cyrilzakka/clinical-trials huggingface dataset:
Can 3D Laparoscopy Improve Surgical Performances in Surgeons in Training?

Due to the inconclusive results on the benefits of 3D laparoscopic system present in literature, this prospective randomised pilot study aims to assess if the operative time of total laparoscopic hysterectomy (TLH) for benign indication performed by trainees could be reduced using 3D laparoscopy instead of standard laparoscopy.

All patients with benign uterine pathology at preoperative examinations (pelvic ultrasound and/or magnetic resonance and/or CT scan) and with indication for total laparoscopic hysterectomy, will be enrolled in the study.

While under general anesthesia, the patient is positioned in the dorsal lithotomic position with both legs supported in stirrups with a Trendelenburg tilt and arms along the body. A four disposable or reusable, sterile trocar transperitoneal approach is used. A 10 mm port is inserted at the umbilicus for the telescope. Once pneumoperitoneum (12 mmHg) is achieved, intra-abdominal visualization will be obtained with a 0° high-definition telescope (HD EndoEye 10 mm, Olympus Winter \& IBE GMBH, Hamburg - Germany) or with 0° 3D laparoscopy high-definition (Olympus Winter \& IBE GMBH, Hamburg - Germany). The instruments used include bipolar grasper, monopolar scissors, monopolar hook, various graspers and a suction irrigation system. Clermont Ferrand uterine manipulator (Model K.Storz Endoskope,Tuttlingen, Germany) is optionally used to move the uterus.

Total hysterectomy is then performed according to standard technique used by the recruiting center (development of the pararectal space and identification of uterine artery, coagulation of ovarian pedicles, development of the vesico-uterine septum, colpotomy).The vaginal vault is then closed with a 0 Vycril suture laparoscopically (continuous suture).

Detailed operative time, intra and post operative early complications will be recorded (Extended Clavien-Dindo classification of surgical complications will be used for post operative complications)

Eligibility Criteria:
Inclusion Criteria:

* Patients suffering from benign uterine pathology (uterine fibromatosis, abnormal blood loss, complex hyperplasia with atypia, uterine prolapse) with indication for total uterine hysterectomy
* Uterine size \</= than 15 cm
* American Society of Anesthesiologists (ASA) class \< 3
* Patient's informed consent
* No actual pregnancies or pelvic inflammatory disease
* No previous major abdominal surgical procedures

Exclusion Criteria:

* Suspected neoplastic pathology
* Patients not eligible for surgery
Effects of COVID-19 Convalescent Plasma (CCP) on Coronavirus-associated Complications in Hospitalized Patients

The purpose of this study assess the efficacy and safety of anti-SARS-CoV-2 convalescent plasma in hospitalized patients with acute respiratory symptoms up to 14 days after the onset of initial symptoms.

A total of 50 eligible subjects will be randomized in a 1:1 ratio to receive either convalescent fresh frozen plasma (frozen within 8 hours of collection) of PF24 (frozen within 24 hours) from blood donors who have recovered from COVID-19 containing antibodies to SARS-CoV-2 or control (standard fresh frozen plasma collected prior to 12/1/2019 or with documented negative SARS-CoV-2 antibody). Should additional anti-COVID agents (anti-viral and/or anti-inflammatory) become available for use as standard of care during implementation, the sample size will be recalculated and increased to account for the estimated impact that these agents may have on the reducing the progression to the primary endpoint of severe hypoxemia.

Eligibility Criteria:
Inclusion Criteria for Enrollment:

1. Patients ≥18 years of age
2. Hospitalized with COVID-19
3. Enrolled within 72 hours of hospitalization OR within day 14 from first signs of illness
4. Pulmonary infiltrates on chest imaging
5. Oxygenation of \<95% on room air
6. Laboratory confirmed COVID-19

Exclusion Criteria

1. Contraindication to transfusion due to inability to tolerate additional fluid, such as due to decompensated congestive heart failure
2. Baseline requirement for oxygen supplementation prior to COVID-19 infection or use of positive pressure therapy for sleep disordered breathing
3. Currently experiencing severe hypoxemic failure, as defined in study endpoints
4. Prior receipt of plasma products, IVIG, or hyperimmune globulin within past 3 months
5. Not currently enrolled another interventional clinical trial of COVID-19 treatment.

Note: If taking medications with potential anti-COVID activity for the purpose of COVID-19 treatment that do not yet have data to support efficacy, such as IL-6 antagonists, these medications must be stopped prior to enrollment. Receipt of current standard of care COVID-19 treatment, including remdesivir and dexamethasone is permitted and should be recorded as a concomitant medication.

Note: Pregnancy is not exclusionary but will merit additional discussion of risks \& benefits in the context of ongoing pregnancy
Survival Outcome of EGFR-TKI in Uncommon EGFR Mutant Advanced NSCLC

This study aims to explore Survival Outcome of EGFR-TKI in Uncommon EGFR Mutant Advanced Non-small Cell Lung Cancer in China

inclusion criteria Uncommon EGFR Mutant Advanced Non-small Cell Lung Cancer EGFR G719X, exon 20 insert mutation without any anti-cancer treatment history

Eligibility Criteria:
Inclusion Criteria:

* 18，Advanced Non-squamous Non-small Cell Lung Cancer Confirmed by Histopathology

  * Uncommon EGFR Mutant Advanced NSCLC

Exclusion Criteria:

* Patients with contraindication of chemotherapy
* Pregnant or breast feeding women
Compassionate Treatment : An Exploratory Clinical Trial to Assess Treatment of Amyotrophic Lateral Sclerosis

The purpose of the study is to determine the safety and possible effectiveness of Autologous Adipose-Tissue Derived Stem Cells treatment in a Amyotrophic Lateral Sclerosis(ALS) patient.

This pilot clinical trial is design to see the safety and possible efficiency of ADSCs treatment in a ALS patient. one subjects will be treated (n=1). The patient will receive brain transplantation of ADSCs and combines intravenous infusion ADSCs 4 times. Subjects will be assessed by adverse effects and functional outcomes of clinical: PI max , PE max,and Haloscale respiration, ALS functional rating scale (ALS-FRS) are analyzed at 1 month, 3 months, 6 months 9 months and 12 months.

Brain MRI scans will be obtained before and after the treatment. Long term follow-up will be performed at 1, 6 , and 12months for safety reasons. Brain CT for check operation safety before and after brain implantation.

Timing of Study: 12months recruitment period after approvals

Eligibility Criteria:
Compassionate Treatment

The number of participants for a person.

The patients (Guo XX) of 28% of lung function assessment (normal lung function was greater than 80%), the daily life of motor function score was 17 points (normal function score of 40 points).
Efficacy and Visual Quality of Orthokeratology Lenses With Different Designs

Orthokeratology (ortho-k) lens is very effective in slowing down axial elongation in myopic children by 30% to 63% when compared to children wearing single-vision spectacles or contact lenses. More recently, it is reported that the children wearing orthok lens of smaller back optical zone diameter (BOZD) demonstrated a smaller axial elongation when compared to children wearing lens with larger BOZD. We aimed to explored the myopia efficacy and visual quality of ortho-k with different BOZD (5.0mm or 6.2mm).

This prospective study aimed to evaluate the efficacy of orthokeratology lenses with different back optical zone diameters (BOZD) in slowing axial elongation. Additionally, visual quality will be assessed through measurements of wavefront aberrations, contrast sensitivity, and subjective visual quality using a validated questionnaire. The study seeks to explore the effectiveness of various Ortho-K lens designs and the potential factors influencing their outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Age between 8 and 13 years.
* Subjective refraction under cycloplegia: spherical power between -4.00 D and
* 1.00 D, with cylindrical power≤ 1.50 D.
* Best-corrected visual acuity (BCVA) of ≥ 1.0 based on subjective refraction.
* Willing to participate in the clinical trial and provide signed informed consent.

Exclusion Criteria:

* One eye met the inclusion criteria
* Patients with systemic diseases causing immunocompromised or affecting orthokeratology
* There are other eye diseases that affect orthokeratology lens wearing, such as dacryocystitis, blepharitis, various inflammation, glaucoma, etc
* Abnormal cornea
* Previous corneal surgery or corneal trauma history
* Active keratitis (e.g., corneal infection)
* Patients with best corrected distance visual acuity of less than 5.0
* Patients with corneal flat curvature lower than 39.00D, or higher than 48.00D
* Patients with refractive instability
* Patients with overt strabismus
* The corneal epithelium showed obvious fluorescent staining, which was not suitable for patients wearing orthokeratology lenses
* Patients with dry eye are not suitable for orthokeratology
* Patients with corneal endothelial cell density less than 2000 cells /mm2
* Patients who had worn rigid contact lenses (including orthokeratology lenses) within the previous 30 days
Modified Dose and Schedule of Recombinant Hepatitis B Vaccination in HIV-infected Adult Subjects

The purposes of this study include 1) to compare the seroconversion rate of an intensive standard-dose regimen (0, 1, 2 and 6 months) to a standard-dose regimen (0,1 and 6 months), and 2) to compare the seroconversion rate of an intensive double-dose regimen (40 μg at 0,1,2 and 6 months) to a standard-dose regimen (20 μg at 0,1 and 6 months) of HBV vaccine in HIV-infected adult patients.

HIV and HBV share similar risk factors and routes of transmission. HIV/HBV coinfection is associated with greater chance of chronic HBV carrier state, higher level of HBV replication and increasing its potential for transmission. Currently, there are no concrete data to determine the best HBV vaccination schedule in HIV-infected patients. Standard HBV vaccination (20 μg at 0, 1 and 6 months) gives seroconversion rate of 33-63% in HIV-infected individuals compared with \>90% in healthy individuals. This study aims to compare the efficacy of an intensive standard-dose regimen (0, 1, 2 and 6 months) to a standard-dose regimen (0,1 and 6 months) and to compare the seroconversion rate of an intensive double-dose regimen (40 μg at 0,1,2 and 6 months) to a standard-dose regimen (20 μg at 0,1 and 6 months) of HBV vaccine in HIV-infected adult patients with CD4 level above 200 permm3 and suppressed viral load.

Eligibility Criteria:
Inclusion Criteria:

* Positive for anti-HIV antibody
* At least 18 years of age
* CD4 \> 200 cell/mm3
* On antiretroviral therapy
* Viral load \< 50 copies/ml
* Negative for any HBV serological marker (HBsAg, Anti-HBs, Anti-HBc)
* No history of previous hepatitis B vaccination
* Anti-HCV negative
* No active opportunistic infection at the time of screening
* Willing to sign informed consent
* Able to follow up

Exclusion Criteria:

* Pregnancy or breast feeding
* History of hypersensitivity to any component of vaccine
* Diagnosis of malignancy and receiving chemotherapy or radiation
* Other immunocompromised conditions not related to HIV infection (solid-organ transplantation, chemotherapy in the last 6 months)
* On Immunosuppressive treatment, immunomodulating treatment or corticosteroid (equal or above 0.5 mg per kg per day of prednisolone)
* Renal failure (creatinine clearance \< 30 mL/min)
* Decompensated cirrhosis (child-pugh C)
* Not able to follow up
Safety and Efficacy of Imatinib in Combination With High Dose Chemotherapy for Acute Phase Chronic Myelogenous Patients

The aim of this phase I/II trial is to determine the dose of daunorubicine to be associated with cytarabine and Imatinib for induction therapy in patients with chronic myelogenous leukemia in myeloid acute phase.

Study design Imatinib: starting at day -3: 600mg/day; continuous administration In combination with cytarabine: continuous iv/24h: 100mg/m² ; 7 days and daunorubicine: 4 levels

level 1: 0

level 2: 15mg/m² ; 3 days

level 3: 30mg/m² ; 3 days

level 4: 45mg/m² ; 3 days

Eligibility Criteria:
Inclusion Criteria:

* CML Ph+ (assessed by cytogenetic or FISH)
* Acute phase with ≥ 20% bone marrow blasts (M0 to M6 , excluding M3)
* Age ≥ 18 year at inclusion
* PS grade 0 to 2 (ECOG)
* Adequate and organ function, defined as the following: total bilirubin \<1.5x uln, sgpt \<3x uln, creatinine \<1.5x uln.
* Informed consent signed up

Exclusion Criteria:

* active malignancy other than CML or non-melanoma cancer of the skin
* current treatment with another investigational agent
* patients with grade 3/4 cardiac disease or any other serious concurrent medical condition.
* patients who are pregnant or nursing. All patients of childbearing potential must practice effective methods of contraception while on study.
* patients with mental illness or other condition precluding their ability to give informed consent or to comply with study requirements patients with performans status 3-4
A Pilot Randomized Controlled Trial to Reduce Salt Intake Among Hypertensive Young Adults in Hong Kong

A pilot randomized controlled trial will be conducted to investigate the feasibility and effectiveness of a salt intake reduction intervention to young hypertension patients in Hong Kong who had high salt intake.

Convenience sample will be recruited from the community in Hong Kong through different channels of promotion.

Eligibility Criteria:
Inclusion Criteria:

* i) adults aged 18 to 44
* ii) diagnosed hypertension or borderline hypertension
* iii) complete collection of 24-hour urine at baseline
* iv) 24-hour urinary sodium excretion above 2000mg at baseline
* v) can communicate in Cantonese

Exclusion Criteria:

* i) renal illnesses;
* ii) taking diuretics;
* iii) taking RAS blockers;
* iv) attending or planning to attend new hypertension education programme or salt intake reduction programme during the study period.
Patients With Epilepsy Taking LAMICTAL Immediate-Release Who Switch To Extended-Release Formulation And Vice Versa

Pharmacokinetic (PK) study to characterize changes in serum concentrations in epilepsy patients when switching from LAMICTAL immediate-release to extended-release and vice versa.


Eligibility Criteria:
Inclusion criteria:

* Confident diagnosis of epilepsy.
* Currently on LAMICTAL and up to 2 concomitant AEDs (anti-epileptic drugs).

Exclusion Criteria:

* Females of childbearing potential cannot be on hormonal contraceptives or hormone replacement therapy.
Personalized CRT - PSR

The purpose of this study is to evaluate the cardiac resynchronization therapy (CRT) response in a real-world patient population and evaluate options to address non-response and patient management.

The Personalized CRT study is a multi-center, single arm, prospective observational study. The purpose of the study is to better understand and characterize heart failure (HF) patient management by characterizing the use and clinical benefit of Medtronic market-released features/tools within the HF Patient Management portfolio.

Eligibility Criteria:
Inclusion Criteria:

* Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements
* Patient has or is intended to receive or be treated with an eligible CRT device
* Patient within 30 days of therapy received at the time of their initial PSR platform enrollment

Exclusion Criteria:

* Patient who is, or is expected to be inaccessible for follow-up
* Patient with exclusion criteria required by local law
* Patient is currently enrolled in or plans to enroll in any concurrent drug and/ or device study that may confound results
Study of the Impact on the Therapeutic Alliance of a Short Initial Psychoeducation Programme in Patients With Early Schizophrenia

Schizophrenia is a serious, disabling and unfortunately common disease. Its prevalence is in the order of 0.6 to 1% in the general population, a figure that remains relatively stable in the various cultures. The overall prognosis, particularly in terms of function, remains largely negative. The investigators know that a global management can considerably slow down this unfavourable evolution: according to the recommendations, the patient suffering from schizophrenia requires an effective and well-tolerated pharmacotherapy, associated with an adapted psychotherapy as well as cognitive remediation workshops, training in social skills, and psycho-education. There are indeed a large number of studies that have shown these elements in patients with schizophrenic disorders that have been present for several years. The investigators now know that early treatment is a key prognostic element. Indeed, the earlier care is provided during the first psychotic episode, the better the subsequent prognosis: the probability of further decompensation is reduced, as is the risk of developing deficits, such as cognitive difficulties. However, there is a lack of access to all the recommended aspects of management in the initial phase of the disorder, particularly concerning early psycho-educational programmes for patients, which have been relatively little studied in clinical research. In this context, it seems relevant to study the impact of a new programme of this type on a fundamental parameter, conditioning the subsequent access to care: the therapeutic alliance. "PPIC" is a short psycho-educational programme in 4 sessions, specifically designed to accompany young patients, and focused on the issues of this crucial period of the care process.


Eligibility Criteria:
Inclusion Criteria:

* French speaking
* Presenting a first or second acute psychotic episode, corresponding according to DSM 5 criteria to:

  * A brief psychotic disorder
  * And/or a schizophrenic disorder evolving for less than 2 years,
* Hospitalized in full time or in day care,
* Understanding and accepting the constraints of the study,

Exclusion Criteria:

* Patient under guardianship
* Patient participating in another study
* Patient in hospital under restraint
To Evaluate Drug-drug Interactions Between DWN12088 and Pirfenidone or Nintedanib in Healthy Volunteers

An open label, 2-part, one-sequence, 3-period study to evaluate drug-drug interactions between DWN12088 and Pirfenidone or Nintedanib in healthy volunteers

This clinical trial is an open label, 2-part, one-sequence, 3-period study to evaluate drug-drug interactions between DWN12088 and Pirfenidone or Nintedanib in healthy volunteers

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults aged ≥ 19 and ≤ 55 years at screening
* Subjects who voluntarily decided to participate in the study and provided written consent to after receiving a detailed explanation on this study and fully understanding the information

Exclusion Criteria:

* Subjects who received another investigational agent in another study (including bioequivalence study) within 180 days prior to the first dose of the IP (The end of prior study participation will be the date of the last dose, and the days will be counted from the next day \[1 day\].)
* Female subjects who are pregnant or lactating
The Effect of Foot Orthoses on the Braking Response Time

Patients often seek advice from their treating doctor if they are able to drive with a foot orthosis after a first metatarsal osteotomy for symptomatic hallux valgus and/or after an additional forefoot surgery. This challenging question is of obvious importance for the patient and other road users. Previous studies already issued driving ability after different orthopedic procedures and with knee and ankle devices on the brake reaction time but missed to address the same for foot orthoses after hallux valgus or forefoot surgery.

This missing evidence made us evaluate the influence of wearing a foot orthosis after a first metatarsal osteotomy or forefoot surgery on driving ability (brake response time; BRT).

The overall time frame is about nine weeks; each appointment for BRT measurement takes about fifteen to twenty minutes. The first BRT measurement is one day before the foot surgery without a foot orthosis (normal shoe)and with the orthoses (control run) (1) at two days (2), two weeks (3), four weeks (4) and six weeks (5) after the operation with a HVS and a FRS and eight weeks postoperative without a foot orthoses (6).

The purpose of this study is to asses driving ability (brake response time) and the influence of two types of different foot orthoses after foot surgery.

Therefore we have two groups:

1. Hallux valgus surgery (Chevron, Austin, SCARF, Akin etc.)
2. Hallux valgus and additional forefoot surgery (Chevron, Austin, SCARF, Akin etc. and WEIL - Osteotomy, Peg-in-Hole, etc.)

BRT (brake response time) is assessed with commonly used right-sided hallux valgus shoes (HVS) and forefoot relief shoes (FRS). We measure the BRT at six different time points: one day before surgery without a foot orthosis (normal shoe)and with the orthoses (control run) (1) at two days (2), two weeks (3), four weeks (4) and six weeks (5) after the operation with a HVS and a FRS and eight weeks postoperative without a foot orthoses (6). The overall time frame is about nine weeks; each appointment for BRT measurement takes about fifteen to twenty minutes.

The BRT was assessed using a custom-made driving simulator as used in previously published studies. Participants were instructed to apply the brake pedal exclusively with the right foot as quickly as possible on a visual stimulus. The time interval until the subject operated the brake was measured 20 times, averaged and then taken as BRT value.

Eligibility Criteria:
Inclusion Criteria:

* participants must have a valid driver´s license,
* used the right foot exclusively for accelerating and braking,
* free of any medical condition that could impair the ability to drive

Exclusion Criteria:

* taking medications that could affect reaction time (e.g. benzodiazepines and over-the-counter allergy and cold medications)
* had a history of alcohol or drug abuse,
* a central nervous system disorder such as epilepsy,
* a metabolic disorder,
* a psychiatric disorder,
* musculoskeletal disease,
* any visual acuity disorder (macular degeneration etc.; glasses allowed)