cyrilzakka/clinical-trials huggingface dataset:
Monitored Anesthesia Care vs. General Anesthesia for Transcatheter Aortic Valve Replacement

This study is being done to evaluate the impact that monitored anesthetic care (MAC) versus general endotracheal anesthesia (GETA) has on hospital length of stay, rate of ICU admission, and procedural mortality for patients undergoing Transcatheter Aortic Valve Replacement (TAVR). Also, the investigators hope to determine if the use of Transesophageal Echocardiography (TEE) during GETA impacts device success. Adult patients undergoing transfemoral approach TAVR for aortic valve stenosis may be eligible candidates for this study.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients ≥ 18 years old
* Adult patients undergoing transfemoral approach TAVR for aortic valve stenosis
* Adult patients who are medically eligible to receive both anesthetics (GA and MAC)

Exclusion Criteria:

* Inability to speak English
* Body Mass Index (BMI) \> 37 kg/m2
* History of difficult airway requiring fiberoptic intubation
* Inability to lie flat
* Women who are pregnant
* Patients who have contraindications to either anesthetic, such as an allergy or history of malignant hyperthermia, will also be excluded from the study.
* Inability or unwillingness of subject to give informed consent based on any reason
* Patients with any of the following absolute contraindications to TEE:
* Perforated Viscus
* Esophageal Stricture
* Esophageal Tumor
* Esophageal Perforation
* Esophageal Diverticulum
* Active upper GI Bleed
Treatment of Patients With Chronic Hepatitis C With PegIntron as Monotherapy or in Combination With Ribavirin (Study P04437)(COMPLETED)

In February 2002, a French Consensus Conference on the management of patients with chronic hepatitis C in France was organized. The jury issued several recommendations on pegylated alpha interferon/ribavirin treatment strategy. Three years after these recommendations, it is of interest to understand the evolution of hepatitis C management in France in real clinical practice. This observational study will permit the identification of patients who are treated and will provide information on the use of PegIntron/ Ribavirin.

To assure a good representation of participants treated for hepatitis C, participants who meet the inclusion criteria will be enrolled on a consecutive basis.

Eligibility Criteria:
Inclusion Criteria:

* Adult participants starting a treatment with PegIntron for the treatment of chronic hepatitis C.

Exclusion Criteria:

* Concomitant participation in a clinical trial for the treatment of hepatitis C.
Amendment (g) Unblinded Extension Phase of Somatropin in Patients With Idiopathic Short Stature

After approval of amendment (g), patients who were still receiving study drug at the time were scheduled for a study visit. In addition, patients who had discontinued early from the core, blinded phase of the study were contacted.

All of these patients were offered the opportunity to enter the unblinded extension phase (if they met eligibility criteria) and continue somatropin treatment (regardless of initial treatment randomization) until they reached final height.


Eligibility Criteria:
Inclusion Criteria:

Participation in core, blinded phase and ability to be contacted by investigators.

For patients who were on treatment at the time of amendment (g), growth velocity greater than or equal to 1.5 cm/year measured over the prior 12-month period. For patients who had chosen to discontinue treatment in the core, blinded phase, bone age less than or equal to 16 years for boys and less than or equal to 14 years for girls.

Exclusion Criteria:

Diabetes mellitus.

History, evidence or signs of active malignancy within 5 years prior to the start of the extension phase.

Any condition or medication that, in the opinion of the investigators, might significantly increase the risk or decrease the efficacy of growth hormone therapy.
Efficacy Study for Treatment of Dementia in Progressive Supranuclear Palsy

to show that

1. patients improve and stabilize after 12 -24 week treatment with rivastigmine in memory function
2. use of rivastigmine has a positive effect on apathy in PSP patients
3. therapy with rivastigmine has a no positive benefit on speech and overall results of the MMST
4. changes in motor activity are associated with changes in language and overall results of the in MMST


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of PSP
* willingness to participate in the study
* informed consent
* ability to speak
* no further CNS diseases
* written informed consent
* stable state of health
* ability to give informed consent, will checked by an independent physician

Exclusion Criteria:

* alcohol abuses
* acute psychosis
* pregnancy or lactation
* known previous drug reaction or hypersensitivity of rivastigmine or other carbamate derivatives
* liver failure
* known sick sinus syndrome or excitation disturbance
* known ulcus ventriculi or duodenal ulcer
* known asthma or COPD
* seizures
* renal failure
RCT:Oropharyngeal Leak Pressure (OLP) - Ambu AuraGain vs LMA Supreme

The purpose of this study is to determine whether the leak pressure of the recently introduced laryngeal mask airway, Ambu AuraGain performs superior to the established laryngeal mask LMA Supreme in surgical patients undergoing general anesthesia. This leak pressure is the pressure at which a gas leaks around the airway, which is a key marker of efficacy and safety of its use; a higher leak pressure suggests a better seal between the artificial airway and patient's airway.


Eligibility Criteria:
Inclusion Criteria

ASA physical status I to III Adults more above 18 years Ambulatory surgeries under general anesthesia in supine position requiring laryngeal masks- Knee arthroscopies, bladder tumour resections, hand, eye and general surgical procedures Muscle relaxant not required

Exclusion Criteria

Reduced mouth opening less than 2.5 cms Recent upper respiratory tract infection and sore throat in last 2 weeks Contraindications to laryngeal mask use as in morbid obesity- BMI more than 40 and severe symptomatic esophageal reflux disease
Definition of Surgical Technique of Lymphadenectomy and Complete Mesocolon Excision for Radical Right Colectomy: a Delphi Consensus

A Delphi consensus to define surgical steps of lymphadenectomy and complete mesocolic excision for radical right colectomy


Eligibility Criteria:
Inclusion Criteria:

* Experts in the fields of radical right colectomy

Exclusion Criteria:

* Panelists who were not able to commit to all rounds of the modified Delphi process
SARS-CoV-2 Infection in COVID-19 Vaccinated Patients

Vaccination of the population is crucial in the fight against the COVID-19 pandemic. Although most available vaccines have an estimated efficacy against symptomatic infection of 65-95%, this can be significantly reduced if the patient has co-morbidities such as immunosuppression or if the full vaccination schedule is not followed. Infection with SARS-CoV-2 variants, carrying mutations, notably on the spike protein, may also be associated with escape from immunity acquired by vaccination. Indeed, in vitro studies have shown a decrease in sensitivity to neutralizing antibodies acquired after vaccination or even after infection for certain variants such as variant B.1.351 (beta variant according to the WHO, first detection in South Africa) or variant B.1.617.2. (delta variant according to the WHO, first detection in India). On the other hand, cases of COVID-19 following a full vaccination regimen have recently been reported. With the increasing detection of new variants and in the context of increasing vaccination coverage of the population, one of the priority missions of the National Reference Centre (NRC) for respiratory infection viruses is to clinically and virologically investigate all cases of infection in vaccinated patients. The main objective is to determine whether a particular variant is over-represented in vaccinated patients with an infection. The secondary objective is to study the humoral immune response in COVID-19 vaccinated patients with and without SARS-CoV-2 infection.


Eligibility Criteria:
Inclusion Criteria:

* Age: ≥ 18 years old
* Persons having given their written consent and accepting a follow-up every 6 months for 24 months, followed by a final visit at 36 months.
* Persons affiliated to a social security scheme or beneficiary of such a scheme

Exclusion Criteria:

- Pregnant or lactating woman
Upper Limb Treatment With "Gloreha Aria" in the Hemiplegic Patients

Stroke is one of the leading causes of death and disability and has been described as a worldwide epidemic (1). Stroke survivors are affected by impairments and limitations of cognitive, language, perceptual, sensory, and motor functions. After a stroke, patients can improve spontaneously within the first 3 months (2) and then more slowly in the following year. The first day, decreased oedema and partial reperfusion of the ischemic penumbra may possibly explain these phenomena, but the improvement of neurological deficit in the following weeks suggests plasticity phenomena and brain cortical reorganization (3). While most recovery is thought to be made in the first few weeks after stroke, patients may make improvements on functional tasks many months after having a stroke (4). Restoring arm and hand skill after a stroke remains challenging, even though stroke rehabilitation programs have proven partial efficacy Repetitive task training has been shown to be effective in some aspects of rehabilitation, such as improving walking distance and speed and improving upper limb function (5).

In this project, the investigators will use "Gloreha ARIA" (7) a new sensor-based therapy device designed for motor recovery of impaired upper limb Gloreha Aria offers specific programs that help patients to move arm, wrist and fingers. Therapists can customize therapy by focusing on a specific motor task.

The hypothesis was that rehabilitation with this device could be not inferior in comparison with hands-on physiotherapy, in the reeducation of upper arm in the patient affected by stroke from cerebral ischemia or hemorrhage that had occurred ≤ 30 days before.

The principle purpose of this study will be to evaluate:

1. The feasibility of this new device
2. Efficacy in improving arm function abilities in the rehabilitation of patients with stroke in the sub-acute phase.

Post-stroke patients admitted for inpatient rehabilitation to the Neurological Rehabilitation will be screened for enrolment and randomized in a controlled trial.

All the patients will be informed about the aim and experimental procedures before enrolment, thus written informed consent will be obtained from all of them. Patients included in the study will be randomly assigned to intervention or control group according to simple randomization technique (computerized random numbers).

Eligibility Criteria:
Inclusion Criteria:

* to exhibit first cerebral vascular disease with unilateral hemispherical lesion confirmed by CT scan or MRI;
* to be sub-acute patients (less than 30 days from the cerebral vascular event);
* being affected by upper limb paresis;

Exclusion Criteria:

1. unable to understand verbal instruction or motor commands;
2. unilateral neglect;
3. apraxia;
4. significant visual impairment;
5. unstable medical condition;
6. significant orthopedic limitation to the shoulder, elbow; wrist and hand;
7. upper arm peripherical nerve lesion;
8. neuromuscular or neurodegenerative diseases;
9. spasticity \> 3 in according to the Modifies Ashworth Scale (3);
Evaluation of Interests of FIT Therapy on Diabetics Children Insulin-dependent

Evaluation of interests of the functional insulin therapy (FIT Therapy) on metabolic control, hypoglycemia prevention and life quality of diabetics children insulin-dependent treated with insulin pump.

Open multicenter randomized study of one year, evaluating two groups of 44 children with diabetes mellitus (diabetes over 1 year) treated with insulin pump, one group by traditional way (fixed doses of insulin and meals providing stable quantities complex carbohydrates) and the other group by FIT Therapy.

Eligibility Criteria:
Inclusion Criteria:

* aged 1-17 years
* diabetic for at least 1 year
* whose HbA1c is between 7.6 and 10% (7.6% \<HbA1C \<10%)
* treated with insulin pump
* agreeing to perform at least three blood glucose/day
* willing to follow the treatment with functional insulin therapy if necessary

Exclusion Criteria:

* Ages \<1 year or\> 17 years
* Duration of diabetes \<1 year
* HbA1c \<7.6% or HbA1c\> 10%
* Treatment-by multiple injections
* Mental disability
* Refusal to adhere to the constraints of the study
* Language barrier, preventing any understanding or cooperation
* Eating behavior-type anorexia or bulimia
* Pregnancy
* Use of alcohol or drugs
* Severe chronic or genetic pathology other than diabetes
* Participation in another clinical study or refusal to participate in the study
Low-Fat Diet and Fish Oil in Men on Active Surveillance for Prostate Cancer

This randomized phase II trial will evaluate if a low omega-6, high omega-3 fat diet combined with fish oil has the potential to delay disease progression in patients with prostate cancer undergoing active surveillance.

PRIMARY OBJECTIVES:

I. Determine if a 1-year low omega-6, high omega-3 fat diet combined with fish oil results in decreased prostate cancer Ki-67 index as compared to a control group in men on active surveillance.

SECONDARY OBJECTIVES:

I. Evaluate the effect of a low-fat (LF)/fish oil (FO) intervention on prostate biopsy tissue markers of progression, prostate biopsy pathologic features (Gleason grade, tumor volume ), prostate-specific antigen (PSA), and long-term clinical outcomes (clinical progression, prostate cancer therapies).

II. Evaluate potential surrogate biomarkers of proliferation (red blood cell \[RBC\] membrane fatty acid analyses, ex-vivo bioassay).

III. Determine if a correlation exists between free fatty acid receptor 4 (GPR120) levels and progression markers in response to the LF/FO intervention.

IV. Evaluate effect of the intervention on the National Comprehension Cancer Network (NCCN) risk group V. Evaluate compliance with a 1-year + 2 year extension LF/FO intervention. VI. Evaluate safety of a 1-year + 2-year extension LF/FO intervention.

OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive no intervention.

ARM II: Patients receive dietary counseling with a research dietitian weekly for 1 month and then monthly for 11 months. Patients are given guidelines with recommended meals to follow a high omega-3, low omega-6 diet comprising 30% kilocalories (Kcal) from fat, 15% Kcal from protein, and 65% Kcal from carbohydrates for 1 year. Patients also receive 4 fish oil capsules per day orally (PO) for 1 year.

After completion of study, patients are followed up yearly for 15 years.

Eligibility Criteria:
Inclusion Criteria:

* Patients sign the informed consent
* Patient had a prostate biopsy performed by Dr. Mark with the Artemis device and has adenocarcinoma of the prostate
* Patient elects to undergo active surveillance
* Clinical stage T2c or less
* Gleason grade 3+4 or less
* PSA \< 25
* Geographically able to have study visits at the University of California, Los Angeles (UCLA) Clinical Research Unit
* Subjects are willing to not consume lycopene, green tea or pomegranate supplements or pomegranate juice during the 1-year study
* If subjects are randomized to the control group they agree to not consume fish oil capsules during the 1-year study

Exclusion Criteria:

* Diagnostic prostate biopsy with only 1 core with cancer and \< 5% of tissue from that core involved with cancer
* Patient has taken finasteride or dutasteride during the prior year
* Patient has taken fish oil during the prior 3 months
* Patient had prior treatment for prostate cancer (surgery, radiation, local ablative therapy, anti-androgen therapy or androgen deprivation therapy)
* Patient has other medical conditions that exclude him from undergoing a repeat prostate biopsy at 1-year
* Patient has allergy to fish
Fractional Microplasma Radiofrequency Technology for Non-hypertrophic Post-burn Scars in Asians: A Prospective Study of 95 Patients

A prospective study to evaluate the efficacy and safety of FMRT for treating non-hypertrophic post-burn scars in an Asian population.

Background: Laser therapy is an emerging, minimally invasive treatment for scars. Among the various techniques, fractional microplasma radiofrequency technology (FMRT) has proved to be effective for various types of scars and skin conditions such as rhytids, striae distensae, and hyperpigmentation.

Method: A prospective clinical trial was conducted to evaluate the efficacy and safety of FMRT for treating non-hypertrophic post-burn scars in an Asian population. All patients underwent three to five treatment sessions at intervals of 8-16 weeks. The patient and observer scar assessment scales (POSAS) were use to evaluate changes in the burn scars before and after treatment. Intermediate and long-term adverse events were recorded for outcome analysis.

Eligibility Criteria:
Inclusion Criteria:

* patients with ≥1-year-old non-hypertrophic burn scars

Exclusion Criteria:

* pregnancy or breastfeeding
* history of hypertrophic scars or keloids
* abnormal medical examination including routine blood count, liver and kidney functions and immune function
* history of treatment including surgery, dermabrasion, laser treatment within the past 6 months
* the presence of a cardiac pacemaker or other metallic implant near the treatment site.
Energy Dispersive Bracing for Conservative Treatment of Knee Osteoarthritis

The goal of this study is to explore the effectiveness of a commercially available, over-the-counter knee brace in the conservative treatment of knee osteoarthritis. Participants will either be fitted with a brace and told to wear it every day during normal activities, fitted with the brace and given instructions on a set of quadriceps strengthening exercises to complete twice daily, every day, or be given the exercise instructions, but not fitted with a brace. Functional and subjective outcomes will be collected preoperatively and at 6 and 12 weeks from baseline, with the goal of informing the effectiveness of bracing alone versus a home exercise program, and whether the combination of those provides the most therapeutic benefit to participants.


Eligibility Criteria:
Inclusion Criteria:

* Subject is being treated for knee joint pain
* Subject is willing and able to comply with the evaluation schedule

Exclusion Criteria:

* Subject is undergoing surgery during the follow-up window that would limit their ability to comply with the evaluation schedule and/or significantly affect the outcomes measures
* Subject has current alcohol, opioid, or other drug dependence
* Subject is taking prescribed medication for pain other than in the knee joint (e.g. back pain)
Cluster-Randomized Trial of Air Filtration and Ventilation to Reduce Covid19 Spread in Homes

Investigators are evaluating whether an intervention consisting of box-fans with MERV 16 filters ("filtration fans") and recommendations for improving ventilation in the home can reduce secondary spread of Covid19 from an index case to susceptible contacts within the home.


Eligibility Criteria:
Inclusion Criteria:

* Household members live in a shared space (apartment, home) with others (as opposed to renting single rooms in a shared space, for example)
* At least 3 other people live in the household aside from index case

Exclusion Criteria:

* If index case test positive day was over 2 days prior
* If half or more household members are thought to be infected already
* If household has fewer than 3 contacts interested in participating in the study
* If fewer than 3 contacts are expected to be present in the house for a majority of the following 7 days
Natural Cycle Versus Hormone Replacement Therapy Cycle for a Frozen-thawed Embryo Transfer in PGT Patients

The aim of the current study is to compare miscarriage rates (before 8 weeks) between a true natural cycle (awaiting spontaneous LH surge) and a hormone replacement therapy cycle prior to blastocyst transfer in preimplantation genetic testing (PGT) patients, with biopsy on day 5 of embryonic development. The advantage of performing the study in PGT patients is the exclusion of aneuploidy as a cause of miscarriage.


Eligibility Criteria:
Inclusion Criteria:

* BMI under 35 kg/m2
* Regular menstrual cycle pattern (i.e. 24-35 days cycle)
* First, second and third ICSI-PGT cycle
* First frozen embryo transfer cycle following a fresh ICSI-PGT attempt
* PGT with trophectoderm biopsy on day 5 of embryonic development
* Signed informed consent

Exclusion Criteria:

* Oligo-amenorrhea
* BMI above 35
* Contraindications for the use of hormonal replacement therapy
A Dose-Escalation Study of SPYK04 in Patients With Locally Advanced or Metastatic Solid Tumors (With Expansion).

Phase I, open-label, multi-center study


Eligibility Criteria:
Inclusion Criteria:

(Both Part I and Part II)

* Age \>= 18 years at time of signing informed consent form
* ECOG performance status of 0 or 1
* Patients with a locally advanced, recurrent, or metastatic solid tumor for which standard therapy either does not exist or has proven ineffective or intolerable

(Part I only)

* Patients with measurable and/or evaluable disease per RECIST v1.1
* Patients with MAPK pathway alterations positive solid tumor (i.e., BRAF, K/N/H-RAS mutations)

(Part II only)

* Patients with measurable disease per RECIST v1.1
* Patients with KRAS mutated NSCLC (NSCLC cohort)
* Patients with KRAS mutated Ovarian Cancer (Ovarian Cancer cohort)
* Patients with RAS mutated solid tumor (Biopsy cohort)

Exclusion Criteria:

(Both Part I and Part II)

* Significant cardiovascular disease, such as New York Heart Association (NYHA) cardiac disease (Class II or greater), unstable angina, or myocardial infarction within the previous 6 months or unstable arrhythmias within the previous 3 months
* Patients with primary central nervous system (CNS) malignancy, untreated CNS metastases requiring any anti-tumor treatment, or active CNS metastases
* Patients with current severe, uncontrolled systemic disease (including, but not limited to, clinically significant cardiovascular disease, pulmonary disease, or renal disease, ongoing or active infection)
* Patients with a history or complication of interstitial lung disease (ILD)