cyrilzakka/clinical-trials huggingface dataset:
24-hour Intraocular Pressure Control With Travoprost/Timolol Fixed Combination Versus Travoprost

This 8-week, crossover study will compare the quality of 24-hour IOP control with TTFC versus travoprost when both medications are dosed in the evening. Such a crossover comparison may determine the real efficacy of the new fixed combination versus travoprost monotherapy. The results should enhance the investigators understanding on the best dosing of TTFC and may influence its clinical use in Europe. Finally, the results would better delineate the future role of TTFC in glaucoma management after PG monotherapy, or instead of unfixed therapy with PG analogs and timolol. This study should assist the general ophthalmologist worldwide to plan optimal stepwise medical therapy.


Eligibility Criteria:
Inclusion Criteria:

* Consecutive adults with primary open-angle glaucoma (POAG) who exhibit a mean untreated IOP greater than 23 m Hg at baseline (10:00).
* Patient has POAG and is older than 29 years
* The IOP without treatment is greater than 23 mm Hg and lower than 38 mm Hg at baseline (2 readings at 10:00)
* Patient can be safely washed out without risk for significant deterioration
* Distance best corrected Snellen visual acuity better than 1/10
* Patient can understand the instructions and comply to medications
* Open normal appearing angles

Exclusion Criteria:

* Contraindications to prostaglandins or β-blockers
* History of lack of response (\<10% reduction) to any medication
* Female of childbearing potential or lactating mother
* History of trauma, inflammation, surgery, past use of steroids (within 2 months), severe dry eyes and use of contact lenses
* Sign of ocular infection, except blepharitis, corneal abnormality that may affect IOP measurements etc
An Arrhythmia Risk Predictor Trial

This prospective single-center study is an observational risk stratification trial in about 250 patients with standard indications for ICD treatment.

Implantable cardioverter defibrillators (ICD) have been shown to improve survival and current guidelines recommend their use for primary and secondary prevention of sudden cardiac death (SCD). However, a large number of patients never receive an appropriate therapy from their device. In contrast, electrical sorm and multiple ICD shocks occur in other patients.

Thus, identification of predictors for survival or ICD shocks is necessary for improved patient selection and optimized therapeutic strategies.

Risk stratification with electrocardiogram (ECG) and signal averaged ECG (SAECG), T-wave alternans (TWA) and Holter ECG including premature ventricular contractions (PVC), non-sustained VT (nsVT), heart rate variability (HRV), heart rate turbulence (HRT) and deceleration capacity, as well as clinical variables is possible, but not implemented in clinical routine in patients with ischemic or dilated cardiomyopathy and newly implanted ICD for primary or secondary prevention of SCD following current guidelines.

Patients will be prospectively followed and the predictive value of the risk markers mentioned above to predict all-cause mortality or appropriate ICD shocks will be investigated.


Eligibility Criteria:
Inclusion Criteria:

* ischemic or dilated cardiomyopathy
* sinusrhythm
* ICD indication strictly following current guidelines (primary and secondary prevention of SCD)
* Age 18 years or older

Exclusion Criteria:

* no consent
* atrial fibrillation
Study Evaluating the Efficacy and Safety of Cyclosporine Reduction in Kidney Transplant Recipients Receiving Sirolimus

To evaluate the safety and efficacy of different doses of cyclosporine given concomitantly with a fixed dose of sirolimus in kidney transplant recipients.

To evaluate the safety and efficacy of different doses of cyclosporine given concomitantly with a fixed dose of sirolimus in kidney transplant recipients. Cyclosporine blood levels, graft rejection rates and renal function will be assessed.

Eligibility Criteria:
Inclusion criteria

* At least 18 years of age
* End-stage renal disease in patients receiving a primary or secondary renal allograft from a cadaveric, living-unrelated, or living-related mismatched donor
* Patients with secondary kidney transplant must have maintained primary graft for at least 6 months

Exclusion criteria

* Antibody induction within one week of current transplantation
* Multiorgan transplants
* Patients at high-risk of rejection
Alvocidib in Patients With Previously Treated Chronic Lymphocytic Leukemia or Prolymphocytic Leukemia Arising From Chronic Lymphocytic Leukemia (CLL)

Multicenter, open-label, study of alvocidib in previously treated chronic lymphocytic leukemia patients.

Primary objective is to determine overall response rate.

The secondary objectives are:

* to assess overall safety,
* to assess duration of response, progression free survival, and overall survival.

Clinical benefit and pharmacokinetics parameters are also evaluated.

Treatment until disease progression or no evidence of treatment response; occurrence of unacceptable toxicity, intercurrent medical problem, or adverse event (AE); or a maximum of 6 cycles.

Follow-up of 6 months after the last treatment with alvocidib.

The maximum duration of the study participation for patient will be about 15 months.

Eligibility Criteria:
Inclusion Criteria:

* Patient must have documentation of histologically confirmed and measurable Chronic Lymphocytic Leukemia (CLL) or Prolymphocytic Leukemia (PLL) arising from CLL;
* Patient must have symptomatic and progressive disease;
* Patient must have received prior alkylating agent(s) and be fludarabine refractory;
* Patient must have the adequate organ functions;
* Patient's Eastern Cooperative Oncology Group performance (ECOG) status must be 0-2;

Exclusion Criteria:

* Patient with de novo PLL;
* Patient with secondary malignancy that will limit survival ≤5 years;
* Patient with prior allogenic or autologous bone marrow transplant or peripheral blood stem cell transplant ≤12 months;
* Patient receiving an investigational agent or an approved agent for an investigational purpose within last 4 weeks prior to study entry;
* Patient with known history of glucose-6-phosphate dehydrogenase deficiency;
* Patient with autoimmune hemolytic anemia;
* Patient with known Central Nervous System involvement;
* Patient with active, uncontrolled serious bacterial, viral or fungal infections

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Hepatitis C Treatment to Prevent HIV, Initiate Opioid Substitution Therapy, and Reduce Risky Behavior

This is an open label, non-randomized, observational pilot study to evaluate a model of care for treatment of hepatitis C in people with ongoing injection drug use. Participants will be treated with direct-acting antivirals (DAA) as per standard of care and will concomittantly be offered pre-exposure prophylaxis for HIV prevention and buprenorphine for treatment of opioid use disorder when clinically indicated.

Hepatitis C (HCV) is a chronic infection with significant morbidity and mortality. The development of directly acting antivirals (DAA) has dramatically improved the cure rate of HCV treatment. However, despite the availability of effective therapy, the global epidemic of HCV infection continues to be driven by people with ongoing injection drug use (PWID), who are largely excluded from HCV therapy. Several critical barriers exist preventing high-risk patients' entry to care, including (1) lack of engagement in the traditional healthcare system by marginalized patient populations, and (2) insurance restrictions due to concerns regarding treatment adherence and HCV reinfection. Furthermore, ongoing injection drug use places these individuals at high risk of HIV acquisition. However, studies have repeatedly demonstrated that pre-exposure prophylaxis (PrEP) reduces HIV acquisition and opioid substitution therapy with buprenorphine reduces HIV and HCV acquisition in PWID.

As such, we propose a comprehensive model of care to engage individuals with ongoing injection drug use in treatment of HCV, in conjunction with collocated services to prevent HIV acquisition and HCV reinfection, including pre-exposure prophylaxis and opioid substitution therapy. This pilot trial will demonstrate whether a comprehensive model of care can simultaneously treat HCV, and prevent HCV reinfection, HIV acquisition and effectively treat opioid use disorder.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years old
2. Able and willing to sign informed consent
3. Chronically infected with HCV, defined as any individual with documentation of positive HCV antibody and positive HCV RNA test (HCV RNA of 2,000 IU/mL or greater).
4. Willing to have samples stored for future use
5. Ongoing injection drug use, defined as self-report of either:

   1. Phase 1 (first 100 enrolled participants) Injection non-prescription drug use within three months of screening visit or
   2. Phase 2 (enrolled participants 101-200) Use of non-prescription opioids within twelve months of screening visit

Exclusion Criteria:

1. Decompensated liver disease (Childs Pugh B or C)
2. Unable to comply with research study visits
3. Poor venous access not allowing screening laboratory collection
4. Have any condition that the investigator considers a contraindication to study participation
5. Pregnant or breastfeeding woman
Evaluating Vertebroplasty and Kyphoplasty for Reducing Trauma-related Fractures

The primary objective of this study is to compare the volume of injected ciment (polymethyl methacrylate) between a group of patients treated with vertebroplasty and a group of patients treated via kyphoplasty. Secondary evaluation will compare the restoration of vertebral height, volume and cyphotic angle between the two techniques, as well as extravation of ciment and functional and quality of life aspects related to these techniques.


Eligibility Criteria:
Inclusion Criteria:

* The patient must have given his/her informed and signed consent
* The patient must be insured or beneficiary of a health insurance plan
* The patient is available for 3 months of follow-up
* Fracture type according to Magerl Classification (1994) must be one of the following: A1, A2.1, A3.1, A3.2
* Cyphose of \>10°
* Spinal pain
* Vertebral fracture \< 3 weeks old located between D5 and L5
* If fragments in the canal, they must protrude less than 40%
* Absence of other lesions, including cancer

Exclusion Criteria:

* The patient is participating in another study
* The patient is in an exclusion period determined by a previous study
* The patient is under judicial protection, under tutorship or curatorship
* The patient refuses to sign the consent
* It is impossible to correctly inform the patient
* Patient cannot read French
* Patient is pregnant or breast feeding
* Patient has a fracture on an adjacent vertebra
* Patient has a contra-indication for a treatment used in this study
* ASA class IV or V
* Patient has a neurological deficit
* Previous spinal surgery
Post-market Surveillance Study to Evaluate the Quality of Life and the Safety and Effectiveness of the TIGR® Matrix After Reconstructive Breast Surgery

The goal of this observational study is to evaluate the quality of life of participants who have undergone implant-based breast surgery. This will be done using the BREAST-Q questionnaire. The study also aims to demonstrate that the fully resorbable TIGR® Matrix is safe and effective.

This national, multicentre, prospective, non-randomized post market surveillance clinical device investigation will be performed to obtain information on the resorbable surgical mesh TIGR® Matrix used during an implant-based breast surgery. Data will be collected on the participants' quality of life as well as on the rate of complications of the device under investigation.

Eligibility Criteria:
Inclusion Criteria:

* Women with histologically confirmed breast cancer or precancerosis or genetic pre- existing conditions with increased risk of breast cancer or with a family history all with an indication for skin sparing or nipple sparing mastectomy (SSM or NSM); or women with indication of prophylactic operation
* The health of women must comply with ECOG performance status 0-2
* The decision for the implementation of the TIGR® Matrix was made before and independently from study enrollment
* Participant is mentally able to understand the nature, aims, or possible consequences of the clinical investigation
* Patient information has been handed out and subject signed informed consent
* Participant has attained full age of 18 years

Exclusion Criteria:

* Pregnancy or breast-feeding patients
* Known intolerance to the material, mesh-implants under investigation
* Metastatic breast cancer (with a life expectancy \< 5 years)
* Medicinal dis-regulated diabetes
* Inadequate bone marrow function with neutrophil granulocytes\<1500 and blood plates \< 100.000/µl
* Lack or withdrawn of written patients informed consent
* Lack of patient compliance regarding data collection, treatment or follow-up investigations in the scope of the protocol
* Participant is institutionalized by court or official order (MPDG §27)
* Participation in another surgical clinical investigation that influence the surgical technique or outcome.
Influence of the Implant Connection on Facial Tissues Maturation

The substitution of a tooth with a fixture often induces undesired morphological changes, resulting in a deterioration of the aesthetic appearance. The purpose of this study is to compare the soft tissue behavior next to two different implant connections: 5° (group 1) and 35° hexed (group 2), conical, internal with switching platform design after 12 months of functional provisionalization


Eligibility Criteria:
Inclusion Criteria:

* Missing teeth
* good oral hygiene
* good systemic health

Exclusion Criteria:

* lactation
* pregnancy
* heavy smoking (more than 20 cigarettes/day)
* severe medical conditions that could affect periodontal health and peri-implant tissue response
* use of drugs correlated to periodontal hypertrophy
* bone volume that required bone augmentation procedures before implant placement as well as soft tissue graft or any kind of peri-implant tissue engineering
Change in Thrombin Generation Potential and Thromboelastography During the Menstrual Cycle

The primary objective of this study is to describe characteristics and trends for thrombin generation (TG) and thromboelastography (TEG) at 4 time points during the menstrual cycle.

We propose that TG and TEG will be more sensitive than traditional coagulation assays to detect physiologic variation in hemostasis, fibrinolysis, and platelet activation throughout the menstrual cycle. We expect that TG and TEG will better discriminate patients with vWD than traditional coagulation studies during the menstrual cycle. In this study we plan to measure TG and TEG in healthy women and women with von Willebrand's disorder during four phases of the menstrual cycle. We will compare specific measurements of endogenous thrombin generation potential from the TG and fibrinolysis and platelet activation from the TEG with standard measures of coagulation, fibrinolysis, and platelet activation markers during the menstrual cycle.

Eligibility Criteria:
Inclusion Criteria:

* Females of reproductive age with regular menstrual cycles and a diagnosis of von Willebrand disease according to the International Society of Thrombosis and Hemostasis diagnostic criteria.

Exclusion Criteria:

* Females who are pregnant, or have a history of endocrinopathy or hormone imbalance
* History of hysterectomy or bilateral oophorectomy
* History of ovarian or uterine cancer
* Use of intrauterine device
* Use of antifibrinolytic therapy, hemostatic agents, or anti-platelet agents.
Chemotherapy Plus Gefitinib for Advanced Lung Adenocarcinoma and Sensitive EGFR Mutations: a Randomized Controlled Trial

The purpose of this study is to compare chemotherapy and gefitinib in combination with gefitinib alone as first-line therapy for adenocarcinoma, in terms of efficacy and safety.

The primary endpoints is to compare the progression-free survival (PFS) of pemetrexed plus carboplatin combined with gefitinib to gefitinib alone as first-line therapy for lung adenocarcinoma.

In addition, the overall survival and safety index will be collected for analyses.

Eligibility Criteria:
Inclusion Criteria:

1. Patients had to voluntarily join the study and give written informed consent for the study;
2. Histologically documented, unresectable, inoperable, locally advanced, recurrent or metastatic stage IIIB or IV Non-Small Cell Lung Cancer (NSCLC);
3. A cytologic diagnosis is acceptable (FNA or pleural fluid cytology)
4. Sensitive EGFR mutations (19del, 21L858R);
5. At least 1 unidimensionally measurable lesion meeting Response Evaluation Criteria in Solid Tumours (RECIST) criteria;
6. Patients did not receive systemic anti-cancer therapy previously;
7. Able to comply with study and follow-up procedures;
8. Age \>= 18 years, ECOG PS: 0-1, estimated survival duration more than 3 months;

Exclusion Criteria:

1. Small cell lung cancer (including patients with mixed small cell lung cancer and non-small cell lung cancer);
2. Evidence of small cell, carcinoid, or mixed small cell/non-small cell histology;
3. EGFR wild-type patients, or patients with rare EGFR mutations or complex EGFR mutations;
4. Previously (within 5 years) or presently suffering from other malignancies, except for cured cervical carcinoma in situ, non-melanoma skin cancers and superficial bladder cancer \[Ta (noninvasive carcinoma), Tis (carcinoma in situ) and T1 (invasion into lamina propria)\];
5. Symptomatic or untreated brain metastases;
6. Unstable systemic disease, including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, or myocardial infarction within 6 months prior to Day 1, or serious cardiac arrhythmia requiring medication (patients with chronic atrial arrhythmia, i.e., atrial fibrillation or paroxysmal supraventricular tachycardia, are eligible);
7. History of other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect the interpretation of the results of the study or render the patient at high risk from treatment complications;
8. Gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for intravenous (IV) alimentation, or prior surgical procedures affecting absorption;
9. Pregnancy or lactation.
Microvascular Endothelial Function in a Cohort of Patients With the Cardiac Form of Chronic Chagas Disease.

The present study aims to evaluate the microvascular endothelial function of a single centre cohort of patients with the cardiac form of Chagas disease, and to search for associations with clinical and laboratory variables.

Chagas disease is an endemic anthropozoonosis in South America, caused by the protozoaTrypamosoma cruzi. Between 15 and 17 million people are estimated to be infected by the parasite in South America. During the chronic phase, 30 to 40% of patients develop the cardiac or intestinal forms of the disease. The myocardial involvement is divided in two subtypes, according to the presence or absence of systolic ventricular dysfunction. The first type is characterized by heart failure symptoms. The second is acknowledged by the development of various degrees of atrioventricular blockade and by tachyarrhythmias.

Microcirculation function is recognized as a fundamental aspect in the pathophysiology of cardiovascular diseases. The identification of endothelial dysfunction by techniques that assess the microvasculature is considered as both a progression and prognostic marker in various conditions, including hypertension, coronary heart disease, and heart failure.

The effects of T. cruzi infection in vascular function were evaluated in previous studies, performed in animals with acute infection. Previous studies in humans observed medium size vessels (brachial artery), in small groups of patients, most without cardiac dysfunction. There are no studies evaluating the microcirculation of patients with the cardiac form of Chagas disease.

Eligibility Criteria:
Inclusion Criteria:

* patients presenting with Chagas cardiomyopathy

Exclusion Criteria:

* diabetes
Diluting With Cerebrospinal Fluid Versus Traditional Intrathecal Administration: Antishivering Effects

This prospective randomized double-blinded study was conducted to compare the antishivering effects of two different types of intrathecal administration.

This prospective randomized double-blinded study was conducted to compare the antishivering effects of two different types of intrathecal administration.Group Control:traditional intrathecal administration; Group Diluting:Diluting with cerebrospinal fluid

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status Ⅰ or Ⅱ who were scheduled for elective surgery under spinal anesthesia were enrolled.

Exclusion Criteria:

* Patients with pre-operative fever (\>38℃), diabetes, , Parkinson's disease, hypo or hyperthyroidism, Raynaud's syndrome, obese patients (weight \>100 kg), patients shorter than 152 cm, those with a history of allergy to the study medications, and patients receiving vasodilators were excluded from the study.
EffectS of prEferred Music on Laparoscopic performancE

The main objective is to investigate whether listening to recorded music has a positive effect on the execution of laparoscopic skills.

Secondary objectives are to investigate the effects of music during surgical performance on blood pressure, mental workload and heart rate.

Study design: This will be a 4-period 4-sequence 2-treatment crossover study, participants will be exposed to both control (noise cancelling headphones without music) and the intervention (preferred music via headphones) whilst performing a laparoscopic task in a box trainer. Every period consists of 5 repetitions of a laparoscopic peg transfer task. In total participants will perform in each condition 10 peg transfer tasks.

Prior to the experiment, all participants practice the laparoscopic peg transfer task 20 times

Study population: Healthy volunteering medicine students without laparoscopic experience.

Intervention (if applicable): Participants will perform 2 periods of 5 laparoscopic peg transfer task whilst listening to preferred recorded music via headphones and 2 periods of 5 laparoscopic peg transfer tasks while wearing noise cancelling headphones without music (2 periods of 5 tasks).

Main study parameters/endpoints: The primary endpoint is laparoscopic performance as defined by time of task completion Secondary endpoints are: laparoscopic task performance (path length, jerk, error score, economy of motion) vital parameters (heart rate, and post test blood pressure) and mental workload (SURG-TLX)


Eligibility Criteria:
Inclusion Criteria:

In order to be eligible to participate in this study a subject must meet all of the following criteria.

* Age ≥ 18 years
* Medicine students
* Provision of written informed consent by the subject.

A potential subject who meets any of the following criteria will be excluded from participation in this study:

* Severe hearing impairment, defined as no verbal communication possible.
* Severe visual impairment, defined as not able to see the monitor on which the laparoscopic task is projected.
* Any physical handicap that impairs laparoscopic performance (unable to stand for 10 minutes, unable to hold and use both instruments.