cyrilzakka/clinical-trials huggingface dataset:
Super Hypofractionated Irradiation for Whole Breast Treatment

The purpose of this trial is to investigate the safety and efficacy of super hypofractionated whole breast irradiation (SHF-WBI) in breast cancer patients treated with breast conserving surgery. Eligible breast cancer patients will be followed for at least 5 years to evaluate the acute and late radiation-induced toxicities, locoregional recurrence, distant metastasis, death, contralateral breast cancer and quality of life.

Eligible breast cancer patients will receive SHF-WBI of 5.2 Gy in 5 fractions to ipsilateral whole breast within one week and a sequential tumor bed boost of 5.2 Gy in 2 fractions at the discretion of the radiation oncologist. All patients are treated with intensity modulated radiation therapy (IMRT) technique. The primary endpoint is ≥2 grade any acute radiation induced toxicity event. Patients will be followed for at least 5 years to evaluate the acute and late radiation-induced toxicity, locoregional recurrence, distant metastasis, death and quality of life.

Calculation of the required number of cases based on an alpha of 0.05 and a power of 80% with a maximal tolerable toxicity difference of 10% during and within 6 months after SHF-WBI comparing to hypofractionated whole breast irradiation(40-42.5Gy/15-16Fx) and lost rate of follow up of 10%. In total 217 patients are needed to be recruited.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Aged ≥18 years old
* breast conservation surgery
* unilateral histologically confirmed invasive breast carcinoma or Ductal Carcinoma In Situ (DCIS)
* For patients with invasive breast cancer，negative axillary lymph nodes or micrometastasis only
* Karnofsky Performance Status ≥80, and Life expectancy of \>5 years
* Histologically negative surgical margin for invasive breast carcinoma or a minimum negative margin width of ≥ 3mm for DCIS
* Surgery wound healed without infection
* ER (estrogen-receptor), PR (progesterone-receptor), HER2 (human epidermal growth factor receptor 2) and Ki67 testing can be performed on the primary breast tumor
* Female patients of child-producing potential must agree to use effective contraception for up to 1 month before study treatment and the duration of study participation

Exclusion Criteria:

* Histological involvement of supraclavicular lymph node
* Histologically or radiologically confirmed involvement of ipsilateral internal mammary lymph nodes
* Pregnant or lactating women
* Severe non-neoplastic medical comorbidities
* Diagnosis of non-breast malignancy within 5 years preceding enrollment (excluding lobular carcinoma in situ, basal cell carcinoma of the skin, carcinoma in situ of skin and carcinoma in situ of the cervix, Pulmonary adenocarcinoma in situ，which are permitted).
* simultaneous contralateral breast cancer
* Previous radiotherapy to the neck, chest and/or ipsilateral axillary region
* Active collagen vascular disease
* Definitive histological or radiologic evidence of distant metastatic disease
* Evidence of T4 disease
Study to Evaluate the Efficacy and Safety of Sirolimus in Subjects With Metastatic, Mismatch Repair Deficient Solid Tumors After Immunotherapy

To evaluate the efficacy of sirolimus by estimating the overall response rate (ORR) as assessed by Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST v1.1) in patients with metastatic dMMR solid cancer after immunotherapy (either due to disease progression or to inability to tolerate treatment).

Despite recent therapeutic strategies, including immunotherapy, treatment alternatives for patients with metastatic mismatch-repair deficient (dMMR) solid tumors remain scarce. Pre-clinical data suggests that dMMR tumors are susceptible to rapamycin (sirolimus), an mTOR inhibitor. In these tumors, characterized by higher levels of oxidative stress, sirolimus can exert a cytotoxic effect, led by the failure to repair DNA damage by inhibition of antioxidant enzymes such as FOXO3a triggered by Akt hyperactivation.

This proposal presents a phase 2 clinical trial designed to evaluate the efficacy of sirolimus in patients with dMMR solid tumors after immunotherapy. The investigators hypothesize that sirolimus will increase the overall response rate (ORR) by 20%.

Eligibility Criteria:
Inclusion Criteria:

* Metastatic solid cancer tumor after immunotherapy (either due to progression of disease or inability to tolerate treatment)
* dMMR by immunohistochemistry (IHC) defined as the loss of expression in any of the four major MMR proteins (MLH1, MSH2, MSH6 and PMS2) or by next- generation sequencing (NGS)
* Age older than 18 at the time of informed consent
* Eastern Cooperative Oncology Group performance status of 0-2
* ≥1 measurable lesion based on RECIST, version 1.1 (16)
* Absolute neutrophil count (ANC) ≥1,500 mm3
* Platelet count ≥75,000 mm3
* Hemoglobin ≥ 9 g/dl
* Aspartate aminotransferase (AST) ≤3.0 times the upper normal limit (UNL)
* Alanine aminotransferase (ALT) ≤3.0 times the upper normal limit (UNL) Bilirubin ≤1.5 times the UNL
* Serum creatinine ≤1.5 times the UNL

Exclusion Criteria:

* Received immunotherapy in the prior 21 days.
* Have not recovered from toxicities of prior treatments to at least grade 1.
* Symptomatic central nervous system (CNS) metastases
* Pregnancy or Breast-feeding.
Spermotrend in the Treatment of Male Infertility

The purpose of this study is to determine whether the administration of the dietary supplement Spermotrend improves spermatogenesis parameters in subjects with male infertility unrelated to major testicular conditions. The duration of this double-blind placebo controlled phase 3 clinical trial will be 24 weeks. The estimated number of males with infertility to be recruited and randomized for the study is 86.


Eligibility Criteria:
Inclusion Criteria:

* Male infertility unrelated to major testicular conditions
* Must have at least one altered seminal parameter.
* Signed informed consent

Exclusion Criteria:

* Hydrocele, varicocele, orchitis, epididymitis, irradiation or Chemotherapy.
* Previously treated and cured testicular condition.
* Non-transmissible chronic diseases
* Use of antioxidant agents within 6 months.
* Use of vitamins within 6 months.
* Use of anti-inflammatory drugs within 6 months.
* Use of hormones prescribed by an andrologist within 6 months
* Positive serology/HIV
* Leukocytospermia
Study of Aspirin and Exemestane as Adjuvant Treatment in Breast Cancer

This is a phase II study to assess efficacy/safety of Exemestane with or without Aspirin as the adjuvant treatment in postmenopausal breast cancer patients.


Eligibility Criteria:
Inclusion Criteria:

* Breast cancer after surgery postmenopausal

Exclusion Criteria:

* contraindication of aspirin
An Open-study to Investigate the Safety and Efficacy of Replenine®-VF in Haemophilia B Subjects Undergoing Surgery

The main objectives of this study were to investigate the safety and efficacy of Replenine®-VF administered in appropriate dosage by bolus infusion to prevent bleeding and achieve haemostasis in subjects with haemophilia B undergoing surgery.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with moderate to severe haemophilia B undergoing major surgery requiring an in-patient stay of generally 5 to 10 days.

Exclusion Criteria:

-
Safety and Efficacy of Adalimumab to Methotrexate and Placebo in Subjects With Moderate to Severe Chronic Plaque Psoriasis

Placebo-Controlled Study Comparing the Safety and Efficacy of Adalimumab to Methotrexate and Placebo in Subjects with Moderate to Severe Chronic Plaque Psoriasis


Eligibility Criteria:
Inclusion Criteria:

* Subject was age 18 or older and in good health (Investigator discretion) with a recent stable medical history who has had a diagnosis of psoriasis for at least 12 months and stable moderate to severe chronic plaque psoriasis
* Subject is a candidate for systemic therapy or phototherapy and has active psoriasis despite treatment with topical agents.
* Subject was able and willing to self-administer sc injections or had available qualified person(s) to administer sc injections.
* Male subjects must hve been vasectomized or practicing birth control.

Exclusion Criteria:

* Previous systemic anti-TNF therapy.
* Prior use of MTX.
* Known hypersensitivity to the constituents of adalimumab.
* Systemic therapy for psoriasis for at least 4 weeks prior to Baseline; except for biologic therapies, which must be discontinued at least 12 weeks prior to enrollment.
* Topical psoriasis therapy for at least 2 weeks prior to Baseline, except for non-corticosteroid shampoos, bland (no alpha or beta hydroxy) emollients and low potency topical corticosteroids on the palms, soles, face, inframammary area, and groin only.
* Use of tanning beds, excessive sun exposure, or phototherapy (UVB, UVA), for at least 2 weeks prior to Baseline.
* Use of PUVA for at least 4 weeks prior to Baseline.
* Use of oral or injectable corticosteroids during the study.
* Subject considered by the investigator, for any reason, to be an unsuitable candidate for the study.
* Female subject who is pregnant or breast feeding or considering becoming pregnant.
Study to Evaluate the Efficacy and Safety of DWP14012 in Patients With Erosive Gastroesophageal Reflux Disease (Phase 3)

The purpose of study is to confirm the efficacy of DWP14012 Xmg, Once daily, compared to esomeprazole 40mg in patients with erosive gastroesophageal reflux disease.


Eligibility Criteria:
Inclusion Criteria:

* Adults between 20 and 75 years old based on the date of written agreement
* Those who have been diagnosed with erosive gastroesophageal reflux disease(EGRD) of LA Grade A-D on the upper gastrointestinal endoscopy
* Those who experienced symptoms of heartburn or acid regurgitation within the last 7 days

Exclusion Criteria:

* Those who have undergone gastric acid suppression or gastric, esophageal surgery
* Those who with clinically significant liver, kidney, nervous system, respiratory, endocrine, hematologic, cardiovascular, urinary system disease
Power Spectral Analysis of EEG During Equi-MAC Inhalation Anesthesia

The purpose of this clinical trial is to compare hypnotic effect of sevoflurane and desflurane at equal minimum alveolar concentrations using power spectral analysis of the electroencephalogram.

Volatile anesthetics vary in their relative hypnotic potency. Recent studies demonstrated that equi-minimum alveolar concentration of various volatile anesthetic agents may produce different spectral entropy or bispectral index values. However, there were no studies that demonstrate the difference of hypnotic potency using power spectral analysis of electroencephalographic signals (e.g., spectral edge frequency 95%, total power, % value of each bandage). The purpose of this clinical trial is to compare hypnotic effect of sevoflurane and desflurane at equal minimum alveolar concentrations using power spectral analysis of the electroencephalogram.

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing arthroscopic knee surgery under general anesthesia using volatile anesthetics
* patients with american society of anesthesiologist physical status I, II
* patients aged 19-65 years
* patients obtaining written informed consent

Exclusion Criteria:

* patients with a history of any psychiatric or neurological disease
* patients who had received any medication affecting the central nervous system
* patients who had received medication affecting the sympathetic or parasympathetic nervous systems
* patients undergoing tracheal intubation for airway management
* pregnant women
Presbyopia-Correcting Intraocular Lenses (IOLs)

The purpose of this study is to prospectively evaluate postoperative visual and refractive parameters in a series of subjects bilaterally implanted with Presbyopia-Correcting Intraocular Lenses (IOLs).


Eligibility Criteria:
Inclusion Criteria:

* diagnosed with bilateral cataracts
* candidate for presbyopic lens

Exclusion Criteria:

* \> 1 Diopter preoperative astigmatism by Keratometry readings
* pre-existing conditions that could skew the results
Esophageal Temperature Management During Cryo AF Ablation (EnsoETM)

The purpose of this pilot study is to determine if esophageal warming using the Attune Medical Esophageal Heat Transfer Device (EnsoETM) limits the frequency or severity of thermal injury during cryoballoon ablation of atrial fibrillation.

Catheter ablation of atrial fibrillation (AF) has become a common ablation procedure performed worldwide. The cornerstone of this procedure is pulmonary vein isolation (PVI). PVI can be achieved by multiple methods, the two most common being radiofrequency (RF) and cryoablation. Energy delivery may extend beyond the atrial myocardium and result in damage to adjacent structures, including the esophagus. Atrio-esophageal fistula (AEF) is a rare, but a well-recognized complication of percutaneous AF ablation. The occurrence rate of esophageal injury has varied depending on the reporting center, timing of endoscopy, and the ablation technique utilized. Esophageal ulceration is likely the initial injury that leads to AEF formation and is probably present within hours to days of the ablation procedure.

The Attune Medical Esophageal Heat Transfer Device (EnsoETM) is a non-sterile, multi-lumen silicone tube placed in the esophagus for the purpose of cooling or warming a patient while simultaneously allowing gastric decompression and drainage. For this study, the EnsoETM tube will be used during cardiac ablation procedures for the intended indication of patient temperature management using approved settings/parameters as detailed in the product instructions for use document. EnsoETM is an FDA approved device.

This prospective, randomized study will include 40 patients with symptomatic AF undergoing index PVI under general anesthesia at Northwestern Memorial Hospital. Patients will be randomized in a 1:1 fashion with 20 patients (Group A) randomized to undergo the ablation procedure with esophageal warming and the other 20 patients (Group B) will serve as the control group and will not have the EnsoETM device used. All patients will undergo esophagogastroduodenoscopy (EGD) 1-2 days following the ablation procedure to evaluate for esophageal injury.

Eligibility Criteria:
Inclusion Criteria:

1. Patients above the age of 18 years old.
2. Patients with the diagnosis of atrial fibrillation undergoing clinically indicated de-novo AF ablation procedure.
3. Patients must be willing to provide informed consent.

Exclusion Criteria:

1. Patients with contraindication to EGD.
2. History of prior AF ablation procedures.
3. Significant co-morbidities that preclude standard ablation procedure.
4. Patient is ineligible for EnsoETM placement due to:

   * Known esophageal deformity or evidence of esophageal trauma (for example history of esophagectomy, previous swallowing disorders, achalasia).
   * Known ingestion of acidic or caustic poisons within the prior 24 hours.
   * Patients with \<40 kg of body mass.
Neonatal Thrombocytopenia Among Newborns Admitted to Neonatal Intensive Care Unit

Thrombocytopenia is diagnosed when platelet count is lower than 150,000 U/L, it is a common hemostatic problem in neonatal intensive care units According to platelets count, it is classified into mild thrombocytopenia with platelet count 100,000 to 150,000 U/L, moderate thrombocytopenia with platelet count 50,000 to 100,000 U/L and severe thrombocytopenia that have platelet count less than or equal to 50,000 U/L.

Platelets are seen under microscope as small anucleated fragments of megakaryocytes that circulate in the blood as discs with an average volume of about 7.5 fimtolitre , 14 times smaller than erythrocytes. Platelets count in premature infant is slightly lower than that of healthy term infant but is still within the normal range (150,000 to 450,000 unit/ litre ).

The most common risk factors for thrombocytopenia are

1. Sepsis: Thrombocytopenia is a frequent problem in neonatal sepsis and is among the most predictive, independent risk factors for sepsis-associated mortality
2. Low birth weight: It is recorded that thrombocytopenia was more common among the smallest patients; 85% incidence among those ⩽800 gram, 60% among those 801 to 900 gram, and 53% among those 901 to 1000 gram
3. Perinatal asphyxia: Thrombocytopenia occurred in 31% of neonates with asphyxia versus 5% of matched non asphyxiated controls admitted to a neonatal intensive care unit
4. Prematurity: In a normal pregnancy, the fetal platelet count reaches adult levels (150-450 × 106/ millilitre) by the second trimester of pregnancy. Thrombocytopenia , defined as less than 150,000/ millilitre, occurs in 18 to 40% of all preterm neonates (gestational age \<37 weeks) admitted to neonatal intensive care units

Eligibility Criteria:
Inclusion Criteria:

1. newborn (term and preterm, inborn or out born) aged from 1-28 day
2. platelet count below one hundred and fifty thousands unit/liter

Exclusion Criteria:

1. Infant above 28 days old.
2. Newborns have platelet count one hundred and fifty thousands unit/liter

Exclusion Criteria:
Haploidentical Allogeneic Hematopoietic Stem Cell Transplantation in Children and Adolescents

Purpose of study: This phase I/II trial is to evaluate the safety and feasibility of TCRαβ-depleted graft from haploidentical family donors in treating children and adolescents with malignant or non-malignant diseases.


Eligibility Criteria:
Inclusion Criteria:

A. Disease inclusions

1. Hematologic malignancy:

   * Acute lymphoblastic leukemia including induction failure, CR1 (Ph+, t(4:11), hypodiploid and other very high risk features), ≥ CR2, infant ALL with MLL or other unfavorable features
   * Acute myeloid leukemia excluding CR1 with t(8:21), inv(16), t(15:17), and Down syndrome
   * Myelodysplastic syndrome: RCC with -7 or RCC in need of transfusion
   * Chronic myeloid leukemia in AP
   * Juvenile myelomonocytic leukemia
   * Malignant lymphoma, NHL or HD, after failed autologous HSCT
   * Other
2. Non-hematologic malignancy

   * Relapsed or refractory solid tumors including neuroblastoma, rhabdomyosarcoma and so on
3. Non-malignant hematologic disease

   * Acquired severe and very severe aplastic anemia
   * Fanconi anemia
   * Paroxysmal nocturnal hemoglobinuria
   * Congenital dyserythropoietic anemia
   * Others
4. Inherited or metabolic disease

   * Hemophagocytic lymphohistiocytosis
   * Malignant osteopetrosis
   * Storage diseases
   * Others B. Recipient inclusions

1. Age \< 21 years 2. No HLA-identical stem cell donor available 3. Lansky-Play performance score \>60 4. No active infection at the time of transplantation

Exclusion Criteria:

1. HIV-infection
2. Presence of active and serious infection
3. Cardiac ejection fraction \<35% on echocardiography
4. Severe pulmonary dysfunction (DLCO \<30%)
5. Liver function abnormalities with bilirubin \>4mg/dL and elevation of transaminases \> 400U/L
6. Concurrent severe or uncontrolled medical disease
7. Patients who are pregnant
8. Patients unwilling or unable to comply with the protocol or unable to give informed consent
A Study of SER-155 to Treat Diarrhea in People on Immunotherapy

The purpose of this study is to find out whether SER-155 may be a safe first treatment that causes few or mild side effects for people due to irEC.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Receipt of ICI (single-agent or combination) within the 180 days preceding screening.

Concurrent treatment with cytotoxic chemotherapy or other tumor-directed agents is permitted.

* Grade 2 - 3 diarrhea (i.e., increase of at least 4 bowel movements a day above baseline during the screening window), deemed by the treating provider as likely related to ICI therapy, with or without concomitant symptoms of grade 1 - 2 colitis (e.g.

abdominal pain, bloody or mucoid stools)

* Able to swallow oral medication
* Individuals of childbearing potential willing to use a highly effective method of contraception (failure rate of \<1% per year when used consistently and correctly) for 30 days after the last dose of SER-155.
* Willing to provide written informed consent, comply with the protocol, and understand the potential risks and benefits of study enrollment and treatment.

Exclusion Criteria:

* Active GI infection, including untreated viral, bacterial or fungal cause(s) of diarrhea.
* Received immunosuppressive therapies for suspected or confirmed irEC, including systemic corticosteroids (either oral or intravenous) and/or infliximab, vedolizumab or ustekinumab
* Grade 3 colitis symptoms, i.e. severe abdominal pain or peritoneal signs
* Admitted to the hospital for irEC
* Prednisone (or steroid equivalent) dose \> 10 mg a day for a non-GI irAE at time of screening
* Pre-existing inflammatory bowel disease (e.g. Crohn's disease or ulcerative colitis) or microscopic colitis
* Pregnant or lactating women
* Any condition that requires ongoing prophylactic or therapeutic antibacterial antibiotics
* Severe neutropenia, as defined by an absolute neutrophil count (ANC) \< 500 cells/mm\^3, at time of screening
* Treatment with investigational medications used for diarrhea/colitis treatment and microbiome therapeutics within 30 days prior to enrollment
* Known allergy or intolerance to oral vancomycin
* Unable to comply with the protocol requirements
* Any condition that in the opinion of the investigator may increase the risk of study participation and/or may interfere with the interpretation of study results
Transversus Thoracis Muscle Plane Block Plus Rectus Sheath Block in the Perioperative Pain Management of Cardiac Surgery

An emerging regional block technique, transverse thoracic muscle block covers the T2-T6 intercostal nerves and can effectively relieve perioperative pain during median sternotomy. Bilateral transverse thoracic muscle plane( TTP) block is expected to be a new analgesic mode in perioperative of cardiac surgery via sternotomy.

This is a single-center, randomized, double-blind, parallel controlled clinical trial. Eighty patients planning to undergo coronary artery bypass grafting or heart valve surgery via median sternotomy were randomly assigned 1:1 to the experimental group or control group. After general anesthesia, all subjects were injected with 0.3% ropivacaine (experimental group) or 0.9% normal saline (control group) 15ml and 10ml respectively after insertion of a needle into bilateral transverse thoracic muscle plane and rectus sheath guided by B-ultrasound by anesthesiologist. The main outcome indicators were the threshold of incision pain and the total amount of analgesics used during the operation and 48h after the operation. Secondary outcome measures were as follows: postoperative VAS score, duration of mechanical ventilation, days in ICU, total days of hospitalization, and hospitalization cost. This study will provide evidence-based medical evidence and clinical data support for the application of TTP block in cardiac surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients voluntarily cooperate with the study and sign an informed consent form;
* Ages between 18 and 65;
* American Society of Anesthesiologists (ASA) classification: I-III;
* Undergo coronary artery bypass grafting (CABG) or heart valve surgery with midsternal incision.

Exclusion Criteria:

* Refuse to participate in the trial;
* Allergic to the anesthetics or analgesics;
* Suffering with serious systemic diseases (kidney, liver, lungs and endocrine system);
* American Association of Anesthesiologists (ASA) classification: IV-V;
* Unstable hemodynamics;
* History of drug abuse or chronic pain;
* Mental disorders or communication difficulties;
* Died during or immediately after the operation.