosis, pancreatitis, uncontrolled DM
* Huge uterine size \> gestational age of 14 weeks
Trial of a Vaccination With Tumor Antigen-loaded Dendritic Cell-derived Exosomes

Lung cancer is the worldwide leading cause of cancer death. In France, with 28,000 new cases per year, lung cancer is the 4th in terms of incidence but remains the leading cause of cancer death. The 5-year survival of lung cancer, all stages and all types, is very low, estimated at 12% among men and 16% among women in France. In advanced unresectable non small cell lung cancer, standard treatment relies on platinum-based induction chemotherapy. The median progression-free survival (PFS) in patients responding or stabilized after 4 chemotherapy cycles ranges from 2 to 2.8 months. Gustave Roussy and Curie institutes have developed an immunotherapy involving metronomic cyclophosphamide (mCTX) followed by vaccinations with tumor antigen-loaded dendritic cell-derived exosomes (Dex). mCTX inhibits Treg functions restoring T and NK cell effector functions and Dex are able to activate the innate and adaptive immunity. Phase I trials showed the safety and feasibility of Dex vaccines but no induction of T cells could be monitored in patients. Since 2007, we validated a new process for isolation of second generation Dex with improved immune stimulatory capacities. We propose a maintenance immunotherapy in 47 advanced unresectable NSCLC patients responding or stabilized after induction chemotherapy with Dex-based treatment to improve PFS rate at 4 months in these patients.


Eligibility Criteria:
Inclusion Criteria:

* advanced unresectable non small cell lung cancer
* responding or stabilizer after induction chemotherapy
A Study of an Investigational Study Drug for Benign Prostatic Hyperplasia (0906-140)

The purpose of this trial is to determine the efficacy and safety of an investigational drug in patients with benign prostatic hyperplasia.


Eligibility Criteria:
Inclusion Criteria:

* Patients with benign prostatic hyperplasia

Exclusion Criteria:

* Patients who are suspected to be suffering from prostatic cancer