cyrilzakka/clinical-trials huggingface dataset:
Advance Care Planning: Promoting Effective and Aligned Communication in the Elderly

In this research study, the investigators are working to help oncologists better serve patients by delivering more patient-centered, goal-concordant care that may improve health care delivery.

- It is expected that about 30,000 people will take part in this research study, 29,550 of these patients, the vast majority, will be included only for medical record review.

The purpose of this study is to improve the quality of care provided to millions of older Americans with cancer. The investigators are working to help oncologists better serve patients by delivering more patient-centered, goal-concordant care that may dramatically improve health care delivery.

This is pragmatic stepped wedge cluster randomized trial (SW-CRT) of a Comprehensive ACP (Advance Care Planning) Program among older oncology patients. The ACP Program will include training clinicians in communication skills and using video decision aids for participants.

- This study will involve medical record review of 30,000 people age 65 or older with advanced cancer.

We will also recruit 450 eligible patients (150 patients from each of our three sites broken down into 75 patients during the control phase and 75 patients during the intervention phase) to conduct a survey for our secondary patient-centered outcomes (confidence, satisfaction with physician communication, patient decisional satisfaction and regret). From among this sub-group we will engage 240 participants (80 from each of our three sites broken down into 40 patients during the control phase and 40 patients during the intervention phase) in an activity to film video declarations of their preferences.

During the first year, three pilot sites (one at each health care system) will trial the intervention. The subjects recruited at these pilot sites will not be included in the final analysis. Thus, the main trial will begin during year 2 and continue through year 5 with recruitment of 30,000 subjects for the primary outcome at 30 oncology clinics. The first year pilot will serve to inform the larger roll-out and the intervention may change during the first year based on pilot-clinic experience.

Eligibility Criteria:
Inclusion Criteria for clinics:

Clinic eligibility criteria include:

* More than one oncologist
* Serve a patient population that is at least 30% aged 65 or older
* Disease-based oncology clinic

Subject Eligibility: (for the in-person surveys):

- Any patient affiliated with one of the study clinics who speaks English and is aged 65 or older with advanced cancer is eligible for participation. Advanced cancer is defined as metastatic disease for solid tumors and recurrent or refractory disease for hematological malignancies. There are no exclusions based on gender, race, or ethnicity.

Exclusion Criteria:

* Adults unable to consent
* Individuals who are not yet adults (infants, children, teenagers)
* Pregnant women
* Prisoners
Efficacy and Safety of Silicone Cream Containing Allium Cepa Extract

The objectives of this study were to evaluate efficacy and safety of silicone cream containing Allium Cepa extract in post-cesarean surgical scars treatment. Post-cesarean surgical scars were equally seperated into 2 parts (left part and right part). Silicone cream containing Allium Cepa extract or commercial scar gel was ramdomly assigned to apply on left part or right part of the scar. They will be applied 2 times per day (morning and evening) for 3 months. Patient and Observer Scar Assessment Scale (POSAS) , Vancouver scar scale (VSS), melanin index, and erythema index (using cutometer) were used for scar evaluation at 0, 1,2,and 3 months. Moreover, adverse effects were also observed.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-40 years
* Have Post-Cesarean Surgical Scars at least 1 month
* REEDA scale = 0 score
* Able to read and write Thai
* Able to follow the research plan
* Able to meet all the researchers throughout the period of participation in the project

Exclusion Criteria:

* Apply other topical application at the post-cesarean surgical scars within 2 weeks before participating in the study and during the study
* There is radiation in the area of the post-cesarean surgical scars
* Chronic skin diseases such as psoriasis, chronic dermatitis, allergies
* Immune deficient or use immunosuppressants within 2 weeks before participating in the study and during the study
* Have a history of silicone allergy or onion extract
Identification of Corticomedullary Differentiation Along Different Stage of Pregnancy

Corticomedullary differentiation (CMD) abnormality (absent/reversed) is a parameter that can indicate possible nephropathy. The evolution of CMD across gestation had not been well established. Devrendt et al demonstrated the presence of CMD in all fetuses older then 20 weeks. In our study we would like to determine the exact timing of it's sonographic visualisation. This is a prospective study recruiting women between 14-24 week gestation during routine ultrasound screening. A midsagittal image of each kidney will be taken by a single sonographer and examined for the presence of the CMD by two other sonographers blinded to gestational age.


Eligibility Criteria:
Inclusion Criteria:

* pregnant women 14-24 weeks
* singleton pregnancy
* Appropriate for gestational age fetuses
* well dated pregnancy

Exclusion Criteria:

* family history of renal disease
* small /large for gestational age fetuses
* known structural anomalies
* unknown dating
A Medical Chart Review of Patients With X-Linked Myotubular Myopathy (XLMTM)

This retrospective medical chart review (RECENSUS) of approximately 100 XLMTM patients (with a goal to obtain 50 deceased and 20 living records) will provide further knowledge about the clinical manifestations and recorded medical management of XLMTM and potentially inform the design of future therapeutic intervention studies.


Eligibility Criteria:
Inclusion Criteria:

* Patient diagnosed with XLMTM resulting from a confirmed mutation in the MTM1 gene, or a combination of XLMTM genetically confirmed family history and muscle biopsy
* Patient is male
* Access to available medical records for each patient
* Signed informed consent by the parent(s) or legal guardians and/or assent by the patient (when applicable), unless the associated IRB provides an appropriate consent waiver

Exclusion Criteria:

* Patient data after participation in an interventional study designed to treat XLMTM (patient data prior to participation in an interventional study may be included)
Weight Loss Impact on Male Fertility

This is a prospective non-randomized unicentric clinical trial, characterized by the inclusion of obese (BMI\> 35) male with subfertility (sperm count showing low sperm counts and / or motility and / or morphology and / or DNA fragmentation). Patients selected at the endocrinology obesity HC-FMUSP outpatient will be submitted to very low calorie diet (VLCK) for 6 months, being reassessed clinically and laboratorially monthly.


Eligibility Criteria:
Inclusion Criteria:

Obesity in male patients

* Metabolic Syndrome (NCEP-ATP III)
* Alteration of some of the seminal parameters evaluated in conventional seminal analysis

Exclusion Criteria:

* Other causes of hypogonadotrophic hypogonadism

  * Hypergonadotrophic hypogonadism
  * Contraindications for performance of ketogenic diet:
  * Type 1 or type 2 diabetes mellitus in insulin use
  * Food drive
  * Alcoholism or drug addiction
  * Severe psychiatric illness
  * Use of coumarin anticoagulants
  * Hepatic insufficiency
  * Severe renal impairment
  * Hematologic diseases
  * Cancer in activity,
  * Cardiovascular or cerebrovascular diseases (arrhythmias, recent myocardial infarction, unstable angina, decompensated heart failure, recent stroke)
  * Gout
  * Renal or biliary lithiasis
  * Major depression or other serious psychiatric illness.
The Effect of Intubation Method on Outcome of Cervical Spine Surgery

The specific aim of this study is to demonstrate that inserting a breathing tube using a standard laryngoscope with the patient fully anesthetized is a safe and effective means of securing the airway in a patient with cervical spine disk herniation or stenosis. The two groups compared are composed of those who are intubated with direct laryngoscopy and those who are intubated with a fiberoptic scope.


Eligibility Criteria:
Inclusion Criteria:

* Over 18 years of age for cervical disk herniation or cervical spine surgery by either Drs Snow or Lavyne from 1998-2006.

Exclusion Criteria:

* Unstable (broken) cervical spine
SURE 18 Registry -Asahi Chikai Black 18 in LVO Stroke

The objective of this study is to obtain post market data on the Asahi Chikai Black 18 neurovascular guidewire in the treatment of intracranial large vessel occlusive stroke. This will be compared to a historical control that will include the prior 50 consecutive patients fitting the same selection criteria.

This is a prospective registry collecting information on 50 patients treated with the ASAHI Chikai Black 18 microguidewire. Patients will undergo mechanical thrombectomy for acute large vessel occlusive stroke within the anterior circulation as is standard of care.

Additionally, this study will have a retrospective portion which will examine 50 consecutive patients who meet inclusion/exclusion criteria treated for acute anterior circulation large vessel occlusive stroke prior to the initiation of the Sure -18 Registry. This retrospective cohort will be 50 consecutive mechanical thrombectomy cases performed using any neurovascular microguidewire other than the device under study (Asahi Chikai Black 18) at the same enrolling centers leading up to December 10, 2018.

Eligibility Criteria:
Inclusion Criteria:

* Male or female patients presenting with acute anterior cerebral circulation large vessel occlusive stroke
* ASPECT score 5 or better
* Occlusion of the ICA terminus and M1 MCA
* Favorable CT perfusion with clinical/radiologic mismatch
* Last known well out to 24 hours
* Age limit \>18 years
* Baseline mRS 0-3

Exclusion Criteria:

* Intracranial hemorrhage
* ASPECTS (Alberta stroke program early CT score) \<5
* Unfavorable CT perfusion
* Baseline mRS 4 or greater
* Large vessel occlusive stroke with tandem lesion of the cervical internal carotid artery or posterior circulation
Oxytocin Effects on the Prosocial Learning

To investigate whether intranasal oxytocin (24 IU) treatment can influence prosocial learning behavior in males.

In a double-blind, within-subject, placebo controlled design, investigators plan to investigate the effect of oxytocin treatment on prosocial learning. Before the self-administration, participants need to finish several questionnaires including IRI, AAS, BASBIS, SPSRQ, SES, PTM, STAI, BDI, ASQ and PNAS. They would finish the PANAS again before the scanning.

Participants are informed that they perform the reward learning task either for themselves, another (unknown) person or no one (control). In the probabilistc reward learning task, associations with two stimuli with different reward probabilities are learned via monetary feedback (reward ￥1 or no reward ￥0). After the experiment, participants need to finish the PANAS.

Eligibility Criteria:
Inclusion Criteria:

* without past or current psychiatric or neurological disorders

Exclusion Criteria:

* history of head injury
* medical or psychiatric illness
Diuretic Effect Evaluation of Petroselinum Crispum (Parsley) in Hypertensive Patients

The use of alternative therapy, particularly herbal treatment is becoming prevalent among patients. Many herbs are in-use for various ailments such as diabetes, digestive problems, fever, hepatitis and hypertension etc. The common belief is, herbs are safe and easy to access as compared to conventional therapy, however, most of the studies reported different side effects which may be toxic at times. These adverse effects are mostly due to incorrect use or lack of patient education.

Parsley is a plant with antioxidant, diuretic and antimicrobial properties. Literature reported use of parsley as a diuretic by different communities in throughout the world. In vitro studies in animal have also reported the diuretic effect as well as proposed mechanisms for the use of parsley as diuretic however none of the studies have been conducted to investigate the diuretic effect of parsley in humans. This study aims to evaluate the diuretic and hence antihypertensive effect of parsley in hypertensive patients.

Parsley botanically known as Petroselinum crispum, belongs to the family Umbeliferae, originated from Mediterranean region however, it is cultivated almost throughout the world now-a-days. The plant has reported folkloric uses in different parts of the world; in Iran the seeds of the plant is used for different pharmacological effects including antimicrobial, kidney stones, digestive disorders etc., in Turkey the leaves of this plant is used to treat hypertension, diabetes and as a diuretic in Morocco the leaves are used for arterial hypertension, diabetes, high blood pressure and cardiac diseases in Spain the leaves of this plant are used to treat hypertension, diabetes, prostititis and anemia whereas in Serbia the leaves of the plant are used to treat urinary tract diseases and infections. Though the aforementioned literature supports the diuretic and anti-hypertensive potential of parsley however no in-vivo studies have been reported to establish its diuretic activity in human subjects. Some studies have reported diuretic activity for seed aqueous extract in rats. Still, to evaluate the effect in human subjects, an in-vivo phase-I clinical study is needed to support the pre-clinical in-vivo and in-vitro diuretic effects of this plant. Our study aims to investigate the diuretic and anti-hypertensive activity of parsley in hypertensive individuals currently using conventional medication.

Eligibility Criteria:
Inclusion Criteria:

* Any male or female patients with hypertension and already using conventional medications i.e. antihypertensive drugs. The consent forms will be provided to the patients and only those patients which are willing to participate will be included in the study. Patients with more than 3 co-morbidities and at high-risk conditions will not be included in the study.

Exclusion Criteria:

* Geriatric, pregnant and lactating patients will not be included in the study. More important, patients on diuretic medications as well as diabetes, will also be excluded from the study.
Comparison of Efficacy of ESWL and Laser Lithotripsy in Chronic Pancreatitis With ERCP

This study will compare the efficacy of ESWL and Laser Lithotripsy in the treatment of pancreatic duct stones with ERCP.

Chronic pancreatitis (CP) is an inflammatory disease that can causes progressive fibrosis of pancreatic tissue and eventually leads to damage of pancreatic exocrine and endocrine. According to statistics, the prevalence of CP in China is 13/10 million, which is still increasing. Pancreatic duct stones are the most important pathological changes of CP. More than 50% of patients with CP are accompanied by pancreatic duct stones, which can lead to pancreatic duct obstruction, hypertension and tissue ischemia. Removal of pancreatic duct stones under Endoscopic Retrograde Cholangiopancreatography (ERCP) are the first choice. ERCP is effective in the treatment of pancreatic duct stones by using basket and/or balloon catheter. But in most cases, ERCP is only suitable for the treatment of pancreatic duct stones (diameter \< 5mm) located in the head/body of the Pancreatic Duct (PD). PD stones larger than 5mm generally require Extracorporeal Shock Wave Lithotripsy (ESWL) or Endoscopic Intraductal Lithotripsy (EIL) for pretreatment. EIL includes Electrohydraulic Lithotripsy (EHL) and Laser Lithotripsy (LL).

ESWL first locates the stone by X-ray, and then uses an electromagnetic pulse generator to direct a higher-energy shock wave to the stone, so that the stone is crushed by thousands of shock waves. The principle of laser lithotripsy is to make the stone absorb strong infrared rays and generate shock waves to achieve the purpose of fragmenting the stone.

In view of the fact that there is no relevant research comparing the overall efficacy of ESWL combined with ERCP and EIL combined with ERCP, it is necessary to evaluate the differences in the therapeutic effects and complications of the two for PD stones. This research helps to provide evidence-based medical evidence, guide physicians' clinical practice, improve the quality of patients' lives, and reduce the economic burden of patients.

Eligibility Criteria:
Inclusion Criteria:

* symptomatic adult patients diagnosed with chronic pancreatitis and pancreatic duct stones;
* at least one stone (\>5 mm in diameter) located in the pancreatic duct of the head/body of the pancreas;
* dilation of the proximal pancreatic duct.

Exclusion Criteria:

* history of ERCP or ESWL treatment;
* suspected to have malignant tumors;
* history of pancreatic surgery or gastrojejunostomy (Billroth II);
* pancreatic pseudocyst with a diameter \>4cm;
* bile duct stricture secondary to cholangitis or chronic pancreatitis;
* acute pancreatitis exacerbation or acute exacerbation of chronic pancreatitis (including biliary pancreatitis);
* coagulation dysfunction (INR≥1.5 or platelet count≤50×10\^9/L);
* pregnant or breastfeeding women;
* patients who refused to participate in the study.
Clinical Trial on the Use of Autologous Bone Marrow Stem Cells in Amyotrophic Lateral Sclerosis

The purpose of this clinical trial is to asses the feasibility and the security of the intraspinal infusion of autologous bone marrow stem cells for the treatment of Amyotrophic Lateral Sclerosis patients.

Patients with Amyotrophic Lateral Sclerosis (ALS) typically endure a progressive paralysis due to the continued loss of motoneurons that leads them to death in less than 5 years. No treatment has changed its natural history. Intraspinal injections of bone marrow mononuclear cells (MNC) have been able to ameliorate the course of ALS in murine models, acting as pumps of trophic factors that keep the motoneurons functional. We have designed a phase I/II clinical trial to check the feasibility of this approach in humans.

Eligibility Criteria:
Inclusion Criteria:

* Diagnose established following the World Federation of Neurology criteria
* More than 6 and less than 36 months of evolution of the disease
* Medullar onset of the disease
* More than 20 and less than 65 years old
* Forced Vital Capacity equal or superior to 50%
* Total time of oxygen saturation \<90% inferior to 2% of the sleeping time
* Signed informed consent

Exclusion Criteria:

* Neurological or psychiatric concomitant disease
* Need of parenteral or enteral nutrition through percutaneous endoscopic gastrostomy or nasogastric tube
* Concomitant systemic disease
* Treatment with corticosteroids, immunoglobulins or immunosuppressors during the last 12 months
* Inclusion in other clinical trials
* Unability to understand the informed consent
A Multicenter, Open-label, Single-arm, Phase II Study of NHWD-870 HCl in Adults and Adolescents with Advanced NUT Cancer

This is a multicenter, open-label, single-arm, phase II study to evaluate the efficacy, safety, and pharmacokinetics of NHWD-870 HCl in adults and adolescents with advanced NUT cancer.


Eligibility Criteria:
Inclusion Criteria:

* A written informed consent signed;
* Subjects must sign and date IEC-approved written informed consent in accordance with the guidelines of the competent authorities and research institutions. Informed consent had to be obtained before any protocol-related procedure that was not part of a participant's routine care was performed.
* Participants must be willing and able to comply with the scheduled visits, treatment protocols, laboratory tests, and other requirements of the study;
* If the subjects were under 18, the participants and their legal guardian authorization signed agreement;
* Both sexes, the first part (adult group) was ≥18 years old and ≤75 years old, the second part (adolescent group) was ≥12 years old and \<18 years old;
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2;
* The expected survival period for 3 months or more;
* The histopathological (histopathological diagnosis was the first time according to the tumor tissue pathologic specimens before three years, if more than 3 years should be confirmed in the center of the study to do a biopsy. If, in the investigator's judgment, a biopsy might increase a subject's risk, archival tumor tissue samples up to 3 years old could be collected after discussion with the sponsor) were diagnosed as midline (NUT) cancer by, but not limited to:
* Determination of ectopic NUT protein expression by IHC;
* Detection of NUT gene translocations by fluorescence in situ hybridization (FISH);
* Detection of NUT gene translocations (e.g. BRD3/4 mutation or ≥ 2-fold amplification) by DNA/RNA sequencing.

Exclusion Criteria:

* Prior treatment with a BET inhibitor;
* 3 years before into the group suffering from other malignant tumors, with the exception of removal of cure of basal cell carcinoma, orthotopic bladder cancer or cervical carcinoma in situ;
* The researchers believe the subjects is the need for systemic anti-infection treatment of active infection;
* Patients with clinically significant bleeding symptoms or clear bleeding tendency within 3 months before enrollment, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, etc.
* Imaging shows that the tumor has invaded important blood vessels or the investigators judge that the tumor is likely to invade important blood vessels and cause fatal hemorrhage during the follow-up study.