cyrilzakka/clinical-trials huggingface dataset:
Plasma Exosomes Reveal the Efficacy of Targeted Therapy in Patients With EGFR Mutation in Lung Adenocarcinoma

The objective of this observational study is to explore the therapeutic trajectory of targeted therapy in lung adenocarcinoma patients with epidermal growth factor receptor (EGFR) mutations. The main objective is to identify potential biomarkers that can predict the efficacy of targeted therapy through plasma exosomes and to explore strategies to reverse drug resistance to targeted therapy. Biological specimens and medical imaging data will be collected from patients already receiving targeted therapy as a first-line treatment, and followed-up will be conducted to analyze prognosis based on different patterns.

The medical imaging data will be collected retrospectively and prospectively, and the blood samples and tumor tissues will be collected prospectively.

Eligibility Criteria:
Inclusion Criteria:

* Pathological examination confirmed lung adenocarcinoma
* No other type of tumor was present
* Common sensitive EGFR (Ex19Del L858R or combined with other sites) mutations have been identified
* Receive targeted therapy with or without chemotherapy as first-line treatment
* ≥ 18 years and ≤80 years old

Exclusion Criteria:

* History of other malignant tumors
* Irregular treatment or poor compliance
* Incomplete clinical information or lost to follow-up
Study of Magrolimab Combination Therapy in Patients With Head and Neck Squamous Cell Carcinoma

The goals of this clinical study are to learn about the safety, tolerability, dosing and effectiveness of the study drug, magrolimab in combination with other anticancer therapies in patients with head and neck squamous cell carcinoma (HNSCC).


Eligibility Criteria:
Key Inclusion Criteria:

* Histologically or cytologically confirmed metastatic or locally recurrent HNSCC that is considered incurable by local therapies.

Safety Run-in Cohort 1 and Phase 2 Cohorts 1

* Should not have had prior systemic therapy administered in the recurrent or metastatic setting.
* Eligible primary tumor locations include oropharynx, oral cavity, hypopharynx, and larynx. Nasopharynx is not included.
* HNSCC per protocol specified inclusion criteria regardless of PD-L1 status.

Safety Run-in Cohort 2 and Phase 2 Cohort 3

* Histologically or cytologically confirmed locally advanced/mHNSCC regardless of PD-L1 status with at least 1 and no more than 2 lines of prior systemic anticancer therapy in the locally advanced/metastatic setting.

Key Exclusion Criteria:

* Active central nervous system (CNS) disease (individuals with asymptomatic and stable, treated CNS lesions who have been off corticosteroids, radiation, or other CNS-directed therapy for at least 4 weeks are not considered active).
* History of (noninfectious) pneumonitis that required steroids or current pneumonitis.
* Progressive disease within 6 months of completion of curatively intended treatment for locally advanced/mHNSCC.

Safety Run-in Cohort 1, Pre-expansion Safety Run-in Cohort for Magrolimab + Pembrolizumab (if Applicable), and Phase 2 Cohorts 1 and 2

* Prior treatment with any of the following:

  * Anti-programmed cell death protein 1 or anti-PD-L1 checkpoint inhibitors.
  * Anti-cytotoxic T-lymphocyte-associated protein 4 checkpoint inhibitors.

Safety Run-in Cohort 2 and Phase 2 Cohort 3

* Prior treatment with a taxane.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Phase 1 Study of Vorinostat and Bortezomib in Multiple Myeloma (MK-0683-015 EXT 1 (AM1))

The purposes of this study are:

* To determine the maximum tolerated dose (MTD) for the combination of oral vorinostat and bortezomib in participants with advanced multiple myeloma
* To assess the safety and tolerability of this regimen and to document the participant's clinical status (by anti-tumor activity) for this combination, as determined per standard of care.


Eligibility Criteria:
Inclusion Criteria:

* Adults with refractory or relapsed multiple myeloma
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 (a measurement to determine participant's ability to perform daily activities)
* Adequate bone marrow reserve
* Adequate hepatic and renal function
* Ability to swallow capsules
* 3 weeks or more since prior chemotherapy and have recovered from prior toxicities

Exclusion Criteria:

* Participants who plan to have a bone marrow transplant within 4 weeks of start of treatment
* Participants with prior treatment with other investigational agents with a similar anti-tumor mechanism
* Participants with other active/uncontrolled clinically significant illness
* Pregnant or nursing female participants
* Participants who received bortezomib within 3 months of start of this trial
Treatment of Chronic GVHD of Liver or Lungs by ECP

Chronic graft-versus-host disease (GVHD) is a major complication of allogeneic hematopoietic stem cell transplantation and the leading cause of death more than 2 years after transplantation.During the past 30 years survival of patients with chronic GVHD has not improved and steroids remained the most often used therapy. Extracorporeal photoimmunotherapy (ECP)has shown to be efficacious in patients with GVHD. We propose a phase II study to evaluate the safety and efficacy of ECP as adjunct first-line therapy in patients with newly diagnosed chronic GVHD of liver or lungs and need for systemic immunosuppression defined according to the NIH consensus criteria.


Eligibility Criteria:
Inclusion Criteria:

* Presence of at least one diagnostic clinical sign of chronic GVHD or an appropriate constellation of distinctive signs confirmed by biopsy or other relevant diagnostic tests
* Presence of liver or lung manifestations of chronic GVHD
* Indication for systemic immunosuppressive therapy defined according to NIH consensus
* No prior immunosuppressive therapy for chronic GVHD of the liver or lungs
* Adequate renal, hepatic, pulmonary and cardiac function
* Karnofsky performance score \>- 50%
* Women of childbearing potential must agree to use a reliable method of birth control for the duration of the study
* Signed written informed consent

Exclusion Criteria:

-
Distal Radius Fractures in Patients Over 70 Years - Volar Plate or Plaster

Distal radius fractures with dorsal dislocation among patients 70 years or older are randomized to conservative treatment with plaster or internal fixation with a volar plate. Thereafter they are followed at 2 weeks, 5 weeks, 3 months and 12 months with x-ray, functional scores and clinical examination.

An additional follow up at three years with X-ray, functional scores and clinical outcome will be conducted after a new written consent of continued participation in the study.

A health economy analysis will be preformed at 1, and 3 years for the participants with complete EQ5D.


Eligibility Criteria:
Inclusion Criteria:

* Dorsally displaced, 20 degrees or from a plane perpendicular do the diaphyseal axis, fracture.
* Low energy injury
* Patient 70 years old or older
* 72 hours or less since injury at time of diagnosis
* Patient registered in the Stockholm region
* Patient understands spoken and written swedish

Exclusion Criteria:

* Intraarticular displacement in radiocarpal joint of more than 1 mm
* Ulna fractured proximal to the base of the styloid process of ulna
* Earlier unilateral functional impairment of hand/wrist
* Injury to tendon, nerve or skin besides the fracture
* Rheumatoid arthritis or other severe systemic joint disease
* Severe psychiatric disorder, ongoing drug abuse or dementia (Pfeiffer score 5 points or less)
* Besides the wrist fracture also other big injuries, for example fracture of hip, shoulder or ankle
* Medical illness that makes general anesthesia impossible
Relation of Implantation Site to Placental Site

Trans vaginal ultrasound with a partially full bladder will be done at gestational age earlier than 10 weeks to assess the site of intrauterine gestational sac to the endometrial cavity and the distance between the implantation site and the internal cervical os . Doppler assessment of the retrochorionic blood flow at the area behind the maximum chorionic tissue to detect resistance index.


Eligibility Criteria:
Inclusion Criteria:

* Single intrauterine pregnancy
* Gestational age less than 10 weeks

Exclusion Criteria:

* Any condition distorting uterine cavity as myoma, uterine anomalies.
* Absent fetal pulsations
* Any condition needing termination of early pregnancy as molar pregnancy or severe deteriorating maternal disease
Effect of Oxytocin Massage and Music on Breastfeeding

The aim of this study is to examine the effect of oxytocin massage and music performed immediately after birth on breastfeeding.


Eligibility Criteria:
Inclusion Criteria:

* mothers who are 20 years or older,
* Primiparous delivery,
* Single fetus pregnancy,
* Born at term (38-42 weeks of gestation),
* Your baby's Apgar score is at least 8 points in the 5th minute,
* Being literate,
* Interviewed on the first day after birth,
* Does not have a problem that prevents breastfeeding,
* No complications during and after birth,
* Staying in the same room with her baby after birth,
* There is no health problem that may affect the baby's suckling,
* Those who become pregnant by normal means (without IVF, IVF, etc.),
* Babies with a birth weight of more than 2500,
* Mothers without chronic disease,
* Non-smoking mothers,
* Mothers who do not give formula to their babies

Exclusion Criteria:

* The mother/baby has a serious health problem that prevents breastfeeding,
* Absence from education for at least two sessions,
* Women with a known disease (HIV, hepatitis B, hepatitis C, etc.) known to be transmitted through breast milk will be excluded from the study.
Spinal Anesthesia and Peri-operative Opioid Consumption in Open Abdominal Prostatectomy

Retrospective analysis to assess the impact of spinal anesthesia on peri-operative opioid consumption during open abdominal prostatectomy. The authors compare the group that had spinal anesthesia in combination with propofol sedation and a laryngeal mask to the second group that underwent the same procedure in general anesthesia with tracheal intubation.

Retrospective analysis to assess the impact of spinal anesthesia on peri-operative opioid consumption during open abdominal prostatectomy. The authors compare the group that had spinal anesthesia in combination with propofol sedation and a laryngeal mask to the second group that underwent the same procedure in general anesthesia with tracheal intubation.

...

Eligibility Criteria:
Inclusion Criteria:

* elective, radical abdominal prostatectomy
* \>18 years

Exclusion Criteria:

* chronic pain therapy (e.g. out-of-hospital opioid therapy)
* laparoscopic approach
RWS of Paclitaxel Liposome Combined With Anti-HER-2 Monoclonal Antibody

This is a retrospective, single-arm real-world study based on the National Anticancer Drug Clinical Application Monitoring Network database.The aim of this study is to evaluate the efficacy and safety of paclitaxel liposome combined with anti-HER-2 monoclonal antibody as first-line salvage treatment for HER-2 positive advanced breast cancer. It seeks to understand the application patterns, efficacy, and safety of paclitaxel liposome combined with anti-HER-2 monoclonal antibody in real-world settings, providing patients with safer treatment options.

The National Anticancer Therapy Data Surveillance System (NATDSS) is the largest oncology diagnosis and treatment database in China to date, covering patient data from over 1400 oncology hospitals and integrated hospitals. It has collected data from approximately 15 million cancer patients since 2013, including mortality information obtained from the CDC death registration database.

Paclitaxel liposome was introduced to the market in 2004 as a formulation of paclitaxel. It utilizes nanotechnology to encapsulate the poorly water-soluble paclitaxel within a lipid bilayer of liposomes, solving the issue of paclitaxel\&amp; low solubility in water. Paclitaxel liposome no longer employs polyoxyethylated castor oil as a solvent. While ensuring efficacy, it reduces the risk of associated adverse drug reactions (such as severe allergic reactions), thereby enhancing the tolerance of cancer patients.

Although paclitaxel liposome is widely used in HER-2 positive advanced breast cancer, there is currently no research on the efficacy and safety of combining paclitaxel liposome with anti-HER-2 monoclonal antibodies as first-line salvage treatment of HER-2 positive advanced breast cancer.

This study aims to conduct a real-world study on the efficacy and safety of combining paclitaxel liposome with anti-HER-2 monoclonal antibodies as first-line salvage treatment of HER-2 positive advanced breast cancer based on the NATDSS

Eligibility Criteria:
inclusion criteria:

1. Patients with unresectable or metastatic HER-2 positive breast cancer (immunohistochemistry 3+ or FISH positive) have received at least 2 cycles of salvage treatment with paclitaxel liposome in combination with anti-HER-2 therapy (monotherapy or dual-targeted therapy) ± other chemotherapy drugs (such as capecitabine, carboplatin, gemcitabine) as first-line treatment.
2. Patients with no visceral metastases, but only have bone metastases or multiple lymph node metastases are eligible for inclusion.
3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2. Expected survival of at least 3 months.

exclusion criteria：

1. Accompanied by other secondary malignant tumors.
2. Male breast cancer or bilateral breast cancer.
3. brain metastasis
Cognitive Remediation and Social Skills Training in Schizophrenia

The purpose of this study is to examine whether patients who participate in cognitive remediation prior to a skills training program learn and perform the skills better than patients who do not participate in cognitive remediation.

Subjects are 40 stable outpatients with schizophrenia or schizoaffective disorder who are receiving medication and routine follow-up care at community clinics in San Antonio, Texas.

Patients receive baseline assessments and then are randomly assigned to either Cognitive Remediation (CR) or Keyboarding Skills (KS) for a period of 8 weeks. Following 8 weeks of treatment in either CR or KS, all patients participated in Social Skills Training (SST) for a period of 8 weeks. Assessments conducted by raters blinded to treatment condition are repeated following either remediation or control treatment, and again following SST.

Treatment groups Cognitive Remediation (CR) -- The CR program is based upon teaching techniques developed within educational psychology that promote intrinsic motivation and task engagement. The program uses existing computer software packages (e.g., Oregon Trail) with engaging story lines or activities, and built-in reinforcement of correct responses to help patients with schizophrenia develop attention, memory, planning, and problem-solving skills. CR is delivered in a computer lab setting with a facilitator present to assist patients.

Keyboarding Skills (KS) -- Control Treatment: The control treatment is an engaging self-paced software program designed to teach typing skills. KS is delivered in a computer lab setting with a facilitator present.

Both the KS and CR are administered in small groups of three to five patients each.

Social Skills Training (SST) -- SST is a manual-driven, behavioral rehabilitation program teaching basic conversation and social problem-solving skills (Bellack et al., 1997). SST runs for 8 weeks and is conducted in small groups that meet twice weekly.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of schizophrenia/schizoaffective disorder
* currently receiving treatment with an atypical antipsychotic medication
* between the ages of 18 and 60 years
* speak English as their primary language
* has at least a 6th grade level of reading (WRAT) Exclusion Criteria
* no current diagnosis of substance abuse or dependence
* no documented history of head injury, epilepsy or mental retardation.
Feasibility Clinical Investigation Using the InPress Device for the Treatment of Postpartum Hemorrhage

Feasibility trial of the InPress Device to treat postpartum hemorrhage (PPH).

10 subjects in first in woman trial with ethics committee oversight. Women who developed postpartum hemorrhage were treated with the InPress Device. The intent of treatment was to quickly reduce or stop blood flow by addressing the driving cause of hemorrhage: uterine atony.

The primary objective is to verify the safety of the InPress Device in humans, including: 1. Absence of SAEs related to the use of the InPress Device intra- and post-procedure. 2. Evaluate any observable damage of the uterus, cervix, or vagina due to the use of the InPress Device. 3. Evaluate occurrence of uterine inversion or folding during the use of the InPress Device.

The secondary objectives include evaluations of: 1. Ability to easily place the InPress Device transvaginally. 2. Ability to connect the InPress Device to vacuum and maintain desired negative pressure. 3. Ability of InPress Device to contract the uterus to a level that reduces or stops blood loss and avoids further surgical intervention. 4. Evaluate time from insertion and start negative pressure to visible reduction of blood loss.

Eligibility Criteria:
Inclusion Criteria:

* Subject or her legally authorized representative is able to understand and provide consent to participate in the clinical investigation
* Female adult subjects (\>18 years of age)
* Subjects who present with an atonic uterus for at least 10 minutes after expulsion of placement with failure to obtain contraction and/or Subjects who have lost blood post-partum \>= 500 ml and according to the Investigator's judgment, require an intervention.

Exclusion Criteria:

* Subjects who do not provide informed consent to participate in the clinical investigation.
* Subjects who deliver at a uterus size \< 34 weeks.
* Subjects who have lost greater than 1000 ml of blood.
* Subjects who have abnormal PT, PTT and INR
* Subjects who present with retained placenta, uterine lacerations, or for any other conditions outside of atonic post-partum hemorrhage.
Development of Perioperative Delirium Prediction Model

Postoperative delirium is an acute organic brain dysfunction that is commonly observed following cardiovascular surgery. It presents with acute and fluctuating changes in the level of consciousness, resulting in impaired cognitive function and perception. The incidence of delirium following cardiac surgery has been reported to range from 11.4% to 55%. In light of the challenges associated with treating delirium once it has manifested, it is imperative to prioritise the early recognition and prevention of this condition. The objective of this study was to develop a perioperative delirium risk prediction model for patients undergoing cardiovascular surgery.

Postoperative delirium is associated with an increased incidence of postoperative complications, which in turn lead to cognitive dysfunction, increased mortality, and the need for long-term care. It is predicted in the literature that the early detection of delirium cases, of which 30% are known to be preventable, improves prognosis. Accordingly, a prediction model based on the identification of delirium risk factors can categorise intensive care patients into distinct risk levels according to their probability of developing delirium, thus enabling healthcare professionals to ascertain the likelihood of delirium and implement suitable preventive measures. A review of the literature reveals the existence of numerous delirium prediction models designed to identify patients at high risk of developing delirium. However, there is a paucity of studies examining models for predicting delirium risk in the context of cardiovascular surgery. The objective of this study is to develop a delirium risk prediction model for the perioperative period in patients undergoing cardiovascular surgery.

Eligibility Criteria:
Inclusion Criteria:

* Over 18 years old
* Previous cardiovascular surgery
* No mental deficiency and visual and hearing impairment
* Participants' acceptance to participate in the research
* The patient is not in coma (RASS score between -3 and +4, GCS score of 10 and above)

Exclusion Criteria:

* Cardiovascular surgery under emergency conditions
* Being diagnosed with delirium, dementia, psychiatric illness and taking medication for this reason before the surgery
* Serious conditions such as cardiopulmonary resuscitation during surgery
* Alcohol and drug addiction
* Duration of mechanical ventilation exceeding 36 hours
* Dying in the intensive care unit within 24 hours
Gaming Technology to Encourage Healthy Weight and Activity in Youth

The goal of the proposed randomized controlled trial is to test the efficacy of exergaming (i.e. video gaming that involves physical activity) to reduce adiposity in overweight and obese children.

The GAMESQUAD study is a 6-month, 2-arm randomized controlled trial among 46 overweight/obese children (aged 10 to 12 years) assigned to: 1) 3 hours/week of in-home exergaming or 2) a control group. An innovative aspect is the inclusion of a fitness trainer who will regularly video chat with the participant and virtually monitor gameplay. The study will advance the field by: 1) establishing the efficacy of exergaming to reduce BMIz among overweight and obese children and 2) demonstrating the potential of exergaming to reduce body fat and improve children's cardiovascular health.

Eligibility Criteria:
Inclusion Criteria:

* BMI percentile \> or equal to 85 on the CDC growth chart
* Participating household has a high-speed internet connection
* At least 1 family member or friend who is willing to exergame in the home with the participant for 3 hours/week

Exclusion Criteria:

* Pregnant
* Impairments that prevent normal ambulation
* Previous history, or current symptoms of, cardiovascular disease, musculoskeletal injury, or epileptic seizures
Improving Management of Patients at High Risk for Osteoporotic Fractures (0000-038)

The purpose of this study is to assess the impact of disease management interventions on percent receiving a bone densitometry test and percent appropriately prescribed a medication for osteoporosis.


Eligibility Criteria:
Inclusion Criteria:

* Members of the Horizon Blue Cross Blue Shield of New Jersey who are at risk for osteoporosis based on age (women age 65 or older, men and women age 45 or older who have a history of fragility fracture or have a history of taking oral glucocorticoids over 3 months).

Exclusion Criteria:

* Individuals who are not members of Horizon Blue Cross Blue Shield of New Jersey and who otherwise do not meet the inclusion criteria.