cyrilzakka/clinical-trials huggingface dataset:
A Retrospective Clinical Registry of Peripheral Nerve Block

Locorregional anaesthesia have been increased its role in different kind of surgeries, alone or combined with general anesthesia. Due to ultrasound, peripheral nerve blocks have been increased their importance in locoregional anaesthesia. They provide excellent intraoperative and postoperative analgesia, decreasing the need for intravenous opioids which increase postoperative nausea and vomiting which may prolong hospital stay.

The primary study objective is to analyze retrospectively the use of peripheral nerve blocks in the current practice of a specialized regional anaesthesia division.

This is an observational, retrospective and unicenter study. 1346 patients scheduled for the surgery needed a peripheral nerve block were enrolled.

Locorregional anaesthesia have been increased its role in different kind of surgeries, alone or combined with general anesthesia. Due to ultrasound, peripheral nerve blocks have been increased their importance in locoregional anaesthesia. They provide excellent intraoperative and postoperative analgesia, decreasing the need for intravenous opioids which increase postoperative nausea and vomiting which may prolong hospital stay.

However, peripheral nerve blocks may be associated with postoperative complications, especially neurological ones. Classically, interscalene brachial plexus block produced a 100% incidence of phrenic nerve paralysis with resultant pulmonary compromise. Little literature has published a following of complications.

The primary study objective is to analyze retrospectively the use of peripheral nerve blocks in the current practice of a specialized regional anaesthesia division. The secondary objectives are assessed the patients characteristics of our sample, local anaesthetic dose used, the peripheral nerve block operator, the nerve location technique, the surgery and the complication rate after peripheral nerve block.

This is an observational, retrospective and unicenter study. 1346 patients scheduled for the surgery needed a peripheral nerve block were enrolled.

Eligibility Criteria:
Inclusion Criteria:

* Every patient who needs a peripheral nerve block performed by Anestesia Department.

Exclusion Criteria:

* Patient refusal of peripheral nerve block.
* Known allergy to amide local anaesthetic drugs
* Absolute contraindications to perform a peripheral nerve block as coagulopathy, active infection at the block site or severe respiratory background.
Harnessing Placebo Effects in Methadone Treatment

More than 2 million individuals in the United States have an Opioid Use Disorder (OUD). Methadone maintenance treatment is the gold standard of medication-assisted treatment for OUD, but high-dose methadone is associated with cardiotoxicity and respiratory complications, among other side effects. These adverse effects make enhancing the effectiveness of lower doses of methadone an attractive therapeutic goal. Long recognized for its capacity to enhance treatment outcomes for a wide range of neuropsychiatric disorders including pain, the placebo effect offers an as-yet untested avenue to such an enhancement. This approach is particularly compelling given that individuals with substance use disorder tend to have higher salience attribution, and may thereby be more sensitive to placebo effects. Our study combines two promising clinical methodologies-open-label placebo and conditioning-to investigate whether placebo effects can increase the effective potency of methadone in treatment-seeking OUD patients.

A total of 120 newly-enrolled treatment-seeking OUD patients will be randomly assigned to one of two different groups: either methadone plus daily open-label placebo (OLP; treatment group), or methadone/Treatment as Usual (TAU; control). Participants will meet with study team members five times over the course of three months of treatment with methadone (baseline, 2 weeks, and 1, 2 and 3 months post-baseline). Throughout this study time period, methadone dosages will be adjusted by an addiction clinician blind to patient assignment, per standard clinical methods. The primary outcome is methadone dose at three months. Secondary outcomes include self-report of drug use; 3-month urine toxicology screen results; and treatment retention. Exploratory outcomes include several environmental as well as personality factors associated with OUD and with propensity to demonstrate a placebo effect.

Eligibility Criteria:
Inclusion Criteria:

* Adult (age 18 or over)
* Newly-admitted to the methadone treatment program

Exclusion Criteria:

* Pregnancy
* Transfers- patients who have initiated methadone treatment course at another methadone treatment facility
* Hospital transfers- patients who initiated methadone treatment course in a hospital setting
* Criminal justice referral
Effects of Home Exercise Intervention on Bone Density, Muscle Functions, QoL, and Curve Progression in Girls With AIS

Studies with exercise intervention aimed to improve the bone health and muscle functions in patients with AIS were lacking. Evidence suggested that low bone mass and low muscle mass were associated with curve severity and occurrence of AIS. Weight-bearing exercise that aimed to improve musculoskeletal and metabolic health could enhance bone health and muscle mass, and could provide a feasible alternative conservative treatment to prevent curve progression as well as the quality of life in AIS girls. This is a pilot feasibility study for future large randomized controlled trial (RCT) aiming at determining the effects of home based exercise program on improving bone mineral density (BMD), muscle mass and functions, quality of life (QoL), and prevent curve progression in skeletally immature girls with adolescent idiopathic scoliosis (AIS).


Eligibility Criteria:
Inclusion Criteria:

* Cobb Angle greater or equal to 15°
* Newly diagnosed at the Scoliosis Clinic without prior treatment
* Cleared for physical activity by doctor

Exclusion Criteria:

* Scoliosis with any known etiology such as congenital scoliosis, neuromuscular scoliosis, scoliosis of metabolic etiology, scoliosis with skeletal dysplasia, or
* Known endocrine and connective tissue abnormalities, or
* Known heart condition or other diseases that could affect the safety of exercise
* Eating disorders or GI malabsorption disorders or
* Currently taking medication that affects bone or muscle metabolism
A Study of First Line Treatment With Avastin (Bevacizumab) in Combination With Carboplatin and Weekly Paclitaxel in Patients With Ovarian Cancer

This single arm study evaluated the efficacy and safety of first-line chemotherapy with carboplatin and dose-dense weekly paclitaxel plus bevacizumab (Avastin) in participants with epithelial ovarian, fallopian tube, or primary peritoneal cancer. Participants received 6-8 3-week cycles of treatment with bevacizumab 7.5 mg/kg intravenously (iv) on Day 1 of each cycle, paclitaxel 80 mg/m\^2 iv on days 1, 8, and 15 of each cycle, and carboplatin iv to an area under the curve (AUC) of 6 on day 1 of each cycle. Following combination chemotherapy, bevacizumab could be continued to be given as a monotherapy.


Eligibility Criteria:
Inclusion Criteria

* Female patients, ≥ 18 years of age.
* Epithelial ovarian, fallopian tube, or primary peritoneal cancer.
* Initial surgery, but no chemotherapy or radiotherapy.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.

Exclusion Criteria

* Non-epithelial tumors.
* Ovarian tumors with low malignant potential.
* Previous systemic anti-cancer therapy for ovarian cancer.
* History or evidence of synchronous primary endometrial cancer.
* Current or recent daily treatment with aspirin (\> 325mg/day) or with full dose anticoagulant or thrombolytic agents for therapeutic purposes.
Exogenous Sodium Lactate Infusion in Traumatic Brain Injury (ELI-TBI)

Metabolic crisis is a state of energy insufficiency due to impaired mitochondrial function as indicated by cerebral microdialysis lactate/pyruvate ratio (LPR). We have performed preliminary mechanistic analysis of alternative fuels in humans and have demonstrated proof of concept that exogenous fuels alter brain metabolism. We will conduct a multicenter, adaptive design-based, proof of concept phase 2 safety study of candidate supplemental fuels in patients with severe traumatic brain injury to determine safety and efficacy.

Metabolic crisis is a state of energy insufficiency due to impaired mitochondrial function as indicated by cerebral microdialysis lactate/pyruvate ratio (LPR). We have performed safety analysis of exogenous sodium lactate infusions in humans and have demonstrated proof of concept that these fuels alter brain metabolism. Animal TBI studies have demonstrated proof of concept for exogenous lactate and pyruvate. We will conduct a multicenter, adaptive design-based, proof of concept biomarker mechanistic safety study of exogenous sodium lactate. The preliminary goal is to determine if exogenous lactate infusion is safe and has a demonstrated effect on selected biomarkers.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients seen in the Medical Center Emergency Department
* Adult patients transferred to the Neurocritical Intensive Care Unit with a physician's diagnosis of brain injury.
* GCS 3-12

Exclusion Criteria:

* Pregnancy at time of injury
* History of diabetes mellitus
* History of hemodynamic instability
* Known terminal illness which alters brain functioning
* Diagnosed AIDS progressed to AIDS dementia
* Known history of chronic severe neurological disturbance
* Severe retardation
* Previous severe diminished mental capacity
* No command of either English or Spanish
* Arrest for a felony
* Active neurologic condition such as stroke, recent TBI
* metabolic disorder
* preexisting hyperlactatemia
* instability precluding experimental intervention
The Effects of Age and Gender on the Advantage of Sniffing Position for Laryngoscopic View

The sniffing position has been regarded as a standard position for direct laryngoscopic view. This study evaluated the effects of the age and gender on the advantage of the sniffing position compared with simple head extension for laryngeal view during direct laryngoscopy.


Eligibility Criteria:
Inclusion Criteria:

* • Patients who are scheduled for elective surgery under general anesthesia

Exclusion Criteria:

* • Patients with anatomical defects of the face, neck, or upper airway
Australian Screening Mammography Decision Aid Trial: A Decision Aid for Women Aged 40 Thinking About Starting Mammography Screening

Women who access the website, are aged between 38-45 years and are considering screening mammograms will be randomized to either the Decision Aid (a booklet providing information and exercises to help them to make a decision about whether to having screening mammograms) group or the Control Group. The Decision Aid group will first read the decision aid, and then will be asked some demographic and knowledge questions. The control group will be asked the demographic and knowledge questions only. The control group will have access to the Decision Aid after they have completed the questions


Eligibility Criteria:
Inclusion Criteria:

* female
* aged between 38-45
* have access to the internet

Exclusion Criteria:

-
Phase 1 Safety Study of Single and Multi-Dose Topically Applied OLT1177 Gel in Healthy Subjects

The purpose of this study is to determine if OLT1177 Gel is safe and can be tolerated when given as a single dose and multidose to a defined area of one knee of healthy subjects.

OLT1177 Gel is being developed for the topical treatment of pain and inflammation emanating from musculoskeletal and certain skin inflammatory conditions.

This is a Phase 1 study evaluating the safety and tolerability of OLT1177 Gel in healthy subjects when given as single-dose or multi-dose applications. The study will be conducted in two parts, Part A and Part B. In Part A, approximately 18 healthy subjects in 3 dose escalating cohorts will be randomized to receive a single dose of the investigational drug (5 subjects OLT1177 Gel and 1 subject placebo gel). Upon completion of Part A, a new subject population of approximately 18 subjects in 3 dose escalating cohorts will be randomized in Part B of the study. Subjects will receive a total of 8 doses over 3 consecutive days given 6 hours apart while awake during the day and will be followed for up to 30 days for safety assessment.

Eligibility Criteria:
Inclusion Criteria:

* Healthy men and women 18 to 60 years of age
* Women of childbearing potential must have a negative urine pregnancy test within 3 days of study enrollment and must agree to use a highly effective form of contraception
* Subjects must be in good health as determined by the Investigator based on medical history, ECG, physical examination and safety laboratory test
* Ability to provide written informed consent prior to initiation of any study-related procedures, and ability, in the opinion of the Investigator, to comply with all the requirements of the study

Exclusion Criteria:

* Subjects with a known hypersensitivity to the investigational drug
* Subjects who are pregnant or lactating
* Participation in any investigational drug or device study and receipt of any investigational drug or device within the immediate 30 days prior to the start of this study
* Concurrent or recent use of analgesics, steroids, allergy medications, H2 blockers within 48 hours of the start of the study
* Subjects with a prior knee injury or surgery within the last 5 years
* Subjects with an active infection or with a fever ≥ 38°C within 3 days of the start of the study
* Subjects with a history of, or known to be positive for, HIV, hepatitis B or C
* Subjects with uncontrolled hypertension as defined by systolic blood pressure (SBP) \> 150 mm/Hg, diastolic blood pressure (DBP) \> 100 mm/Hg
* Subjects with a wound or skin irritation or any skin condition, e.g., psoriasis in the treatment area
* Subjects who are taking prescription medications with the exception of oral or systemic contraceptives
* Subjects who have systemic diseases
* Subjects who have a history of anaphylactic reactions to any systemic or topical compounds
Prospective Cohort Study of Germline Variant Carriers with BRCA1 or BRCA2

To determine the incidence and risk factors in the development of ovarian, fallopian tube, and peritoneal cancers in Japanese women carrying Breast Cancer Susceptibility Gene (BRCA)1/2 variants.

1. To estimate the incidence of ovarian, fallopian tube and peritoneal cancers in women carrying BRCA1/2 variants.
2. To investigate risk factors concerning the development of ovarian, fallopian tube, and peritoneal cancers (loci of BRCA1/2 genetic variants, modifier genes, genetic polymorphism, hormones, and lifestyle habits.) in women carrying BRCA1/2 variants.
3. To estimate the detection rates of occult cancer based on histopathological evaluations, using risk-reducing salpingo-oophorectomy (RRSO).
4. To examine the risk-reducing effect of RRSO on the development of ovarian, fallopian tube, and peritoneal cancers in women carrying BRCA1/2 variants, and compare with those not undergoing RRSO.
5. To identify clinicopathological features in women carrying BRCA1/2 variants who had undergone RRSO.
6. To identify the appropriate interval or degree of surveillance.

Eligibility Criteria:
Inclusion Criteria:

1. Women carrying BRCA1/2 variants (those with either BRCA1 or BRCA2 variants, or those carrying both variants) and women carrying a variant of uncertain significance (VUS).
2. Women who have received sufficient genetic counseling at any medical institution, prior to enrollment to the study.
3. Women who provide consent should be 20 years of age or older.
4. Women who provide written consent.

Exclusion Criteria:

1. Women without ovarian or fallopian tube cancer at the time of informed consent.
2. Women previously diagnosed with ovarian, fallopian tube, or peritoneal cancer, and not excluding those with a personal history of breast cancer development.
3. Other individuals considered inappropriate for involvement in this study by the investigator.
Study of CGC-11047 in Patients With Metastatic Hormone Refractory Prostate Cancer

The purpose of this research is to determine the effectiveness of CGC-11047 in subjects with metastatic hormone refractory prostate cancer as measured by changes in PSA.


Eligibility Criteria:
Inclusion Criteria:

* Metastatic hormone refractory prostate cancer.
* Eastern Cooperative Oncology Group (ECOG) Performance status of 0-1.
* testosterone \<50ng/dL. Patients must continue primary androgen deprivation with an LHRH analogue if they have not undergone orchiectomy.
* Progressive disease after androgen deprivation.

Exclusion Criteria:

* Patients whose clinical condition would make chemotherapy clearly indicated.
* Patients who have received systemic chemotherapy for the treatment of metastatic disease.
* Peripheral neuropathy \> Grade 1
* Prior anti-angiogenic therapy, including thalidomide.
* Patients with inadequate recovery from any prior surgical procedure, or patients having undergone any major surgical procedure or radiation within 4 weeks prior to study entry.
* Patients who have received radiopharmaceuticals (strontium, samarium) within 8 weeks prior to enrollment.
* Patients with known brain metastases or history of brain metastases.
* History of stroke within 6 months of treatment or other significant neurological limitations.
* Patients who have received more than 2 prior investigational treatments.
* Uncontrolled intercurrent illness
* Patients with a history of a myocardial infarction within the prior 6 months or, hospitalizations for decompensated congestive heart failure within the prior 6 months, or history of significant / symptomatic cardiac arrhythmias
Safety and Tolerance Study of IBI355 in Health Volunteers

This study is being done to find out if IBI355 is safe and tolerance in health volunteers. The study will test increasing single doses of IBI355 given to adult health volunteers. The goal is to confirmed the safety of the highest dose of IBI355 or to find out the highest dose of IBI35 that can be given to health volunteer that dose not cause unacceptable side effects. Different dose regimens will be evaluated. The pharmacokinetics and ADA of IBI355 will also be evaluated.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects who have decided to voluntarily participate in the study and provided a written consent regarding observance of precautions after having been informed of and having fully understood the objectives, methods, and effects of the study in detail;
2. Healthy male and female aged 18 years or above ;
3. Subject with a Body Mass Index (BMI)\* between 18.5 and 28.0 kg/㎡;
4. subjects with a normal laboratory examination，ECG， X-ray.

Exclusion Criteria:

1. Subjects with a history of allergy；
2. Subjects participated in the other clinical trail in 1 month or less than 5 t1/2 since the previous clinical trial (which is longer)；
3. Subjects with an infection requiring systemic medication was present within 30 days prior to randomization;
4. HIV-Ab、RPR、HCV-Ab、HBV、HBeAg or HBcAb, one of them positive;
5. There have a clinical or imaging evidence that the subject with active tuberculosis, or there is evidence that the subject is in the incubation period for tuberculosis;
6. Patients with a history of central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, blood system, metabolic disorders and other systemic diseases;
7. Subject with a hcg positive;
8. Patients with a history of neuropsychiatry or who are considered unfit to participate in this clinical trial
Bimodal and Coaxial High Resolution Ophtalmic Imaging

The knowledge of the pathogenesis of retinal affections, a major cause of blindness, has greatly benefited from recent advances in retinal imaging. However, optical aberrations of the ocular media limit the resolution that can be achieved by current techniques.

The use of an adaptive optics system improves the resolution of ophthalmoscopes by several orders of magnitude, allowing the visualization of many retinal microstructures: photoreceptors, vessels, bundles of nerve fibers.

Recently, the development of the coupling of the two main imaging techniques, the Adaptive Optics Ophthalmoscope with Optical Coherence Tomography, enables unparalleled three-dimensional in vivo cell-scale imaging, while remaining comfortable for the patients.

The purpose of this project is to evaluate the performance of this system for imaging micrometric retinal structures.

The goal of the project is the capture and analysis of images with AOSLO system, in order to evaluate the performance of this system compared to OCT imaging devices and existing Adaptive Optics used at National Hospital of Ophthalmology.

Eligibility Criteria:
Inclusion Criteria:

* People over 18
* Patient with a pathology affecting the eye or healthy volunteer
* Participant who signed the consent
* Beneficiaries of the health insurance

Exclusion Criteria

* Patients with a history of photosensitivity.
* Patients who have just received a photodynamic therapy treatment
* Patients taking drugs with photosensitivity as a side effect.
* Persons with pacemakers or other implanted electronic medical device
* Patients with viral conjunctivitis or any other infectious disease.
* Patients with skin lesions on the neck or forehead
* Patients at high risk of damage from optical radiation, such as aphakic patients, or patients with decreased sensitivity to light due to fundus disease.
* Participant unable to be followed throughout the study
* Advanced cataract or severe opacities in the anterior segment of the eye.
Effect of Platelet-Rich Plasma Biomembrane on Enhancing Bone Regeneration Following Endodontic Surgery

This study was conducted to evaluate clinical and radiographical outcome of using a standardized platelet-rich plasma (PRP) biomembrane following endodontic surgery and its correlation with the growth factors content in this concentrate.

15 healthy patients of both genders, between 20 and 45 years of age, presenting with 22 anterior/premolar teeth in need of endodontic surgery were recruited. Teeth presented with failed non-surgical root canal therapy and periapical radiolucency of ≥ 1cm in size. Patients were randomly divided following surgery into two groups, with 11 teeth each.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy patients.
2. Selected tooth with previous root canal therapy failure and in need of endodontic surgery.
3. Existence of a periapical radiographic lesion surrounding the root canal treated tooth, of size ≥ 1 cm.
4. Healthy periodontal condition (probing depth, mobility \& epithelial attachment level are all within normal range).

Exclusion Criteria:

1. Leaking coronal restoration.
2. Periodontal ligament breakdown and presence of apicomarginal defects.
Postoperative Multiparameter Outcomes During the Six Months After Rotator Cuff Repair

Rotator cuff tears are common amongst 50-60 year olds with no connection to their physical activity. When symptomatic, the injury affects all aspects of general health, quality of life and function. Surgical intervention is recommended only if conservative treatment fails. The purpose of the surgical intervention is to reduce pain, and improve function while improving range of motion and muscle strength around the shoulder. The purpose of the current study is to measure physical, functional, expectation, satisfaction and quality of life outcomes after rotator cuff repair surgery. Another purpose is to learn the reproducibility components of the above outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Patients with chronic tears in supraspinatus and infraspinatus tendon
* Symptoms of up to 12 months
* No relief from conservative treatment
* Complete or almost complete tears of up to 3cm
* Hebrew speakers

Exclusion Criteria:

* Previous trauma
* Shoulder Infection
* Recurrent dislocation
* Avascular necrosis
* Frozen shoulder
* Additional tears
* Otherwise healthy