cyrilzakka/clinical-trials huggingface dataset:
Shouldice Hospital Outcome Study

A prospective cohort study recruiting participants from the Shouldice Hospital. The study population consists of healthy patients electing to receive hernia surgery for a primary inguinal hernia on an inpatient basis. The goal of this study is to determine the incidence of hernia pain and its intensity as well as other related outcomes up to one year after primary unilateral inguinal hernia repair.


Eligibility Criteria:
Inclusion Criteria:

* Provide signed and dated informed consent form.
* Willing to comply with all study procedures and be available for the duration of the study (patients have fixed address, access to phone, email, internet, and/or a computer)
* Male or female, aged 18 to 90 years.
* Subjects having surgery on a primary unilateral inguinal hernia
* In good general health as evidenced by medical history
* Capable of speaking and reading English sufficiently well to complete the questionnaires

Exclusion Criteria:

* Surgery is deemed an emergency procedure (any obstruction, incarceration or irreducible hernias).
* Other abdominal hernias being operated on at the same time or surgery is planned during the follow-up period (incisional and umbilical hernias)
* If hernia recurs within the study period and there is a reoperation within the year
* BMI \>40kg/m2
* Patients unable to understand English, written and spoken
* Patients with collagen or connective tissue disorders
* Local (site of surgery) or systemic infection
* Any known diseases that impair nerve function
* Patients who end up getting a mesh repair during surgery
* Impairment of cognitive function (e.g. dementia)
* Pregnancy or lactation
* Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study.
Neoadjuvant Therapy for Locally Advanced Rectal Cancer

This study aims to evaluate the clinical efficacy and safety of anlotinib in combination with penpulimab and conventional chemoradiotherapy for the neoadjuvant treatment of locally advanced rectal cancer

Penpulimab 200mg IV D1 Anlotinib 12mg P.O. QD D1-14 Radiation therapy 1.8-2Gy/50-55Gy

Chemotherapy:

Capecitabine 800mg/m2 P.O. BID D1-D14, or capecitabine plus oxaliplatin 130mg/m2. Every 21 days is 1 cycle In the above regimen, two cycles of targeted therapy (chemotherapy + immunotherapy + targeted therapy) are synchronized during radiotherapy; After the end of radiotherapy, two cycles of adjuvant chemo-immunotherapy (chemotherapy + immunotherapy) were continued.

Eligibility Criteria:
Inclusion Criteria:

-Patient's age: 18 years old - 80 years old -

* Rectal cancer patients diagnosed with adenocarcinoma by pathological examination of primary biopsy
* Patients with no prior treatment, preoperative clinical stage: cT3-4N+M0 rectal cancer patients (AJCC 8th);
* Patients who agree to undergo radical surgical treatment and have no contraindications to surgery as judged by the surgeon;
* No other multiple primary cancers;
* At least 1 measurable or evaluable lesion according to the efficacy evaluation criteria for solid tumors version 1.1 (RECIST v1.1);
* Expected survival time≥ 3 months;
* A score of 0-1 based on the United States Eastern Cooperative Oncology Group Performance Status Score (ECOG PS score);
* The investigator plans to give PD-1 monoclonal antibody combined with chemotherapy treatment regimen after evaluation, and signs informed consent.

Exclusion Criteria:

* Active, known or suspected autoimmune disease;
* Known history of primary immunodeficiency;
* Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation;
* Pregnant or lactating female patients;
* Patients with intestinal obstruction, intestinal perforation, intestinal bleeding, etc., requiring emergency surgery;
* Uncontrolled intercurrent illness including but not limited to:
* People living with HIV (HIV antibody positive)
* Severe infections that are active or poorly clinically controlled
* Patients with active hepatitis
* Evidence of severe or uncontrolled systemic disease (e.g., severe psychiatric, neurological, epilepsy or dementia, unstable or incompensable respiratory, cardiovascular, hepatic or renal disease, uncontrolled hypertension \[i.e., greater than or equal to CTCAE grade 2 hypertension despite medication\]).
* Patients with active bleeding or new thrombotic disease, taking therapeutic dose of anticoagulant drugs or bleeding tendency, abnormal coagulation function (INR\&gt;1.5×ULN, APTT\&gt;1.5×ULN);
* Those who are currently undergoing clinical trials of other drugs;
* Other patients who are considered by the investigator to be unsuitable for inclusion.
Biological Markers for the Diagnosis of Central Nervous System Infective Diseases

Bacterial meningitis is a potentially life-threatening disease that is associated with substantial neurological morbidity and mortality. Accurate diagnosis is essential to improve outcome and prevent antibiotic overuse. Here we try to explore new biological markers for the diagnosis of the central nervous system infection disease.

To investigate the diagnosis value of procalcitonin,interleukin-6, agiotensininⅡin the cerebrospinal fluid in the central nervous system infection disease.

Eligibility Criteria:
Inclusion Criteria:

1. Aged 13 years or older;
2. At least two of the following clinical characteristics:headache, fever, neck stiffness, mental symptoms or consciousness impairment or seizures
3. Patients' family signed informed consent.

Exclusion Criteria:

1. Contraindications to lumbar puncture
2. Patients with active malignancy
The Deep Sedation for Ablation Study

Catheter ablation (CA) is an established therapeutic option for patients with symptomatic atrial fibrillation (AF). During the procedure, patients are usually sedated and analgesized, most commonly by administration of Propofol combined with opioids under the supervision of the electrophysiologist. However, due to the depressive effect of Propofol on the respiratory system, this regimen is not without risk. Dexmedetomidine is a highly selective alpha 2 agonist that demonstrates both analgesic and hypnotic properties with only weak effect on the respiratory system. The pharmacological profile of Dexmedetomidine may be advantageous for sedation during CA of AF. The aim of this randomized trial is to test this hypothesis and explore the safety and efficacy of Dexmedetomidine during CA of AF.

Atrial fibrillation (AF) is the most common arrhythmia. In symptomatic patients, electroanatomic mapping aided catheter ablation (CA) is an established therapeutic option. The intervention may last several hours, during which patients are required to lie as still as possible, as inadequate patient movements disturb the electroanatomic map, prolong the intervention and increase its complication risks. Therefore patients are usually sedated and analgesized, most commonly by administration of Propofol combined with opioids under the supervision of the electrophysiologist. Despite its wide use, this regimen is not without risk, as Propofol has a pronounced depressive effect on the respiratory system.

Dexmedetomidine is a highly selective alpha 2 agonist that demonstrates both analgesic and hypnotic properties with only weak respiratory depression. By reducing sympathetic activity it also reduces the stress response to an intervention. For these reasons, Dexmedetomidine is commonly used in intensive care units, where it has been shown to be well tolerated. Consequently, its range of application has been increasingly widened and good experience has been made with its use in transfemoral valve replacement procedures or gastroenterological interventions.

The pharmacological profile of dexmedetomidine may be also advantageous for sedation during CA of AF. The aim of this randomized trial is to test this hypothesis and explore the safety and efficacy of Dexmedetomidine during CA of AF.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Informed consent as documented by signature
* Catheter ablation of atrial fibrillation at the Department of Cardiology, Inselspital Bern

Exclusion Criteria:

* Contraindication to sedation by the electrophysiologist
* Contraindications to either propofol or dexmedetomidine sedation
* Contraindication for targeted controlled propofol infusion (BMI \> 35)
* American Society of Anesthesiologists (ASA) classification \> III
* Advanced heart block (second or third degree), if no pacemaker or internal cardioverter defibrillator is implanted
* Arterial hypotension (mean \< 80 mmHg)
* Severe heart failure (LVEF ≤ 30%)
* Indication for general anaesthesia
* Pregnant or breast-feeding women
Pain and Bleeding Following Hypertonic Saline Sclerotherapy Compared to Brand Ligation for Symptomatic Hemorrhoids

The investigators aim at prospectively comparing procedural pain, adverse events and rebleeding rates of anoscopic rubber band ligation and endoscopic hypertonic saline injection in patients with symptomatic hemorrhoidal disease

Hemorrhoidal disease is a common encounter in a gastroenterologist's practice. These are often symptomatic, either bleeding or prolapsing. There are no set guidelines in our institution (The American University of Beirut Medical Center - AUBMC) for the treatment of symptomatic hemorrhoidal disease. Two types of treatment are available at our institution: anoscopic rubber band ligation (RBL) or endoscopic sclerotherapy (ESC) with hypertonic (20%) saline. Both methods have been shown to be effective in the literature, with above 75% complete symptomatic relief from a single application after 8-12 months. Post procedural pain of RBL in two randomized studies ranged 40-47%, while different studies showed post procedural pain following ESC to be 12-39%. However no study has ever compared these two therapeutic methods head-on, neither has any study compared both procedures for tolerability and rebleeding rates.

Research design and methods:

This study is a randomized, prospective study conducted at the American University of Beirut Medical Center which will involve 30 patients suffering from symptomatic hemorrhoidal disease requiring therapeutic intervention. Patients meeting inclusion criteria will be randomized using a computer generated randomization list to either Rubber Band Ligation (RBL) or Hypertonic Saline Sclerotherapy as a therapeutic interventional procedure.

- Patients will be approached by their Gastroenterologist during clinic visits and informed about the study. If participants wish to take part in the study, they will be given additional study information, screened for inclusion criteria, and consented by the research assistant or clinic nurse. Recruitment and randomization will occur during the same visit after patient consent in order to properly schedule patients for their therapeutic interventional procedures. All rubber band ligations will be performed by one endoscopist and all sclerotherapies will be performed by the other endoscopist.

Eligibility Criteria:
Inclusion Criteria:

* Age 18+
* Consent to the study
* Bleeding grade 1,2 and 3 hemorrhoids

Exclusion Criteria:

* Age under 18 years
* Refusal to sign consent
* Prior surgical and non surgical hemorrhoid procedure/manipulation
* External hemorrhoids
* Thrombosed hemorrhoids
* Active Anal Fissure
* Active anal fistula
* Immunocompromised
* Grade 4 internal hemorrhoids
* Chronic Pain requiring analgesics
* Antiplatelets and anticoagulation intake other than Aspirin
Supporting Parents in Affirming Their Children's Experiences of Stigma

The purpose of this study is to develop and test two brief online writing interventions to improve parental acceptance of sexual and gender minority youth (SGMY) in the Southeast United States.

The purpose of this study is to develop and test the acceptability, feasibility, and preliminary efficacy of two brief online writing interventions to improve parental acceptance of sexual and gender minority youth (SGMY) in the Southeast United States. Parental support represents the strongest predictor of sexual and gender minority youth's (SGMY) mental health. However, many parents react to their SGMY's disclosure with rejection. Even relatively accepting parents can experience discomfort, while SGMY often report lingering unmet needs from their parents into adulthood. Few interventions exist to help parents support their SGMY child and none has been tested in a randomized trial with efficacy for decreasing parental rejection and increasing support of their SGMY. This proposal will develop and test the efficacy of two theory-based interventions that aim to address this gap. Results will identify mechanisms contributing to parental rejection and develop scalable approaches to reduce these mechanisms to shrink the substantial mental health disparities affecting SGMY. If efficacious, these interventions can be scaled up through online platforms capable of bypassing barriers to parental support of SGMY across high-stigma regions.

The focus of this registration is the randomized controlled trial.

Eligibility Criteria:
Inclusion Criteria:

1. Parents are eligible if they meet the following criteria:

   1. Be a parent, grandparent, or any other family member who considers themselves a guardian of an SGMY between 15-29 years old,
   2. Live in the Southeast United States (Louisiana, Mississippi, Alabama, Georgia, South Carolina, North Carolina, Tennessee, Arkansas, Kentucky, Florida),
   3. Identify as heterosexual and cisgender, and
   4. Report non-acceptance of their SGMY.
2. SGMY are eligible if they meet the following criteria:

   1. Self-identify as SGM,
   2. Are 15-29 years old,
   3. Live in the Southeast United States, and
   4. Have a parent enrolled in the trial

   Exclusion Criteria:
3. Any individual who meets any of the following criteria will be excluded from participation in this study:

   1. Active mania, psychosis, or suicidality, and
   2. Unable to provide informed consent.
Open Label Study for Adults With Pyoderma Gangrenosum and Inflammatory Bowel Disease

Subjects must be 18- 75 years old and have a history of both inflammatory bowels disease (Crohn's or ulcerative colitis) and pyoderma gangrenosum.

This is a 6 month open label study of an intravenous (IV) medication. Visits occur every 2 weeks initially, then every 1-2 months later in the study.


Eligibility Criteria:
Inclusion Criteria:

* Must Be ages 18-75
* Must have both inflammatory bowel disease and moderate to severe pyoderma gangrenosum
* Must never have received Infliximab for the treatment of pyoderma gangrenosum

Exclusion Criteria:

* Have had any previous treatment with monoclonal antibodies other than infliximab used to treat IBD or antibody fragments.
* Have a history of serious infections
The Efficacy and Safety of Endostar Combined With Taxane-based Regimens for HER-2-negative MBC Patients

The purpose of the present study was to prospectively evaluate the efficacy and safety of endostar, a recombinant product of endostatin, combined with taxane-based regimens for HER-2 negative metastatic breast cancer (MBC) patients.

Endostar is a recombinant product of endostatin, which is an endogenous inhibitor of angiogenesis. Animal studies have shown that endostatin is capable of blocking the proliferation and organization of endothelial cells into new blood vessels in vitro and inhibiting angiogenesis and growth of both primary tumors and secondary metastasis. Regarding breast cancer, in vivo studies showed that the combination of paclitaxel and P125A-endostatin inhibited mammary cancer growth, delayed the onset of multifocal mammary adenocarcinomas, decreased tumor angiogenesis, increased the survival of treated mice in the prevention model, and inhibited lung and lymph node metastasis in the intervention model. Moreover, in a prospective, randomized, controlled, phase II neoadjuvant trial, the combination of rh-endostatin with chemotherapy produced a higher tumor response rate without increasing toxicity in breast cancer patients. Considering these promising data, this prospective study was conducted to evaluate the efficacy and safety of endostar combined with taxane-based regimens for HER-2-negative MBC patients.

Eligibility Criteria:
Inclusion Criteria:

* women with ages between 18-70 years with histologically confirmed MBC documented as HER-2-negative

Exclusion Criteria:

* cannot tolerated chemotherapy
* cardiac insufficiency
Study Evaluating the Clinical Remission in Early Aggressive Rheumatoid Arthritis

This is an observational prospective, multicenter study. The aim of the study is to evaluate how the Italian population of patients are treated with early aggressive RA, defined by the Italian Society of Rheumatology Guidelines, (GIARA Registry Study Group. Clin Exp Rheumatol 2003;21(Suppl. 31):S129-S132), in rheumatologic clinical practice and whether recent scientific evidence or new treatments available to rheumatologists can change their practice in a 2 year follow-up. The observation will primarily focus on the disease activity and clinical remission in patients who are receiving different treatment strategies. The primary goal is to define prevalence of clinical remission, according to the (Disease Activity Score) DAS 28 definition of clinical remission, in patients with early aggressive RA receiving different therapies at 1 year.

Secondary objective are assessment of:

* Prevalence of Remission at the second year
* Disease activity at the first and second year.
* ACR 20%, 50%, 70% response at the first and second year.
* Quality of Life in patients with or without remission at the first and second year
* Safety Evaluations

It was expected that approximate 200 patients were enrolled in the study. Have been enrolled 152 patients. A Statistical Analysis Plan will contain a detailed description of criteria for valuable patients for analyses and a description of statistical analyses. In general, all patients who respond inclusion/exclusion criteria at baseline will be considered valuable for the study. The summaries will include descriptive statistics (mean, standard deviation, sample size) for the continuous parameters, and absolute frequencies and percentages for the remaining categorical parameters.

Eligibility Criteria:
Inclusion Criteria:

Inclusion Criteria Based On Clinical Practice of Aggressive RA

* Diagnosis of early aggressive RA in accordance with local guideline
* Disease duration \< 2 years and at least six months since onset of symptoms
* Patients naïve to anti-TNFa drugs and DMARDs, including MTX, or assuming one or more DMARD without complete response

Exclusion Criteria:

Exclusion Criteria Based on Clinical Practice of Aggressive RA

* Patients should not be included in the study if they have participated in any interventional clinical trial within the previous 2 years.
Anesthesia and Cancer Study: Renal Cell Carcinoma

This study investigates the influence of type of anesthesia on recurrence and survival of renal cell carcinoma in patients undergoing nephrectomy. The participants will be allocated to either the group receiving the total intravenous anesthesia (TIVA) using propofol or the group receiving the inhaled anesthetics, such as sevoflurane or desflurane.

The effect of anesthesia on cancer recurrence and survival is controversial. According to some retrospective studies and preclinical studies, TIVA is suggested to be more favorable than inhalation anesthesia regarding cancer recurrence and survival after surgery. However, to our knowledge, there is no study which investigates the influence of type of anesthesia on recurrence of renal cell carcinoma after nephrectomy.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients scheduled for elective nephrectomy due to renal cell carcinoma

Exclusion Criteria:

* Emergency surgery
* Pregnancy
* Allergies to anesthetics
* Palliative surgery
* Refusal to participate in the study
* History of diagnosis or surgery for other cancer
App for Reducing Cravings to Smoke

The overall goal of the study is to assess the efficacy of using cue exposure delivered via a smartphone application as an adjunct to Tobacco Quitline treatment to improve smoking abstinence.

The aims of the study are: (1) to update a recently developed study-related smartphone application to reduce cravings to smoke to be an engaging, user-friendly treatment tool, and verify user satisfaction; and (2) to test in a randomized controlled trial the efficacy of the app as an adjunct to quitline smoking cessation treatment in improving smoking abstinence compared to the quitline only.

Eligibility Criteria:
Inclusion Criteria:

* \>18 years of age
* Daily smokers that have quit smoking within the past 3 months (Aim 1) or currently smoking ≥ 3 cigarettes per day for the past year (Aim 2)
* Functioning telephone number
* Owns a smart phone capable of supporting AR and willing to download the app
* Can speak, read and write in English

Exclusion Criteria:

* Has another household member already enrolled in the study
Transverse Abdominis Plane Block in Laparoscopic Ventral Hernia Repair

The current study aims to determine if transverse abdominis plane block using local anesthetic agents (bupivacaine 0.25% + Ropivacaine 0.20%) decreases the post operative pain and helps in early mobilization or discharge from hospital in patients undergoing laparoscopic ventral hernia repair.

Patients meeting inclusion criteria would be randomised after admission. Those patients in experimental arm shall receive the TAP block under USG guidance while those in control arm do not receive any block. Surgery shall be proceeded in the usual manner in all the patients and assessment for pain starts in the immediate post operative or recovery room after the patient is completely conscious. The total amount of analgesic required by the patient is measured. Pain assessment is done using the visual analog scale (VAS) at regular intervals until follow up review.

Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing laparoscopic ventral hernia repair during the study period

Exclusion Criteria:

* Age \<15 or greater than 75 years
* ASA \> 3
* Obstructed , recurrent or strangulated hernia
* Lap assisted open hernia repair
* Patients undergoing component separation
* Parastomal hernia, spigelian hernia, lumbar hernia
* Patients with Chronic kidney disease, bronchial asthma
* Patients allergic to bupivacaine or NSAIDs
* Not willing to participate