cyrilzakka/clinical-trials huggingface dataset:
Cryotherapy for Barrett's Esophagus and Early Esophageal Cancers

This is a single center study to evaluate the efficacy and safety of a new ablation technique involving the spray of liquid nitrogen through a catheter (cryotherapy) via an upper endoscopy (EGD) to ablate Barrett's esophagus with changes of high-grade dysplasia (HGD) or intramucosal cancer (IMCA) and patients with esophageal cancer limited to the esophageal wall, in whom there are no standard treatment options available.

The Cryo-Ablator System is a cryosurgical unit with a liquid nitrogen cooled cryocatheter and accessories to destroy tissue during surgical procedures by applying extreme cold.

Patients will prepare for esophagogastroduodenoscopy (EGD) in the standard fashion using an overnight fast with only clear liquids and required medications allowed up to 2 hours before the procedure. The EGD will be performed using a therapeutic Olympus endoscope. The cryocatheter is passed into the therapeutic channel of the endoscope. Liquid nitrogen is sprayed through the cryocatheter for a duration of 10 seconds as measured by the device integrated timer. This process will be repeated four times in piecemeal fashion such that for any given area treated it will be maintained in a frozen state for a total of 40 seconds. Following circumferential treatment, the process will be repeated again applying the spray to the same section of mucosa for a duration of 20 seconds. Patients will be contacted the following day to assess for any immediate complications.

Patients will repeat treatment every 6 weeks if no evidence of esophageal mucosal injury, until complete ablation of the Barrett's mucosa has been achieved. Follow up period of five years to monitor healing and progression.

Eligibility Criteria:
Inclusion Criteria:

Group 1:

* Co-morbid conditions such as severe heart, lung, kidney or liver disease.
* Refusal of surgical intervention after a thorough discussion of the highly experimental nature of cryotherapy.

Group 2:

* Patients with inoperable esophageal cancer (adenocarcinoma oe squamous cell CA) with lesions extending beyond the mucosa but limited to the esophageal wall

Exclusion Criteria:

* Age less than 18 years
* Co-morbid illness expected to cause death within 6 months
* Pregnancy
* Refusal or inability to give consent
Efficacy and Safety of BIA 9-1067 in Idiopathic Parkinson's Disease Patients.

Parkinson's disease (PD) is a neurodegenerative disorder of unknown aetiology with an estimated incidence of 4.5-16/100,000 persons/year.

BIA 9-1067 is currently being developed by BIAL (Portela \& Cª,S.A.) to be used in addition to L-DOPA (Levodopa) /carbidopa or L-DOPA (Levodopa) / preparations in PD patients. Promising results have been obtained for BIA 9-1067 in previous studies.

This study aims to demonstrate the efficacy and safety of BIA 9-1067 used in addition to L-DOPA/DDCI to control the "wearing-off" phenomenon in patients with PD.

DDCI (DOPA decarboxylase inhibitors): benserazide and carbidopa

Eligibility Criteria:
Inclusion Criteria:

1. Able to comprehend and willing to sign an informed consent form.
2. Male and female subjects between 30 and 83 years old, inclusive.
3. Diagnosed with idiopathic PD according to the UK Parkinson's Disease Society Brain Bank Clinical Diagnostic Criteria for at least 3 years.
4. Disease severity Stages I-III (modified Hoehn \&Yahr staging) at ON.
5. Treated with L-DOPA/DDCI for at least 1 year with clear clinical improvement.
6. Treated with 3 to 8 daily doses of L-DOPA/DDCI, which can include a slow-release formulation.
7. On a stable regimen of L-DOPA/DDCI and other anti-PD drugs for at least 4 weeks before screening.
8. Signs of "wearing-off" phenomenon (end-of-dose deterioration) for a minimum of 4 weeks before screening with average total daily OFF time while awake of at least 1.5 hours, excluding the early morning pre-first dose OFF, despite optimal anti-PD therapy (based on the investigator's judgment.

Exclusion Criteria:

1. Non-idiopathic PD (atypical parkinsonism, secondary \[acquired or symptomatic\] parkinsonism, Parkinson-plus syndrome).
2. Dyskinesia disability score \>3 in the Unified Parkinson's Disease Rating Scale UPDRS) Sub-section IV A, item 33.
3. Severe and/or unpredictable OFF periods.
4. Treatment with prohibited medication: entacapone, tolcapone, neuroleptics, venlafaxine, MAO inhibitors (except selegiline up to 10 mg/day in oral formulation or 1.25 mg/day in buccal absorption formulation or rasagiline up to 1mg/day), or antiemetics with antidopaminergic action (except domperidone) within the month before screening.
5. Treatment with apomorphine within the month before screening or likely to be needed at any time during the study.
6. Dosage change of concomitant anti-PD medication within 4 weeks of screening.
7. Previous or planned (during the entire study duration, including the OL period)deep brain stimulation.
8. Previous stereotactic surgery (e.g. pallidotomy, thalamotomy) for PD or with planned stereotactic surgery during the study period.
9. Any investigational medicinal product within the 3 months (or within 5 half-lives, whichever is longer) before screening.
10. Any medical condition that might place the subject at increased risk or interfere with assessments.
Effect of Celecoxib Versus Placebo Before and After Knee Surgery on the Overall Use of Analgesics After Surgery

To compare the total analgesic use at 24 hours after arthroscopic knee surgery in patients treated with celecoxib versus placebo.


Eligibility Criteria:
Inclusion criteria:

* Diagnosed knee meniscus pathology requiring ambulatory arthroscopic meniscectomy or partial meniscectomy
* Willing to participate in study for 36 hours and come to follow-up visit 7 days post-surgery

Exclusion criteria:

* Osteoarthritis, inflammatory arthritis, or previous fracture of index joint
* Received acetaminophen or low-dose narcotic within 8 hours of surgery
* Have received oral (4 weeks), intramuscular (2 months), intra-articular (3 months) or soft-tissue (2 months) injections of corticosteroids of the first dose of study medication or received intra-articular injections of hyaluronic acid in the index joint within 9 months of the first dose of study medication
Happy Quit for Smoking Cessation in China

The primary objective of this proposed three-year (January 01, 2016 to December 31, 2018) project is to assess whether a program of widely accessed mobile phone-based text message interventions ('Happy Quit') will be effective at helping people in China who smoke, to quit. Based on the efficacy of previous studies in smoking cessation, it is hypothesized that 'Happy Quit' will be an effective, feasible and affordable smoking cessation program in China.

Background: Considering the extreme shortage of smoking cessation services in China, and the acceptability, feasibility and efficacy of mobile phone-based text message interventions for quitting smoking in other countries, here a study of "the efficacy of mobile phone-based text message interventions ('Happy Quit') for smoking cessation in China"has been proposed.

Objectives: The primary objective of this proposed three-year (January 01, 2016 to December 31, 2018) project is to assess whether a program of widely accessed mobile phone-based text message interventions ('Happy Quit') will be effective at helping people in China who smoke, to quit. Based on the efficacy of previous studies in smoking cessation, it is hypothesized that'Happy Quit' will be an effective, feasible and affordable smoking cessation program in China.

Methods: In this single-blind, randomized trial, undertaken in China, about 2,000 smokers willing to make a quit attempt will be randomly allocated, using an independent telephone randomization system that includes a minimization algorithm balancing for sex (male, female), age (19-34 or \>34 years), educational level (≤ or \>12 years), and Fagerstrom score for nicotine addiction (≤5, \>5), to 'Happy Quit', comprising motivational messages and behavioral-change support, or to a control group that receives text messages unrelated to quitting.

Outcome measures: The primary outcome will be continuous smoking abstinence. A secondary outcome will be point prevalence of abstinence. Abstinence will be assessed by means of brief telephone interviews at six time points (4, 8, 12, 16, 20 and 24 weeks post-intervention). A third outcome will be reductions in number of cigarettes smoked per day.

Implications: The results will provide valuable insights into bridging the gap between need and services received for smoking cessation interventions and tobacco use prevention in China. It will also serve as mHealth model for extending the public health significance of other interventions, such as mental health interventions.

Eligibility Criteria:
Inclusion Criteria:

1. Daily Chinese cigarette smokers.
2. 18 years of age and older living.
3. Being able to read and write in Chinese.
4. Owning a text-capable cell phone and knowing how to text.
5. Willing to make an attempt to quit smoking in the next month.
6. Willing to provide informed consent to participate in the study.

Exclusion Criteria:

1. Nonsmokers
2. Below 18 years old.
3. Unable to read and write in Chinese.
The p53 Colorectal Cancer Trial

Single center, open labeled, phase 2 clinical trial, where patients with metastatic colorectal cancer are selected for treatment with dose dense Cyclophosphamide every second week based on TP53 mutation status; i.e. only patients with TP53 mutated tumors may be included in the treatment arm.


Eligibility Criteria:
Inclusion Criteria:

* Metastatic colorectal cancer patients for whom conventional therapy has failed; defined as 2 lines of chemotherapy including oxaliplatin or irinotecan- containing regimens as well as an EGFR inhibitor if applicable.
* Tumor lesion suitable for biopsy
* Age \>18 years
* Clinically or radiologically measurable tumor deposits according to the RECIST criteria
* WHO performance status 0-1
* Radiology studies (CT thorax/abdomen/pelvis) and echo cor and ECG must be performed within 28 days prior to registration.
* Before patient registration in the trial, written informed consent must be given according to national and local regulations.
* Blood test requirements:

Neutrophils \> 1.0 e9/L Platelets \> 75 e9/L Bilirubin \< 20 µmol / L. Serum creatinine \< 1.5 x ULN

Exclusion Criteria:

* Co-morbidity including, but not limited to, impaired renal-, liver or bone marrow function, that based on the assessment of the treating physician, may preclude the use of cyclophosphamide at actual doses.
* Known hypersensitivity to the study drug, its metabolites or any excipients in the infusion solution.
* Psychological, familial, sociological or geographical condition(s) potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
* Pregnant or lactating patients cannot be included.
* Clinical evidence of serious coagulopathy. Prior arterial/venous thrombosis or embolism does not exclude patients from inclusion, unless patient is considered unfit by study oncologist.
* Patient not able to give an informed consent or comply with study regulations as deemed by study investigator.
Knee Osteoarthritis, Kinesiophobia and Physical Activity

Although the importance of regular physical activity in patients with knee osteoarthritis is known, and fear of movement is considered as one of the causes of physical inactivity and is widely researched in terms of its role in the pathogenesis of pain, there remains to be limited number of studies on kinesiophobia in these patients. In this study, we aimed to evaluate the levels of kinesiophobia and physical activity in patients with knee osteoarthritis and to investigate whether they were associated with demographic characteristics, body mass index, pain intensity, depression, disability, radiological grade, and quality of life.

A total of 96 female and male patients aged 50 to 75 years with knee osteoarthritis (OA) and knee pain lasting for more than three months (knee pain intensity over 20 mm on Visual Analog Scale-VAS) were included in the study. The severity of pain at night, pain at rest and activity-related pain was evaluated by Visual Analog Scale (VAS), kinesiophobia by Tampa Scale of Kinesiophobia (TSK) and Brief Fear of Movement Scale (BFOM), depression by the Beck Depression Inventory (BDI), disability by the Western Ontario and McMaster Universities Arthritis Index (WOMAC), physical activity level by the International Physical Activity Questionnaire (IPAQ) short form and quality of life by the Short Form 12 Health Survey Questionnaire (SF-12). Age, gender, marital status, educational status, additional disease, drug history, and sociodemographic data such as BMI were obtained from the patients and recorded in the evaluation form.

Eligibility Criteria:
Inclusion Criteria:

knee osteoarthritis aged 50 to 75 years knee pain lasting for than three months knee pain intensity over 20 mm on Visual Analog Scale-VAS

Exclusion Criteria:

knee operation, Malignant diseases Systemic infectious diseases inflammatory diseases Fibromyalgia syndrome physical therapy and/or a knee injection within the last three months antidepressants, pregabalin or duloxetine usage
An Efficacy Study to Evaluate Alfuzosin to Treat Men With Erectile Dysfunction and Mild Lower Urinary Tract Symptoms

The purpose of this study is to assess the effect of Alfuzosin in treating Erectile Dysfunction in men with mild lower urinary tract symptoms based upon a change from baseline in erectile function (EF) domain of International Index of Erectile Function (IIEF).

This protocol is a placebo-controlled, double-blind, crossover trial. Patients will be screened and then randomized to Group A or Group B at a 1:1 ratio to receive a placebo tablet once daily or Alfuzosin (10 mg) daily for 12 weeks. Patients will then crossover with the original placebo group receiving Alfuzosin for 12 weeks and the original Alfuzosin group receiving placebo. At every visit the patients will complete an IIEF and an AUA symptom index.

Eligibility Criteria:
Inclusion Criteria:

* Male, 30-69 years of age
* Has mild to moderate Erectile Dysfunction with a score \< 25 on EF domain in IIEF
* AUA score of less than or equal to 14
* Negative urinalysis with no evidence of a Urinary Tract Infection

Exclusion Criteria:

* Blood pressure \< 90/50 or \> 170/110
* Neurological disorder (MS, SCI, CVA, Parkinson's disease, ALS)
* Diabetes Mellitus
* History of PSA \> 10
* History of confirmed or suspected prostate cancer
* History of Moderate/Severe Hepatic Insufficiency defined as \> 2X ULN
* On Alpha Blocker or PDE 5 inhibitor within 2 weeks of randomization
* Receive treatment with other investigational agents within 30 days prior to enrollment
Cohort Study on Treatment of Cardiovascular Diseases With Traditional Chinese Medicine

This is a cohort study performed in patients with cardiovascular diaeases who were treated with oral Chinese medicine and Western medicine. Collect indicators such as the incidence of cardiovascular events, all due to readmission, all due to death. To hospital using clinical samples to detect genomics, proteomics, metabolomics, intestinal flora and sclerotia.To explore the clinical efficacy of Chinese patent medicine in the treatment of cardiovascular diseases, and provide reliable data support for its clinical application.


Eligibility Criteria:
Inclusion Criteria:

All patients admitted to the Department of Cardiovascular Medicine at The First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, The Second Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin Chest Hospital, Tianjin Hospital of ITCWM Nankai Hospital and Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital were considered for inclusion in this study, and all Western medical diagnoses were identified and classified according to the International Classification of Diseases, 11th Revision (ICD-11).

Exclusion Criteria:

No exclusion criteria.
Study of Mattress Type in Fibromyalgia

The purpose of this research study is to determine if a new mattress relieves the symptoms of fibromyalgia and improves sleep, and if this is the case, whether one type of mattress is better than the other in doing so.

The various stages of sleep will be monitored via polysomnography(PSG) and scored to indicate the degree to which they reflect a normal sleep pattern. Changes in the severity of fibromyalgia symptoms will be assessed by tender point exam and study questionnaires administered at 2 month intervals.

Eligibility Criteria:
Inclusion Criteria:

* Female subjects who fulfill the American College of Rheumatology's case definition for Fibromyalgia -- that is they have both wide spread pain and more than 10 of the 18 tender points
* 18 years of age or older
* Has to be on stable medications and followed by one physician

Exclusion Criteria:

* Subjects with the existence of an undiagnosed sleep disorder - namely obstructive sleep apnea or periodic leg movement syndrome
* Pregnancy
The Effectiveness of Temple Stay in Irritable Bowel Syndrome

This research is a clinical trial aimed at improving the gut microbiome of patients with Irritable Bowel Syndrome (IBS) through a temple stay experience.

Participants in the study are expected to participate in a temple stay experience for a maximum of 8 days. During the temple stay experience, participants are required to fill out a daily symptom questionnaire related to irritable bowel syndrome and record their diet and bowel movements using a dedicated mobile application. Upon completion of the temple stay, participants will conduct an evaluation of personal satisfaction with the experience.

Through this, the study aims to collect and analyze data related to the Templestay experience with the goal of improving the gut microbiome of patients with IBS.

Irritable Bowel Syndrome (IBS) is a syndrome characterized by recurrent abdominal pain accompanied by abdominal discomfort, changes in bowel habits, and abdominal bloating. It is a common condition, affecting approximately 10% of the population in Korea, and its chronic gastrointestinal symptoms significantly impact patients' daily life and quality of life.

Factors such as changes in the intestinal microbiota and the intestinal ecosystem are crucial in its etiology. Modern individuals, who are often exposed to numerous stressors, frequently experience persistent intestinal hypersensitivity and inflammation. Foods that are not well digested and fermented in the intestines, producing a significant amount of gas - such as those rich in seasonings, dairy products, caffeine, and alcohol - are known to trigger symptoms. Therefore, it is suggested that a controlled environment like a Temple Stay, which provides both dietary regulation and stress control, could lead to meaningful symptom improvement. However, there is currently a lack of objective scientific research on this.

Our research team hypothesizes that a Temple Stay experience of more than a week could consistently change the microbiome and stabilize psychosocial factors. This might control chronic intestinal inflammation and hypersensitivity, leading to subjective symptom improvement and enhanced treatment satisfaction for patients.

Through this study, we aim to validate the hypothesis that the dietary changes in a Temple Stay environment will drastically alter patients' dietary intake, enrich the composition of the gut microbiome, and consequently reduce the symptoms of IBS, thereby improving the quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 20-69 with diarrhea-predominant irritable bowel syndrome

Exclusion Criteria:

* Monk
* history of irritable bowel syndrome (constipation-predominant), history of inflammatory bowel disease, history of colorectal cancer, history of gastrointestinal resection,
* abnormal blood test (liver function test: AST or ALT more than 1.5 times the normal limit, total bilirubin increase of more than 1.5mg/dL, CCr \< 30 mL/min, platelets less than 100,000, PT/aPTT increase of more than 20% of the normal upper limit),
* uncontrolled hypertension and diabetes
Oral Anticoagulant Apixaban for Treatment of Venous Thromboembolism

Patients who have developed a venous thrombosis will receive apixaban to treat and prevent a secondary thromboembolism.


Eligibility Criteria:
Inclusion Criteria:

* Children and adolescents with a newly diagnosed primary VTE.
* Treatment with apixaban has to begin within 72 hours of the diagnosis of VTE.
* Patients who have received heparin at the beginning of their diagnosis and are willing to switch to apixaban, are allowed to do so within 72 hours of their treatment. Patients who are switched to apixaban are not allowed to receive any other systemic anticoagulant therapy.
* VTE confirmed by diagnostic imaging.
* Children with body weight of ≥ 40 kg and are able to tolerate medication by mouth or administered via an NG or GT tube.
* Adequate liver function: AST and/or ALT \<5 times ULN, and/or Direct bilirubin \<2 times ULN
* Platelet count of at least ≥ 30,000/ul.
* Adequate renal function: \>30% of GFR for age
* Female subjects of childbearing potential must not be nursing or pregnant with negative urine pregnancy test within 72 hours prior to dosing with study medication.
* Signed written informed consent

Exclusion Criteria:

* Current or recent (within 3 months) apixaban administration.
* Patient is unable to tolerate medications by oral route or by n/g administration, peptic ulcer disease, intestinal obstruction, toxic megacolon, typhlitis, or short gut syndrome.
* History of primary bleeding disorder and first degree family history of bleeding disorder.
* Active bleeding or high risk of bleeding at the time of study entry.
* History of significant head injury and/or any history of intracranial hemorrhage.
* Conditions predispose to intracranial bleed; e.g. brain tumor, brain metastasis.
* Uncontrolled Grade 3 or 4 severe hypertension.
* History of allergy to apixaban or factor Xa inhibitors.
Presurgical Planning With Functional MRI (fMRI) Mapping of Motor Cortex in Patients With Cerebral Tumors

The purpose of this study is to determine if functional MRI is precise enough to provide information about the location of brain functions in patients who have brain tumors. This might allow physicians to use a non-invasive procedure to assist with brain mapping prior to surgery

The purpose of this study is to determine if fMRI is precise enough to be used in preoperative decision making for patients who have brain tumors. Before a patient has brain surgery to have the tumor removed, functional mapping of the brain takes place either intra-operatively or post operatively after a subdural grid implant has been placed. Mapping helps the surgeon determine which areas of the brain are responsible for different important body functions. During this mapping procedure the surgeon determines if they can safely remove all or part of a brain tumor. The investigators are hoping to show that fMRI is just as accurate in mapping out different areas of the brain, without having to utilize an invasive form of brain mapping.

Eligibility Criteria:
Inclusion Criteria:

* All patients with brain tumors and healthy volunteers

Exclusion Criteria:

* If patients are pregnant.
* If patients suffer from a significant degree of claustrophobia.
* If patients are claustrophobic and requires general anesthesia to complete the diagnostic MRI.
* Contraindications for an MRI due to surgeries and/or implantation of pacemakers or pacemaker wires, open heart surgery for placement of an artificial heart valve, brain aneurysm surgery, middle ear implants, hearing aids, braces or extensive dental work, cataract surgery or lens implant, any implanted mechanical or electrical device, implanted neurological stimulators or artificial limbs or joints.
* Contraindications from an MRI due to foreign metallic objects in the body such as: bullets, BBs, pellets, surgical magnetic metal clips, joint or bone pins, metal plates, shrapnel or any one who has a history of working near metal who could have metal shavings in their eyes.