cyrilzakka/clinical-trials huggingface dataset:
A Study of HQK-1001 in Patients With Sickle Cell Disease

The purpose of this study is to evaluate the safety and tolerability of three dose levels of HQK-1001 administered once daily for 26 weeks in subjects with sickle cell disease.


Eligibility Criteria:
Inclusion Criteria:

* Established diagnosis of SCD
* Males and females between 12 and 60 years of age, inclusive
* At least 3 episodes of a SCD-related crisis or complication in the 3 years prior to screening OR 1 episode of acute chest syndrome in the 5 years prior to screening
* If receiving hydroxyurea, must be receiving a stable dose for at least 6 months prior to screening
* If hydroxyurea treatment has been discontinued, at least 3 months have elapsed since last dose
* If transfusion in the 4 months prior to screening, then HbA level \< 20% at screening
* Average of the initial two HbF levels ≥ 2.0 % within ≤ 7 days prior to the initial dose of HQK-1001. The two must be obtained ≥ 24 hours apart
* Ability to swallow tablets
* Able and willing to give informed consent and assent (if applicable)
* If subject is a woman of child-bearing potential (WCBP), she must have a negative serum pregnancy test within 7 days of first dose of HQK-1001
* If a subject is a WCBP, she must agree to use an effective form of contraception within 7 days of the initial dose of HQK-1001 and for one month after HQK-1001 discontinuation
* Sexually active male subjects (with WCBP partners) must agree to use latex condoms or ensure that their partner(s) use an effective form of contraception
* In the view of the Investigator, subject is able and willing to comply with necessary study procedures

Exclusion Criteria:

* More than 4 hospitalizations for acute sickle cell related events in the previous 12 months prior to screening
* Pulmonary hypertension requiring oxygen therapy
* QTc \> 450 msec (male) or 470 msec (female) on screening ECG (QT corrected by Fridericia's formula)
* Assigned to a regular transfusion program
* Use of erythropoiesis stimulating agents within 90 days of screening
* ALT \> 3x upper limit of normal (ULN)
* Serum creatinine \> 1.2 mg/dL
* A serious, concurrent illness that would limit ability to complete or comply with the study requirements
* An acute vaso-occlusive event within 3 weeks prior to screening
* Creatine phosphokinase (CK) \> 20% above the ULN
* An acute illness (e.g., febrile, GI, respiratory) within 72 hours prior to screening
* History of syncope, clinically significant dysrhythmias or resuscitation from sudden death
* Chronic opiate use, which, in the view of the Investigator, could confound evaluation of an investigational drug
* Current abuse of alcohol or drugs
* Received another investigational agent within 4 weeks or 5 half-lives, whichever is longer, prior to screening
* Currently pregnant or breast feeding a child
* Known infection with HIV-1
* Infection with hepatitis B or hepatitis C, such that patients are currently on therapy or will be placed on therapy during the trial
Ten Fraction Adjuvant Hypofractionated Radiotherapy in Node Positive Breast Cancer

Post-operative loco-regional (LR) hypofractionated radiotherapy (Hypo-RT) is an attractive approach in locally advanced breast cancer (LABC).

The present is a single arm phase II study assessing toxicity levels after 34 Gy/10 fxs/2 wks to the whole breast/chest wall and to the draining lymph nodes; an optional single fraction 8 Gy boost was administered with electrons to the tumor bed in patients who had undergone conservative surgery. Both acute (CTCAE v4.0) and late (LENT/SOMA) toxicity were collected. All pts but those who underwent mastectomy without reconstruction or with temporary expander were also asked to rate their cosmetic outcome according to the Harvard. Toxicity was assessed weekly during RT and then at each follow-up examination (1, 3, 6 months and then yearly).

Eligibility Criteria:
Inclusion Criteria:

* Patients affected by invasive breast cancer who underwent conservative breast surgery or mastectomy and axillary dissection, followed by post operative radiotherapy at the level of the breast/chest wall, and of the supraclavicular, third axillary level +/- internal mammary chain nodes.
* pT1-3 disease pN1-2, cT1-3 disease if neoadjuvant chemotherapy , cN + cytologically and/or histologically assessed;
* ECOG Performance status ≤2;
* histologically negative surgical margins
* no distant metastases
* no prior chest radiotherapy
* life expectancy ≥ 5 years
* no prior cancer

Exclusion Criteria:

* Non-epithelial breast cancer (sarcoma, lymphoma etc.)
* Metastases at the level of the internal chain mammary and / or supra-clavicular lymph nodes histologically assessed
* pT4 neoplasms or inflammatory breast carcinoma
* Distant metastasis
* Concomitant chemotherapy
* history of prior controlateral breast tumor
Exploring the Mechanism of Primary Resistance to Third-generation EGFR-TKIs as First-line Treatment in EGFR-positive Advanced NSCLC (PRECISE Study)

Lung cancer is currently the world's largest malignant tumor for cancer-related deaths with non-small cell lung cancer (NSCLC) accounting for 80%-85%. Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs), especially the 3rd-generation EGFR-TKIs have demonstrated strong antitumor effects in EGFR-positive patients.

However, approximately 20% of EGFR-positive were primarily resistant to 3rd generation EGFR-TKIs, i.e., clinical non-response or disease progression in the short term.

This study aimed to clarify the molecular indicators that predict the benefits of 3-rd EGFR-TKIs as first-line therapy in NSCLCpatients with EGFR-positive. Further, to clarify their primary drug resistance mechanisms, which is of great significance for the treatment and clinical decision-making of NSCLC disease.


Eligibility Criteria:
Inclusion Criteria:

1. Age \>18 years;
2. Histological or cytopathological diagnosed NSCLC;
3. According to the American Joint Committee on Cancer (AJCC) eighth edition of the Lung Cancer Staging Manual, the clinical stage is unresectable IIIB-IV or recurrence and metastasis after surgery;
4. At least one measurable lesion can be evaluated according to the Response Evaluation Criteria In Solid Tumours v1.1 (RECIST1.1) criteria;
5. Positive EGFR mutation confirmed by tissue or cytology (pleural fluid, cerebrospinal fluid, etc.);
6. Use of third-generation EGFR-TKIs approved by the NMPA for NSCLC as first-line therapy;
7. Cooperate with the provision of clinicopathological data, imaging data, sample collection, and follow-up required for the research process, and agree to use the test data for subsequent research and product development;
8. Agree to participate in this study and sign an informed consent form.

Exclusion Criteria:

1. Patients who cannot understand the content of the experiment and cannot cooperate, and those who refuse to sign the informed consent form;
2. Pregnant and lactating women;
3. Other malignant neoplastic diseases within 3 years;
4. Patients who have undergone other clinical drug trials;
5. Received systemic anti-tumor therapy within 2 years;
Compare the Difference of P4 Concentration in Serum and Endometrium After Vaginal and IM P Administration

Crinone is a micronized progesterone gel which is administrated via vaginal route and targeted drug delivery to uterine (first uterine pass effect) with lower serum concentration. This study is to investigate the difference of progesterone concentration in serum and endometrium after administration with crinone and intramuscular progesterone.

The study will be conducted as a single centre, randomized, active controlled study. Recruitment duration will be 6-8 months long. Day 1 of Crinone administration will be the baseline. On Day 7 of Crinone administration endometrial tissue will be taken for P4 test. Last visit will be at 3-5 days after withdraw bleeding.


Eligibility Criteria:
Inclusion Criteria:

* Perimenopausal women aged \<55 years old with amenorrhea\>=2 months or reproductive aged women with amenorrhea \>= 6months due to premature ovarian failure or other reasons.;
* Serum progesterone level \< 1ng/mL
* Endometrial thickness ≥5mm
* No contraindication of progesterone administration;
* Informed consent is signed.

Exclusion Criteria:

* The other kind of progestin was applied 1 month before recruitment;
* Any serious diseases that does not allow to receive the progestin treatment;
* Under any vaginal treatment;
* Any vaginal infectious disease;
* Any other hormone treatment contraindications;
* drug abuse or untreated STD;
* Prior hypersensitivity to Crinone or one of their excipients.
* Pregnant women who indicate hCG positive.
Technical Skills Training Programme for Conducting Vacuum Assisted Deliveries

Training is very important for acquisition and maintenance of obstetric skills. As a one-to-one practical teaching needs time and personal resources, the investigators want to prove the benefit and necessity of the one-to-one training program compared to a theory-based training program in conducting vacuum assisted deliveries (VAD).

The aim of this study is to prove that a practice-based training program (one-to- one teaching) leads to better training results compared to a theory-based training program in conducting VAD.


Eligibility Criteria:
Inclusion Criteria:

* employees of the Department of Obstetrics and Gynaecology
* oral and written informed consent

Exclusion Criteria:

* no oral and written informed consent
UGT1A1 Combined With Pharmacokinetics of SN-38 in CPT-11-based CRT in Patients With Advanced Rectal Cancer

The study evaluates the associations between peak and valley concentrations of SN-38 with the efficacy and adverse effects of advanced rectal cancer patients carrying genotype (TA) 6 /(TA) 6 or (TA) 6 /(TA) 7 after neoadjuvant chemoradiotherapy with CPT-11.All participants will be scheduled to receive surgery 6-8 weeks after the completion of CRT. The primary end point are toxicity and pCR rate.


Eligibility Criteria:
Inclusion Criteria:

* pathological confirmed adenocarcinoma
* clinical stage T3-4 and/or N+
* the distance from anal verge less than 12 cm
* without distance metastases
* performance status score: 0\~1
* UGT1A1\*28 6/6 or 6/7
* without previous anti-cancer therapy
* sign the inform consent

Exclusion Criteria:

* pregnancy or breast-feeding women
* serious medical illness
* baseline blood and biochemical indicators do not meet the following criteria: neutrophils≥1.5×10\^9/L, Hb≥90g/L, PLT≥100×10\^9/L, ALT/AST ≤2.5 ULN, Cr≤ 1 ULN
* DPD deficiency
* UGT1A1\*28 7/7
Multi-omics Study on Gut Microbiota in Critical Ill Patients After Cardiopulmonary Bypass

Using metagenomics as well as metabolomics, the variation of the gut microbiota and host metabolite profiles of patient after undergoing CPB were explored.

This protocol is designed as a prospective observational case-control study in patients who underwent cardiopulmonary bypass (CPB) due to cardiac surgery. 30 healthy persons were selected as control group. The case group included patients admitted to intensive care unit (ICU) after cardiac surgery and extracorporeal circulation which is performed by the Department of cardiac surgery of Peking Union Medical College Hospital. The patients enrolled should be divided into two groups according to their primary outcomes: one grouped fever and/or hemodynamic instability after cardiopulmonary bypass and the other grouped normothermia and normal hemodynamic during 48 hours after surgery(cause an infection manifested \>48 hours after admission was defined as hospital acquired. ). Sample collection was terminated when both groups received 30 cases. These 60 cases would regard as the case group. Additionally, all the CPB patients we observed will be divided into survivors and non-survivors based on the 28-day survival. Feces and blood samples will be obtained at certain time points（initial sampling at least one day before the surgery, repeat sampling within 24-48 hours after CPB）. The fecal samples analysis will apply metagenomics and the feces and blood samples will be analyzed using untargeted metabolomics method. In this study, the stratification of gut microbial communities in patients underwent extracorporeal circulation were explored and analysed the variation of metabolite in patients's plasma and fecal samples. Predictive bio-markers and possible pathogenesis of fever and/or hemodynamic instability after CPB will be also provided by clinical outcomes analysis combined with multi-omics study.

Eligibility Criteria:
Inclusion Criteria:

* Patients will be admitted to ICU between 18 and 85 years of age who will undergo extracorporeal circulation during cardiac surgery and provided written informed consent will be enrolled as candidates of case group.
* Healthy volunteers will be enrolled as control group.

Exclusion Criteria:

* Patients had a fever before surgery, regardless of the etiological evidence of infection;
* had anti-infective treatment before surgery;
* had gastrointestinal surgery which left the digestive system dysfunctional;
* had a history of CPB in 6 month;
* reject or abandon ICU therapeutic intervention.
Dexmedetomine as Adjuvant for Spinal Anesthesia in Elective Cesarian Sections : a Pilot Study

The proposed pilot study is a prospective, randomized, controlled, double-blind, single-center pilot study.The aim of this pilot project is to evaluate the feasibility of a phase III study on the use of dexmedetomidine in intrathecal in the context of elective cesarean section.

The target population for the study will be adult pregnant women undergoing elective cesarean section under spinal anesthesia. This study will be carried out at a single site, the CHU Sainte-Justine as part of a research internship as part of the anesthesiology residency program at the University of Montreal.

52 patients will be recruted for this study, and will be randomized in two equal groups.

All the interventions carried out will be standardized. Medical care for patients will be the same as usual care, except for administration of dexmedetomidine or intrathecal narcotics.

In the test group, bupivacaine (12 mg, 1.6 ml) will be injected with 3 mcg of dexemedetomidine.

In the second group, bupivacaine (12 mg, 1.6 ml) will be injected with 100 mcg of morphine and 15 mcg of fentanyl with 0.25 ml of normal saline, which corresponds to the standard treatment.

The patients will receive standard analgesia, described in the protocol, post-operatively and will also have access to anti-nausea and anti-pruritics.

The patient will then be seen the day after surgery to collect her validated self-assessment scales for pain, nausea and vomiting, pruritus, chills and complete her QoR15 questionnaire.

This will be collected to establish preliminary data for a second study of non-inferiority for analgesia and gradation of side effects.

Eligibility Criteria:
Inclusion Criteria:

* Patient will receive an elective c-section under spinal anesthesia
* Gestational age \> 37 weeks

Exclusion Criteria:

* ASA score ≥ 3
* Allergy or contraindication to receiving opioids (morphine or fentanyl)
* Allergy or contraindication to receiving anti-inflammatory drugs (ketorolac, Naprosyn)
* Allergy or contraindication to receiving acetaminophen
* Height \<152 cm or\> 183 cm
* Weight \<50 or\> 110 kg
* Contraindication to spinal anesthesia
* Conversion to general anesthesia
* Combined spinal-epidural anesthesia
* Inability to give informed consent, either secondary to a mental or physical disability or a significant language barrier (Inability to understand English or French)
* Need for transfusion or other major complication
Dosimetric Analysis of Vaginal Cuff Brachytherapy in Endometrial Carcinoma

The purpose of this study is to investigate the effect of certain variables such as the fullness of the patients bladder and the position of the treatment applicator on the dose of radiation that other organs such as the bladder and the rectum receive during radiation treatment for endometrial carcinoma.

* This study is separated into 2 phases. In phase 1, patients will be asked to have their bladder full for the second planned insertion of the brachytherapy applicator and empty for the third insertion. For phase 2, the effect of cylinder angle on normal tissue dosimetry will be investigated. Of the two bladder states assessed in phase 1 (empty or full), the one deemed to give the lower dose to the total amount of bladder tissue will be considered the standard and applied to all patients in phase 2.
* In phase 1, to standardize bladder filling, patients will be asked to empty their bladder, then to drink 32 oz of water one and a half hours before the CT scan. The patient will undergo a treatment-planning scan after the brachytherapy cylinder is inserted and before brachytherapy treatment.
* In phase 2, patients will be asked to fill or empty their bladder according to the results of phase 1. The vaginal cylinder will be placed horizontally for the second treatment. The cylinder will then be angled at a specific angle for the subsequent treatment.
* A history and physical exam will be performed within 2 weeks of study entry, then at 14 days, 90 days, and 180 days following the completion of therapy.

Eligibility Criteria:
Inclusion Criteria:

* Histologic documentation of carcinoma of the uterus, post-hysterectomy stages I-IVA or vaginal cuff recurrence. Or post-hysterectomy cervix cancer stages IA or IB or post hysterectomy vaginal cancer stage I.
* ECOG performance status of less than or equal to 2
* 18 years of age or older

Exclusion Criteria:

* Distant metastases
* Inoperable disease
Biomarker Establishment for Superior Treatment of PTSD

The purpose of Biomarker Establishment for Superior Treatment of PTSD is to accelerate research on the discovery of biological, neurological and neuroimaging markers for Post- Traumatic Stress Disorder (PTSD). The investigators hope to validate and extend the network efficiency and verbal memory biomarker for PTSD. The investigators hope to learn whether there are pretreatment biological factors that can predict response to therapy. They want to do this by understanding the brain network function, relating EEG to functional magnetic resonance imaging, and application of network analysis tool.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of PTSD by VA clinicians and acceptance into PE or CPT treatment as part of the PCT
* Veterans of any era

Exclusion Criteria:

* MRI safety contraindications
* Active, uncontrolled medical illness
* Acute suicidality
* Current substance dependence
* Current use of thyroid medication or active hyper/hypothyroidism
* Neurological disorder affecting the CNS Seg stroke, epilepsy, tumorW or penetrating head injury
* Use of PRN within 48 hours of the MRI/EEG
Rituximab After Autologous Stem Cell Transplant for Relapsed B-cell Non-Hodgkin's Lymphoma

Conventional therapy is effective for diffuse aggressive lymphomas and low grade lymphomas, but is limited by relapse occurs in 40 to 50% of subjects.

This study assesses autologous stem cell transplant (ASCT) supplemented with high-dose therapy increases the event-free survival in diffuse aggressive lymphomas and low grade lymphomas, as an alternative to the limitations of conventional therapy.

Preliminary studies with rituximab in low grade lymphomas indicate a response rate of about 50% with very little toxicity. Rituximab is hypothesized to be a candidate for post-transplant therapy because the majority of malignant lymphomas express the CD20 antigen; rituximab has impressive independent anti-tumor activity; and the antibody has little toxicity outside of the acute administration.

The first 4 subjects received rituximab weekly for 4 weeks at the standard dose of 375 mg/m2, starting 6 weeks after ASCT transplant.

After an observation period to assess acute and late toxicity for the first 4 subjects, subsequent subjects received induction as above followed by an additional 4 week course at 6-months post-ASCT.

Eligibility Criteria:
Inclusion Criteria:

* B-cell, CD20+ NHL
* Evidence of engraftment post-autologous peripheral blood stem cell transplant (PBSC-T), aka autologous stem cell transplant (ASCT)
* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
* Creatinine \< 2 mg/dL
* Bilirubin \< 2.0 mg/dL
* Liver function tests (LFTs) \< 5 x upper limit of normal (ULN)

Exclusion Criteria:

* Graft source from bone marrow
* Non-responders \[progressive disease (PD) or stable disease (SD)\] to prior anti-CD20 therapy
* PD after ASCT
* Post-ASCT radiotherapy
* Concomitant treatment with radiotherapy, chemotherapy or immunotherapy including rituximab
* Evidence of active pneumonitis
* Evidence of active infection
* Concurrent prednisone or other systemic steroid medication
* Nitrosourea therapy within 6 weeks of the first treatment with rituximab
* Presence of anti-murine antibody (HAMA) reactivity
Heart Biomarker Evaluation in Apnea Treatment

This study examines the role of sleep apnea treatment in improving cardiovascular biomarkers.

This is a Phase II randomized controlled trial that will evaluate the effects of supplemental nocturnal oxygen or Positive Airway Pressure (PAP) therapy, compared to optimal medical preventive therapy for Cardiovascular Disease (CVD) risk, on biomarkers of CVD risk in Obstructive Sleep Apnea (OSA) patients at high risk for CVD events. The study will focus on patients with moderate to severe OSA but only mild OSA symptoms.

Eligible participants have a history or symptoms of heart disease AND have symptoms of sleep apnea or snoring. Participants will be contributing to medical knowledge about different options that can be used to improve heart disease in people with sleep apnea.

Eligibility Criteria:
Inclusion Criteria:

* established Coronary Artery Disease or established cardiovascular disease risk factors
* home sleep test that showed moderately severe sleep apnea

Exclusion Criteria:

* poorly controlled health
* currently using supplemental oxygen or PAP for OSA