cyrilzakka/clinical-trials huggingface dataset:
Intra-Articular Autologous Bone Marrow Mesenchymal Stem Cells Transplantation to Treat Mild to Moderate Osteoarthritis

Osteoarthritis is a progressively degenerative disease resulting in increasing pain, impairment and ultimately disability. While the available treatments seek to ameliorate pain or improve mobility, these treatments rarely modify the course of the disease, but rather attend to its consequences. For early stage osteoarthritis, treatment is largely limited to addressing the symptoms of inflammation with non-steroidal anti-inflammatory drugs (NSAIDs). These drugs do not stop the progression of the condition or regenerates damaged cartilage.

This is a randomized and open labelled study aimed to determine the efficacy of intra-articular implantation of autologous bone marrow-derived mesenchymal stem cells in patients with mild to moderate osteoarthritis.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with mild to moderate osteoarthritis based on Kellgren-Lawrence radiographic classification
* Has a history of joint swelling, pain, stiffness, altered gait and loss of motion due to degenerative cartilage

Exclusion Criteria:

* Has systemic bone or cartilage disorders
* Has significant vascular impairment proximal to implant site
* Has substantial joint destabilization including extensive osteophyte formation
* Has substantial surface erosion of the weight-bearing articular cartilage
* Evidence of infection or fractures in or around the joint
* Contraindication to bone marrow aspiration
* Any acute or chronic communicable diseases including Hepatitis B, Hepatitis C and HIV
* Any past history of neoplasia and primary hematological disease
* Renal impairment indicated by serum creatinine greater than 200mM
* Liver impairment indicated by serum aspartate transaminase and serum alanine transaminase greater than 120 IU
* Any other co-morbidity which the physician deems as a contraindication to stem cell transplantation and bone marrow biopsy
SCOUT Reflector for Tagging Lymph Nodes for Targeted Removal in Patients With Breast Cancer

This pilot clinical trial will evaluate whether the SCOUT reflector can be used to tag abnormal lymph nodes in patients with breast cancer prior to chemotherapy for targeted removal at the time of surgery. The SCOUT localization system with the SAVI reflector is non-radioactive and completely internal so can be placed into an abnormal lymph node prior to chemotherapy treatment, which theoretically will allow easier identification and therefore more reliable targeting of the abnormal lymph node for surgical removal.

PRIMARY OBJECTIVES:

I. Percentage of patients with successful retrieval of the reflector confirmed by specimen radiography.

II. Percentage of patients with successful retrieval of the biopsied node, confirmed by presence of clip, biopsy changes or treatment-related changes on pathology.

SECONDARY OBJECTIVES:

I. Total number of lymph nodes removed. II. Percentage of patients in which clipped node was a sentinel node. III. Percentage of patients with nodal pathologic complete response (PCR). IV. Residual cancer burden (RCB) score for patients with residual nodal disease.

V. Percentage of patients requiring axillary dissection. VI. Days prior to surgery of reflector insertion.

OUTLINE:

Patients undergo image-guided placement of the SCOUT reflector prior to course 2 of standard of care neoadjuvant chemotherapy. Patients undergo standard of care surgery approximately 4-8 weeks after chemotherapy completion.

Eligibility Criteria:
Inclusion Criteria:

* Able to give written informed consent to participate in the study
* Patients with a breast cancer diagnosis of any subtype and a biopsy-proven positive axillary lymph node who will be treated first with chemotherapy
* Enlarged lymph node and/or clip targetable with image guidance
* Patients who are eligible for surgical resection of the primary breast cancer and targeted dissection of the axilla

Exclusion Criteria:

* More than 3 positive axillary nodes on imaging or matted nodes on clinical exam
* Stage IV breast cancer
* Pregnant or lactating females
* Patients with inflammatory breast cancer
* Patients with allergies to isosulfan blue or technetium, which would preclude sentinel node mapping
* Patients who have had previous axillary surgery, including sentinel lymph node biopsy
Chest Wall Influence on Respiratory System Mechanics in Morbidly Obese Patients

The goal of this study is to describe the influence of the chest wall on the respiratory system mechanics in morbidly obese patients and in patients with high intra-abdominal pressure.

The effects of increasing and decreasing positive end-expiratory pressure (PEEP) on chest wall and total respiratory system mechanics, lung volumes and gas exchange will be evaluated, both during controlled and assisted mechanical ventilation.

Patients will be studied, first, during the acute phase of respiratory failure, when requiring intubation and controlled mechanical ventilation. Then, patients will be evaluated again during weaning from the ventilator to assess the influence of PEEP in assisted ventilation prior to extubation.

The goal of this study is to describe the influence of the chest wall on the respiratory system mechanics. Investigators want to describe how extreme obesity and Intra-Abdominal Hypertension (IAH) affect normal respiratory system behavior. The effects of increasing and decreasing positive end-expiratory pressure (PEEP) on respiratory system mechanics, lung volumes and gas exchange will be evaluated, both during controlled and assisted mechanical ventilation.

Investigators will record and compare lung volumes, airway and transpulmonary pressure, gas exchange and hemodynamic changes caused by variations of PEEP. Patients will be studied, first, during the acute phase of respiratory failure, when requiring intubation and controlled mechanical ventilation. Patients will then again be evaluated during weaning from the ventilator to assess the influence of PEEP in assisted ventilation prior to extubation.

Investigators believe that assessment of the transpulmonary pressure and lung volumes is essential to correctly evaluate respiratory system function in patients in which the relationship between the lung and chest wall is altered. Improper mechanical ventilation leads to lung damage. High ventilatory volume/pressure are associated with lung overdistension, while low volume/pressure leads to lung collapse and cyclic opening and closing of alveoli. All of these mechanisms have been associated with ventilator induced lung injury and poorer outcomes. Adequate PEEP and transpulmonary pressure are fundamental in preventing this vicious cycle.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Requiring intubation and mechanical ventilation
* BMI≥40 kg/m2 or IAP≥12 mmHg

Exclusion Criteria:

* Known presence esophageal varices
* Recent esophageal trauma or surgery
* Severe thrombocytopenia (PTL≤10,000/mm3)
* Severe coagulopathy (INR≥2)
* Presence of pneumothorax
* Pregnancy
* Patients with diagnosed moderate to severe ARDS or with poor oxygenation index (PaO2/FiO2 \< 200 mmHg)
Long-Term Study of Multi-target Therapy as Maintenance Treatment for Lupus Nephritis

An multi-site, randomized, prospective study to compare the efficacy and safety of multi-target therapy as continuous induction and maintenance treatment versus CTX- Aza therapy.

Azathioprine (AZA) has been used for maintenance therapy of lupus nephritis for many years. We compare the efficacy and safety of multi-target therapy as continuous induction and maintenance treatment vs CTX-Aza.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who signed written informed consent form
2. SLE patient, aged between 18-65 years, female or male;
3. Patients diagnosed lupus nephritis according to ISN/RPS 2003 classification criteria, class Ⅲ, Ⅳ,Ⅳ+Ⅴ, Ⅲ+Ⅴ or Ⅴ LN by renal biopsy
4. All patients had received induction therapy for 6 months with multi-therapy (FK506 + MMF) or intravenous CTX pulses.
5. Patients were recruited when received partial remission or complete remission after 6 months induction therapy.

Complete remission: proteinuria \<0.4 g/24h, negative urine sediment, serum albumin \>35 g/L, elevated scr \<0.3mg/dl, no extra-renal complications; Partial remission: proteinuria \<1.0 g/24h, urine RBC \<50X104/ml without casts, serum albumin \> 30 g/L, elevated Scr \<0.3mg/dl,no extra-renal complications.

Exclusion Criteria:

1. Patients who didn't sign written informed consent form or could not obey the protocol.
2. Patients who didn't received the CR or PR criterion.
3. Patients who have impaired liver function, with ALT/GPT or AST/GOT twice more than the normal upper limit or who have active hepatitis.
4. WBC \<3000/mm3 in peripheral blood .
5. Patients with central nervous system symptoms. -
20- Versus 23- Gauge System for Pars Plana Vitrectomy

The aim of the present study is to compare the functional and clinical differences and advantages between a standard operating system and a newly developed even smaller system for pars plana vitrectomy.

The present study may work out the possible advantages and disadvantages between the routinely used 20-gauge vitrectomy system and the newly developed 23-gauge device.

60 patient randomized into 2 groups of 30 each. All of them operated in general anesthesia, vitrectomized and cataract extracted by phacoemulsification if indicated. Preoperative and postoper5ative controls at days 1,2,3 and week 1, month 1,3 and 12 performed. Parameters of interest are: postoperative conjunctival injection, pain, eye pressure, complications intra- and postoperative as well as the durations of surgery divided into opening time, vitrectomy time, retinal manipulation time, closing time.

Eligibility Criteria:
Inclusion Criteria:

* Over 18 years of age
* Written form of consent
* Vitreous and retinal pathologies requiring surgery

Exclusion Criteria:

* Previous history of vitreous or retinal surgery
* Pregnant or breastfeeding women
* Prohibiting general medical conditions or diseases
* No informed consent signed
* Under 18 years of age
Trapeziometacarpal Prosthesis vs. Resection-Interposition Arthroplasty

Rhizarthrosis is a frequently occurring pathology leading to severe limitations in daily life due to pain and loss of function. Good clinical results have been reported for some carpometacarpal (CMC) joint prosthesis designs, but high failure rates due to loosening and dislocation must be considered. The study aim was to investigate a new, double mobility CMC-prosthesis design with special focus on (1) the functional outcome and (2) patient quality of life (QOL)

The Epping resection-suspension arthroplasty procedure was described in 1983 to address the proximal migration of the first ray while providing pain free grip strength without any implants. It has shown rather good functional outcome and pain relief. A reduction in thumb opposition strength of 27% compared to the contralateral side and intermittent pain in physical activity is reported, however. Further, studies comparing trapeziectomy and trapeziectomy with tendon interposition recommend trapeziectomy due to the simple technique and comparable outcome.

Endoprosthesis of the first carpometacarpal (CMC) joint represents a different treatment strategy aiming at an exact reconstruction of the joint geometry. Some studies report excellent functional outcome and pain relief. However, there are some prosthesis designs (cemented and uncemented) with high rates of loosening, luxation and poor subjective results. To address these issues, a prosthesis was designed combining a cylindric, double mobility cup and a hydroxyapatite covered stem and cup available in different sizes. The aim of this study was to compare this new prosthesis design to the Epping arthroplasty as the current standard in the investigator's institution regarding (1) the functional outcome with special focus on mobility and strength and (2) patient quality of life (QOL) and pain relief.

Note: The registration of this trial on Clinicaltrials.gov was carried out retrospectively after primary completion of the study.

Eligibility Criteria:
Inclusion Criteria:

* symptomatic rhizarthrosis grade 2 and 3 according to Eaton's classification,
* failed conservative treatment prior to surgery,
* written informed consent to the study.

Exclusion Criteria:

* scaphotrapezotrapezoidal (STT) arthrosis,
* former CMC joint surgery,
* patients under custodianship.
Vitamin D3 Supplementation and Stress Fracture Occurrence in High-Risk Collegiate Athletes

The main objective of this study is to find a correlation between vitamin D deficiency and stress fracture occurrences in athletes who participate in high-risk activities. These high-risk athletes undergo elevated bone turnover, which requires adequate levels of vitamin D in order to support bone health. It is hypothesized that providing supplemental treatment to athletes showing lower than normal serum vitamin D levels will decrease the occurrence of stress fractures. By recording the dates and specific occurrences of fractures, it may be possible to correlate injury rates with seasons, providing more supportive data to pre-existing literature.

This area of research is lacking in the quantity of prospective studies. Previous studies primarily focus on adolescent, elder, or military recruit populations. While literature has shown that vitamin D plays an important role in bone health, there are no previous studies that directly examine vitamin D deficiency and supplemental treatment in conditioned collegiate athlete populations. This study will add to the existing knowledge and will provide a more specific analysis for athletes.

This study will focus on athletes who are at a higher risk of lower extremity stress fractures. Specifically, this study will be looking at male and female athletes on the track, cross-country, soccer, and basketball teams at the University of South Carolina. During the pre-season physical of each student athlete, serum vitamin D levels will be taken and recorded. There will be a certified nurse to draw the blood samples. This will take place at the University of South Carolina Athletic Department and/or the Palmetto Health Lab at 2 Medical Park. Potentially, every athlete of the given teams will be enrolled in the study unless they choose not to. Only subjects showing concentrations below 30 ng/mL, which is indicative of insufficient or deficient levels, will be provided supplemental treatment of 25-(OH) vitamin D. Every enrolled subject will be monitored for injury throughout the season. Any and all injuries will be positively identified, and any confirmed stress fractures will be recorded. Data from prospective seasons will be compared to an incidence percentage of athletes from previous seasons. Previous athletes did not receive any vitamin D treatment. These will be used as a control to determine if treatment affected the occurrence of stress fractures. All physicals and tests will be performed at the University of South Carolina Sports Medicine clinic by the sports medicine staff.

Eligibility Criteria:
Inclusion Criteria:

* Athlete on one of the following teams at local University: Men/Women Track and Field, Soccer, Basketball, and Women's Cross Country.

Exclusion Criteria:

* Athlete currently diagnosed with a stress fracture
* Athlete recovering from a lower extremity musculoskeletal injury
Supporting Patient Decisions About UE Surgery in Cervical SCI

The goal of this study is to collect and describe patient and caregiver reported outcomes regarding surgical and non-surgical treatment for improving hand and arm function in the setting of cervical spinal cord injury. Eligible study participants will be recruited across the 4 sites and the investigators plan to recruit the following groups and numbers of participants:

1. Nerve or tendon transfer recipients: people who have elected to undergo nerve (N=10) or tendon (N=10) transfer surgery to restore some hand and arm function as part of their standard clinical care and their caregiver (N=20)
2. Non-surgical control group: people with cervical SCI (N=20) and their caregiver (N=20)

At present, there is limited information that provides the exact time course and probability of gain in specific function (such as hand function) that might help patients and clinicians make decisions regarding novel and time-sensitive surgical treatment options.

Understanding the pros and cons of any surgical intervention, especially in the setting of complex and often incomplete information, is challenging. Ultimately, this project will create a decision support intervention (DSI) that can be used to help clinicians and people living with cervical level SCI and their caregivers. It will be most useful to those with acute or sub-acute injury (\< 1year after SCI) for both military personnel and the general public. Clinicians and patients will have evidence to help them make decisions about treatments to improve upper extremity function.

In such a manner, patients can make more well-informed choices that are consistent with their values, needs and goals.

Eligibility Criteria:
CERVICAL SPINAL CORD INJURY PARTICIPANTS

Inclusion criteria:

* Adult subjects (≥18 years and \< 80 years) with cervical level SCI ASIA A, B or C (minimum 6 months and maximum 20 years post-injury).

Exclusion criteria:

* Patient who chooses simultaneous tendon and nerve transfer procedure (this would preclude separation of the influence of one surgery compared to the other)
* Patient has ASIA D status (these patients may have progressive return of functionally useful motor function below the level of the SCI and would not routinely be offered acute surgical intervention and their experiences are less-relevant to the target patient population).

CAREGIVER PARTICIPANTS

Inclusion criteria:

* At least 18 years of age
* Able to answer questions about the primary participant's experiences with cervical spinal cord injury

Exclusion criteria:

* The caregiver/spouse declines to participate in the study. Note: Caregiver participation is preferred, but not required, for SCI participant enrollment.
Anti-COVID-19 Vaccine Side Effects

In 2021 and following the COVID-19 (corona virus disease 2019) pandemic, different vaccines were initially authorized in Italy and Lebanon. Notably, vaccine side effects were poorly recorded. Thus, the investigator performed a survey study to monitor COVID-19 vaccine side effects among Italian and Lebanese citizens according to gender and age through a web-based questionnaire in Italian and Arabic languages including 21 items by "Google Form", investigating 13 symptoms, and employing social-media platforms

The COVID-19 pandemic has presented a real challenge to the public health system worldwide since the year 2019, spreading to more than 200 countries and regions worldwide.The emergence and rapid spread of COVID-19 were caused by the coronavirus SARS-CoV-2. Worldwide, the use of COVID-19 vaccines was initially authorized for emergency use and the side effects were not stated clearly. Common side effects were expected but specific side effects linked with COVID-19 vaccines remained uncertain. In this context, survey studies are needed for a comprehensive evaluation of the relationships between vaccine administration, related undesired effects and vaccine safety.

This study represents the first survey following early COVID-19 vaccines administration in two geographic areas, comparatively considering possible differences due to gender and age. A web-based survey was conducted on a cohort of 1975 Italian and 822 Lebanese people who received at least one dose of COVID-19 vaccine. The study was conducted between March and July 2021 on a voluntary basis, and by a tailored anonymous web-based questionnaire. The protocol was approved by the local Ethics Committee, University of Bari 'Aldo Moro' (study number 6752, protocol number 0031044). A specific questionnaire was designed in English and translated into Italian and Arabic. It contains 21 items including demographic data, the history of vaccine administration before COVID-19, the administration of the first and second dose of COVID-19 vaccine, and possible adverse effects.

The survey link was shared by a "Google Form" employing social-media platforms or by personal interview.

The questionnaire explored the presence of 13 possible symptoms appearing following the administration of the first and second dose of COVID-19 vaccine: pain at the injection site, redness at the injection site, swelling at the injection site, induration at the injection site, allergic-urticarial reaction, anaphylaxis, fever (\>37 °C), diarrhea, vomiting, asthenia/fatigue, muscle pain, rash, sleepiness/insomnia, irritability/nervousness, headache, lymphadenopathy. The presence and intensity of symptoms were assessed semi-quantitatively by a Visual Analogue Scale (VAS). Besides symptoms, the following aspects were also evaluated: need of drug intake, consultation of a doctor, emergency admission to hospital, and possible hospitalization.

Eligibility Criteria:
Inclusion Criteria:

* Anti-COVID-19 vaccine

Exclusion Criteria:

* Subjects who living outside Italy or Lebanon
RW Study of Adjuvant Radiotherapy in Locally Advanced Thyroid Cancer

This study is a real-world study to observe the role of adjuvant radiotherapy in locally advanced recurrent high-risk thyroid cancer. The study included thyroid cancer that requires adjuvant radiotherapy to increase local control rate, excluding undifferentiated cancer. Local-regional recurrence free survival is the primary endpoint of the study.


Eligibility Criteria:
Inclusion Criteria:

* Patients voluntarily join this study and sign an informed consent form;
* Age: ≥ 14 years old,\<80 years old, male or female not limited;
* Thyroid cancer diagnosed by histopathology, including differentiated thyroid cancer, medullary carcinoma, poorly differentiated carcinoma, etc;
* High risk of local late recurrence, meeting any of the following criteria:

  1. The surgery did not achieve R0 resection;
  2. After neoadjuvant therapy;
  3. Pathological types with poor prognosis, such as poorly differentiated cancer, CASTLE, etc;
  4. Thyroid cancer with obvious extracapsular invasion, invading important structures such as the esophagus, trachea, and recurrent laryngeal nerve, requiring adjuvant radiotherapy;
  5. For patients with distant metastasis, researchers need to determine the value of local treatment;
* The main organ functions are normal;
* Good compliance and cooperation with follow-up.

Exclusion Criteria:

* Untreated thyroid cancer or thyroid cancer that has only undergone surgical biopsy;
* Within 5 years or simultaneously suffering from other active malignant tumors. Cured local tumors, such as skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, prostate carcinoma in situ, cervical carcinoma in situ, breast carcinoma in situ, can be included in the group;
* Previously received radiation therapy for the head and neck area;
* Pregnant or lactating women;
* There are other physical illnesses that affect patients' ability to receive standard treatment;
* According to the researcher's judgment, there may be other factors that could force the subject to terminate the study midway, such as suffering from other serious illnesses (including mental illnesses) that require concurrent treatment, severe abnormal laboratory test values, family or social factors that may affect the subject's safety or the collection of trial data;
* Individuals with claustrophobia who are unable to undergo radiation therapy;
* Other patients deemed unsuitable for inclusion by the treating physician.