cyrilzakka/clinical-trials huggingface dataset:
Retinal Vascular Network and Obstructive Sleep Apnea

Obstructive sleep apnea syndrome (OSA) is thought to lead to systemic vascular lesions that may be preceded by early microvascular lesions in the eyes and in particular in the retina. The improvement of ophthalmological imaging techniques by OCTangiography allows a precise non-invasive study of the retinal microvascular network. This new rapid and non-invasive retinal imaging tool could reveal micro-vascular lesions related to OSA. To the investigator's knowledge, this would be the first OCT-angiography description of a cohort of patients with OSA. If these results are confirmed, it would be interesting to study the correlation between these micro-vascular lesions and the cardiovascular risk of his patients.


Eligibility Criteria:
Inclusion Criteria:

* person who has given oral consent
* person who can be followed throughout the study
* adult

Patient group:

- Patient seen in sleep apnea screening consultation by a pulmonologist and referred for polysomnography diagnosis of OSA

Control Group:

- Person initially without obstructive sleep apnea syndrome

Exclusion Criteria:

* a person who is not affiliated to or not a beneficiary of the national health insurance system
* person subject to a measure of legal protection (curatorship, guardianship)
* person subject to a safeguard of justice
* pregnant, parturient or breastfeeding woman
* adult incapable or unable to consent
* person with a contraindication to Tropicamide or Neosynephrine
* person with a history of eye disease affecting ocular circulation (examples: acute anterior ischemic optic neuropathy, retinal central artery occlusion, retinal central vein occlusion, diabetic retinopathy, glaucoma, uncontrolled hypertonia, AMD, severe myopia...)

Control Group:

* person with a history of chronic lung problems (e.g. COPD, chronic respiratory failure, etc.)
* person with at least one of the following risk factors for obstructive sleep apnea syndrome:

  * Obesity with IMC≥30
  * Alcohol consumption \> 3 glasses per day

Exclusion criteria: positive result in one of the 3 self-questionnaires
Effect of Goal-directed Crystalloid Versus Colloid Administration on Major Postoperative Morbidity

A trial in which patients having open abdominal surgery are randomized to receive either crystalloids or colloids intraoperatively, guided by esophageal Doppler. The investigators test the primary hypothesis that goal-directed colloid administration during elective abdominal surgery decreases a composite of postoperative complications within 30 days of surgery.

Patients will be given 5-7 ml/kg of crystalloid (lactated Ringer's) in the immediate preoperative period, which will be followed by 4 ml/kg/h crystalloid for maintenance normalized to ideal body weight \[Men: Ideal Body Weight (in kilograms) = 52 kg + 1.9 kg for every 2.5 cm over 150 cm; Women: Ideal Body Weight (in kilograms) = 49 kg + 1.7 kg for every 2.5 cm over 150 cm\].

They will then be randomly assigned to additional volume replacement, guided by esophageal Doppler, to either lactated Ringer's solution of Voluven starch.

Eligibility Criteria:
Inclusion Criteria:

* ASA Physical Status 1-3
* Body Mass Index \< 35
* Moderate risk elective abdominal surgical procedures scheduled to take ≥ two hours done under general anesthesia.

Exclusion Criteria:

* cardiac insufficiency (EF\<35%)
* coronary disease with angina (NYHA IV)
* severe chronic obstructive pulmonary disease
* coagulopathies
* symptoms of infection or sepsis
* renal insufficiency (creatinine clearance \<30ml/min or renal replacement therapy)
* ASA Physical Status \> 3.
Intrapulmonary Percussive Ventilation (IPV) Versus Nasal Continuous Positive Airway Pressure Ventilation (nCPAP) in Transient Respiratory Distress of the Newborn

During caesarean section, transient respiratory distress which occurs frequently (3%) with possible complications are at present managed by non invasive nasal continuous positive airway pressure ventilation (nCPAP) associated with oxygen therapy. Intrapulmonary Percussive Ventilation (IPV) is a non-invasive ventilatory mode used in some intensive care units to treat some respiratory distress syndrome of the newborn with a good tolerance, but without evaluation in prospective studies

* Principal Objective: To show that IPV ventilation can decrease the duration of transient respiratory distress as well as the risk of complications.
* Secondary Objective: Comparison between the two groups regarding: Length of oxygen therapy, complications (pneumothorax, pulmonary infections), need for intensive care hospitalization
* Study design: Open, prospective randomized trial.
* Inclusion criteria: Neonates with gestational age ≥ 35 weeks and weight ≥ 2000g, caesarean section, respiratory distress syndrome (modified Silverman score \> 5, SpO2 \< 90%), management within 20 minutes after birth.
* Exclusion criteria: clinical thoracic retraction, congenital lung malformation, meconium aspiration, neonatal infection, other congenital malformations.
* Study plan: After the screening evaluation and written consent document, neonates will be randomized into two groups: nCPAP ventilation or IPV. During the 6 hours after randomization, clinical data will be monitored: cardiac and respiratory frequency (CF -RF), saturation (SaO2), oxygenotherapy, Silverman Score. Then, neonates will be supervised 3 days after normalization of the respiratory distress.
* Number of subjects: 100 (50 in each group)

Eligibility Criteria:
Inclusion Criteria:

* Caesarean newborn
* Gestational age ≥ 35 weeks
* Weight ≥ 2 kg
* SaO2 \< 90% after 10 min of life
* Silverman score ≥ 5
* Treated less than 20 min after birth
* Social security affiliation (parents)
* Informed consent signed (parents)

Exclusion Criteria:

* Thoracic retraction
* Congenital intrathoracic malformations
* Meconium aspiration
* Early neonatal infections with hemodynamic troubles
* Severe neonatal asphyxia
* Polymalformative syndrome
Nordic Randomized Trial on Laparoscopic Versus Vaginal Cerclage

Every year 15 million babies are born prematurely, which can lead to death or life-long disabilities. It is often caused by a dysfunction of the uterine cervix, which constitutes the narrow channel between the vagina and womb. During pregnancy, this channel must remain closed until the beginning of term labor. A weak cervix may not withstand the weight of the fetus, the amniotic fluid and the placenta and the cervical canal will open and cause late miscarriage or preterm delivery. To prevent this, a band (cerclage) can be applied around the cervix either vaginally or laparoscopically prior to a new pregnancy.

To evaluate which treatment is best for most women, we will randomize (allocate by chance) women at risk for preterm birth, to either vaginal cerclage or laparoscopic cerclage in the Nordic countries and England

Both vaginal and abdominal cerclages are procedures that have been used to prevent preterm birth for more than 50 years. However, only one previous study (MAVRIC, Shennan et al. 2020) has compared the two methods in a randomised trial. Other than evidence from the MAVRIC trial there is uncertainty whether an abdominal cerclage should be preferred over vaginal cerclage, and which women would benefit from it the most.

NORACT is an open, multicenter, superiority, randomized controlled trial with the overall objective to compare laparoscopic versus vaginal cerclage in woman in whom the clinician has equipoise as to whether an elective vaginal or abdominal cerclage will be the best intervention to prevent preterm birth. Participants will be recruited pre-pregnancy or in early pregnancy and randomised to vaginal or laparoscopic cerclage. If randomised to laparoscopic cerclage this will be inserted pre-pregnancy or before 10+0 weeks of gestation. The vaginal cerclage will be inserted during pregnancy, before 16+0 weeks of gestation. A total sample of 188 participants will be included to detect a target difference of 15% in the primary outcome between the two groups. The two primary outcomes are delivery before 32+0 weeks of gestation and baby death. The study extends from sites in Denmark, Sweden, Norway, Finland, Iceland, and the United Kingdom.

Eligibility Criteria:
Inclusion Criteria:

* Women in whom the clinician has equipoise as to whether an elective vaginal or abdominal cerclage will be the best intervention to prevent preterm birth.
* Not yet pregnant or \<10 weeks' pregnant.

Exclusion Criteria:

* Any circumstance under which the clinician is not willing to randomize is an exclusion criterion.
* Any condition or circumstance under which laparoscopic or vaginal cerclage surgery is contraindicated (i.e. on-going pregnancy of more than 10+0 gestational weeks).
* Language difficulties.
Restoration of Cutaneous Sensorum in Patients With Diabetic Peripheral Neuropathy (DPN) Via Metanx®

The purpose of this research study is to determine if Metanx improves sensory neuropathy in persons with Type 2 diabetes. Metanx is a medical food available with a prescription from a physician. It consists of L-methylfolate, Pyridoxal 5'-phosphate, and Methylcobalamin, which are the active forms of folate, vitamin B6, and vitamin B12, respectively. Subjects will be assigned to receive Metanx for 12 months. Baseline quantitative sensory testing will be done before the patient receives Metanx. Additional quantitative sensory testing will be done at 6 and 12 months to evaluate.


Eligibility Criteria:
Inclusion Criteria:

* Consecutive diabetic patients entering the office (private practice)
* Subjective symptoms of numbness, burning, paresthesia, etc.
* Failed Monofilament of at least two points on each foot
* Abnormal PSSD study
* Willing to participate in protocols or study

  * Taking one Metanx tablet bid for 2 weeks then one Metanx tablet daily
  * Keep scheduled appointments for follow up studies
  * Report any other medical interventions, studies, or medication changes
  * Report any problems of medical or psycho-social matters to investigators
  * HgbA1c NOT monitored or specific value required for participation

Exclusion Criteria:

* History of back problems (Surgery or ECSI) or other large fiber neuropathies
* History of chemotherapy
* History of chemical exposure
Anti-PD-1 Antibody Combined With Pegaspargase in the Treatment of Advanced Stage NK/T-cell Lymphoma

This open-label, single arm study will evaluate the efficacy and safety of anti-PD-1 antibody in combination with pegaspargase in treatment of newly diagnosed advanced stage NK/T-cell lymphoma.

Extranodal natural killer (NK)/T-cell lymphoma (ENKTL), nasal type, is a distinct and heterogeneous histopathologic subtype of non-Hodgkin lymphoma (NHL), accounting for 5%\~10%. The frequency of ENKTL among NHL patients is significantly higher in Asia than in Western countries, with poor prognosis. L-asparaginase-based chemotherapy has improved the survival for these patients with advanced stage. However, there is no standard of care for those patients with advanced stage. Anti-PD-1 antibody has been proven its efficacy in relapsed or refractory NK/T cell lymphoma. This open-label, single arm study will evaluate the efficacy and safety of PD-1 antibody in combination with pegaspargase in treatment of newly diagnosed advanced stage NK/T-cell lymphoma.

Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed NK/T cell lymphoma based on 2016 WHO classification
* Treatment naive
* Age \> 18 years
* Advanced stage
* Must has measurable lesion in CT or PET-CT prior to treatment
* ECOG 0,1,2
* Informed consented

Exclusion Criteria:

* Aggressive NK/T-cell leukemia
* Has accepted PD-1,PD-L1 or PD-L2 antibody before
* Has accepted autologous Stem cell transplantation before
* History of malignancy except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix 3 years prior to study treatment
* Uncontrollable cardio-cerebral vascular, coagulative, autoimmune, serious infectious disease
* Primary CNS lymphoma
* Lab at enrollment (Unless caused by lymphoma): Neutrophile\<1.5\*10\^9/L ;Platelet\<50\*10\^9/L; ALT or AST \>3\*ULN; Creatinine\>2\*ULN
* Other uncontrollable medical condition that may that may interfere the participation of the study
* Not able to comply to the protocol for mental or other unknown reasons Pregnant or lactation
* HIV infection
* HBV-DNA or HCV-RNA positive
* Diagnosed immunodeficiency or received systemic corticoid therapy 2 weeks prior to first dose.
* Received attenuated live vaccine 4 weeks prior to first dose.
Demonstration Study of the Effect of the Transcranial Direct Current Stimulation (tDCS) on Depressed Patients

Purpose of research: It aims to demonstrate the effectiveness of transcranial direct current stimulation (tDCS) in the clinical domain for patients with depression and to optimize home-based e-medication technology.

As a home-based clinical empirical study of transcranial direct current stimulation for depressed patients, male and female subjects aged 19 to 65 who meet the criteria for mild and moderate Major depressive disorder (MDD) were enrolled, and real-world data (RWD) was obtained through self-application of transcranial direct current stimulation (tDCS) at home for 6 weeks. This is a study that secures and derives real-world evidence (RWE) that can be applied to clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* Male and Female aged 19 to 65 with mild and moderate Major depressive disorder (MDD)

Exclusion Criteria:

* Those diagnosed with Post-traumatic stress disorder (PTSD), Obsessive compulsive disorder (OCD), bipolar or psychotic major depressive disorder, high suicide risk, Electroencephalography (EEG) and DC stimulation electrode attachment problems (such as scalp deformity, inflammatory response or other dermatological problems), Transcranial direct current stimulation (tDCS) medical device taboos (such as head metal plate insertion), clinical trials that have been inadequate for clinical trials
The Effect of Guided Imagery on Activity-Specific Balance Confidence, Pain, and Psychological Well-Being

The aim of this clinical trial is to evaluate the effect of guided imagery on activity-specific balance confidence, pain, and psychological well-being in elderly orthopedic patients. In the study, guided imagery will be applied by the researchers and will be applied over 2 days for a total of 3 repetitions. The study will be conducted in the postoperative period of the patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are open to communication and collaboration,
* Those who are over 65 years old,
* Those who have a mini-mental test score of 24 and above,
* Those who have the same type of analgesic protocol,
* Those who have a numerical pain score of at least 4 will be included.

Exclusion Criteria:

* Patients who have developed any complications,
* Patients who have hearing, vision and perception problems,
* Patients who have been diagnosed with any psychiatric disease,
* Patients who have developed any complications after surgery will be excluded.
Ultrasound-Guided Popliteal Plexus Block Versus Fascia Iliaca Block After Total Knee Arthroplasty

This study aims to investigate the effect of the Popliteal Plexus Block versus Fascia Iliaca Block on postoperative pain after total knee arthroplasty.

The Popliteal Plexus entwines the popliteal artery and vein contiguous to the adductor hiatus in the popliteal fossa and innervates the posterior capsule as well as intraarticular genicular structures. It was recently confirmed in a cadaver study that injection of 10 mL of dye into the distal end of the adductor canal spreads via the adductor hiatus to the popliteal fossa and stains the Popliteal Plexus.

Recently, fascia iliaca block was proposed as a popular analgesic technique which involves local infiltration anesthesia under the fascia of the iliacus muscle. The method depends on the local anesthetics spread beneath the fascia to block the peripheral nerve. It has been proposed to avoid the complications by anesthetizing the femoral nerve remotely from major neurovascular structures and achieve adequate analgesia.

Eligibility Criteria:
Inclusion Criteria:

* Age 40 - 75 years.
* Both sexes.
* American Society of Anesthesiologists (ASA) score I-II.
* Scheduled for unilateral, primary TKA under spinal anesthesia.

Exclusion Criteria:

* Coagulopathy.
* Diabetes.
* Obesity.
* Heart failure.
* kidney failure.
* Liver failure.
* Reduced sensation on the lower limb.
* Daily intake of opioids.
* Contraindication to any drug used in the study.
Success and Safety of the Implant Placement Using Navigated Surgery

Subjects with severely atrophic mandibles were treated with implants and implant-based restorations. Subjects will be required to consent to study participation and data processing according to General Data Protection Regulation (GDPR). Implant positions were planned digitally in a dental software DTX Studio, and implants placed with navigated surgery (Nobel Biocare X-Guide). Implants eligible for this study must be placed 2 mm or less from the alveolar nerve. Implants placed are NobelParallel TiUnite and NobelActive TiUnite. All subjects were followed up for 1 year after surgery to monitor success and adverse events related to the alveolar nerve. Data analysis will include demographics, medical history, Cone-beam Computed Tomography (CBCT) scans/peri-apical x-ray data, soft tissue parameters, and adverse events.

The study aims to evaluate the success and safety of immediate navigated implant placement in the atrophic mandible or post-extraction sockets near the alveolar nerve, as an alternative to guided bone regeneration followed by delayed implant placement.

This single-center retrospective study includes 20 subjects with severely atrophic mandibles or post-extraction sockets, followed for 1 year after implant placement.

The primary objective is to assess treatment success, defined as the implant supporting a dental prosthesis, no adverse events related to the alveolar nerve, and minimal bone loss around the implant. The secondary objective focuses on safety, particularly concerning the alveolar nerve. Subjects must meet specific inclusion criteria, such as implants placed within 2 mm of the alveolar nerve and being at least 18 years old and must have signed consent forms. Exclusion criteria include the absence of 1-year follow-up data.

Data collected includes demographic and medical history, plaque, bleeding, and gingival indices at pre-treatment and 1-year follow-up, and radiographic exams (CBCT and intra-oral radiographs) to assess bone levels. Written informed consent is required, and all data is de-identified and transferred to Switzerland for analysis, complying with EU regulations. This study aims to provide a less invasive alternative to traditional methods, potentially reducing the number of surgical interventions needed.

Eligibility Criteria:
Inclusion Criteria:

* Implants placed in 2 mm distance or less of the alveolar nerve
* Subject was at least 18 years old at the time of surgery
* Subject signed consent form
* Subject signed GDPR form

Exclusion Criteria:

* 1-year follow-up data on treatment success not available
Remote Optimization, Adjustment and Measurement for Deep Brain Stimulation

The purpose of the ROAM-DBS study is to compare the time needed to achieve a 1 point improvement Patient's Global Impression of change (PGIC) relative to the subject's status at the end of the ADROIT initial programming visit in subjects who receive programming updates via in-clinic sessions and subjects who additionally have the option of receiving programming updates via Virtual Clinic sessions. The study intends to demonstrate shorter times to achieve benefit in the Virtual Clinic cohort.

The ROAM-DBS study is a prospective, multi-center, randomized control, open-label, post-market cohort study intended to gather clinical data on the effect of the NeuroSphere Virtual Clinic feature (remote care) on the time needed to optimize DBS stimulation parameters after implant. The study will enroll up to 100 subjects from up to 15 centers in geographies where Abbott DBS systems with the Virtual Clinic feature are approved, which may include North America, and Europe. Subjects should be participants in the ADROIT study (NCT04071847). Subjects will be followed to a 3 month visit where the primary endpoint will be assessed. Subjects will be further followed for 1 year for final data assessment. Subjects will remain enrolled in ADROIT after the end of the ROAM study, and will complete the ADROIT 6 month and 1 year visits under that protocol. The study is expected to enroll subjects for up to 2 years, and complete all follow-up visits within 3 years.

Eligibility Criteria:
Inclusion Criteria:

1. Subject is a participant in the ADROIT study.
2. Subject is over 21 years old.
3. Subject is able to read and write.
4. Subject is indicated for implant with an Infinity IPG for Parkinson's disease.
5. Subject has not previously been implanted with a DBS system.
6. The treating physician believes Virtual Clinic is appropriate as a component in the treatment regime for this subject.
7. Subject will have access to the Abbott Virtual Clinic system through a participating site.
8. Subject will have internet access on their Patient Controller in a location suitable for a Virtual Clinic session.
9. Subject, or a legally acceptable representative, must provide written informed consent prior to any study-related procedure.

Exclusion Criteria:

1. Subject is currently enrolled or plans to enroll in an investigational study that may confound the results of this study.
2. Subject has anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the study or to comply with follow-up requirements, or impact the scientific soundness of the study results.
3. As assessed by the treating physician, lead misplacement would prevent the DBS therapy from providing clinically meaningful benefit.
4. Subject is unable to use the Virtual Clinic feature.
5. Subject will not be able, in the investigator's opinion, to demonstrate or articulate symptoms during a Virtual Clinic visit.
A Follow-up Colonoscopy Examination in Patients Who Had Previously Undergone Screening Colonoscopy

* To determine the prevalence of colonic neoplasm in patients who had previously undergone screening colonoscopy
* To determine the optimal time interval for re-screening in average risk individuals
* To determine potential baseline characteristics that predicts adenoma recurrence

Colorectal cancer (CRC) is the second commonest cancer in Hong Kong, and tends to be increasing. Screening for colorectal cancer can reduce the cancer incidence and mortality by detecting early lesions. However, the best interval for a follow up colonoscopy, particularly for those with normal baseline colonoscopy, remains largely unknown.

This study aim to determine the prevalence of colonic neoplasm in average-risk patients who had previously undergone screening colonoscopy and the optimal time interval for re-screening.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who are previously participated in one of our two screening colonoscopy studies \[Sung, Gastroenterol 2003; Leung, AJG 2004\]
* Asymptomatic on first screening colonoscopy
* Age\>50and \<75
* No family history of CRC
* No other colonoscopy except the baseline screening colonoscopy

Exclusion Criteria:

* Subjects who refused consent
* Subjects who are not warrant follow up colonoscopy