cyrilzakka/clinical-trials huggingface dataset:
Bone Metastasis and Surgery in Breast Cancer

A registry trial evaluating resection of the primary breast tumor in women presenting with de novo stage IV breast cancer with bone metastasis only. Previous reports of carefully selected patients presenting with stage IV breast cancer suggest that surgery on the primary tumor may result in improved survival, but this remains unproven. The early results of our ongoing trial MF07-01 trial (a phase III randomized controlled trial of breast cancer women with distant metastases at presentation who receive loco-regional treatment for intact primary tumor compared with those who do not receive such treatment) showed that patients with bone metastasis only have a trend toward improved survival with initial surgery.

This registry trial evaluating resection of the primary breast tumor in women presenting with de novo stage IV breast cancer with bone metastasis only. Previous reports of carefully selected patients presenting with stage IV breast cancer suggest that surgery on the primary tumor may result in improved survival, but this remains unproven. The early results of our ongoing trial MF07-01 trial (a phase III randomized controlled trial of breast cancer women with distant metastases at presentation who receive loco-regional treatment for intact primary tumor compared with those who do not receive such treatment) showed that patients with bone metastasis only have a trend toward improved survival with initial surgery. Our goal is to test if primary surgery improves overall survival in bone only metastasis.

Eligibility Criteria:
Inclusion Criteria:

* Primary breast tumor amenable for complete surgical resection
* Patients in good physical condition for receiving protocol driven locoregional and systemic treatment
* Patients eligible for sentinel lymph node (SLN) biopsy and receiving radiotherapy.

Exclusion Criteria:

* Primary tumor not amenable for complete resection (such as tumor extending to neighboring tissues; T4a,c or inflammatory breast cancer; T4d)
* Primary tumor with extended infection, bleeding, or necrosis
* Patients with poor physical condition which prevents the patient from receiving protocol driven locoregional and systemic treatment
* Synchronous primary cancer at the contralateral breast
* Previous diagnosis of other cancers (excluding basal cell skin cancer
* Squamous cell skin cancer
* Cervical intraepithelial neoplasia)
* Clinically involved contralateral axillary nodes
* Patients not suitable for adequate follow-up
* Failure to give informed consent
Efficacy and Safety Evaluation of PD1-BCMA-CART

This trial aims to evaluate the safety and efficacy of PD1-BCMA-CART in treating patients with relapsed or refractory multiple myeloma.

Using gene editing, chimeric antigen receptors recognizing BCMA were integrated into subject self-derived T cells to obtain a large number of BCMA-CART by in vitro amplification, and BCMA-CART back into the subjects could identify and kill myeloma cells in the subjects.This open-label, dose-escalation study was designed to evaluate the safety and antitumor efficacy of PD1-BCMA-CART in the treatment of relapsed or refractory multiple myeloma.

Eligibility Criteria:
Inclusion Criteria:

* Have the capacity to give informed consent;
* Confirmed diagnosis of active MM as defined by NCCN and IMWG criteria;
* Have a diagnosis of BCMA+ multiple myeloma (MM), (≥ 5% BCMA+ in CD138+ plasma cells by flow cytometry obtained within 45 days of study enrollment);
* Refractory and relapsed MM patients after \> 2 cycles of induction therapy,or,have relapsed or treatment refractory disease following autologous stem cell transplant (ASCT);
* ECOG score=0-2.
* Subjects according with any of the following options:

  * Age≥50;
  * Failure with separation of T cells during autologous CART processing; or,
  * Failure with expansion of autologous CART; or,
  * The proportion of T cells in PBMC \<10%; or,
  * Won't benefit from autologous CART therapy because of disease progress.

Exclusion Criteria:

* Pregnant or nursing women; Women of reproductive potential must have a negative serum pregnancy test performed within 48 hours of starting conditioning chemotherapy
* Active infection, HIV infection, syphilis serology reaction positive;
* Active hepatitis B, hepatitis C at the time of screening
* Significant hepatic dysfunction as following, SGOT(serum glutamic-oxaloacetic transaminase)\> 5 x upper limit of normal; bilirubin \> 3.0 mg/dL;
* Lymphotoxic chemotherapeutic agents within 2 weeks of leukapheresis
* serious mental disorder;
* With severe cardiac, liver, renal insufficiency, diabetes and other diseases;
* Participate in other clinical research in the past three months; previously treatment with any gene therapy products
* Contraindication to cyclophosphamide or fludarabine chemotherapy
Blood Coagulation Parameters in Patients Receiving Intravitreal Aflibercept for Age-related Macular Degeneration

This study aims to evaluate coagulation parameters in treatment naive patients with neovascular age-related macular degeneration (AMD). Treatment naive patients with neovascular AMD, scheduled to undergo treatment with intravitreal injections of aflibercept will be enrolled in the study. Blood samples will be collected before the first intravitreal injection and at 7 and 30 days after aflibercept administration.

Neovascular age-related macular degeneration is one of the leading causes of severe visual loss in the aging population. Intravitreal anti-VEGF agents constitute the mainstay in the treatment of neovascular AMD.

Aflibercept is a recombinant fusion protein targeting vascular endothelial growth factor A(VEGF A) and placenta growth factor (PlGF), developed for intravitreal administration in conditions such as neovascular age related macular degeneration, macular edema due to retinal vein occlusion, diabetic macular edema or myopic choroidal neovascularization. However, treatment with anti-VEGFs like aflibercept, carries a potential risk of arterial thromboembolic events, including stroke and myocardial infarction.

Eligibility Criteria:
Inclusion Criteria:

* treatment naive patients with neovascular AMD scheduled to undergo treatment with intravitreal aflibercept(IVA) in one eye.

Exclusion Criteria:

* patients under systemic treatment with anti-VEGF agents
* patients under intravitreal anti-VEGF treatment in both eyes
* patients unwilling to return 1 week and 1 month after the first IVA
* patients undergoing dialysis, with chronic liver disease or malignancy, under systemic treatment with nonsteroidal anti-inflammatory drugs or under anticoagulation therapy
* patients with a history of any ATE event during the last 6 months
Effectiveness of Castor Oil in Preventing Formal Induction of Labour in a Tertiary Institution

This study demonstrated that castor oil was effective in reducing the need for formal induction of labour and the administration-delivery interval with minimal maternal side-effects, at an initial dose of 30ml and single repeat dose of 30ml.

Background: Pregnancy extending beyond 42 week is attended by maternal and perinatal complication including death. It is the commonest reason for induction of labour. Various agents have been used to induce labour but it is not without maternal and fetal side effects. Alternative agents such as castor oil have been widely used in clinical practice for induction of labour without any concrete evidence of effectiveness.

Objective: To evaluate the effectiveness of castor oil in the prevention of formal induction of labour amongst pregnant mothers at Alex Ekwueme Federal University Teaching Hospital Abakaliki as well as to evaluate the possible maternal and fetal/ neonatal effects.

Methods: This was a randomized controlled trial among pregnant women at Alex Ekwueme Federal University Teaching Hospital Abakaliki to verify the effectiveness of castor oil in the prevention of formal induction of labour at gestational ages between 41weeks and 0 days and 41 weeks and 2 days. One arm received 30ml of castor oil (Group A) and the other arm received 30ml of water (Group B). These doses were repeated once more after 24 hours if the patients failed to enter spontaneous labour. The data obtained was analyzed using IBM SPSS software (version 24, Chicago II, USA) and the intention to treat concept. A difference with a P value of ≤ 0.05 was taken to be of statistical significance.

Eligibility Criteria:
Inclusion Criteria:

1. Gestational age of 41weeks+0day to 41weeks+2days
2. Pregnancies with cephalic presenting fetuses
3. Pregnant women with singleton fetus
4. Absence of contraindications to vaginal delivery
5. Absence of uterine contraction
6. Bishop score ≤ 5
7. Ultrasound confirmed GA in early pregnancy

Exclusion Criteria:

1. Pregnant women in latent phase of labour
2. Preterm or term premature rupture of membrane
3. Antepartum haemorrhage
4. Previous Caesarean section and myomectomy
5. Multiple gestation
6. Medical disorders of pregnancy
7. Unsure date
Chemoradiotherapy in Elderly Patients with Locally Advanced Pancreatic Cancer (70+).

The goal of this observational study is to learn about the therapeutic effects of chemoradiotherapy for older adults (age 70-85) with locally advanced pancreatic cancer. The main question it aims to answer is:

Does chemoradiotherapy represent an effective and safe treatment for older participants without radical surgery? Participants will sequentially receive combined chemotherapy followed by concurrent chemoradiotherapy and subsequent maintenance therapy.


Eligibility Criteria:
Inclusion Criteria:

* Voluntarily participate and sign the informed consent form
* Age 70-85 years old, life expectancy \> 1 year and gender is not limited
* Eastern Cooperative Oncology Group Physical Status Score (ECOG) physical state score\<=1 point
* Pathological or cytological confirmation of pancreatic ductal adenocarcinoma (including IPMN malignant transformation, acinar carcinoma, etc., excluding adenosquamous cell carcinoma and neuroendocrine carcinoma)
* The clinical stage is stage III (locally advanced pancreatic cancer), and no radical surgery has been performed (bypass surgery is acceptable), or the patient has resectable pancreatic cancer, but cannot accept surgery or refuse surgery due to physical strength or concomitant diseases
* Have not received any form of anti-tumor therapy before treatment, including systemic chemotherapy, interventional chemotherapy, high-energy focused ultrasound, radiotherapy, immunotherapy, molecular targeted therapy, and anti-tumor traditional Chinese medicine therapy
* No serious hematological, cardiological, pulmonary function abnormalities and autoimmune deficiencies (refer to their respective diagnostic criteria)
* Blood routine index: white blood cell (WBC) \>=3.0 × 109/L; Absolute neutrophil count (ANC) \>=1.5 × 109/L; Platelets (PLT) \>=100 × 109/L; hemoglobin (Hgb) \>=90 g/L
* Blood biochemical indexes: AST (SGOT), ALT (SGPT) \<=2.5 × upper limit of normal value (ULN); Total bilirubin (TBIL) \< = ULN; Serum creatinine (CRE) \<=1.5 × ULN
* Coagulation function: prothrombin time (PT), international normalized ratio (INR) \<=1.5 × ULN
* Able to comply with the requirements of the study visit plan and other programs.

Exclusion Criteria:

* Accompanied by malignant tumors of other systems
* Received any form of anti-tumor therapy before treatment, including systemic chemotherapy, interventional chemotherapy, high-energy focused ultrasound, radiotherapy, immunotherapy, molecular targeted therapy, and anti-tumor traditional Chinese medicine therapy
* Have used any other non-anti-tumor research drugs within 4 weeks before treatment
* Combined with uncontrollable hypertension, diabetes, infection, etc.
* Poor compliance, unable or unwilling to sign informed consent
* Patients who are expected to be out of the observation period for 14 days or more during the treatment period.
Intracanal Dexamethasone Extrusion and Postoperative Endodontic Pain

The aim of this research is to assess the effect of intentionally extruding a corticosteroid intracanal solution into the periapical tissues on the postoperative pain after root canal treatment in patients with symptomatic irreversible pulpitis and symptomatic apical periodontitis (SIP/SAP). The main question it aims to answer: Is there an analgesic effect of extruding an intracanal solution of DXA into the periapical tissues in patients diagnosed with SIP/SAP? Researchers will compare dexamethasone to a placebo to see if the extrusion dexamethasone works in reducing post-endodontic treatment pain.


Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of irreversible pulpits with symptomatic apical periodontitis
* Adult patients (aged 18 - 70)
* Healthy patients or those with a well-controlled disease (ASA I \& II)

Exclusion Criteria:

* A diagnosis of necrotic pulp, or normal apical tissues
* Patients with a severe systemic disease (ASA III or higher)
* Patients who received analgesics12 hours before presentation
* Previously treated/initiated Endodontics treatment on the same tooth
* Unopposed teeth
* Third molar teeth
* Non-restorable teeth
* Periodontally compromised teeth
* Pregnant or lactating patients
The Effect of Anti-viral Drugs Used in Late Pregnancy on Long-term Development of Children

Mother to child transmission(MTCT) is the main route of hepatitis B virus(HBV) transmission.High HBV DNA level of pregnant women is the main risk factor of MTCT. Many literatures demonstrate that using nucleoside (acid) analogs in late pregnancy can significantly reduce HBV DNA level and effectively blocking MTCT. Therefore, treatment guidelines of hepatitis B in Europe and the Asia Pacific region clearly pointed out: Nucleoside (acid) analogs can be used in pregnant women after 28 weeks of gestation for blocking MTCT in mothers with high HBV DNA level. At present, the drugs used in late pregnancy including lamivudine (LAM) ,telbivudine(LdT) and tenofovir(TDF).

The safety of nucleoside (acid) analogues used in late pregnancy on children is not clear.In most of the related researches,the observation termination was 7-12 months after birth, and most were concentrated on the blocking effect of MTCT.The long-term impact of Nucleoside (acid) analogues on children's development has not been reported in the literatures. The aim of this study is to make clear of the effect of nucleoside (acid) analogues used in late pregnancy on long-term impact of children's development.

The one year old children born in Beijing Ditan hospital and whose mothers had taken LAM,LdT or TDF during late pregnancy will be enrolled as study group, and eligible children whose mothers untreated will be enrolled as control group. The children's height, weight, nutritional status, developmental quotient and immune response to hepatitis B vaccine etc will be evaluated at baseline and at 3 years old. By comparing the children's development in different groups as well as in self-control of different ages, we will discuss the effect of Nucleoside (acid) analogues on children's long-term development.


Eligibility Criteria:
Inclusion Criteria:

* The one year old children whose mothers had taken Lamivudine,Telbivudine or Tenofovir in late pregnancy(28-30 weeks of gestation);
* The one year old children whose mothers untreated in late pregnancy;
* Children had completed standard hepatitis B vaccine and hepatitis B immune globulin combined active and passive prophylaxis;
* HBV DNA level of the children's mothers were over 6.0 log10 IU/ml before 28 weeks of gestation.

Exclusion Criteria:

* Children whose mothers over 35 years old at delivery;
* The couple having family hereditary disease or abnormal malformation has been found at fetal screening before 28 weeks gestation;
* History of amniocentesis during pregnancy;
* Co-infection with either hepatitis C virus, hepatitis D virus, human immunodeficiency virus, syphilis, toxoplasmosis, rubella or cytomegalovirus.
* Complications of pregnancy-induced hypertension, premature rupture of membranes, preterm birth, placenta previa or placental abruption; asphyxia at birth.
Single Bundle Anterior Cruciate Ligament Reconstruction in Active Young Men

The clinical outcomes of anterior cruciate ligament reconstruction using free tendon Achilles allograft are comparable to those using Achilles allograft with bone block on its end.


Eligibility Criteria:
Inclusion Criteria:

* male subjects
* subjects who had concomitant medial collateral ligament injury which was managed conservatively
* subjects who had meniscus tear which was managed by partial meniscectomy

Exclusion Criteria:

* subjects who underwent a subtotal or total meniscectomy, meniscal repair, or meniscal transplantation due to meniscus injury
* subjects who underwent an operation due to any concomitant ipsilateral ligament injuries
* subjects who underwent microfracture or cartilage transplantation due to full thickness cartilage injury
* female
* subjects who were older than 45
* subjects who had histories of injuries on either knee
Intervention to Address Psychosocial Needs Among Socially Disadvantaged Older Adults With Cancer

The purpose of this study is to convene a group of diverse North Carolina-based community representatives (patients, caregivers, leaders of faith-based organizations, social workers, and patient navigators) to inform the adaptation of materials used to train lay navigators in the delivery of psychosocial support interventions tailored to older socially disadvantaged adults with cancer.

This behavioral study will explore community representatives' perspectives on the resources and training needed to support the development of a lay navigation program tailored to older socially disadvantaged adults with cancer.

It was hypothesized that diverse community representatives could inform the adaptation of training materials (Peer Connect) and subsequent training of community lay navigators, who will then be positioned to address the psychosocial needs of older adults with cancer

Eligibility Criteria:
Inclusion criteria to participate in the study:

1. Patients aged 65 and older diagnosed with hematological cancer for at least one year with stable disease
2. Community representative 18 years or older who also identifies as at least one of the following:

   1. Cancer caregivers
   2. Social workers, social work students, or patient navigators Community leader (e.g., leader of a faith-based organization)
   3. Previously or currently serve as a lay navigator/peer supporter, community health worker, or coach
   4. Have personal experience with any of the following (being Black race, previously or currently facing socioeconomic challenges, or living in a rural community)
   5. Patient or community representative who is Able to understand and speak in English

Exclusion Criteria

All participants meeting any of the following exclusion criteria at enrollment will be excluded from the study:

1. Inability to read and speak English
2. Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent

Exclusion Criteria

All participants meeting any of the following exclusion criteria at enrollment will be excluded from the study:

1. Inability to read and speak English
2. Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent
Comparison of the Quality of Recovery After Cesarean Section Surgery

Inadequate pain control after cesarean section surgery causes postpartum depression, persistent pain and delayed mother-infant bonding. The investigator's aim is to asses whether ultrasound guided transversalis fascia plane block (TFPB) or transversus abdominis plane (TAP) block would improve postoperative quality of recovery and decrease postoperative opioid consumption after cesarean section surgery.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists physical status II-III
* Cesarean section surgery under spinal anesthesia

Exclusion Criteria:

* American Society of Anesthesiologists physical status IV
* Emergency surgery
* General anesthesia
* Additional surgical intervention at the same session
* Body mass index of more than 35 kg/m2
* Allergy to any study drugs
* Local infection at the injection site
* History of drug abuse
* Communication problem
* Coagulopathy
* Preeclampsia and eclampsia
Early, Objective Detection of Autism.

1- To test the hypothesis that using the SensoDetect Brainstem Evoked Response Audiometry (BERA) technology may be an effective support tool for pediatricians to detect autism.

This study will be conducted through two phases:

Phase I: A case-control study.

This will be done at Princess Noura University/ King Abdullah Abdulaziz University Hospital, Riyadh, Kingdom of Saudi Arabia from January 2024 to January 2027.

The SensoDetect BERA technology previously described8,9,13,14 will be used in all parts of the study in the following way:

All recruited participants are to be tested using SensoDetect's patented technology. All tests shall be performed in a quiet and darkened room. Participants will be asked to comfortably sit in an armchair in a resting position (part 1 only). Surface electrodes will then be attached to the skin over the mastoid bones behind the left and right ear, with a ground electrode on one arm. Two reference electrodes will also be placed on the forehead. Before each test session, the procedure shall be fully explained to the test subject or parents.

The subjects will then be instructed to relax with their eyes closed and are permitted to fall asleep (with modifications in part 3). The test will require no active participation other than sound stimulation. The subjects will be tested one at a time, and the duration of the testing procedure will be 15 min.

The method is based on an electrophysiological test battery that emits 1024 click sounds divided into 4 sessions for 14 minutes. The data analysis software uses advanced mathematical algorithms and Artificial intelligence (AI) to analyze and distinguish the patient's markers and compare them with diagnostic and non-diagnostic groups. BERA is CE and MDD (MDD stands for Medical Device Directive and is an approval for the device to be used under European law) approved. SensoDetect holds the ISO standard under medical technical products 13485:2016. After the test is completed, the result will be sent for analysis using SensoDetect's analytical software (SensoLytics). The AI classification model used for analyzing traits and predicting diagnosis is Gaussian Naïve Bayes.

Eligibility Criteria:
Phase I:

Inclusion Criteria:

- All patients attending the clinic of Autism.

Exclusion Criteria:

* Hearing impairment
* Down syndrome
* Cerebral Palsy
* Significant brain damage Intellectual disability.