cyrilzakka/clinical-trials huggingface dataset:
Outcome After MTX & Transvaginal Surgery or UAE & Uterine Curettage in Patients With Cesarean Scar Pregnancy

Cesarean scar pregnancy (CSP)is one of the more serious complications of pregnancies that occur after a prior cesarean delivery. No clinical guidelines have been issued for the management of CSP. More than 30 treatment methods are reported to be used in managing CSP. However, which management can achieve better clinical effects remains unknown. Therefore, this prospective study is designed to compare the outcome between MTX + transvaginal surgery and UAE + D\&C in the treatment of CSP.


Eligibility Criteria:
Inclusion Criteria:

Increased levels of serum β-hCG and ultrasonography findings. The criteria for diagnosis by ultrasonography was the presence of the following: (1) an empty uterine cavity and endocervical canal; (2) detection of the placenta and/or a gestational sac embedded in the hysterectomy scar; (3) the presence of the gestation sac with or without a fetal pole and with or without fetal cardiac activity (depending on the gestational age) in the anterior part of the uterine isthmus; and (4) a thin (1-3 mm) or absent myometrial layer between the gestational sac and the bladder. All patients had taken Magnetic Resonance Imaging (MRI) to clarify the diagnosis . Pregnancy tissues were identified by histopathology examinations of the surgical tissues.

Exclusion Criteria:

All enrolled patients had no contraindications for transvaginal surgery or UAE, including renal failure, active pelvic infection, clotting disorders, or known allergy to the contrast material.
Refined Fecal Microbiota Transplantation (FMT) for Ulcerative Colitis (UC)

The researchers intend to prospectively study the safety, clinical efficacy and microbial outcomes in patients with recently diagnosed UC with FMT capsule therapy derived from pre-defined donors. Donors will be specifically screened for Fusobacterium and Sutterella species as well as for global diversity. It is unknown if treatment with antibiotics before FMT improves the engraftment and/or efficacy of FMT in UC, therefore the researchers plan to randomize subjects to receive pre-treatment with antibiotics or not before FMT therapy. The research team enroll patients from The Susan and Leonard Feinstein IBD Center and our established early diagnosis clinic at Mount Sinai Hospital (MSH).

This is an open-label two arm pilot study to measure the safety, microbiological and clinical impacts of FMT in patients with ulcerative colitis. The researchers will prospectively enroll 16 UC patients (up to 20 subjects accounting for subjects dropping out) with moderate-severe disease from one tertiary care referral center. The overall objective of the study is to collect robust clinical data and create a tissue repository including blood, stool and biopsies to understand the safety, efficacy and microbial changes FMT has on UC patients. The central hypothesis is that pre-defined oral capsule administered FMT is safe and effective for the treatment of UC.

Objectives: To determine the tolerability, feasibility, and safety of using fecal microbiota transplantation orally as an induction agent for patients with ulcerative colitis. To determine whether fecal microbiota transplantation (FMT) delivered via oral capsules can induce clinical remission in patients with mild to moderate ulcerative colitis. Assess whether pretreatment with antibiotics improves engraftment and efficacy of FMT in UC. To characterize the impact of orally administered FMT on the microbiota of patients with ulcerative colitis, particularly those changes associated with response or lack of response.

Study Outcomes: Clinical remission at Week 8, defined as: Steroid-free clinical remission (Total Mayo less 2) and Endoscopic remission (Mayo endoscopic subscore 0 or 1)

Eligibility Criteria:
* Adults aged 18 to 75 with UC, with initial diagnosis of UC \>3 months prior to time of study enrollment visit
* Partial Mayo score of 4-10 with endoscopic subscore ≥2 on flexible sigmoidoscopy
* Permissible UC medications include oral or rectal administered mesalamines
* Corticosteroids must be discontinued at least 4 weeks before enrollment
* Documented negative C. difficile and GI PCR for enteric pathogens (BioFire) testing before commencement of fecal microbiota transplantation
* Previous documentation of ulcerative colitis based on colonoscopy/flexible sigmoidoscopy with compatible histology
Pre-operative One-on-One Physical Therapy Education Improves Postoperative Function and Patient Satisfaction After Total Joint Arthroplasty

The purpose of this study was to evaluate the efficacy of a one-time, preoperative physical therapy protocol on postoperative (1) discharge disposition, (2) pain, function and stiffness and (3) patient satisfaction.


Eligibility Criteria:
Inclusion Criteria:

* Subjects will be required to meet the following inclusion criteria in order to participate:

  * Unilateral Primary Knee OA or Hip OA
  * Patients at least 18 years old up to 85.
  * Undergoing surgery with one of the following study surgeons
  * Able to independently ambulate ≥ half a block with or without assistive device
  * Able to independently perform non-reciprocal stairs with or without assistive device/rails
  * Patients that plan to D/C home post TKA / THA
  * Patients that speak English only.

Exclusion Criteria:

* Rheumatoid arthritis
* Psoriatic arthritis
* Juvenile rheumatoid arthritis
* Knee or Hip revisions
* Patients under 18 years of age
* Patients unwilling or unable to complete PRO instrument or study questionnaires at the specified study time points pre-operatively or post-operatively
* Bilateral TKA and THA
* Uni-condylar knee arthroplasty or Hip resurfacing
* Patellar reconstruction
* Patient on disability, workman's compensation
* Patients unwilling to participate in PEdPTWP and/or Patient education class and booklet.
* Patients that plan to D/C to rehabilitation center post TKA and THA
* Patients that do not speak English
* Patients that do not have access to computer
Biochemical Evaluation of Periodontal Effects of Orthodontic Treatment with Aligners

The aim of this study was to determine the effect of orthodontic treatment with aligner on changes in osteoprotegerin (OPG) and receptor activator of NF-κB ligand (RANKL) levels in saliva samples and to investigate the possible relationship between periodontal clinical parameters. Materials and Methods: A total of 25 (n=25) saliva samples were taken from systemically healthy non-smoking individuals who were planned to receive orthodontic treatment with aligner before treatment. Whole mouth clinical periodontal measurements including probing depth (PD), clinical attachment level (CAL), bleeding on probing (BOP), gingival index (GI) and plaque index (PI) were also recorded and repeated at 1 and 3 months. Enzyme-linked immunosorbent assay (ELISA) was used to determine OPG and RANKL levels in biological samples.


Eligibility Criteria:
Inclusion Criteria:

* Systemically healthy (The determination of healthy volunteers will be based on the statements of the patients in the anamnesis. No additional examinations will be made.)
* Must receive orthodontic treatment with aligners and must have accepted the treatment
* Non-smoker
* No medication for continuous use
* Those who have not used antibiotics, anti-inflammatory and systemic corticosteroid drugs in the last 6 months.
* Not in pregnancy or lactation period.

Exclusion Criteria:

* Any oral or systemic disease
* Regularly using a systemic medication
* During pregnancy or lactation
* Received periodontal treatment within the last 6 months.
* Those who received antibiotic, anti-inflammatory or systemic corticosteroid medication in the last 6 months
* Smokers are not included in the study
Protocol for Radiofrequency Ablation of Pulmonary Neoplasms

This research trial involves the development of a new treatment for lung tumors. It is for patients whose tumor cannot be surgically removed, have refused surgery, or the tumor has not responded well to other forms of treatment. This treatment uses a needle probe to deliver energy into the lung tumor. This probe is placed utilizing a CT scan image. The energy heats the tumor causing tumor cell death.


Eligibility Criteria:
Inclusion Criteria: The patients enrolled in this study should be judged to have sufficient survival to benefit from control of local disease and include at least one of the following:

1. unresectable primary or metastatic lung tumors
2. may benefit from multiple modalities of therapy
3. chemotherapeutic or radiation oncologic options have been exhausted

Exclusion Criteria:

1. co-existing morbidities that preclude the use of surgery
Rehabilitation in Multiple Sclerosis: Influence of Exercise on Development of Insulin Resistance, Muscle Power and Aerobic Capacity

the purpose of this study is to investigate the development of insulin resistance in multiple sclerosis patients + explaining the effects of a combined training programme on insulin resistance, muscle power and aerobic capacity in multiple sclerosis patients


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed MS according to the McDonald criteria
* Expanded Disability Status Scale (EDSS) between 0.5 and 6
* Be able to train 5 times in 2 weeks at the University

Exclusion Criteria:

* Comorbidities like cardiovascular-, respiratory-, orthopaedic or metabolic diseases (like diabetes type 2)
* Having had an relapse in a period of 3 months prior to the start of the intervention period
* Having an relapse during the intervention period
* Pregnancy and other contra indications for physical activity
* Mental disorders
Radium-223 Dichloride Long-term Follow-up Program

Patients will be followed up in this study after prior treatment with BAY88-8223 / Radium-223 dichloride / Xofigo.

This long-term follow up study will enroll subjects who will be transferred from selected interventional, company sponsored trials with radium-223 dichloride (feeder trials).

The primary objectives are to define the long term safety profile of radium-223 dichloride (for up to 7 years after the last dose of radium-223 dichloride); to assess the incidence of leukemia, myelodysplastic syndrome, aplastic anemia, and primary bone cancer or any other new primary malignancy; to assess the incidence of bone fractures and bone associated events (e.g., osteoporosis); and, in subjects who receive cytotoxic chemotherapy, to assess the incidence of febrile neutropenia and hemorrhage during their chemotherapy treatment and for up to 6 months thereafter at a frequency based on local clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* Subject was previously enrolled in a selected company sponsored feeder trial, and has received at least 1 dose of radium 223 dichloride or placebo in the feeder trial

Exclusion Criteria:

* Not applicable to this follow up study
Rehabiliation Using HUBER 360 to Reduce the Risk of Falls

Aim: The aim of the present study was to analyse the effects of training performed on a rotating, motorised platform (the Huber/SpineForce device from LPG Systems, Valence, France) intended to reduce the risk of falls.

Subjects: any patient 1) benefiting from a physiotherapy rehabilitation program at the CHU Liège, CNRF, Belgium; 2) presenting a pathological situation justifying functional rehabilitation with HUBER 360®; 3) presenting any pathology not constituting an exclusion criterion; 4) giving informed consent to research will be include in this 8-week interventional trial.

Design: randomized open-label trial. Patients will be randomized into the intervention group (HUBER trainig, 45 minutes of training, twice a week during 8 weeks) or in the control group (standard care).

Outcomes: the effect of the training will be measured on the Time-Up-and-Go test, on the Short-Physical performance battery test and on quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Patient benefiting from a physiotherapy rehabilitation program at the CHU Liège, CNRF
* Patient presenting a pathological situation justifying functional rehabilitation with HUBER 360®
* Patient presenting any pathology not constituting an exclusion criterion
* Patient giving informed consent to research.

Exclusion Criteria:

* Cardiac or respiratory or neurological or rheumatological disease incompatible with physical activity ;
* Joint inflammation;
* Rheumatic disease in acute phase;
* Recent trauma, infection of the musculoskeletal system;
* Fever;
* Venous thrombosis ;
* Discopathy in acute phase;
* Neuropsychological problems that do not allow to integrate the instructions or other serious psychological problems;
* Cardiovascular diseases and any progressive, chronic, counter-indicative disease;
* Large anatomical deformities.
Developing and Evaluating an Indoor Air Pollution Intervention Among Cardiovascular Patients: the AIRWISE Study

This pilot study (n=20) is a prospective evaluation of the implementation of an indoor air pollution intervention among patients who have undergone recent percutaneous coronary intervention procedures. The intervention, called Air Improvement and Real-time Monitoring for Wellness through Interactive Strategies and Education (AIRWISE), is focused on improving indoor air quality through air filtration, education, and behavioral recommendations. All participants will receive the AIRWISE intervention with the objective of evaluating acceptance and use of the individual intervention components. This implementation study will inform the submission of a larger NIH proposal for a randomized trial. The central study hypothesis is that an intervention program with educational strategies and visual behavioral cues will increase knowledge and awareness of air pollution exposures among the participants and lead to improved intervention compliance.


Eligibility Criteria:
Inclusion Criteria:

* Adult of at least 20 years of age
* Undergone a percutaneous coronary intervention (PCI) procedure at the Providence Heart Institute (PHI).
* One primary residence (5+ days per week)
* Own a computer or electronic device (tablet or phone with web browser), and reliable internet connection or cell phone service (required to submit study surveys)
* Access to a working email address (required to submit study surveys)
* Electricity in the home (required to power the study equipment)

Exclusion Criteria:

* Current smoking of any kind (tobacco, cannabis, vape pens, cigars, etc.) or living in a household with someone who currently smokes
* Current use of stand-alone home high efficiency purified air (HEPA) filtration or PAC unit in the home
* Intention to move in the next 6 months
* Another person in the household is enrolled in this study (one person per household can enroll)
* Having any health condition that prevents the participants from having blood pressure measured using an upper-arm cuff: lymphedema, paresis or paralysis, arterial or venous lines/catheters, dialysis shunt, recent surgical wounds, or mastectomy
24-h Movement Behaviors and Adherence to the Mediterranean Diet in Children

The purpose of this study is to determine the effects of the Archena Infancia Saludable project on adherence to MD and 24-h movement behaviors in schoolchildren


Eligibility Criteria:
Inclusion Criteria:

Schoolchildren aged 6-13 years will be eligible

Exclusion Criteria:

* Participants with any pathology that contraindicate exercise or that request special attention.
* Participants under pharmacological treatment that prevent them from receiving the contents of the activities of the program.
* Participants or parents/legal guardians presenting Spanish learning difficulties.
* Participants do not authorized by the parents/guardians to be included in the research project.
* Participants do not agree to take part in the research project.
Biliary Metal Stent Study: Metal Stents for Management of Distal Malignant Biliary Obstruction

The primary purpose is to compare patency of two different types of biliary metal stents, i.e. covered versus uncovered Nitinella metal stent. Secondary purposes are to determine frequency of complications in the two groups, e.g. cholecystitis, pancreatitis, and cholangitis.


Eligibility Criteria:
Inclusion Criteria:

* 20 years of age or older
* oral and written information given and informed consent obtained
* clinical data in accordance with malignant bile duct obstruction
* ultrasonography signs of extrahepatic malignant common bile duct obstruction
* typical radiological findings at ERCP of malignant common bile duct stenosis
* proximal margin of the bile duct stenosis at least 2 cm from the hepatic confluence
* bilirubin \> 50 micromol/L
* radical surgery estimated not possible (temporary stenting with insertion of a plastic stent can be obtained but should be replaced by a metal stent within 4 weeks after the first ERCP procedure, and the patient is randomized at the time of insertion of the metal stent)

Exclusion Criteria:

* patients with active hepatitis or other hepatic diseases that may cause jaundice
* informed consent not obtained
* metastasis with numerous significant intrahepatic stenosis causing blockage of one or more segments of the liver (if no segment blockage, liver metastasis is not an exclusion criteria)
* the patient is probably a candidate for surgical resection
* suspicion of a non-malignant bile duct obstruction, e.g. stones or benign stenosis (should initiate further investigations)
* the proximal end of the stenosis is located within 2 cm from the hepatic confluence
* the patient has previously undergone BII or Roux-en-Y gastric resection, or has a significant duodenal obstruction making ERCP difficult
* previously (more than 4 weeks earlier) treated with a bile duct stent
* severe coagulation disturbance (PK-INR \> 1.6)
Alcohol and Other Psychoactive Substances in Road Traffic - a Case-control Study

The main purpose of the study is to determine the accident risk when driving under the influence of psychoactive substances, including alcohol (DUI). Other aims are to find out the prevalence of psychoactive substances in road traffic and to obtain information on the role of these substances in road traffic accident causations.

For the purposes of the study, drivers of motorised vehicles are randomly stopped and interviewed and breath alcohol is recorded. Also, an oral fluid sample is taken and psychoactive substances are investigated in the laboratory. For cases, drivers injured in traffic accidents are asked to participate to the study. A whole blood sample and, if possible, an oral fluid sample is taken and psychoactive substances are determined in the laboratory. Also, people diseased in road traffic accident are included in the study. The information required for these subjects are taken from a register database.

The study is part of an EU-project DRUID. Altogether 13 European countries take part to the study.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* driver of a motorised vehicle or bicycle
* is willing to participate to the study (not applicable to the diseased drivers; information obtained from a register database)

Exclusion Criteria:

* 17 or younger
* not the driver of a motorised vehicle or bicycle
* does not want to participate (not applicable to the diseased drivers; information obtained from a register database)
A Study on BMS-986177 for the Prevention of a Stroke in Patients Receiving Aspirin and Clopidogrel

The purpose of this clinical study is to determine whether the addition of an oral Factor XIa Inhibitor to Aspirin and Clopidogrel is more effective than standard therapy in secondary stroke prevention.


Eligibility Criteria:
Inclusion Criteria:

* Male and Female ≥40 years of age
* Acute Ischemic Stroke or Transient Ischemic Attack
* Intracranial or Extracranial Atherosclerotic Plaque proximal to the affected brain area

Exclusion Criteria:

* Predicted inability to swallow study medication
* Any condition that, in the opinion of the Investigator, contraindicates anticoagulant therapy or would have an unacceptable risk of bleeding
* Use of thrombolytic therapy or mechanical thrombectomy for treatment of index stroke

Other protocol defined inclusion/exclusion criteria could apply
Pola-ZR2P in Previously Untreated DLBCL

The goal of this phase 2 trial is to test the safety and efficacy of Pola-ZR2P as induction therapy in patients with DLBCL.

The investigators will evaluate safety and efficacy of Pola-ZR2P as induction therapy in Previously Untreated Diffuse Large B-Cell Lymphoma. ORR(Overall response rate, progression-free survival (PFS), overall survival (OS), adverse events (AEs) will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed Diffuse Large B Cell Lymphoma according World Health Organization (WHO) classification;
* Patient is ≥ 18 years of age at the time of signing the informed consent form (ICF).
* Patient must understand and voluntarily sign an ICF prior to any study-specific assessments/procedures being conducted;
* Patient is willing and able to adhere to the study visit schedule and other protocol requirements;
* Patient has not received chemotherapy previously.
* Anticipated life expectancy at least 3 months

Exclusion Criteria:

* Active or uncontrolled infections requiring systemic treatment within 14 days before enrollment.
* Any instability of systemic disease, including but not limited to severe cardiac, liver, kidney, or metabolic disease need therapy.
* Pregnant or lactating women
Sensor Glove and Non-Invasive Vibrotactile Feedback Insole to Improve Hand Prostheses Functions and Embodiment

State-of-the-art myoelectric prostheses provide upper limb amputees with a remarkable variety of grip patterns but lack proper feedback from touch sensation. This restriction limits the controllability of multi-articulated robotic hands, resulting in the rejection of the device in many cases.

Amputees have often reminiscing sensations in the stump, i.e. by touching certain regions, it feels as if no longer existing fingers were touched. These regions form a phantom map and show promising results for touch feedback. However, not every amputee has one and the socket of a prosthesis offers limited space for additional devices. Thus, the investigators developed a feedback display which is worn in the shoe instead of the prosthesis itself. The investigators want to assess the viability of vibrotactile feedback stimulus on the foot as a substitution for pressure on the fingers of an artificial hand in a clinical study. The efforts are based on the hypothesis that a hand prosthesis with tactile feedback has better performance in manipulating fragile and heavy objects, compared with a standard commercial hand prosthesis without tactile feedback.


Eligibility Criteria:
Inclusion Criteria:

* Sign the consent form
* Have basic knowledge of and trust in modern technologies
* Understand the experimental procedures and are willing to participate in the study
* Unilateral below- or above-elbow amputee
* Familiar with the usage of a myoelectric prosthesis

Exclusion Criteria:

* Any form of skin disease
* Contraindication in the device, e.g. hypersensitivity or allergy against materials used in the device
* Impaired condition
* Known or suspected abuse of alcohol or drugs
* Unable to follow the instructions given during the experiments
* Participation at another clinical study with drugs or devices within 30 days before the study at hand
* Homeless person
* Enrollment of the Head of Studies, his/her family members, employees or other dependent persons
Influence of Music on 6 Minutes Walking Distance in Healthy Children

To evaluate the effect of different distractive auditory stimuli (fast, slow and preferred) on 6 Minute Walking Test (6MWT) and the measured parameters (dyspnea, heart rate, oxygen saturation) in healthy children.


Eligibility Criteria:
Inclusion Criteria:

* the participation to the physical education program after the annual medical investigation

Exclusion Criteria:

* a lung disease
* an overweight
* a motor disability based on parent's answers to a questionnaire