cyrilzakka/clinical-trials huggingface dataset:
Vaginal Progesterone Versus Placebo in Multiple Pregnancy

The purpose of this study is to see if daily use of vaginal progesterone will prevent preterm birth in women carrying 2 or more babies.

Women who are pregnant with twins or any higher order multiple will be approached to take part. Women will be randomized to get either vaginal progesterone gel or a placebo gel daily from study entry until 35 6/7 weeks. Women can enter the study between 16 - 20 6/7 weeks. Two hundred women will be recruited to take part. Data will be collected on the women and their infants to see if the active medication prolongs pregnancy.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed multiple pregnancy
* Ultrasound confirmed minimum of 2 live fetuses
* Gestational age 16-20 6/7 weeks

Exclusion Criteria:

* Placenta previa
* Pre-existing hypertension
* Major fetal anomaly
* Monoamniotic, monozygotic multiples
* Maternal seizure disorder
* History of, or active, thromboembolic disease
* Maternal live disease
* Breast malignancy or pathology
* Progesterone dependent neoplasia
* Plans to move to another city during pregnancy
* Sensitivity to progesterone
* Participation in other clinical trials during the pregnancy
Cognitive and Emotional Factors in Visual Exploration Among Patients With Post-Traumatic Stress Disorder (SAILLANCE2)

Post-traumatic stress disorder (PTSD) is characterized by hypervigilance. In particular, previous works suggest that patients tend to scan constantly the environment for possible threats. The present project aims at investigating such attentional bias in patients with PTSD using the change blindness paradigm that offers the interesting possibility of studying sensitivity to sudden changes using ecological stimuli. More precisely, the investigators will investigate whether patients are more sensitive than matched controls to sudden changes in the visual environment and whether this hypersensitivity is specific or even stronger when visual information has an emotional content. The attentional bias will be measured using motor responses (accuracy and speed to indicate the occurrence of a change by pressing a button) as well as eye movements.


Eligibility Criteria:
Inclusion Criteria:

* a diagnosis of PTSD based on the standard DSM-IV criteria,
* normal or corrected vision.
* clinically stable at the testing time

Exclusion Criteria:

* history of neurological illness or trauma that occurred in the previous six months, - pregnant and nursing women,
* drugs use in the last 24 hours,
* an acute ocular disorder.
* Participants will not be under tutorship, curatorship or deprived of liberty.
A Study to Explore the Role and Impact of Wearable Smart Devices in Perioperative NSCLC Patients

The trial was designed as a single-center non-interventional prospective observational study to explore the role and impact of wearable smart devices in perioperative NSCLC patients.


Eligibility Criteria:
Inclusion Criteria:

1. Participants must provide voluntary consent to participate in this research and possess the capacity to sign an informed consent form.
2. Participants must be aged over 18 years.
3. Participants must have undergone pulmonary resection surgery with a postoperative pathological confirmation of primary lung cancer.

Exclusion Criteria:

1. Patient refusal to participate in this research.
2. Inability to wear wearable smart monitoring devices due to various reasons.
3. The pathological report suggests a non-small cell lung cancer (NSCLC) exclusion.
4. History of secondary lung cancer surgery.
Prenatal Breast Pump Education of Mothers and Their Support Person

The study will follow a prospective cohort of racially and economically diverse mothers of premature infants for 3 weeks following delivery to test whether antenatal education of the support person of mothers may decrease time to initiation of breast pumping, decrease time to lactogenesis stage II and increase breast milk production.

Compelling evidence exists that breast milk helps protect premature infants from prematurity-specific morbidities, including feeding intolerance, late onset sepsis, and necrotizing enterocolitis. Unfortunately, mothers of VLBW infants often exhibit delayed lactogenesis stage II (when the milk "comes in") and inadequate breast milk production. Earlier initiation of breast milk expression following delivery is associated with increased lactation success. However, lack of nursing time and lack of hospital personal are significant barriers to the early initiation of milk expression in this population. The proposed study will follow a prospective cohort of racially and economically diverse mothers of premature infants for 3 weeks following delivery to test 1 primary aim and 1 secondary aim. Aim 1: will evaluate the feasibility of antenatal BM pumping education for SPs of mothers of preterm infants. Issues related to recruitment, randomization acceptance of the intervention, and refinement of the education materials and process will be scrutinized. Aim 2 will estimate variability of outcome measurements and effect sizes needed to calculate the sample size for a subsequent larger, adequately powered, randomized clinical trial. Eligible women and their SP will be randomly assigned to one of two groups. Group 1 will receive a prenatally delivered lactation educational program including video recordings, a demonstration of how the pump works and will have a breast pump available in their room. The volume of breast milk produced, timing of lactation stage II, duration of lactation and stress during initial expression will be measured. In addition, breast milk sodium levels will be analyzed on Day 1-7, Day 14 and 21.

Eligibility Criteria:
Inclusion Criteria:

* English speaking
* stated intent to breastfeed
* anticipating the birth of a premature infant \< 35 weeks gestation.

Exclusion Criteria:

* known illicit maternal drug use
* history of breast reduction or augmentation
* positive HIV status
* infant not expected to live over 2 weeks following delivery.
Comparison of Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks With Sofosbuvir and Ribavirin for 24 Weeks in Adults With Chronic Genotype 3 HCV Infection

The primary objectives of this study are to compare the efficacy of treatment with sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) for 12 weeks with that of sofosbuvir (SOF) + ribavirin (RBV) for 24 weeks and to evaluate the safety and tolerability of each treatment regimen in participants with chronic genotype 3 hepatitis C virus (HCV) infection.


Eligibility Criteria:
Inclusion Criteria:

* Willing and able to provide written informed consent
* HCV RNA ≥ 10\^4 IU/mL
* HCV genotype 3
* Chronic HCV infection (≥ 6 months)
* Females of childbearing potential must have a negative serum pregnancy test
* Males and females of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception

Exclusion Criteria:

* Current or prior history of clinically-significant illness (other than HCV) that may interfere with subject treatment, assessment or compliance with the protocol
* Screening ECG with clinically significant abnormalities
* Laboratory results outside of acceptable ranges at Screening
* Pregnant or nursing female or male with pregnant female partner
* Chronic liver disease of a non-HCV etiology (e.g., hemochromatosis, Wilson's disease, alfa-1 antitrypsin deficiency, cholangitis)
* Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
Evaluation of the Healthy Families Alaska Program

This study will assess the effectiveness of early home visitation by a professional in preventing child maltreatment, promoting healthy family functioning, and promoting child health and development.

The investigators will test the following hypotheses regarding the effectiveness of early paraprofessional home visiting for at-risk families

* Actual home visiting services adhere to HFAK standards.
* HFAK promotes healthy family functioning, promotes child health and development, and prevents child abuse and neglect.
* Adherence to HFAK process standards is positively associated with achievement of outcomes.

Healthy Families Alaska (HFAK) is a well-established child abuse prevention program targeted to at-risk families. HFAK is based on the Healthy Families America initiative promoted by Prevent Child Abuse America. The State Department of Health and Social Services (DHSS) administers the HFAK program.

In 1998, the Alaska State Legislature requested a controlled study of HFAK to determine its effectiveness in preventing child maltreatment, promoting healthy family functioning, and promoting child health and development. DHSS awarded the Johns Hopkins University School of Medicine a contract to conduct the study from July 1999 through June 2004.

The study is a randomized trial of six HFAK sites throughout Alaska. It aims to compare services actually provided to HFAK standards, assess program success in achieving intended outcomes, and relate program impact to service delivery.

Families are enrolled over 21 months beginning in January 2000. Families are randomized to either the HFAk group or the control group. Baseline data on family attributes are collected from HFAK files and maternal interviews. HFAK service data are collected from the program's management information system, record reviews, surveys of staff, and staff focus groups. Outcome data are collected when the children were two years old through maternal interview, home-based observations, child developmental testing, review of medical records, and review of OCS child welfare records.

Eligibility Criteria:
Inclusion Criteria:

* Family resides in a community served by one of six HFAK programs participating in the study
* Family identified as at-risk by HFAK staff following the usual HFAK protocol

Exclusion Criteria:

* Family was previously enrolled in HFAK
* Mother unable to speak English well enough to complete study activities.
* Family unwilling to enroll in the HFAK program.
Safety and Pharmacokinetic Profile of CKD-581

This study is to determine the maximum tolerated dose (MTD), dose limiting toxicity (DLT), safety and pharmacokinetics (PK) profile of a single agent CKD-581 injection in patients with Lymphoma failed to standard therapy. The usefulness of the this regimen is evaluated by response rate, progression free survival.

Recently, the role of transcriptional repression through epigenetic modulation in carcinogenesis has been clinically validated with several inhibitors of histone deacetylases and DNA methyltransferases. It has long been recognized that epigenetic alterations of tumor suppressor genes was one of the contributing factors in carcinogenesis. Inhibitors of histone deacetylase (HDAC) de-repress genes that subsequently result in growth inhibition, differentiation and apoptosis of cancer cells. CKD-581 is developed for HDAC inhibitors. Such as to determine the maximum tolerated dose (MTD), dose limiting toxicity (DLT), safety and pharmacokinetics (PK) profile of a single agent CKD-581 injection in patients with Lymphoma failed to standard therapy.

Eligibility Criteria:
Inclusion Criteria:

* 20 years and older
* Histologically or cytologically confirmed Lymphoma or Multiple myeloma that have failed to standard therapy or for which no life prolonging treatment exists
* ECOG(Eastern cooperative oncology) performance status ≤ 2
* Life expectancy 12 weeks
* Hematopoietic: ANC(Absolute Neutrophil Count) ≥ 1,500/mm3, Platelet count(PLT) ≥ 100,000/mm3, Hemoglobin ≥ 9.0g/dL
* Hepatic: Total bilirubin \> 1.5×upper limit of normal(except Gilbert's syndrome patients), aspartate aminotransferase(AST) \> 3×upper limit of normal, alanine aminotransferase(ALT) \> 3×upper limit of normal(AST, ALT ≤ 5.0×ULN in case of liver metastases)
* Renal: serum creatinine ≤ 1.5×upper limit of normal
* Serum calcium ≤ upper limit of normal (If the Multiple myeloma only)
* Signed a written informed consent

Exclusion Criteria:

* Have symptoms with Brain metastases
* History of Ischemic heart disease(e.g., myocardial infarction, unstable angina pectoris) or Clinically significant heart disease such as NYHA Class III and IV Congestive atrial arrhythmias, within 6 months prior to first dose of study drug
* Acute infection or blooding tendencies that would preclude study compliance
* Other psychiatric disorders or other conditions that would preclude study compliance
* Receiving antitumor therapy(surgery, immunotherapy or chemotherapy) within 4 weeks prior to first dose of study drug(6 weeks for nitrosoureas and mitomycin C, 2 weeks for radiation therapy)
* Other concurrent antitumor therapy
* Have Cardiac disease by nature
* Administration history of Histone Deacetylase Inhibitor
* History of Serious hypersensitivity or allergy
* Pregnant or nursing, active serum pregnancy test. Fertile patients must use effective contraception
* Participation in a clinical trial within 4 weeks of first dose of study drug
Laparoscopic Versus Open Liver Resection for Hepatocellular Carcinoma

The purpose of the study is to observe the curative effect and safety of laparoscopic versus open liver resection for hepatocellular carcinoma.

Liver resection is the most important treatment of hepatocellular carcinoma (HCC). Open hepatectomy was regarded as a giant surgery because of its big incision, influence of the liver function, and long hospital stay. Laparoscopic hepatectomy was widely used since it was reported by Reich in 1991. With the constant innovation of laparoscopic technique and equipment, there is no penalty area in laparoscopic hepatectomy. The Louisville consensus proposed that the best indication for laparoscopic hepatectomy was the tumor diameter \< 5cm, located in segment II-VI.

Previous studies shows that compared with the open surgery, laparoscopic hepatectomy has the advantages of shorter operation time, less bleeding, shorter hospitalization time. The mortality, mobility, the overall survival and the disease-free survival was same in these two groups.

So far, however, the curative effect and safety research of laparoscopic versus open liver resection for HCC is limited to retrospective study and case-control study. A prospective, randomized, controlled study is urgently needed.

This study was proceeded to observe the curative effect and safety of laparoscopic versus open liver resection for HCC.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis was HCC
2. The tumor was located in segment: II, III, IVb, V, VI
3. The tumor diameter \< 5cm
4. Without thrombosis in the portal vein, hepatic vein or bile duct
5. Without intrahepatic and systemic metastasis
6. The Child-pugh score was A-B7
7. The ASA（American Society of Anesthesiologists） score was I-III
8. The patient age was between 18-75
9. Sign the informed consent, and can fully understand the research content

Exclusion Criteria:

1. Have surgery contraindications
2. Pregnant or lactating women
3. The Child-pugh score was B8-C
4. The ASA（American Society of Anesthesiologists） score was IV-V
5. With other malignant tumor
6. With mental illness
7. Participated in other clinical trials in the last three months
8. Underwent other treatments(chemotherapy or radiotherapy) before operation
Sharing Our Strength: A Research Study for Bone Marrow/Stem Cell Transplant Survivors

The Sharing Our Strength study is being conducted to help us understand people's experiences with hematopoietic stem cell transplantation and to test a new program designed to help people recover physically and emotionally after transplant.

This is a study for survivors of hematopoietic stem cell transplantation (also known as bone marrow transplant), which is an intensive medical treatment for cancers such as leukemia, lymphoma, and multiple myeloma as well as other diseases. Because it is a physically and emotionally demanding treatment, many people report having ongoing physical and emotional difficulties after having a transplant. The Sharing Our Strength study is being conducted to help us understand people's transplant experiences and to test a new program designed to help them recover physically and emotionally after transplant. All parts of the study are completed by mail and telephone. Participants will receive compensation for their time.

Eligibility Criteria:
Inclusion Criteria:

* Be a transplant survivor who is 9 months to 3 years beyond transplant and not currently relapsed. and not currently relapsed
* Be at least 18 years old now (and at least 16 when they had their transplant)
* Speak English
* Have telephone service

Exclusion Criteria:

* None
Anatomical Resection VS. Nonanatomical Resection for Colorectal Liver Metastases With Gene Mutation or Right-sidedness

In this study, colorectal cancer patients with initially resectable liver-only metastases, as prospectively confirmed by a local multidisciplinary team (MDT) according to predefined criteria, will be tested for RAS and BRAF tumor mutation status. Patients with gene mutant or right-sidedness will be randomised between anatomical resection (AR) or nonanatomical resection (NAR). The primary end-point is the relapse-free survival.

This study is a prospective, single-center, randomized control trial. The major including criteria are (1) Histologically confirmed colorectal cancer initially resectable liver-only metastases ; (2) patient has the opportunity to perform either anatomical resection (AR) or nonanatomical resection (NAR) surgery; (3) the number of metastasis is 1-3; (4) KRAS/NRAS/BRAF mutation or right-sidedness. Patients will be randomised between AR or NAR. Patients will be stratified for gene mutation and right-sidedness.

Based upon the segmental anatomy of the liver according to Couinaud system, AR is defined as the resection of one or more complete hepatic segments in our study, including bisegmentectomy, right hemihepatectomy, left hemihepatectomy, extended right hemihepatectomy, extended left hemihepatectomy, single segmentectomy, caudate lobectomy, or a combination thereof. NAR, also called as wedge resection, is defined as the resection of the tumor with a margin of normal parenchyma regardless of the hepatic anatomy.

The primary end-point is the relapse-free survival. The secondary end-points are postoperative complication, postoperative mortality, hospital length of stay, and overall survival.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 and ≤ 75 years;
2. Histological proof of colorectal adenocarcinoma;
3. Resectable colorectal liver metastasis without detectable extrahepatic distant metastatic disease (determined by a local MDT);
4. Suitable for anatomical or nonanatomical liver resection (determined by a local MDT);
5. Number of metastasis is 1 to 3;
6. KRAS/NRAS/BRAF mutation or right-sidedness;
7. Performance Status (ECOG) 0\~1;
8. Adequate hematological function: Neutrophils≥1.5 x109/l and platelet count≥100 x109/l; Hb ≥9g/dl (within 1 week prior to randomization);
9. Adequate liver and renal function: total bilirubin ≤2.0 mg/dl, serum transaminases ≤ 5x upper limit of normal(ULN), and serum creatinine ≤ 1.5x ULN and creatinine clearance ≥ 30 ml/min;
10. Written informed consent.

Exclusion Criteria:

1. Previous systemic treatment for metastatic disease;
2. Previous surgery for metastatic disease;
3. Extrahepatic metastases;
4. Unresectable primary tumor;
5. Major cardiovascular events (myocardial infarction, severe/unstable angina, congestive heart failure, CVA) within 12 months before randomisation;
6. Second primary malignancy within the past 5 years;
7. Acute or subacute intestinal obstruction;
8. Drug or alcohol abuse;
9. No legal capacity or limited legal capacity;
10. Pregnant or lactating women.
Reminders, Cost Sharing, and Healthcare Use

The investigators conduct a large-scale randomized controlled trial in Finland by sending three types of information letters to households to examine whether the reminder letters affect healthcare use. All letters remind of the importance of seeking care to treat potential health problems.

This study has two primary objectives are: to evaluate the effects of an information nudge reminding on the importance of diagnosing and treating health problems and to evaluate the effects of additionally providing information on the fact that primary care nurse visits have become exempt from copayments. Main outcomes include the number of primary care nurse visits and general practitioner (GP) visits in a six-month follow-up.

This study has two main objectives: (i) to evaluate the effect of an information nudge reminding on the importance of diagnosing and treating health problems and (ii) to evaluate the effect of providing information on the fact that primary care nurse visits have become exempt from co-payments.

Eligibility Criteria:
Inclusion Criteria:

* Residency in one of the 25 target municipalities as of September 15, 2021.
* Born in 1966 or earlier (aged 55 or more at the end of 2021).
* Living in a household with a maximum of three individuals aged 55 or above.

Exclusion Criteria:

* Individuals living in households (postal address) with more than three individuals aged 55 and above.
Epidemology of Acute Kidney Injury in Diabetic Patients Infected With covid_19 In Assiut University Hospital

The novel coronavirus SARS-CoV-2 was identified as the causative agent for a series of atypical respiratory diseases in Wuhan, China in December of 2019(.1) The disease termed COVID-19, was officially declared a pandemic by the World Health Organization on March 11, 2020. SARS-CoV-2 contains a single-stranded, positive-sense RNA genome surrounded by an extracellular membrane containing a series of spike glycoproteins resembling a crown.COVID-19 infection results in diverse symptoms and morbidity depending on individual genetics, ethnicity, age, and geographic location. In severe cases, COVID-19 pathophysiology includes destruction of lung epithelial cells, thrombosis, hypercoagulation, and vascular leak leading to sepsis.(2) COVID-19 risk factors include cardiovascular disease, hypertension, and diabetes.(2)

Notably, in several studies, diabetes is one of the most reported comorbidities with poor prognosis in patients with severe COVID-19 due to Compromised innate immunity, pro-inflammatory cytokine reduced expression of ACE2 and use of renin-angiotensin-aldosterone system antagonists. (3) On the other hand, COVID-19 contributes to worsening of dysglycemia in people with diabetes mellitus by direct β-cell damage, cytokine-induced insulin resistance, hypokalemia and drugs used in the treatment of COVID-19 (like corticosteroids, lopinavir/ritonavir).(4) Nearly half of critically ill patients would develop AKI at some point during their ICU admission.(5) Acute kidney injury (AKI) has been reported to be the second observed complication in deceased patients after ARDS.it is reported that patients who died with covid19 had different degrees of AKI .The pathogenesis of kidney injury in patients infected with covid19 is multifactorial: (1) prerenal azotemia, ATN can occur owing to many contributing factors including volume depletion, cytokine storm, hypoxia, shock, or rhabdomyolysis (2) proximal tubular injury, (3) glomerulopathy, (4) thrombotic microangiopathy, and (5)complications from the treatment of COVID_19. (6)

Eligibility Criteria:
Inclusion Criteria:

* patients admitted because of COVID-19 infetion.

Exclusion Criteria:

* Patients with ESRD on regular dialysis ,Patients with stage 4 or 5 non-dialysis if the condition proven to be progression of the already known diagnosis.