cyrilzakka/clinical-trials huggingface dataset:
Improving Maternal and Child Health Through Prenatal Fatty Acid Supplementation

The purpose of the study is to test whether nutritional supplementation during pregnancy is associated with 1) improved maternal health during pregnancy; 2) improved infant birth and neurodevelopmental outcomes, and 3) whether the association between nutritional supplementation during pregnancy and infant outcomes is partially mediated by reductions in maternal perceived stress and stress reactivity during pregnancy.

Low-income pregnant women often experience chronic stress and consequently higher levels of stress hormones. In utero exposure to high levels of stress hormones can negatively affect the developing fetus and the infant's capacity for emotion and behavioral regulation. This program of research is designed to reduce the negative impact of prenatal stress on infant health and development via nutritional supplementation of docosahexaenoic acid (DHA) during pregnancy. DHA is a long-chain polyunsaturated fatty acid member of the omega-3 fatty acid family. DHA is found in its highest concentrations in neural cell membranes, affecting receptor function, neurotransmitter uptake, and signal transmission. There is growing evidence that low levels of dietary DHA intake are associated with suboptimal response to stress and that DHA supplementation can modulate stress response.

One hundred sixty-two pregnant women will be randomly assigned to receive 450 mg/daily of DHA or placebo beginning at 9-12 weeks of gestation through the end of pregnancy. Perceived stress, stressful life events, anxiety, and depression, inflammatory markers, DHA levels and response to a laboratory stressor will be assessed at baseline and at 24, 30, and 36 weeks of pregnancy. Neonatal outcomes (e.g., gestational age, birth weight, delivery complications) will be collected from medical records, and infant neurodevelopmental outcomes and stress reactivity will be assessed at 1, 4 and 9 months of age. Coded data will be analyzed by the Investigators at University of Chicago and University of Pittsburgh

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 34
* Household recipient of public assistance (e.g. Medicaid insurance) due to low income
* Low levels of DHA consumption as defined as less than two fish servings per week

Exclusion Criteria:

* Reports of known medial complications
* Regular use of steroid medications, alcohol, cigarettes, or illegal substances (by maternal report)
* Use of blood thinners or anti-coagulants
* Use of psychotropic medications
* Allergy to iodine and/or soy
Sentinel Node Extended in Squamous Cell Vulvar Cancer

The aim of this study is to investigate the feasibility of sentinel node biopsy in patients with squamous cell vulvar cancer, currently not regarded suitable for the sentinel node technique, i.e. patients with tumors ≥4cm, multifocal tumors or locally recurrent disease. A positive result of this pilot study might constitute the basis for a future full-scale multinational trial.

PRIMARY OBJECTIVES:

This study is primarily a pilot and feasibility trial, aiming to evaluate if sentinel node biopsy has a satisfactory detection rate and negative predictive value in certain groups of vulvar cancer patients.

OUTLINE:

The study is planned as a prospective, multi-center cohort study in Sweden. Since 2017, the treatment of vulvar cancer patients has been accredited to four tertiary referral university hospitals in Sweden; the Sahlgrenska University hospital in Gothenburg, the Linköping University hospital, the Skåne University hospital in Lund and the Karolinska University hospital in Stockholm.

Eligible patients will undergo a sentinel node biopsy additionally to their radical inguinofemoral lymphadenectomy and detection rate and negative predictive value for the sentinel procedure will be calculated. The study will consist of four patient groups: Patients with squamous cell vulvar cancer and:

1. primary tumors ≥4cm
2. primary multifocal tumors
3. local recurrence, earlier no treatment of the groins or only sentinel node biopsy
4. local recurrence, earlier treatment of the groins with radiotherapy / inguinofemoral lymphadenectomy

It is estimated to include 20-30 patients in each study group during a time frame of about 24 months.

RESULTS:

Results are to be expected in the end of 2021.

Eligibility Criteria:
Inclusion Criteria:

* Patients with squamous cell vulvar cancer and

  1. primary tumors ≥ 4cm
  2. multifocal primary tumors
  3. local recurrence, earlier no treatment of the groins or only sentinel node biopsy
  4. local recurrence, earlier treatment of the groins with radiotherapy / inguinofemoral lymphadenectomy
* ≥ 18 years of age
* Considered clinically appropriate for surgery
* Informed consent

Exclusion Criteria:

* Eastern Cooperative Oncology Group performance status \> 2
* Disability to read or write in Swedish
* Dementia / severe psychiatric illness leading to disability to understand the study / study information
* Signs of inguinal lymph node or distant metastases
* Ongoing pregnancy
Voriconazole as Prophylaxis for Liver Transplant Recipients

The study aims to determine if voriconazole prevents invasive fungal infections in liver transplant recipients. Endpoints would be: occurrence of invasive fungal infection and fungal colonization. Two groups will be compared: patients who received voriconazole as prophylaxis and historical controls who did not receive this prophylaxis.

The following variables will be followed: time and location of positive cultures, underlying diseases and severity of illness, voriconazole usage prophylactically, physical exam findings, laboratory and radiographical data, antimicrobial usage, microbiological data and resistance patterns, choice of antifungal drugs once organism identified, suspected source of infection, microbiological outcomes, laboratory results, demographic information, medications, clinical outcome, gender, weight, ethnicity, and past medical history.

Eligibility Criteria:
Inclusion Criteria:

* Patients receiving a liver transplant at University of Pittsburgh Medical Center (UPMC) between January 1, 2001 and June 30, 2005.
Practical Pattern of Surgical Timing of Childhood Cataract in China

In the current study, the investigators analyzed the surgical RWD of 2,421 children with childhood cataracts from the Childhood Cataract Program of the Chinese Ministry of Health (CCPMOH) at the Zhognshan Ophthalmic Center and proposed data-based clinical experience for the timings of cataract extraction and IOL implantation.


Eligibility Criteria:
Inclusion Criteria:

* childhood cataracts present at the ZOC at the first time age: 0-18 years

Exclusion Criteria:

* complicated with other type of cataracts
Evaluation of Microcirculatory Function and Mitochondrial Respiration After Cardiovascular Surgery

This study will examine the differences in microcirculatory function and mitochondrial respiration in patients with shock after cardiovascular surgery.

Post-cardiotomy shock (PCS) occurs in up to 5% of cardiovascular surgeries and has an in-hospital mortality rate as high as 75%. It is unclear if patients with PCS despite achieving standard resuscitation goals have impairments in oxygen delivery or oxygen utilization. This study will examine the difference in microcirculatory function and mitochondrial respiration in patients with shock to better understand the driving mechanism of bioenergetic failure in patients with PCS.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (\>18 years old)
* Receiving elective coronary artery bypass graft (CABG)
* Receiving valvular surgery requiring cardiopulmonary bypass

Exclusion Criteria:

* Unable to tolerate sublingual microcirculatory flow imaging (e.g., non-intubated patients dependent upon oxygen by facemask, poor mouth opening)
* receiving an emergent procedure
* have an actively treated malignancy
* mitochondrial disorder
* receiving surgery requiring deep hypothermic circulatory arrest.
Study of S1 Efficacy and Toxicity as Second-line Treatment on Inoperable or Advanced Gastric Cancers

The primary purpose of the study is to investigate the correlation between the efficacy and toxicity of S-1 on gastric cancers and the expression of thymidylate synthase (TS), dihydropyrimidine dehydrogenase (DPD) and orotate phosphoribosyltransferase(OPRT).

TS, DPD and OPRT are the key enzymes on the metabolic pathway of 5-Fu. We will retrospectively analyze the clinicopathological features of the patients who have suffered an inoperative or recurrent gastric cancers and administrated with S-1, such as the overall survival (OS), progressive-free survival (PFS), Lauren's classification and toxicity of S1, etc. We will divide the patients into several subgroups according to the parameters above, and then investigate the correlation between the parameters and the expression of TS, DPD and OPRT.

All of the analysis is retrospective, there is no different treatment operation once the subject enrolled in this study.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed, inoperable or advanced gastric cancer patients who received at most 1st line treatment
2. Aged 18 years or older
3. KPS performance status of ≥ 70.
4. Anticipated life expectancy of ≥ 3 months.
5. Adequate organ function, including bone marrow, kidney and liver.

   * ANC ≥ 1.5×109/L and hemoglobin ≥ 8g/dL and platelet count ≥ 100×109/L
   * Serum total bilirubin ≤ 1.5 x ULN, Serum ALT and AST ≤ 2.5 x ULN (Serum ALT and AST ≤ 5 x ULN, if liver metastases are present)
   * Serum creatinine ≤ 1.5 x ULN and CLcr \> 60 ml/min
6. Written informed consent can be obtained prior to their participation in the trial.

Exclusion Criteria:

1. History of severe drug allergy , or an allergy to any components of S1
2. Subjects who have received chemotherapy, immunotherapy or radiotherapy within two weeks
3. Alimentary tract hemorrhage, diarrhea or aphagosis at the present stage
4. Subjects with uncontrolled CNS metastasis or epilepsia or severe psychiatric disorders.
5. Subjects who are regarded to be unsuitable for this trial by the investigator.
6. Subjects who are participating in other clinical trials
7. Subjects with ascites draining or severe infection
8. Pregnant or breast-feeding women
Prevention of Imminent Paralysis Following Spinal Cord Trauma or Ischemia by Minocycline: A Multi-center Study in Israel With IDF Primary Care Involvement

Spinal cord trauma and the consequent paraplegia are possibly among the most devastating injuries in soldiers and during spine surgery, and are significant in the medical, social and financial aspects. Limited mobility, the need for assistance in all human activities, shame, and many medical complications related directly to the neural deficits make paraplegia an important target for prevention. Our study will evaluate the efficacy of Minocycline in two different groups:

1. Minimizing the neurological damage among trauma patients.
2. Preventing neurological damage through operation in spinal tumors patients.

2.OBJECTIVES

The primary objectives of the trial are to determine:

1. Efficacy of administrating minocycline in minimizing the neurological damage among acute spinal cord injury patients and spinal cord tumors (primary and metastases) patients?
2. Efficacy of administrating minocycline at changing the natural history and rehabilitation of spinal cord trauma patients.
3. Safety of applying minocycline in spinal cord injuries patients and spinal cord tumors?


Eligibility Criteria:
Inclusion Criteria:

Trauma patients with incomplete spinal cord syndromes related to fractures, dislocations, blunt trauma (central cord syndrome).

1. Inclusion Criteria:
2. Patients with incomplete spinal cord syndromes related to fractures, dislocations, blunt trauma (central cord syndrome).
3. Ages: 18 to 65
4. Males - including those involved in active military duty.
5. Females - of child-bearing potential who have a negative pregnancy test (hCG urine) within 72 hours of informed consent. Pregnant women will be excluded from the study.

Exclusion Criteria:

1. Complete cord transection, severe head injury, coma, or other disease of the CNS, and spinal injury diagnosed later than 24 hours.
2. Pregnant women (minocycline can cause fetal harm) and children.
3. Lower extremity fractures, mildly reduced consciousness and frail cognitive status will not be considered for exclusion.
4. Patients who will not be enrolled will be listed and reason for non inclusion will be recorded.

Spinal tumors:

Inclusion Criteria:

1. Intrathecal extramedullary tumors, vertebral metastases or primary vertebral tumors causing cord compression with or without incomplete cord syndrome.

Exclusion criteria:

1.Intramedullary tumors or tumors causing complete cord syndrome

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Randomized Controlled Trial of TCRFVR and LAUP in Snorers

We hypothesis that radiofrequency will cause less post-operative discomfort when compared with laser assited uvulopharyngoplasty. 40 patients with primary snore will be enrolled into this study. After overnight sleep test confimred that no obstructive sleep apnea existed, cases were informed consented. Then they were randomized into two groups. Post-operative pain, duration of analgesics were recorded.

Although Rf group was less effective, they felt less discomfort.

Eligibility Criteria:
Inclusion Criteria:

* RDI \< 5/h

Exclusion Criteria:

* Previous treated snoring, coagulation disorder
Zanubrutinib-based Maintenance Therapy of Newly Diagnosed DLBCL With Initial Remission

This single-arm, prospective clinical study will evaluate the efficacy and safety of Zanubrutinib-based maintenance therapy for post-remission in newly diagnosed DLBCL who are intolerant to first-line intensive chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

1. Patients were informed about this study and voluntarily signed written informed consent
2. Patients were intolerant first-line intensive chemotherapy, including R-CHOP or R-DA-EPOCH: a) age≧70 years, or unfit or frail according to CGA; b) ECOG 0-2; c) measurable lesions
3. DLBCL with initial CR/PR according to 2016 WHO Classification of Tumor of Haematopoietic and Lymphoid Tissues
4. Life expectancy \> 3 months
5. Normal blood count as defined as: absolute neutrophil count ≥1.0 × 10 9 /L independent of growth factor support, platelet count ≥ 100,000/mm 3 or ≥ 50,000/mm 3 if bone marrow (BM) involvement independent of transfusion support in either situation Normal organ functions defined as: creatinine ≤1.5 times the upper limit of normal (ULN) or estimated Glomerular Filtration Rate (Cockroft-Gault) ≥50 ml/min/1.73m 2 , aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤2.5× the ULN; total bilirubin ≤ 1.5 × the ULN unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin: patients with documented Gilbert disease may be enrolled if total bilirubin is ≤ 3.0 × the ULN;
6. Women of childbearing potential and men who are sexually active must be practicing a highly effective method of birth control during and after the study consistent with local regulations regarding the use of birth control methods for subjects participating in clinical trials. - Women of childbearing potential must have a negative serum (beta-human chorionic gonadotropin \[Beta-hCG\]) or urine pregnancy test at Screening. Women who are pregnant or breastfeeding are ineligible for this study.

Exclusion Criteria:

1. Contraindication to any drug in the study
2. Seropositive for or active viral infection with HBV or HCV
3. Human immunodeficiency virus (HIV) infection
4. Any grade 3 or 4 heart disease as defined by the New York Heart Association (NYHA) functional class;
5. QTc (corrected by Fridericia formula): \>480ms;
6. Prior malignancies other than lymphoma in the last 5 years with exception of currently treated basal or squamous cell carcinoma or melanoma of the skin or in situ carcinoma of the cervix
7. If female, the patient is pregnant or breast-feeding
8. Any uncontrolled active systemic infection
Nonmyeloablative Stem Cell Transplantation With CD8-depleted or Unmanipulated Peripheral Blood Stem Cells (PBSC)

Prospective randomized study of allogeneic minitransplantation from HLA-identical family or unrelated donors comparing unmanipulated or CD8-depleted PBSC. The conditioning regimen will be 2 Gy TBI alone (related donor with low-risk of transplant rejection) or 2 Gy TBI and 3 x 30 mg/m2 fludarabine (unrelated donor or high risk of transplant rejection). Patients will receive a short but intensive immunosuppressive treatment (cyclosporine and mycophenolate mofetil) to ensure both graft-versus-host and host-versus-graft tolerance. The rationale for using PBSC instead of marrow transplant is to avoid general anesthesia of the donor and to minimize the risk of rejection. The rationale for CD8+ depletion is to diminish the risk of GVHD after PBSC transplantation or DLI.


Eligibility Criteria:
1. Patients

   1.1. Diseases

   Malignant diseases confirmed histologically and not rapidly progressing:
   * Hematologic malignancies
   * AML;
   * ALL;
   * CML and other myeloproliferative disorders;
   * MDS;
   * Multiple myeloma;
   * CLL;
   * Non-Hodgkin's lymphoma;
   * Hodgkin's disease.
   * Non-hematologic malignancies
   * Renal cell carcinoma (metastatic).

   1.2. Inclusion criteria
   * Male or female; female patients must use a reliable contraception method;
   * Age lower than 70 yrs (family donor) or lower than 65 yrs (unrelated donor);
   * HIV negative;
   * No terminal organ failure;
   * No uncontrolled infection, arrhythmia or hypertension;
   * Family donor (HLA-identical) or unrelated donor (matched for A-B by low resolution typing and for DRB1-DQB1 by high resolution typing);
   * No previous radiation therapy precluding the use of 2 Gy TBI
   * Informed consent given by patient or his/her guardian if of minor age.

   1.3. Clinical situations
   * Theoretical disease indication for a standard allo-transplant, but not feasible because:
   * Age \> 55 yrs;
   * Unacceptable end organ performance;
   * Patient's refusal.
   * Indication for a standard auto-transplant:

     * perform mini-allotransplantation 2-6 months after standard autotransplant.
   * Not an indication for intensification but a potential candidate for cellular immunotherapy.
2. Donors

2.1. Inclusion criteria

* Related to the recipient (sibling, parent or child) or unrelated;
* Male or female;
* Weight \> 15 Kg (because of leukapheresis);
* HIV negative;
* No major contraindication for allogeneic PBSC donation by generally accepted criteria;
* Informed consent given by donor or his/her guardian if of minor age.

2.2. Exclusion criteria

* Any condition not fulfilling inclusion criteria;
* Unable to undergo leukapheresis because of poor vein access or other reasons.
Extension Study of Bomedemstat (IMG-7289/MK-3543) in Participants With Myeloproliferative Neoplasms (IMG-7289-CTP-202/MK-3543-005)

This is a multi-center, open-label extension study to assess the long-term safety and efficacy of bomedemstat (MK-3543, formerly called IMG-7289) administered orally once daily in participants with an MPN who participated in a prior bomedemstat study such as, but not limited to, IMG-7289-CTP-102 and IMG-7289-CTP-201 (referred to hereafter as 'feeder studies').


Eligibility Criteria:
Inclusion Criteria:

* Completed at least one Treatment Period (TP) in a prior bomedemstat Myeloproliferative Neoplasm (MPN) protocol (such as, but not limited to, IMG-7289-CTP-102/MK-3543-002 or IMG-7289-CTP-201/MK-3543-003).
* In the estimation of the Investigator, the risk-benefit favors continued dosing with bomedemstat.

Exclusion Criteria:

* Ongoing participation in another investigational study (except observational studies).
* A history of non-compliance in a prior bomedemstat study (excluding dose suspensions that were medically warranted).
* Current use of a prohibited medication (e.g., romiplostim).
* Medical, psychiatric, cognitive, or other conditions that, in the Investigator's opinion, compromise the patient's safety, ability to give informed consent, or comply with the trial protocol.
* Females who are pregnant or breastfeeding or plan to become pregnant or breastfeed during the study.
* Women of childbearing potential (WOCBP) and fertile men unwilling to agree to use an approved method of contraception from time of enrollment until 14 days after last bomedemstat dose.
Clinical Pathways and Patients' Attitudes in Acute Low Back Pain

In France the prevalence of low back pain is 70 to 80 %. It's the leading cause of health expenditure in Europe and costs 900 million euros per year to health insurance in France. This is the second reason to consult a general practitioner. Acute low back pain is defined as low back pain lasts less than 6 weeks. It represents 60 to 70 % of low back pain but only 20% of the costs induced by low back pain in general. In fact, acute low back pain often heals spontaneously.

Risk factors for acute low back pain and risk factors for chronic low back pain have been the subject of many publications. They remain very difficult to prevent in practice because of their multiplicity. Preventing acute low back pain is part of the prevention of chronic low back pain. Patient care management of low back pain is well codified and consensual in the various international recommendations. However, their application is sometimes very disparate and bad habits on both patients and professionals persist. Advices recommended in the case of low back pain are widely disseminated but their applications are little studied. In 2017, in France, health insurance started a "back pain" prevention campaign with the objective of raising awareness of good attitudes in the event of back pain. It made an initial assessment of the different knowledges concerning spinal pain in the general population but also in the medical population with the aim of improving them. It appears that number of patients would not consult physician in this case. The many proposals of care and the diversity of medical professionals, paramedics and other stakeholders, proposing to cure low back pain form as many different clinical pathways. Use of alternative or unconventional medicines is poorly assessed. In this context, it seems relevant to evaluate patient clinical pathways and patients' attitudes.

The aim of the study is to explore patient clinical pathways and patients' attitudes in acute low back pain

Eligibility Criteria:
inclusion criteria :

* men and women
* aged between 18 and 65 years old
* living in France
* to have ever had an acute low back pain
* accepting to participate in the study

exclusion criteria :

- over 65 or under 18 years old