cyrilzakka/clinical-trials huggingface dataset:
A Retrospective Clinical Study on the First-line Maintenance Treatment of PTCL With Chidamide.

The efficacy and safety of chidamide in first-line maintenance therapy for PTCL will be assessed through a retrospective case analysis.

The study design belongs to a retrospective study, collecting information on patients with PTCL who were diagnosed and treated with chidamide as maintenance therapy at our center. The collected data includes age, gender, previous treatment regimens, results of auxiliary examinations (such as blood routine, biochemistry, bone marrow cytology, pathology, flow cytometry, NGS, etc.), as well as PET-CT images. The safety and efficacy of Chidemide as first-line maintenance therapy in PTCL will be analyzed.

Eligibility Criteria:
Inclusion Criteria:

* (1) Age: 18 years and older; (2) Gender: Male/Female; (3) Diagnosed with PTCL; (4) Received chidamide as maintenance therapy after first-line treatment.

Exclusion Criteria:

* (1) Patients with other types of lymphomas; (2) Pregnant women.
Case Control Psychological Autopsy of Suicide

Suicide is a leading cause of death worldwide, and identifying risk factors has been considered as the key initiative of suicide prevention. Considering that, the study aimed to explore the factors leading towards suicide in Pakistan through Case-Control Psychological Autopsy of Suicide. Also, the study aimed to Translate, Adapt and Validate American Association of Suicidology (AAS) Semi-Structured Interview for Psychological Autopsy (Generic Version, 2018).


Eligibility Criteria:
Inclusion Criteria:

* The age of the deceased by suicide and living controls will range from 10 to 35 years.
* The key informants will be of 18 years of age and above without any learning
* disability.
* The key informants will be a close family member or immediate friend.
* Only suicides took place in 2019 to September 2021.

Exclusion Criteria:

* If contact was deemed to pose a risk to the safety of the researcher (likely intoxication; history of or potential for violence).
* Informants who are not willing to give written informed consent will be excluded from the study.
* Informants who are taking any psychological help in the past and present will be excluded from the study.
EUS-guided Hepatico-gastrostomy With Hot Giobor

Endoscopic ultrasonography-guided hepaticogastrostomy (EUS-HGS) is a method of obtaining biliary drainage in patients with failed or difficult endoscopic retrograde cholangiopancreatography (ERCP). The reason for failure of ERCP can be due to gastric outlet obstruction or failed cannulation. HGS involves placement of a stent between the bile duct and the stomach under the guidance of endoscopic ultrasound to create a biliary drainage route similar to surgery. The overall reported success rate is 94% with an overall complication rate of 14%. The most common complications include pneumoperitoneum (air leaking into the abdomen) and bile leak. Both complications are usually managed conservatively. EUS-gudied HGS has been commonly performed but the type of stent used for the procedure is still under evolution. A specific stent is needed to prevent complications. The most commonly used stent in HK is a hybrid stent where the liver portion is uncovered to avoid stent migration and the rest of the stent is covered to avoid bile leakage and pneumoperitonum. This stent is already available and is called the Giobor stent. However, in order to use this stent, during the EUS procedure, the bile duct needs to be first punctured by a EUS needle, then a guidewire passed, then dilate the tract with an energy deviced 6Fr cytotome, then the stent can be passed. This process is cumbersome and increase the chance of complications during exchange of the devices. A newly developed stent that is cautery-fitted has been developed. The use of this stent shortens the steps of stent application. The current study aims to evaluate the feasibility and safety of a novel stent that is cautery-fitted designed for performance of EUS-HGS (Niti-S HOT Giobor).


Eligibility Criteria:
Inclusion Criteria:

* Consecutive patients ≥ 18 years old
* Anatomically feasible for EUS-guided hepatico-gastrotomy
* Patient with clinical symptoms and/or sign of extra-hepatic biliary obstruction (jaundice, biliary-type pain, cholangitis)
* Patients with unsuccessful ERCP (failed ECRP, anticipated difficult ERCP or high risk for pancreatitis)
* Written informed consent (and assent when applicable) obtained from subject

Exclusion Criteria:

* Severe comorbidities precluding the endoscopic procedure (such as cardiopulmonary disease, sepsis, or a bleeding disorder)
* Life expectancy of less than 1 month
* History of gastric surgery
* Coagulation disorders
* Pregnancy, breastfeeding, or unwilling to practice birth control during participation in the study
* Severe allergy to Nickel
Three Drugs in Advanced Gastric Cancer Neoadjuvant Chemotherapy for Stage Ⅲ Clinical Study

The purpose of this study is to assess the relationship of pCR rate and efficacy by comparing the two drugs and three drugs as neoadjuvant chemotherapy in advanced gastric cancer patients.

Eligible patients will be randomly assigned by a randomisation system in a 1:1:1 ratio to three group. The group A wil receive four cycles of DOX (docetaxel 60mg/m2 on day 1,oxaliplatin 130mg/m2 on day 1 and capecitabine 1,000 mg/m2 per day on days 1 to 14, repeated every 3 weeks) as neoadjuvant therapy and four cycles of Xelox (capecitabine 1,000 mg/m2 per day on days 1 to 14 and oxaliplatin 130mg/m2 on day 1, repeated every 3 weeks) as adjuvant therapy.The group B wil receive four cycles of Xelox (capecitabine 1,000 mg/m2 per day on days 1 to 14 and oxaliplatin 130mg/m2 on day 1, repeated every 3 weeks) as neoadjuvant therapy and four cycles of Xelox as adjuvant therapy.The group C wil receive eight cycles of Xelox (capecitabine 1,000 mg/m2 per day on days 1 to 14 and oxaliplatin 130mg/m2 on day 1, repeated every 3 weeks) as adjuvant therapy.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically or cytologically proven in operable advanced gastric adenocarcinoma;
2. Subjects who were identified as potentially resectable cases by a multidisciplinary consultation;
3. KPS\> 80; ECOG score: 0-1;
4. Expected survival\> 6 months;
5. Age 20 -60;
6. Major organ function has to meet the following criteria:

   Neutrophil count ≥1.5 × 109 / L, platelet count ≥100 × 109 / L, Hemoglobin ≥90g / L, liver function \<1.5 times the upper limit of normal, serum bilirubin ≤1.0 × UNL, serum creatinine \<1.5 × UNL, PT-INR / PTT \<1.7 times the upper limit of normal;
7. Subjects has to voluntarily join the study and sign the Informed Consent Form for the study;

Exclusion Criteria:

1. Associated with serious diseases in liver ,kidney, cardiovascular system and other vital organs;
2. History of hypersensitivity to docetaxel, capecitabine, oxaliplatin or the ingredients of this product;
3. Receiving any form of chemotherapy or other study medication;
4. Pregnancy or lactation women, or women with suspected pregnancy or men unless using a reliable and appropriate contraceptive method;
5. Associated with inability to swallow, haemorrhagic peptic ulcer, mechanical or paralytic ileus, gastrointestinal active bleeding.
Study Of Celecoxib Or Diclofenac And Omeprazole For Gastrointestinal (GI) Safety In High GI Risk Patients With Arthritis

To determine whether celecoxib is superior to combined therapy with diclofenac and omeprazole in the incidence of clinically significant upper and/or lower gastrointestinal (GI) events in high GI risk subjects with osteoarthritis and/or rheumatoid arthritis.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with a clinical diagnosis of OA or RA and who are expected to require regular anti-inflammatory therapy for arthritis symptom management
* Subjects must be aged 60 years or older with or without a history of gastroduodenal (GD) ulceration; or be of any age 18 years or older and have had documented evidence of GD ulceration 90 days or more prior to the screening visit

Exclusion Criteria:

* Active GD ulceration or GD ulceration within 90 days of the screening visit.
* Concomitant use of low dose aspirin
* Previous MI, stroke or significant vascular disease.
Desflurane and Brain Relaxation in Craniotomy

Optional brain relaxation improves the surgeon's operating conditions and is likely to minimize the degree of retraction injury ,with the potential for providing patients with a better outcome. The choice of anesthetic drugs can affect intraoperative brain relaxation. Propofol suppresses brain metabolism, reduces cerebral blood flow, and provides satisfactory brain relaxation. Desflurane is often criticized in neurosurgery due to its cerebral vasodilation and potential to increase intracranial pressure, however, it has been found to have a little clinical significance. This study intends to compare the effects of desflurane with propofol on brain relaxation in patients with supratentorial tumors under mild hyperventilation, and to provide new clinical evidence for the use of desflurane in neurosurgical anesthesia.

To compare the effect of desflurane versus propofol combined with remifentanil anesthesia on brain relaxation in patients undergoing supratentorial tumor surgery with mild hyperventilation, and compare the emergence time and common complications during recovery.

Eligibility Criteria:
Inclusion Criteria:

* 18-60 years
* Scheduled for elective craniotomy for supratentorial cerebral tumors
* ASA status I-III
* Glasgow score of 15
* No clinical signs of intracranial hypertension
* Preoperative brain imaging (CT or MRI) with midline shift less than 5mm
* Informed consent signed by patients

Exclusion Criteria:

* Scheduled intraoperative motor evoked potential monitoring
* Patients with cerebral vascular diseases
* Uncontrolled cardiopulmonary disease
* Schedule to retain tracheal intubation after surgery
* Unable to comprehend and cooperate with the examination
* BMI \> 30 Kg/m-2
* Emergency surgery
* History of related anesthetic allergy
Effects of Low Molecular Weight Heparin Therapy With Soft-Mist Inhaler for COVID-19 Induced Hypoxemia

This is an investigator initiated, single-center, open-label, Phase IIb clinical trial with 40 patients (for a total of 80 patients) to assess efficacy of Low molecular weight heparin using soft mist inhaler in the treatment of critically ill patients with COVID-19 (coronavirus disease of 2019) induced ARDS (acute respiratory distress syndrome). The patients will be assigned in a 1:1 ratio to receive standard treatment protocol plus inhaled Low molecular weight heparin. The primary objective is to determine the hypoxemia improvement on a 5-point clinical scale for COVID-19 induced ARDS patients.

Lungs are the major target organ of COVID-19, caused by the SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2). Multiple drug options have been evaluated for efficacy against worsening symptoms of COVID-19 patients. Low molecular weight heparin, known for its antiviral and anti-inflammatory effect, was determined to be applicable for ARDS-induced Hypoxemia.

In cases of viral diseases that primarily targets the lungs, oral drugs and parenteral applications have shown to be insufficient due to low drug accumulation in the target organ site. An increase in drug dosage in order to achieve the necessary drug concentration leaves the patient with intolerable side effects. An inhalation delivery route of the drug would not only directly target the lungs but would also require less dosage. This is expected to increase patient tolerability and the efficacy of the treatment.

Soft mist inhalers are advantageous above the other inhalation devices, for it reaches a higher retention rate in the lungs. Furthermore, the device to be used in this clinical study provides an "enclosed system" which decreases the risk of environmental contamination, thus is meant to protect healthcare professionals or to minimize associated contamination risks.

This Phase-IIb clinical trial is to include 40 critically ill COVID-19 induced ARDS patients, that will receive Low molecular Weight Heparin via a soft mist inhaler at a dose of 4000 IU per administration, twice a day for 10 days in addition to the standard treatment determined by the Turkish Ministry of Health. A total of 80 patients will be enrolled, in which the drug receiving group will be assigned. The primary outcome of the clinical study is the improvement of ARDS induced hypoxemia on a 5-scale determination method at the end of the 10th day. The study inquires to perceive the early effects of inhaled Low molecular weight heparin on critically ill COVID-19 patients.

Eligibility Criteria:
Inclusion Criteria:

* Positive reserve transcriptase polymerase chain reaction (RT-PCR) test of nasopharyngeal swab for COVID- 19, and pneumonia confirmed by a Computed Tomography (CT).
* Negative reserve transcriptase polymerase chain reaction (RT-PCR) test of nasopharyngeal swab for COVID- 19, but radiological and biochemical examinations unambiguously suggest COVID-19, when other possible diagnoses were excluded.

Exclusion Criteria:

* Pregnancy
* History of heparin and associated drug allergies.
A Prospective Study to Assess the Screening Value of N-terminal Pro-B-type Natriuretic Peptide (NT-proBNP) for the Identification of Patients That Benefit From Additional Cardiac Testing Prior to Vascular Surgery

The purpose of this study is to validate the screening potential of NT-proBNP for the identification of patients scheduled for vascular surgery who would benefit from additional pre-operative cardiac testing. All patients will have NT-proBNP concentrations measured pre-operatively. For low-intermediate risk patients only those with abnormal values will receive further cardiac testing; all high risk patients will be referred for additional testing.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \&#8805;18 years of age
* Patients with peripheral vascular atherosclerosis, scheduled for vascular surgery

Exclusion Criteria:

* N/A
Effect of Organic Naked Oat With Whole Germ on Type 2 Diabetes Mellitus

Dietary modification is of great essential for the prevention and treatment of type 2 diabetes mellitus. Common oat (Avena sativa L.) and its products showed a great potential benefits on NCDs including type 2 diabetes mellitus. But data about such effects of naked oat (Avena nuda L.) is still unavailable. The investigators aimed to examine the effects of organic naked oat with whole germ (ONOG) plus diet on patients with type 2 diabetes.

After a pre-study with healthy adults, a randomized, single-blinded, multi-arm parallel trial of 30 days would be carried out in adults of 50-65 years old with type 2 diabetes. Participants would be randomly assigned to one of the four following groups: usual care group (only basic health advice, no other interventions), diet group (systematic education, structured dietary), 50g-ONOG plus diet group (all the interventions of diet group plus replacement of 50g ONOG per day) and 100g-ONOG plus diet group. A regular follow-up for years would be carried out to predict the long-term effects of ONOG plus diet intervention on patients with type 2 diabetes.

The investigators hypothesized that ONOG combined with diet would have better effects on glycaemia and insulin resistance control in addition to those yielded by diet or usual care.


Eligibility Criteria:
Inclusion Criteria:

* all adults aged 50-65 years old with Type 2 Diabetes Mellitus
* stable physical condition
* fasting plasma glucose (FPG) concentration ≥7.8mmol/L or 2-h postprandial blood glucose (PG) ≥11.1mmol/L after 75g oral dextrose with an glycated hemoglobin (HbA1c)\>7 %, stable medication.

Exclusion Criteria:

* pregnancy
* breastfeeding
* severe renal or hepatic complications
* treatment by glucocorticoid
* having pancreatic disease or malignancy in recent 3 months
* other factors that may limit adherence to interventions or affect conduct of the trial or participation in another supplementary feeding programme.
AWARENESS Trial (AWARENESS) of Storytelling Through Music in Healthcare Workers

This research study is examining the feasibility and effectiveness of an online version of the Storytelling Through Music (STM) program with oncology nurses who have worked during the COVID-19 pandemic.

This study employs a two-group, randomized controlled trial design that will utilize quantitative and qualitative methods to evaluate the feasibility and intervention effect of an alternative delivery (online) of the Storytelling Through Music program (STM).

Previous study of In-person delivery of Storytelling Through Music program STM with oncology nurses found it to be feasible and beneficial to coping with stress and work-related emotions.

The research study procedures include: screening for eligibility and study intervention including follow-up surveys.

Participants will be randomized into two (2) groups: Storytelling Through Music (STM) and Waitlist (Storytelling Through Music-Hybrid)

STM group: Participants are led through a writing workshop over an online platform (i.e., Zoom or an equivalent) to develop their story. Simultaneous with the writing sessions are 10-minute self-care lessons. At the end of the development workshop, each participant will be paired with a songwriter who will turn participant stories into songs. A final workshop will be held for participants to debrief about the emotional experience of participating in the Storytelling Through Music program (STM)

Waitlist control group (Storytelling Through Music-Hybrid), will listen to songs created by healthcare workers in the Storytelling Through Music program (STM) for 2 weeks.

Participation length will be based on the randomized group assignment, a total of 19 weeks for the STM group and 13 weeks for the waitlist group.

It is expected that about 50 people will take part in this research study.

Eligibility Criteria:
Inclusion Criteria:

* The inclusion criteria for the study is as follows: a) \>18 years old; b) licensed oncology nurse; c) provided direct patient care during COVID-19 pandemic.

Exclusion Criteria:

* Key exclusion criteria include: a) have previously participated in the STM intervention.
Treatment of Severe Heart Failure by Ultrafiltration

Patients with severe congestive heart failure show increased fluid body content which is often resistant to conventional diuretic therapy. Therefore, chronic heart failure patients have frequent access to the emergency room and hospital for hemodynamic instability. Ultrafiltration is a simple renal replacement therapy which reduces fluid overload. The purpose of this study is to determine whether periodic ultrafiltration sessions maintain patients in stable clinical condition and reduce hospitalisations as well as access to emergency heart failure treatment.

Patients with severe heart failure (New York Heart Association \[NYHA\] III-IV) and fluid overload will be randomized to ultrafiltration (UF group) or conventional medical treatment (Control group). Patients follow-up at least monthly visit for one year. Ultrafiltration will be repeated during follow-up in case of body weight gain due to fluid accumulation. Ultrafiltration will be performed during short term hospitalization.

Eligibility Criteria:
Inclusion Criteria:

* Severe heart failure (NYHA III-IV) with fluid overload
* Ejection fraction \< 40%
* Estimated fluid overload \> 4 kg

Exclusion Criteria:

* Severe renal insufficiency
* Acute pulmonary edema and/or cardiogenic shock
Efficacy of Methimazole Dosing Algorithm

To prospectively study the efficacy and safety of the Cook County Health (CCH) methimazole (MMI) dosing algorithm in the setting of new onset Graves' disease.

To conduct a prospective observational study in 60 patients with newly diagnosed Graves' disease who are either methimazole naive or who have been initiated on MMI within previous 4-6 weeks per CCH algorithm and assess for efficacy and safety of MMI dosing administered. Study group size is based on 90% power and projected efficacy of 70% patients reaching target.

Eligibility Criteria:
Inclusion Criteria:

* Non-pregnant adults (\>18 years of age) with new diagnosis of Graves' Disease (elevated free T4, Free T3, low or suppressed TSH, positive TSI and or thyroid eye disease) and
* either drug naïve or who have been initiated on MMI within previous 4-6 weeks per CCH algorithm.

Exclusion Criteria:

* Pregnant patients
* hyperthyroidism due to other causes, example - Toxic Multinodular Goiter, Iodine induced thyrotoxicosis, etc.
* Graves patients who present with atrial fibrillation, CHF or other end organ damage
Efficacy of a Brown Seaweed Extract Rich in Polyphenols on Glycemic Response to Sucrose in Human

The primary endpoint of this trial will be to evaluate if a single administration in human of a lemon ice tea containing 500 mg of a polyphenol-rich algal powder is able to reduce postprandial glycemia and insulinemia.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteer aged 18 to 60
* BMI between 20 and 30
* Non-smoking
* Using valid contraceptive method (women of childbearing age)

Exclusion Criteria:

* Iodine allergy, or allergy to components of the test product or placebo or standard meal
* Diabetes
* Use of dietary supplements for duration of study
* History of gastro-intestinal affections, anemia, major surgeries or surgeries of the stomach or digestive tract
The Efficacy of Analgesic Buffering With Sodium Bicarbonate for the Pediatric Dental Patient

As a dentist, administering anesthetic to patients, especially children, proves to be one of the most difficult parts of a procedure. Pain is one of the most common symptom in dentistry, and a serious concern for the dentist. The pain of the local anesthetic injection has several causes. Of the many reasons for pain at the site of injection, the acidity of the solution is thought to be most important. This study will be measuring the effects of adding sodium bicarbonate (buffer) to local anesthetic during dental procedures. This is commonly used in medical applications but is not widely used in the dental setting. Using this biochemistry and human physiology, one can predict when buffering the lidocaine injection, a quicker response in analgesia and a decrease in pain during administration. I will be measuring the effect using several measuring devices to gauge if buffering the local anesthetic will benefit the pediatric dental patient by reducing the time it takes for the analgesic effect as well as decreasing the pain during administration. Along with time, I will be using the Wong-Baker Scale to assess the pain. This scale is standard protocol for assessing pain in the pediatric population. The pediatric dental population has aversions to dental procedures because of the associated pain produced from most procedures. If limiting the time it takes for the analgesic to take effect and decrease the pain altogether, the pediatric patient will be less likely to skip treatment therefore, increase dental health.


Eligibility Criteria:
Inclusion Criteria:

* Current patients of Children's Hospital Colorado Dental Clinic
* Existence of carious primary molars necessitating administration of an anesthetic agent
* No history of post traumatic stress disorder or specific phobia related to a dental setting
* No allergic reaction to lidocaine
* Patient's between the ages of 5 to 12.

Exclusion Criteria:

* Allergies to local anesthetics or sulfites
* History of significant medical conditions
* Taking any medications that may affect anesthetic assessment
* Active sites of pathology in areas if injection
* Outside the age range of 5 -12.