cyrilzakka/clinical-trials huggingface dataset:
Intrathecal Fentanyle Versus Dexamethasone in Gynacological Laparoscopic Surgeries

Laparoscopy was first introduced to the medical field of in the middle of the last century. It revolutionized the surgical interventions; it reduced the total medical expenditures and hastened postoperative recovery . General anaesthesia (GA) was considered the only anesthetic technique suitable for laparoscopic interventions, and several myths and facts prevented regional anaesthesia (RA) implementation. Respiratory and Cardiovascular impairment were the main aspects of concern which are thought to be best controlled by GA


Eligibility Criteria:
Inclusion Criteria:

* ASA I, II
* elective gynacological laparoscopic surgery

Exclusion Criteria:

* patient refusal
* chronic kidney and hepatic diseases
Clinical Application of the Apex of the Deep Cartilage in Evaluating the Femoral Tunnel of the ACL Reconstruction

With the apex of the deep cartilage (ADC) as the symbol, the consistency of the two methods in the postoperatively computed tomography (CT) and microscopic evaluation of the position of the femoral tract of the anterior cruciate ligament (ACL) was studied.Expected results:P1 and P2, D1 and D2 were positively correlated, and the linear relationship was significant. Bland-Altman diagram shows a good consistency.

Objectives:

With the apex of the deep cartilage (ADC) as the symbol, the consistency of the two methods in the postoperatively computed tomography (CT) and microscopic evaluation of the position of the femoral tract of the anterior cruciate ligament (ACL) was studied.

Methods:

Prospective cohort study.

Fifty-two patients requiring arthroscopic anterior cruciate ligament reconstruction were enrolled in the Sports Medicine Department of Peking University Third Hospital.

Collect patients' basic information and preoperative conditions. During the operation, the patient's knee was bent 90°, and the center point was positioned according to the intact femoral stump. The horizontal distance from the ADC to the anterior bone margin (L1) and the horizontal distance from the center point of the bone tract (L1) were measured by the master, the first aid and the second aid, and the distance from the center point of the bone tract to the lower bone margin (D1) was measured, and the ratio of L1 /L1 was calculated (P1).

The horizontal distance from the ADC to the anterior bone margin (L2) and the horizontal distance from the center of the bone tract (L2) were measured by three investigators on postoperative CT films, and the distance from the center of the bone tract to the lower bone margin (D2) was also measured, and the ratio of L2 /L2 was calculated (P2).

Linear regression, Pearson correlation and Bland-Altman analysis were used to compare the consistency between the endoscopic assessment and CT assessment.

Expected results:

P1 and P2, D1 and D2 were positively correlated, and the linear relationship was significant. Bland-Altman diagram shows a good consistency.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have isolated ACL injury and receive ACL reconstruction surgery at Peking University Third Hospital.
* With isolated ACL injury (an ACL injury with no need for surgical repairs to other knee structures).
* All participants have no known disorders or diseases other than ACL rupture.

Exclusion Criteria:

• Other injuries affecting movement performance.
Safety, Pharmacokinetics, and Antiviral Activity of Remdesivir in Hospitalized Children with RSV

THAI-CARES RSV Study is a Phase II, open-label, multicenter, randomized controlled trial with a two-arm, parallel-group design. The study aims to assess the safety, efficacy, and acceptability of a five-day course of Remdesivir in children under two years of age who are hospitalized with confirmed respiratory syncytial virus (RSV) infection, as determined by either a rapid antigen test or RT-PCR. The primary objectives include evaluating the treatment's safety profile, its ability to significantly reduce RSV replication, and its overall acceptance in this patient population.

An overall target of 120 participants will be involved in the study. Eligible participants will be randomized (1:1) to receive ARM 1: Standard of care alone (control arm). ARM 2: Remdesivir in combination with the standard of care. Remdesivir will be administered by intravenous infusion every 24 hours for five (5) consecutive days. Each participant will be followed during hospitalization plus 7-10 days after Day 6\* for final visit.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent from parents/caregivers
* Aged 0 to \<2 years
* Weighing at least 2.0 kg
* Onset of RSV associated-symptoms within 1 week of screening
* Confirmed\* with RSV infection (by rapid antigen test or RT PCR)
* Hospitalized children fulfilling at least two of the following three RSV disease severity criteria:

  * Inadequate oral feeding
  * Inadequate oxygen saturation (peripheral capillary oxygen saturation \[SpO2\] \<95% on room air or requiring oxygen supplementation to maintain SpO2 ≥95%)
  * Signs of respiratory distress (respiratory rate of ≥60 breaths per min for children aged up to 1 year, or ≥40 breaths per min for those older than 1 year, or accessory respiratory muscles use \[subcostal, intercostal, or suprasternal retraction\], or both)

Exclusion Criteria:

* Preterm infants (gestational age at birth less than 37 weeks) who are aged \<56 days
* Being hospitalized for other clinically relevant concurrent conditions (except for risk factors for severe RSV, e.g., cardiac disease, pulmonary disease, genetic disease, and prematurity)
* Concurrent treatments with other agents with actual or possible direct antiviral activity against RSV \<24 hours prior to study drug dosing (e.g. ribavirin)
* ALT or AST \> 5 × ULN
* eGFR \<30 mL/min/1.73m2 using the Schwartz formula if aged ≥1 year; or if aged \<1 year based on a creatinine value cut off dependent on chronological age
* Any major congenital renal anomaly if \<28 days
* Apgar score \< 5 when last recorded if age \<24 hours
* Known hypersensitivity to the study drug, the metabolites, or formulation excipient.
* On renal replacement therapies (e.g., intermittent hemodialysis, peritoneal dialysis, continuous renal replacement therapy)
* Any condition that, in the opinion of the site investigator, would make participation in the study unsafe for the child, or comprise the study objectives
Treatment Effect of Edaravone in Patients With Amyotrophic Lateral Sclerosis (ALS)

Amyotrophic Lateral Sclerosis (ALS) is a neurodegenerative disease that causes the death of 30,000 affected individual every year. Complex nature and unknown pathogenesis of this disease are 2 major reasons for failure of therapeutic interventions. Edaravone is a free radical scavenger that slows down functional decline and prevents from disease progression in ALS patients. FDA newly approved this drug in these patients (2017/5/5). In this study, investigators aimed to assess the treatment effect of this newly approved drug in patients with ALS in a representative Iranian population.


Eligibility Criteria:
Inclusion Criteria:

1. Patients diagnosed as definite or probable ALS according to El Escorial Criteria.
2. ALS patients who are graded as mild or moderate according to ALS Health State Scale.
3. Forced vital capacity of at least 80%
4. Desire of the patient to participate in this study and Signing Written Informed Consent.

Exclusion Criteria:

1. Incidence of drug's side effects that requires discontinuation of the drug (Edaravone's side effects: Acute kidney injury, Acute allergic reactions, DIC, Thrombocytopenia, Leukopenia).
2. Desire of the patient to discontinue participating in this study.
3. the patient starts another drug or herb for ALS during the study.
Aggressive Onset Multiple Sclerosis: A Practical Definition and Study of Its Clinical Course

Chart review.

A chart review will be completed on patients with multiple sclerosis to determine potential early characteristics that might be helpful in defining aggressive onset MS and predicting subsequent disease course and disability

Eligibility Criteria:
Inclusion Criteria:

* Two or more relapses in the preceding year and 2 or more gadolinium enhancing lesions on brain MRI scan or a significant T 2 lesion burden or
* One relapse if it results in sustained EDSS of 3.0 along with 2 or more gadolinium enhancing lesions or significant T2 lesion burden ( T2 lesion burden being determined by factoring the number of lesions, the size of the lesions and lesion location)

Exclusion Criteria:

-
Microbotox for Lower Face Rejuvenation

The purpose of this study is to evaluate the efficiency of the intradermal injection of botulinum toxin in lower face rejuvenation. The study will also compare this intervention with the "Nefertiti Lift" intramuscular injection technique.

The abobotulinumtoxinA will be used for the intervention. The abobotulinumtoxinA will be prepared by adding 2.5 cc of normal saline to a 500-unit Dysport© (Ipsen Ltd, Berks, UK) vial. Further dilution to the appropriate Microbotox concentration will be done in the syringe itself. Each 1mL syringe of Microbotox solution will contain 20-28 units of onabotulinumtoxinA per mL of solution.

Preinjection frontal, oblique and lateral patient pictures will be taken (at rest and with contraction)

Injection points:

A series of 100-150 intradermal microdroplets injection points 1 cm apart will be delivered in the lower face. The area to be injected is bounded by a line 3 fingerbreadths above and parallel to the lower border of the mandible, 1 fingerbreadth posterior to the depressor anguli oris, and all the way down over the cervicomental angle and anterior neck to the upper border of the clavicle, and posteriorly to the anterior border of the sternocleidomastoid.

In the average patient, 2 syringes of 28 units per mL of microbotox will be used to cover the entire area.

In heavier necks, 3 syringes of 28 units per mL will be used. In thinner necks, 2 syringes of 20 units per mL will be used.

Follow up will be done at 15 days for post injection pictures. A total of 15 patients will be recruited

Eligibility Criteria:
Inclusion Criteria:

Female patients presenting to our clinic for neck rejuvenation who:

* Were deemed nonsurgical candidates for neck rejuvenation
* Were not willing to undergo invasive surgical procedures
* Had a medical contraindication to surgery

Exclusion Criteria:

* Patients with lower face botulinum toxin injection in the past 12 months
* Patients with resorbable lower face fillers injection in the past 12 months
* Patients with previous permanent lower face fillers injection
* Pregnant patients
* Lactating patients
* Patients with preexisting neuromuscular conditions (myasthenia gravis, Eaton Lambert syndrome)
* Patients using medication that could potentiate the effect of botulinum (ex: aminoglycoside antibiotics)
* Patients with sensitivity to botulinum toxin or human albumin
Emotion Regulation Group Study

A clinical trial to evaluate the effects of an eight-week emotion regulation group intervention designed for adolescents (16-20 years old) on the levels of emotion dysregulation both self-reported by the adolescent and reported by his/her parent/caregiver (pre-post comparison). The long-term effect will also be measured at a third-time point, three months after the end of the intervention. The intervention will consist of 90-minute sessions once a week for 8 weeks, in groups of eight participants. The intervention proposed for this study is an adaptation from different interventions already in use for adolescents in clinical practice, such as Dialectical Behavior Therapy (DBT), Mentalization-Based Treatment (MBT) and Mindfulness-Based Intervention (MBI).


Eligibility Criteria:
Inclusion Criteria:

* Aged between 16 to 20 years old.
* \> 4 criteria of borderline symptoms (out of the 9 listed in the DSM-5) including emotional liability
* French speaking
* Availability during the whole study
* Willingness in participating to the intervention and the research
* Informed consent read and signed

Exclusion Criteria:

* Current hospitalization
* Psychotic disorder
* Severe and persistent substance addiction
* Antisocial personality disorder
* Inability to participate in group sessions
* Current pregnancy
* Non-French speaking
* Previous enrolment into the current study
A Prospective Randomized Study of Medial Patellofemoral Ligament (MPFL) Reconstruction

The operative management of chronic patellar instability has been controversial. Medial patellofemoral ligament reconstruction has gained success recently and might be superior to other soft-tissue procedures. The objective of this prospective study was to compare the clinical outcome after medial patellofemoral ligament reconstruction compared with medial reefing for chronic patellar instability.

Many of the previous studies on medial patellofemoral ligament (MPFL) reconstruction for patellar instability have been difficult to interpret, either because the study setting has included both first-time and recurrent dislocations, or because a lack of control group. Moreover, several studies have enrolled patients with a wide age range, and the majority of the studies have employed retrospective and nonrandomized study designs. Therefore the investigators designed a prospective, randomized study with the primary goal to compare the outcome after MPFL reconstruction with medial reefing for chronic patellar instability. The distance between tibial tubercle and trochlear groove is measured on MRI and corrected if it exceeds 17mm. Primary outcome measure is the occurrence of recurrent objective and subjective patellar instability. The second goal is to evaluate the development of articular cartilage lesions within the patellofemoral joint, and assess clinical scores.

Eligibility Criteria:
Inclusion Criteria:

* Chronic patellar instability (more than 2 dislocations)
* Minimum 6 months nonoperative treatment

Exclusion Criteria:

* Severe PF OA
* Acute patellar dislocation
Effect of ADC4022 Co-Administered With Budesonide on Pulmonary Inflammation in Subjects With Moderate to Severe COPD

The purpose of this study is to assess the tolerability and efficacy of inhaled theophylline (ADC4022) on markers of pulmonary inflammation (white blood cells) in induced sputum and in bronchial biopsy samples in subjects with moderate to severe Chronic Obstructive Pulmonary Disease (COPD) when co-administered with budesonide and compared to placebo.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of COPD that has been symptomatic for at least 2 years
* The subject has moderate to severe COPD, as defined by the American Thoracic Society and the European Respiratory Society
* The subject can produce an adequate sputum specimen after induction
* The subject has a history of ≥ 10-pack years of cigarette smoking
* The subject has either a ≤15% increase or ≤200 ml increase in FEV1 from pre-dose following a fixed dose of bronchodilator therapy
* The subject is able to provide written, informed consent to participate

Exclusion Criteria:

* The subject has experienced a respiratory tract infection and/or an exacerbation of COPD within 30 days
* The subject uses systemic corticosteroids (oral or parenteral)
* The subject has received long term oxygen therapy within 30 days
* The subject has a previous history or diagnosis of asthma
* The subject has a chest x-ray within the past 12 months which is diagnostic of an active or clinically significant disease other than COPD
* The subject has a history or presence of active tuberculosis, cystic fibrosis, bronchiectasis, lung cancer or sarcoidosis or any other clinically important lung diseases
* The subject has had radiation or chemotherapy within the previous 12 months
* The subject has a history of anaphylaxis associated with medicinal products
* The subject is pregnant, intends to become pregnant, or is breast feeding
* The subject's alcohol intake is excessive.
* The subject participated in another study (for a marketed drug) within 3 months before the start of this study or (for an investigational drug) within 4 months before the start of this study.

Other inclusion/exclusion criteria may also apply
Pioglitazone and Quetiapine XR Pharmacogenetic Study

Obtain phenotypic data and a DNA/blood sample from mood disorder patients undergoing pioglitazone or quetiapine XR treatment as a part of an IRB approved clinical trial conducted at the Mood Disorders Program. Pioglitazone treatment is examined in metabolic syndrome comorbid with bipolar depression (IRB # 07-08-24) and unipolar depression (IRB # 07-07-20). Quetiapine XR treatment is examined in generalized anxiety disorder comorbid with bipolar depression (IRB # 10-06-19) and unipolar depression (IRB # 12-01-29). Please refer to the respective IRB protocols for more information.


Eligibility Criteria:
Inclusion Criteria:

* Must have participated in IRB protocols 10-06-19, 12-07-29, 07-07-20, and 07-08-24
* Patient must give consent to participate, sign and date the IRB approved written informed consent form prior to the initiation of any procedures for this study
* Patient must be diagnosed with Bipolar Disorder or Major Depressive Disorder
* Patient must be at least 18 years old
* Patient must be willing to give a blood sample

Exclusion Criteria:

* Patient lacks the capacity to provide informed consent
Comparison of Left and Right Transradial Approach for CAG and PCI

This trial will compare the procedural success rate between right and left radial approach in patients undergoing coronary angiography and coronary intervention.

The three operators who are proficient in the left radial approach for coronary angiography and coronary intervention will be assigned to the right radial approach for 3 months (phase 1). After then, these three operators will switch approach site to the left radial for another 3 months (phase 2).

Procedural success, time of the procedure, use of contrast agent, and fluoroscopic data will be compared between right radial approach (phase 1) group and left radial approach (phase 2).

Eligibility Criteria:
Inclusion Criteria:

* Subjects undergoing coronary angiography via radial approach
* Subjects undergoing coronary intervention via radial approach
* Subjects give written informed consent

Exclusion Criteria:

* Subjects undergoing procedure(s) other than coronary angiography or intervention
* Subjects with contraindication of radial approach (i.e, non-palpable radial pulsation, abnormal Allen's test, known radial artery tortuosity or occlusion, arteriovenous fistula for dialysis)
Prospective Registry of Corona Virus Disease 2019 (Covid-19) Patients With Neuromuscular Involvement

Prospective registry for multimodal assessment of neuromuscular pathology associated with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, enrolling consecutive patients with corona virus disease 2019 (Covid-19), who are admitted to the intensive care unit of the department of anesthesiology and intensive care medicine, or the department of neurology at Tübingen University Hospital.

The prospective registry shall provide new insights into muscular involvement associated with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. For that reason consecutive patients with proven corona virus disease 2019 (Covid-19), who are admitted to the intensive care unit of the department of anesthesiology and intensive care medicine, or the department of neurology at Tübingen University Hospital, are enrolled. Multimodal assessment of neuromuscular pathology is based on medical history, laboratory biomarkers including inflammation parameters and autoimmune antibodies, vital parameters monitoring, muscle ultrasound, transthoracic echocardiography, electroneurography, as well as electromyography. Inclusion of follow-up visits permit longitudinal and prognostic evaluation of diagnostic and therapeutic interventions (e.g. immunomodulation with immunoglobulins, corticosteroids, or interleukin 6 receptor antagonists).

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Proven severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection

Exclusion Criteria:

* active or known history of myopathy or advanced stage neuropathy
* refusal to participate in clinical research
Neoadjuvant Chemotherapy Versus Surgery Alone for Esophageal Squamous Cell Carcinoma

The effect of neo-adjuvant chemotherapy on survival of patients with thoracic esophageal squamous cell carcinomas remains the most controversial part of neo-adjuvant therapy for esophageal carcinomas. One of our objectives is to evaluate whether the neo-adjuvant therapy with cisplatin and paclitaxel followed by right thoracic approach esophagectomy with total 2-field lymph node dissection improves the overall survival of thoracic esophageal cancer patients.

The effect of Neo-adjuvant chemotherapy on survival of patients with thoracic esophageal squamous cell carcinomas remains the most controversial part of Neo-adjuvant therapy for esophageal carcinomas. Therefore, the optimal management of resectable esophageal squamous cell carcinomas differs widely among different areas based on local randomized controlled trials.

The neo-adjuvant chemotherapy might be a good strategy if sufficient local control is achieved by surgical treatment. This study defined the detail of surgery procedure and the region of lymphadenectomy and adopted cisplatin and paclitaxel as neoadjuvant chemotherapy regimens. We try to evaluate the efficacy and safety of this neo-adjuvant strategy.

Eligibility Criteria:
Inclusion Criteria:

1. Histologic diagnosis of squamous cell thoracic esophageal carcinoma of Stage IIA to IIIB, (7th Union for International Cancer Control, UICC-TNM).
2. Patients must not have received any prior anticancer therapy of esophageal carcinoma.
3. Age ranges from 18 to 75 years.
4. Without operative contraindication.
5. Absolute white blood cells count ≥4.0×109/L, neutrophil ≥1.5×109/L, platelets ≥100.0×109/L, hemoglobin ≥90g/L, and normal functions of liver and kidney, total bilirubin（TBIL）≤1.5N, aspartate aminotransferase (AST)≤2.5N, alanine aminotransferase(ALT)≤2.5N, prothrombin time(PT)≤1.5N, and activated partial thromboplastin time(APTT) is in normal range, endogenous creatinine clearance rate(CRE)≤1.5N.
6. Patients must not have diagnosed with other cancer and must not received any prior anticancer therapy except prostatic cancer with more than 5 years disease-free survival(DFS).
7. expected R0 resection.
8. ECOG 0～2.
9. Signed informed consent document on file. 10.No metastatic lymph node in cervical by color doppler sonography.

Exclusion Criteria:

1. Multiple primary cancer.
2. The subject cannot understand and sign the informed consent form(ICF).
3. Patients with concomitant hemorrhagic disease.
4. Any un expected reason for patients can't get operation.
5. Inability to use gastric conduit after esophagectomy because of a prior surgery.
6. Pregnant or breast feeding.
7. Patients are diagnosed or suspected to be allergic to cisplatin or Paclitaxel.