cyrilzakka/clinical-trials huggingface dataset:
Stroke in Young Fabry Patients (sifap1): Frequency of Fabry Disease in Young Stroke Patients

More than one million people in Europe suffer from a stroke every day. Normally older people have a stroke, but also a significant number of younger people between 18 and 55 years. Usually, these cannot be explained by the classical risk factors such as diabetes, overweight and high blood pressure. New studies indicate that in about 1 - 2 % of the younger stroke patients the cause could have been an undiagnosed genetic disease, the so called Fabry disease. The purpose of this study is to determine in a large number of young stroke patients, how many strokes were caused by Fabry Disease.

Aim:

To determine the frequency of Fabry disease in an unselected group of young patients (18 - 55 years of age) with acute cerebrovascular event (CVE)

Fabry disease and stroke:

Rolfs and co-workers have shown a high frequency of Fabry disease in a cohort of patients with cryptogenic stroke (4 % \[28/721\]) aged between 18 and 55 years. This corresponds to about 1.2 % in the general population of young stroke patients. Therefore the authors stated that Fabry disease must be considered in all cases of unexplained stroke in young patients, especially in cases with the combination of infarction in the vertebrobasilar artery system and proteinuria.

Cryptogenic strokes are cerebrovascular lesions of unknown origin. Clinical and laboratory data show that Fabry disease is itself a risk factor for accelerated atherosclerosis and cardiac and renal disease, which can lead to emboli and hypertension. The pilot-phase started April 2007; the official study started January 2008.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (18 - 55 years of age) with an acute cerebrovascular event of any etiology defined as patients having an acute ischemic stroke or transient ischemic attack less than 3 months before enrollment into the study
* MRI-scan evidence of associated corresponding brain infarction or hemorrhage, regardless of the duration of symptoms. Alternatively also patients with no signs of stroke in the MRI can be included if a stroke-experienced neurologist has done the initial diagnosis as ischemic stroke, transient ischemic attack or hemorrhage.
* Detailed MRI documentation at admission to entry to the study
* Diagnostic procedures for CVE according to the EUSI recommendations
* Written informed consent from patient or legal representative according to local regulations

Exclusion Criteria:

* Patients being younger than 18 years or older than 55 years of age.
* Acute ischemic stroke or transient ischemic attack longer than 3 months before enrolment into the study
* Diagnosis of the CVE within the last 3 months has been done by a non-neurologist if there is no MRI-scan evidence of associated brain infarction or hemorrhage
* No detailed MRI documentation at admission to entry to the study
Kidney Dysfunction in Children and Young Adults Who Have Received Methotrexate for Acute Lymphoblastic Leukemia

RATIONALE: Gathering information about how often kidney dysfunction occurs in children and young adults receiving methotrexate for acute lymphoblastic leukemia may help doctors learn more about the disease and plan the best treatment.

PURPOSE: This research study is looking at kidney dysfunction in children and young adults who have received low-dose or intermediate-dose methotrexate for acute lymphoblastic leukemia.

OBJECTIVES:

* Examine the incidence of renal dysfunction in children and young adults being treated for acute lymphoblastic leukemia with low- to intermediate-dose methotrexate.

OUTLINE: Medical charts are reviewed to obtain the following information: gender, age, diagnosis, regimen, day of therapy, renal function, creatinine level, mucositis, skin sloughing, methotrexate level at highest level, and number of days after intravenous methotrexate.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of acute lymphoblastic leukemia

  * Receiving low- to intermediate-dose methotrexate or received treatment (chemotherapy and/or radiation) at Vanderbilt Children's Hospital

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Hysteroscopic Myomectomy for Submucosal Myomas Without Energy Instruments

Uterine fibroid are the most common benign tumor in the female reproductive system. Although many patients with uterine fibroid do not need to be treated because they are asymptomatic, some patients can experience compression, menorrhagia, pain, irregular bleeding or infertility. The symptoms caused by uterine fibroid are related to its location and size. Submucous fibroids constitute 5-10% of all uterine fibroids.The submucous hysteromyoma is the most likely to cause symptoms, often leads to menorrhagia, irregular bleeding or infertility.

Hysteroscopic myomectomy is a commonly used minimally invasive procedure. The submucous myoma can be resected out by endoscopic resectoscope with electricloop (unipolar and bipolar) . It can preserve the uterus and fertility, also effectively alleviate symptoms.

However, some specific complications have also followed，such as： hemorrhage，uterine perforation， pneumonedema，infections，adhesions，etc. Uterine perforation occurs when the electrode is working, there is a high risk of injury to adjacent anatomical structures. And even without perforation, sometimes thermal injury to adjacent organs may still be discovered in a few days after surgery.In addition，Many scholars have found that hysteroscopic electromyectomy has a higher risk of intrauterine adhesion than other intrauterine operations.

In order to reduce the damage caused by energy source, especially the adverse effects of thermal damage on the endometrium, the new methods of hysteroscopic myomectomy currently include: the hysteroscopic tissue removal (HTR) system, the cold loop myomectomy， the Hysteroscopy Endo Operative system (HEOS)，etc. Existing studies show that，These manipulation techniques did not cause the myometrium damage by radiofrequency energy source, greatly reducing the risk of postoperative intrauterine adhesions. The cold knife hysteroscopic myomectomy in this study is a series of procedures using cold instruments（mechanically, with scissor, grasping or morcellation） to remove uterine submucosal fibroids. The purpose of this surgical technique is to make the operation safe and effective, with greater emphasis on the anatomical and physiological integrity of the myometrial and endometrial layers. This study aims to evaluate the safety and efficacy of cold knife hysteroscopic myomectomy.

According to the inclusion and exclusion criteria，collecting the data of participants who have undergone cold knife hysteroscopic myomectomy. The investigators will analyze the safety and efficacy of cold knife hysteroscopic myomectomy through the collected data.

Eligibility Criteria:
Inclusion Criteria:

All patients who underwent cold knife hysteroscopic myomectomy and excised tissue that showed pathology confirmation of leiomyoma.

Exclusion Criteria:

Patients has gynecologic malignancy.
The Efficacy of Amway Uric Acid Lowering Product on Hyperuricemia

The goal of this three arms, randomized, double-blind controlled interventional study is to evaluate the efficacy of Amway uric acid lowering product improving hyperuricemia in patients aged 18 and 65 years old. The main question it aims to answer is:

- whether the serum uric acid level of patients with hyperuricemia could be significantly lowered after 3 months intervention with Amway uric acid lowering product

180 eligible participants will be enrolled in one study site and randomized to three study groups (two product group and one placebo group), who will consume the assigned products for 3 months and be arranged to 3 site visits. All relevant clinical data will be captured and recorded into CTMS (Clinical Trial Management System) for statistical analysis and reporting.

Researchers will compare the three study groups to conclude how Amway uric acid lowering product will improve hyperuricemia.


Eligibility Criteria:
Inclusion Criteria:

* Participants aged between 18 and 65 years old (mostly above 35 years old), including male and female and the ratio of male to female is not limited;
* Patients with hyperuricemia: meet the diagnostic criteria set out in the "Chinese Guidelines for Diagnosis and Treatment of Hyperuricemia and Gout (2019)", and fasting blood uric acid level exceeds 420 μmol/L twice on different days. Further classification using the Janssens Gout Diagnostic scale included asymptomatic hyperuricemia (that is, never had a gout attack) and patients with a history of gout, with a ratio of about 1:1;
* Participants agree not to take any drugs, supplements, or performance enhancers during the study, or they will be eliminated
* Participants understand the test procedure, read, and sign an appropriate Informed Consent Form indicating their willingness to participate.

Exclusion Criteria:

* Secondary gout caused by kidney disease, blood disease, drug use, tumor radiotherapy and chemotherapy;
* Subjects who are using drugs during gout attacks;
* Malignant diseases: patients with severe lung, cardiovascular, blood and hematopoietic system, central nervous system or other system diseases, as well as tumor patients;
* Severe obesity (BMI\>32kg/m2);
* Abnormal liver and kidney function: abnormal level of alanine aminotransferase or aspartate aminotransferase; Serum creatinine was higher than the upper limit of the normal range;
* Allergic to the test drug or weak or allergic;
* Pregnant or lactating women or those who have pregnancy plans; Sex hormone replacement therapy and oral contraception in the past 3 months;
* Subjects who have participated in other research projects within three months;
* Subjects that other researchers considered should be excluded.
A Study to Assess the Effects of MK0822 in Prolonging Time to First Bone Metastasis in Men With Castration-Resistant Prostate Cancer (0822-030)

The purpose of this study is to investigate the effects of MK0822 in prolonging the time to first bone metastasis in men with castration-resistant prostate cancer.

Merck Duration of Treatment : odanacatib; approximately 36 months (even driven study) - Comparator Duration of Treatment : placebo (unspecified); approximately 36 months (event driven study)

Eligibility Criteria:
Inclusion Criteria:

* Castration-resistant prostate cancer; increased risk for prostate cancer progression
* Patient underwent bilateral orchiectomy 6 months or more (i.e., =180 days) prior to Visit 1, or is receiving androgen-deprivation therapy and is on a stable regimen for at least 3 months (i.e., =90 days) prior to Visit 1. Androgen-deprivation therapy may include gonadotropin-releasing hormone agonists such as leuprolide, goserelin, or triptorelin

Exclusion Criteria:

* Bone metastases or history of bone metastases
* Patient has other distant metastases (e.g., visceral, including brain, or soft-tissue). Patients with regional lymph nodal metastases are eligible
* Patient has ANY of the following:

  1. currently is receiving a bisphosphonate or other drug therapy for osteoporosis
  2. has been treated with an oral bisphosphonate for osteoporosis for more than 3 months within the 2 years prior to Visit 1, or for a total of more than 6 months at any time prior to Visit 1
  3. has been treated with an intravenous bisphosphonate within the 12 months prior to Visit 1
* Patient has received chemotherapy within the 2 years prior to Visit 1 (for example, doxorubicin, cytoxan, estramustine, paclitaxel, docetaxel, etoposide, vinblastine, 5-fluorouracil, interferon, mitoxantrone). This exclusion criterion does not include androgen-deprivation therapy (e.g., gonadotropin-releasing hormone agonists such as leuprolide, goserelin, or triptorelin)
* Patient has a history of any malignancy other than prostate cancer \<5 years prior to signing informed consent, except for adequately treated basal cell or squamous cell skin cancer. Melanoma, leukemia, lymphoma, and myeloproliferative disorders of any duration are excluded
* Patient is currently participating in, or has participated in a study with an investigational compound or device within 30 days of signing the informed consent
* Patient is currently participating in or has at any time in the past participated in a prostate cancer study with a registered medication (i.e., approved by the regulatory agency in which he resides) being tested for the treatment of prostate cancer (an unapproved indication)
* Patient is currently using a systemically administered azole antifungal (for example, ketoconazole, fluconazole, itraconazole, miconazole, posaconazole, ravuconazole, and voriconazole). Patients taking these medications must discontinue their use at least one week prior to starting blinded study medication
The Physical Activity Loyalty Card Scheme

The purpose of this study is to investigate the effectiveness of using incentives to encourage adults to be physically active.

The investigators developed the Physical Activity Loyalty Card (PAL) Scheme which integrates a novel physical activity tracking system with web-based monitoring and nudge initiatives. The tracking system used Near-Field Communication (NFC) technology and a "loyalty card" (PAL Card) which contained a passive Radio Frequency Identification (RFID) tag. Sensors were placed along footpaths in the outdoor environment, in the gym and exercise studio, and participants scanned their PAL card at the sensor when doing physical activity (e.g. walking). A transaction (card ID, sensor ID, and timestamp) was recorded and sent via SMS to a secure data centre. Participants logged onto a personal account on the study website (www.palcard.co.uk) and received real-time feedback on various aspects of their physical activity including minutes, distance and calories expended.

Eligibility Criteria:
Inclusion Criteria:

* males and females
* aged 18-65 years old
* able to complete 15 minutes of moderate intensity physical activity
* based at least 4 days per week (and 6 hours per day) at worksite

Exclusion Criteria:

* advised by General Practitioner not to participate in exercise
Influence of Epidural Analgesia in Elective Laparoscopic Colorectal Resections

Epidural anaesthesia in open surgery is a effective method for analgesia and has a positive effect on postoperative resolution of ileus. In laparoscopic surgery, the role of epidural surgery is not established. This prospective observational trial evaluates the effect of epidural analgesia in patients undergoing elective, laparoscopic colorectal surgery.

All patients with elective, laparoscopic colorectal resection between November 2004 and January 2007 were included in the trial. The decision for epidural analgesia was made by the anaesthetist and the patient. Contraindications were previous back surgery, coagulopathy, severe spondylarthrosis and refusal by the patient as contraindications.

Primary outcome was subjective feeling postoperatively, assessed with a VAS for pain and cramps and amount of analgesics used. Secondary outcomes were duration of postoperative bowel dismotility (first flatus, first defecation, first solid food intake) and general and specific morbidity.

Eligibility Criteria:
Inclusion Criteria:

* elective laparoscopic colorectal resection

Exclusion Criteria:

* emergency surgery
* preoperatively planned stoma formation
Exercise Training Versus Best Medical Treatment Only in Peripheral Artery Disease

The aim of the investigators' study is to analyze the value of supervised exercise training combined with medical therapy versus best medical treatment only with respect to quality of life. Furthermore, the investigators aim to evaluate the effect of supervised exercise training on microcirculation, peripheral endothelial progenitor cells as well as on future major cardiovascular adverse events.

Peripheral arterial disease (PAD) affects 7 - 12% of the population aged over 50 years. Over an age of 60 years up to 20% are suffering from PAD in Western societies. Both, percutaneous transluminal angioplasty (PTA) and surgical repair (bypass graft, thrombectomy) are well established procedures to improve peripheral arterial perfusion. However, long-term results remain disappointing: Low patency-rates are associated with clinical deterioration. Moreover, clinical outcome is often limited by early major cardiovascular adverse events (myocardial infarction, stroke).

Therefore, medical therapy plays a major role in the management of PAD patients: Antihypertensive medication, statins as well as an adequate diabetes therapy are important cornerstones in the therapeutical management of PAD. Prior studies have shown that regular supervised exercise training can improve patients´walking impairment.

We hypothesize that regular supervised exercise training significantly improves Quality of Life and decreases the occurence of future major cardiovascular adverse events. We further aim to investigate the effect of exercise training on peripheral microcirculation and endothelial progenitor cells.

Eligibility Criteria:
Inclusion Criteria:

* Peripheral artery disease with intermittent claudication (Rutherford 2-3)
* Exercise tolerance
* Ankle brachial index \< 0,9
* Ability to life independently at home

Exclusion Criteria:

* No PAD
* Asymptomatic PAD
* Ischemic rest pain
* Exercise tolerance limited by other factors than claudication (e.g., coronary artery disease, dyspnoea, poorly controlled blood pressure, any kind of restriction of the musculoskeletal system which might have an influence on the efficiency of exercise training)
AMT-151 in Patients With Selected Advanced Solid Tumours

This first-in-human study will evaluate the Maximum Tolerated Dose (MTD) / the Recommended Phase 2 Dose (RP2D), safety, tolerability, anti-tumor activity, pharmacokinetics, pharmacodynamics and immunogenicity of AMT-151, a novel antibody-drug conjugate against folate receptor alpha, in patients with selected advanced solid tumors.


Eligibility Criteria:
Key Inclusion Criteria:

* Patients must be willing and able to sign the Informed Consent Form, and to adhere to the study visit schedule and other protocol requirements.
* Age ≥18 years (at the time consent is obtained).
* Patients with the following histologically confirmed, advanced cancer diagnoses:

  1. Serous, endometrioid, clear-cell, or mucinous epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.
  2. Serous, endometrioid, or clear-cell endometrial cancer.
  3. Adenocarcinoma of the lung.
  4. Triple-negative breast cancer.
  5. Pancreatic ductal adenocarcinoma.
  6. Malignant pleural mesothelioma.
* Patients who have undergone any number of prior systemic therapies and have radiologically or clinically determined progressive disease during or after their most recent line of therapy, and for whom no further standard therapy is available, or who are intolerable to standard therapy.
* Patients must have at least one measurable or non-measurable lesion as per RECIST version 1.1.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Adequate function of bone marrow, liver, kidneys, heart.
* Both male and female patients must agree to use effective contraceptive methods.
* Women of child-bearing potential (WCBP) must have a negative serum pregnancy test.
* Availability of tumour tissue sample (either an archival specimen or a fresh biopsy material) at screening.

Key Exclusion Criteria:

* Prior treatment with any agent targeting Folate Receptor Alpha.
* Active central nervous system metastasis.
* Persistent toxicities from previous systemic anti-neoplastic treatments of Grade \>1.
* Systemic anti-neoplastic therapy within five half-lives or 21 days, whichever is shorter, prior to the first dose of the study drug.
* Radiotherapy to lung field at a total radiation dose of \>= 20 Gy within 6 months, wide-field radiotherapy (\>30% of marrow-bearing bones) within 28 days, or focal radiation for analgesic purpose or for lytic lesions at risk of fracture within 14 days prior to the first dose of the study drug, or no recovery from side effects of such intervention.
* Major surgery (not including placement of vascular access device or tumor biopsies) within 28 days prior to the first dose of the study drug, or no recovery from side effects of such intervention.
* Prior allogeneic or autologous bone marrow transplantation.
* Significant cardiac or lung disease, active or chronic ocular disorders, thromboembolic or cerebrovascular events within 6 months prior to the first dose of the study drug, acute and/or clinically significant bacterial, fungal, or viral infection.
* Pregnant or breast-feeding females.

Note: Other protocol defined Inclusion/Exclusion criteria apply.
Sub-Hertz Analysis of Viscoelasticity of Limbs in Patients With Lymphedema

Researchers are trying to validate the use of ultrasound sub-hertz analysis of viscoelastisty (SAVE) method to monitor tissue-fluid dynamics and stage disease severity in patients diagnosed with lymphedema.


Eligibility Criteria:
Inclusion Criteria:

* Adult (18+ years of age)
* Ability to provide written consent
* Has been diagnosed with Lymphedema

Exclusion Criteria:

* Under the age of 18 years old
* Inability to provide written consent
* Previous lymphovenous bypass or lymph node transfer surgery
Clinical Data Collection in Studying Clinical Factors Associated With Post-Surgery Chronic Opioid Use in Patients With Head and Neck Cancers

This trial studies the risk of developing disorders associated with chronic opioid use post-surgery in patients with head and neck cancers. Clinical data collection may help doctors to learn how often and how likely disorders associated with the use of opioid pain medication may occur in patients with head and neck cancer who are having surgery as part of their treatment plan.

PRIMARY OBJECTIVES:

I. Assess prevalence of chronic opioid use and severity of symptom burden (M. D. Anderson Symptom Inventory-Head and Neck \[MDASI-HN\]) in patients undergoing surgery of head/neck cancer.

SECONDARY OBJECTIVES:

I. To investigate the extent of association of chronic opioid use with risk of opioid use disorder (as assessed by Screener and Opioid Assessment for Patients with Pain\[SOAPP-14\] and Cut down, Annoyed, Guilty and Eye Opener \[CAGE\] scores) and psychosocial factors (as assessed by MDASI).

II. To assess frequency of positive risk of opioid use disorder as assessed by Screener and Opioid Assessment for Patients tool (SOAPP-14) and CAGE-adapted to include drugs (AID).

III. Assess frequency of aberrant opioid use behaviors. IV. Assess frequency of post-operative complications.

OUTLINE:

Patients complete questionnaires and quality of life assessments over 10-15 minutes at pre-surgery, after-surgery, at discharge, within 2-3 weeks after surgery, and within 90 days after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients with head and neck cancer scheduled for combined head and neck surgery - plastic surgery free flap
* Competent to give informed consent
* Ability to read and write in English

Exclusion Criteria:

* Patient not willing to participate
* Not competent to give informed consent
* Inability to read and write in English