cyrilzakka/clinical-trials huggingface dataset:
Improved Drainage Strategy for Patients With Lung Wedge Resection

This study evaluates the viability and safety of two-lumen catheterization versus complete omission of chest tube in patients with lung wedge resection. Half of participants will receive complete omission of chest tube, while the other half will receive a two-lumen central venous catheterization along the midclavicular line, second intercostal space for remedial gas-remove.

With the development of video-assisted thoracoscopic surgery (VATS) techniques, minimally invasive thoracic surgery has evolved considerably over the last three decades. The concept of "tubeless" involves non-intubated anesthesia with spontaneous ventilation and no chest tube placement. Chest tube placement always causes pain, and its duration is known to be one of the most important factors influencing hospital stay and costs. Early tube removal allows patients to breathe deeply with less pain, which leads to more compliance with chest physiotherapy, as demonstrated by a concomitant improvement in patients' ventilatory function. Hence, more and more experienced surgeons choose the omission of chest tube placement after lung wedge resection. However, based on previous retrospective studies, residual pneumothorax was noted in about 10% cases, and some of them need re-intervention. Hence, the investigators designed a intra-operative two-lumen catheterization as improved drainage strategy. Therefore, this study evaluates the viability and safety of two-lumen catheterization versus omission of chest tube placement in patients with lung wedge resection.

Eligibility Criteria:
Inclusion Criteria:

1. Preoperative radiology revealed solitary peripheral pulmonary nodule, with both size and depth less than 3 cm
2. Lung wedge resection for tumor biopsy to elucidate drug resistant mechanism or confirm diagnosis

Exclusion Criteria:

1. Previous ipsilateral thoracic surgery or extensive adhesion
2. Preoperative radiology revealed pneumonia or atelectasis
3. Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease).
4. Bleeding tendency or anticoagulant use
5. Pregnancy or breast feeding
6. Patient who can not sign permit
Corticosteroids as Additive in Temporomandibular Joint (TMJ) Arthrocentesis

The aim is to compare the effectiveness of corticosteroid administration (dexamethasone) with a placebo (saline), following arthrocentesis of for the temporomandibular joint (TMJ). Twenty-eight participants with TMJ arthralgia, mainly related to osteoarthritis ae randomly assigned to two arms of a parallel double blind RCT. In both arms an arthrocentesis procedure is carried out, while a single dose intraarticular dexamethasone was delivered to participants in one arm. Saline was delivered in the other arm to serve as a control. Follow up visits were scheduled after 1, 3 and 24 weeks. During each visit TMJ pain (on a 100mm VAS) and joint stiffness (mouth opening in mm) are scored. Generalized estimating equations (GEE) are used for statistical analysis.

The arthrocentesis procedure was performed under local anaesthesia and took place in a closed operation room under controlled conditions. After marking the points for insertion of the needles, a first 18 gauge injection needle was inserted into the upper intra-articular space of the TMJ. Correct positioning of the needle was determined by injecting and aspirating saline. Subsequently, a second 18 gauge needle was inserted into the upper joint space about 8-10 mm anterior of the first needle. Correct positioning of the second needle was confirmed by allowing injected saline to leave the joint through the first needle. After positioning of the needles, one needle was connected to a medical infusion system to passively allow isotonic saline of 37 degrees Celsius to enter the upper joint compartment. The other needle was connected to an outflow tube to allow the fluid to exit the joint. In about 15 minutes, approximately 300 ml saline passively flushed the joint. Thereafter, the inflow was stopped and the prepared syringe (see randomisation procedure) that contained either dexamethasone or saline was connected to the inflow needle. In this way, either 1 cc of dexamethasone or an equal amount of saline was washed through the joint in a blinded way. At the end of the procedure, the needles were removed from the joint, and after hemostasis by compression (if necessary) the skin overlying the TMJ was covered with a sterile band aid.

All patients were then instructed to avoid TMJ loading by following a soft diet for at least two weeks, then gradually advancing to more tough food. In addition, ibuprofen 600 mg 3dd was prescribed for the first 2-5 days to reduce any postoperative pain. All procedures were performed by one surgeon.

Follow up visits were scheduled after 1 (T1), 3 (T2) and 24 (T3) weeks.

Eligibility Criteria:
Inclusion Criteria:

Pain localized in one of the TMJs (TMJ arthralgia).

Exclusion Criteria:

* No significant relief of pain within 10 minutes after anaesthesia (injecting 0,1 ml articaine 40 mg/ml) of the TMJ
* Past history of open surgery in the affected joint
* Known polyarthritis (mostly rheumatoid arthritis)
* Age under 18 yrs
* Ankylosis of the TMJ
* Reported pregnancy
Facilitating Functional Independence in Patients Receiving Prolonged Mechanical Ventilation

The primary aim of this proposal is to test the effectiveness of neuromuscular electrical stimulation (NMES) in improving functional status and muscle function in patients receiving prolonged mechanical ventilation.


Eligibility Criteria:
Inclusion Criteria:

* Duration of mechanical ventilation \>14 days
* Sufficiently awake
* Able to speak and comprehend English
* Willingness to participate

Exclusion Criteria:

* Cardiopulmonary Instability
* Acute-onset neuromuscular disease
* Lower-extremity amputee or paresis
* Open wound at electrode application points
* Pitting edema grade ≥3
* Presence of pacemaker, implanted defibrillator, or ventricular-assist device
* inability to transfer from sitting to standing before critical illness
Video Versus Conversational Contraceptive Counseling During Maternity Hospitalization

A randomized trial comparing LARC uptake and satisfaction after either video or conversational-based contraceptive counseling for pregnant women in labor.

This was a multi-center randomized, controlled trial examining contraceptive counseling in the setting of long-acting reversible contraception (LARC) uptake and immediate provision. At two urban public hospitals with large adolescent populations, participants were randomized to a structured, in-person conversation with a trained counselor or a 14-minute video providing the same information. Both participant groups were provided written materials and both had the opportunity to ask questions of the counselor. The total time to complete counseling was measured, as well as participant satisfaction, pre- and post-intervention contraceptive knowledge, and intended postpartum contraceptive method.

Eligibility Criteria:
Inclusion Criteria:

* Live pregnancy \>20 weeks gestation
* Admission to maternity ward for labor
* Age \>14

Exclusion Criteria:

* Pain \>=8 on Wong-Baker FACES pain scale
Pre Transplant Rapamycin Treatment in Islet Transplantation Alone

Numerous changes to the original Edmonton protocol have been proposed in the attempt of improving the still unsatisfactory long-term function of ITA. Rapamycin may blunt the early inflammatory response to islet transplantation in the liver, thus favoring islet engraftment.

Aim of the investigators study was to evaluate the effect of a pre-transplant treatment with rapamycin in patients with type 1 diabetes receiving islet transplant alone and immunosuppression according to the Edmonton protocol.

Pre-transplant rapamycin is administered for at least four weeks prior to the first islet infusion at the dose of 0.1 mg/kg (target trough levels: 8-10 ng/mL). During the pre-transplant rapamycin treatment rapamycin trough levels, renal and liver function, white blood cells count, total lymphocytes and lymphocytes subpopulations, hemoglobin, fibrinogen, cross-linked fibrin degradation products, C-reactive protein, exogenous insulin requirement every week for the first month, and monthly thereafter are measured. Induction and maintenance immunosuppressive regimen after each islet infusion is administered according to the Edmonton protocol (daclizumab, rapamycin, target trough levels: 12-15 ng/mL during the first 3 months and 10-12 ng/mL thereafter and tacrolimus 2 mg/day,target trough levels: 4-6 ng/mL). Islets are infused into the liver through the portal vein under local anesthesia Portography is performed before and after infusion. The islet function is evaluated measuring fasting C-pep, EIR, and HbA1c, immediately before the first islet infusion and subsequently every day for the first week, and then weekly for the first month ; every month after the last islet infusion for the first year and every 6 month thereafter.

Eligibility Criteria:
Inclusion Criteria:

* type 1 diabetes
* ≥5 years of type 1 diabetes
* hypoglycaemia unawareness
* progression of chronic complications of diabetes despite intensive insulin regimen

Exclusion Criteria:

* overt kidney disease
* chronic liver disease
* hepatic haemangioma
* severe cardiomyopathy
* untreated coronary artery disease
A Randomized Control Trial for Patient Reported Outcomes and Safety in Outpatient Thyroid Lobectomy

To compare same-day discharge and overnight (or longer) observation practices and learn more about the differences in patient preferences, safety outcomes, and economic and resource impact

Primary Objective:

--To determine whether same-day discharge is non-inferior to usual care (overnight stay) with regard to the MD Anderson Symptom Inventory - Thyroid (MDASI-Thyroid) mean severity score, as assessed at 2 weeks post-procedure in patients undergoing thyroid lobectomy.

Secondary Objectives:

* To determine whether same-day discharge is non-inferior to usual care (overnight stay) with regard to the MDASI-Thyroid mean severity score, as assessed at 24 hours post-procedure in patients undergoing thyroid lobectomy.
* To determine whether the two arms differ by incidence of deviations from normal as defined by post-operative hematoma, emergency care presentation, readmission/re-intervention, high pain severity scores, and 30-day mortality.
* To determine whether morphine milligram equivalents (MME) used over the 2-week post-operative period differs between patients who receive same-day discharge vs. those who receive usual care (overnight stay) after receiving thyroid lobectomy.

Eligibility Criteria:
Inclusion Criteria:

1. Patients ≥18 years of age
2. Patients undergoing initial partial or complete thyroid lobectomy
3. English and non-English speaking patients are eligible

Exclusion Criteria:

1. Increased risk of bleeding (e.g., Aspirin, antiplatelet therapy, or anticoagulation that cannot be held 5 days before surgery, baseline thrombocytopenia \<50,000/µL)
2. Pre-existing medical comorbidities or poor performance status (Eastern Cooperative Oncology Group performance status \>2) that would otherwise dictate overnight in-hospital postoperative observation
3. Increased distance of residence from index hospital (\>50 miles) or inability to stay within the targeted area (\<50 miles) postoperatively prohibiting timely return to the index hospital in emergent situations
4. Lives alone or unable to independently perform Activities of Daily Living and no available caregiver in the immediate postoperative period (POD 0-3)
5. Pregnant women will not be included in this study
Removable Walker for Neuropathic Ulcers

1. Objective: To evaluate the efficacy of removable cast walker compared to non-removable fiberglass off-bearing cast in the treatment of diabetic plantar foot ulcer
2. Research design and methods: Forty-five adult diabetic patients with non-ischemic, non-infected neuropathic plantar ulcer were randomized to treatment with a non-removable fiberglass off-bearing cast (TCC group) or walker cast (Stabil-D group). Treatment duration was 90 days. Percent reduction in ulcer surface area and total healing rates were evaluated after treatment.

Study design:

Two centers specializing in diabetic foot management (located in Sesto S. Giovanni and Milan, Italy) participated to this open, randomized clinical trial. The ethics-committee approved the study on January 10th, 2008. Enrollment of consecutive patients began February 2008 and ended March 2009. Eligible patients were fully informed of the study aim and procedures and written consent was obtained prior to study participation. Patients were then randomly assigned to one of the two treatment groups by opening randomization codebreak envelopes containing one of the two options. Separate randomization was performed for each center, and a copy of all randomization envelopes was kept at the statistical department of the Multimedica center. The two arms were composed of patients managed with non-removable fiberglass off-bearing cast (TCC group) and patients offloaded with the Stabil-D® (Podartis srl, Montebelluna, Treviso, Italy) walker cast (Stabil-D group).

Eligibility Criteria:
Inclusion Criteria:

* The presence of neuropathic plantar ulcer with an area graded IA according to the Texas University classification, AND
* The presence of peripheral neuropathy. Peripheral neuropathy was diagnosed based on insensitivity to a 10-g Semmes-Weinstein monofilament in more than 6 out of 9 areas of the foot and by a vibration perception threshold measured by biothesiometer (Neurothesiometer SLS, Nottingham, UK) at the malleolus \> 25 volts.

Exclusion Criteria:

* Presence of an ankle-brachial pressure index (ABI) \< 0.9 and/or transcutaneous oxygen tension (TcPO2) \< 50 mmHg tested on the dorsum of the foot,
* Presence of clinical signs of infection, including edema, erythema, increased local skin temperature, or drainage,
* The probe-to-bone maneuver was required to be negative,
* Tthe standard X-ray examination of the foot was required to be negative for osteomyelitis,
* Use of steroids or cytostatic drugs,
* Presence of sensory, motor, or visual problems that could impair functional autonomy,
* Active ulcer on the contralateral foot,
* Previous major amputation of the contralateral limb,
* Previous or current deep venous leg thrombosis, OR
* Mental disorders interfering with patient compliance.
Mother-Baby Study - Relative Reinforcing Value (RRV)

The study will test a model of biobehavioral mechanisms involved in the development of a system of emotion, attachment, and nutritive intake in the mother-infant dyad and the association of this system with maternal feeding behavior, child eating behavior, dietary intake, and adiposity.

To participate in this study the infant must also be enrolled in long-term observational study, NCT06039878.

This interventional task is done with children while they are in the long-term observational study, NCT06039878, at approximately ages 18 and 36 months. In the observational study there are 240 participants (120 mothers and 120 children). In this trial only data from the children is collected and therefore only 120 participants are listed.

Eligibility Criteria:
The child is a participant in the observational study (NCT06039878).
A Retrospective Cohort Study for Main Postoperative Complications After SARS-CoV-2 Infection

To explore the relationship between SARS-CoV-2 infection in different time before operation and postoperative main complications (mortality, main pulmonary and cardiovascular complications) 30 days after operation; To determine the best timing of surgery after SARS-CoV-2 infection.


Eligibility Criteria:
Inclusion Criteria:

* Age≥18 years;
* Patients undergoing any type of surgery in operating room.

Exclusion Criteria:

* Surgery under local anesthesia (without participation of anesthetist)
* Surgery outside the operating room, such as gastrointestinal endoscopy, puncture biopsy, etc
* Patients who cannot determine whether they have had SARS CoV-2 infection before surgery.
Analyzing the Effect of Disinfection Additives on the Linear Dimensional Stability of Dental Alginate Impressions: A Quasi-Experimental Comparative Study

This quasi-experimental comparative study investigates the effects of incorporating various self-disinfecting agents-0.2% Chlorhexidine (CHX), 1% Chitosan solution, 0.2% Silver Nitrate (AgNO3), green-synthesized Silver Nanoparticles (AgNPs), and 15% PVP-Iodine-on the linear dimensional stability of dental alginate impressions. Alginate is widely used in dentistry but is prone to dimensional changes and contamination. This study aims to assess whether integrating these disinfectants can reduce microbial risks without compromising the material's dimensional accuracy, thereby improving infection control and the precision of dental prostheses


Eligibility Criteria:
Inclusion Criteria:

* Dental stone casts free from excessive porosity, fractures, or other visible defects that could affect dimensional stability measurements.
* Typodont models with intact maxillary arch configurations.

Exclusion Criteria:

* Distorted impressions, under-extended impressions, impressions that detach from the tray before pouring, and impressions with voids, on visual inspection.
* Dental cast with a fracture component, incomplete pouring, and those with voids or bubbles.
TOMO Versus IMRT in Nasopharyngeal Carcinoma Patients

Tomotherapy is a new radiation planning and delivery technology which may allow for delivery of higher radiation doses with less damage to normal tissues. The investigators aim to compare the treatment efficacy and quality of life between tomotherapy and intensity-modulated radiotherapy for patients with nasopharyngeal carcinoma


Eligibility Criteria:
Inclusion Criteria:

1. Patients with newly histologically confirmed non-keratinizing carcinoma.
2. Tumor staged T1-4N0-3M0 （according to the 8th AJCC staging system）
3. Performance status: KPS\>70
4. With normal liver function test (ALT, AST \<1.5ULN)
5. Renal: creatinine clearance \>60ml/min
6. Without hematopathy,marrow: WBC \>4\*109/L, HGB\>80G/L, and PLT\>100\*109/L.
7. Written informed consent

Exclusion Criteria:

1. WHO type I squamous cell carcinoma or adenocarcinoma
2. Age \>65 or \<18
3. Prior malignancy (except adequately treated carcinoma in-situ of the cervix or basal/squamous cell carcinoma of the skin)
4. Previous chemotherapy or radiotherapy (except non-melanomatous skin cancers outside the intended RT treatment volume)
5. Patient is pregnant or lactating
6. Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose \>1.5×ULN), and emotional disturbance.

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Geriatric Assessmen of Elderly "Unsuited" Patients Receiving Trabectedin in First Line Treatment For Advanced Soft Tissue Sarcomas (STS)

The aim of the non-interventional study is to prospectively collect and analyze data on the geriatric assessment of patients undergoing systemic 1st line therapy with trabectedin with focus on patients who have been assessed by the treating physician as being unsuited to receive standard chemotherapy with anthracyclines and / or ifosfamide.

Trabectedin will be used according to the local SmPC. Modification of the treatment schedule should follow the standard medical practice at the discretion of the treating physician and is not part of this Observational Plan.


Eligibility Criteria:
Inclusion Criteria:

Written informed consent

* Age of ≥ 60 years at study inclusion with a limited number of "unsuited" patients younger than 60 years
* Histologically proven advanced and/or metastatic STS, intermediate/high grade
* Presence of measurable disease according to RECIST 1.1. (optional, according to local clinical practice)
* Patients indicated for 1st line treatment with trabectedin according to local SmPC
* ECOG Performance Status 0, 1 or 2
* bone marrow function according to local SmPC
* hepatic function according to local SmPC
* Ability to understand and follow study-related instructions

Exclusion Criteria:

* Histologically proven advanced and/or metastatic STS of the following tumor types:
* Embryonal rhabdomyosarcoma
* Chondrosarcoma (excluding extraskeletal myxoid chondrosarcoma)
* Osteosarcoma (excluding extraskeletal osteosarcoma)
* Ewing tumors/primitive neuroectodermal tumor
* Gastrointestinal stromal tumors
* Dermatofibrosarcoma protuberans
* Use of any investigational agent within 28 days prior to treatment start
* Exclusion periods from other studies or simultaneous participation in other clinical studies
* Contraindications according to the local SmPC of Yondelis® (see Appendix A)
* Subject is in custody by order of an authority or a court of law
* Previous assignment to the E-Trab study (An individual subject may only be included once in the study)
* Criteria which in the opinion of the investigator preclude participation for scientific reasons, for reasons of compliance, or for reasons of the subject's safety
Postural Correction Exercises for Forward Head Posture

The purpose of this study is to investigate the changes of spinal muscle activation in cervical, thoracic and lumbar segments for subjects with forward head posture (FHP) after application of two correction programs; a conventional one including cervical and thoracic spine, and a second program involving lumbosacral segment.


Eligibility Criteria:
Inclusion Criteria:

* adults with craniovertebral angle less than 50◦

Exclusion Criteria:

* Participants will be excluded if they have
* congenital spinal deformity such as scoliosis
* spinal conditions such as cervical trauma, fracture, instability of cervical spine, inflammation, infection, or neurological deficit
* a history of surgery at cervical spine or shoulder
* pregnant woman