cyrilzakka/clinical-trials huggingface dataset:
Prospective, Randomized, Parallel Clinical Controlled Study of Early Diet Opening on Postoperative Gastrointestinal Hemorrhage in Patients With Colonic Polyps

Currently, hemorrhage remains the most common postoperative complication in patients with colon polyps, with an incidence of approximately 1.5%. The main reasons for postoperative hemorrhage are: the patient's own condition, the nature of the polyp and the operation. The number of patients treated for colon polyps has increased, postoperative care is confusing, medical resources are wasted, and the time span for postoperative diet recovery is large. However, studies on the effect of postoperative dietary recovery timing on postoperative polyp bleeding are rare.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-75, no gender restrictions,
* Patients with colonic polyps identified by colonoscopy and requiring endoscopic treatment,
* Polyp size 0.5cm-2cm,
* Patients agreed to enroll and signed a written informed consent,
* Adherence is good and agrees to be treated and evaluated as required by the study protocol.

Exclusion Criteria:

* Patients with contraindications to endoscopic treatment of colonic polyps, including platelets ≤50×109/L, prothrombin time prolonged by 4 seconds or more, and INR≥2.0,
* Patients with severe heart, brain, lung, blood system diseases, uremia, connective tissue disease,
* Patients requiring treatment with NSAIDs, aspirin, glucocorticoids, or clopidogrel within the first 7 days of the study,
* During the course of the study, due to other concomitant/complications, patients who need to use drugs that affect the efficacy of the trial, including various anticoagulants, antiplatelet drugs and hemostatic drugs,
* Alcoholics, drug addicts or those with uncontrollable neuropsychiatric diseases and others who are not suitable for participating in the trial,
* Pregnant, breastfeeding women, or women in childbearing age who wish to become pregnant,
* Patients with malignant tumor of digestive system,
* Other circumstances in which the investigator believes that the patient should not participate in this trial
Sentinel Node Detection in Cervical Cancer

Evaluation of sensitivity of Sentinel lymph nodes for detecting nodal metastases in cervical cancer

Consecutive women with stage 1a2-2a1 cervical cancer scheduled for surgery will be approached for eligibility by defined criteria.

Sentinel nodes will be detected by a combined use of Indocyanine green and Tc99 radiocolloid ( first 75 patients) and for the continuation with either the combined use or the best performing of those tracers.

Technical success rates, adverse events (related study intervention and overall) sensitivity and negative predictive values will be estimated.

An interim analyse will be performed after 34 node positive patients based on the Fleming two stage analyse. The null hypothesis of sensitivity of 85% will be tested against an estimated sensitivity of 95%. At this stage the study may be closed for futility, closed as hull hypothesis is rejected or continued to reach another 28 node positive patients.

As a full pelvic lymphadenectomy will be performed after detection of sentinel nodes patient will act ast their own controls.

Eligibility Criteria:
Inclusion Criteria:

* Women of age 18 years and older at the time of informed consent.
* Women with a pathologically proven cervical carcinoma of any histologic subtype, clinically stage 1a2- 2a1 planned for primary surgery
* Absence of any exclusion criteria

Exclusion Criteria:

* Non consenting patients
* Ongoing pregnancy
* Inability to understand written and/or oral study information
* Who performance status III or more
* Previous lower limb lymphedema
* Surgical contraindication to a laparoscopic approach or lymphadenectomy at surgeons discretion.
* Anesthesiologic contraindication to a laparoscopic approach at the anesthetist's discretion
* Locally advanced disease or intraabdominal/distant metastases at preoperative CT, MRI or ultrasonography
* Radiologically suspect pelvic nodal metastatic disease according to the RECIST criteria (\>= 1 node with \>=16 mm short axis diameter)
* Allergy to Iodine
* Patients with a known liver disease
* Patients with a significant bleeding disorder or mandatory antithrombotic treatment.
High Intensity Training for Neurological Injury Using Overground Exoskeletons in Inpatient Rehabilitation

The purpose of this study is to see if it's possible to reach high cardiovascular intensity training parameters (exercise at a rate that elevates heart rate to the level recommended for improving strength and endurance) while walking in a wearable robotic exoskeleton. This study will also evaluate if exercising at high intensity will lead to improvement in walking ability. Participants in this study will be asked to attend 5 walking training sessions using Ekso exoskeleton. There will be two additional sessions, one before and one after the five training sessions. At these two sessions, study participants will be asked to participate in seated balance, walking speed and endurance tests and breathing assessments.

The purpose of this study is to determine the feasibility and potential efficacy to implement high cardiovascular intensity training parameters (70-80% heart rate reserve) with the use of overground wearable robotic exoskeletons in an inpatient rehabilitation setting for locomotor recovery.

The second aim is to investigate the potential functional improvements in gait after receiving high-intensity locomotor training with an overground exoskeleton, as measured on the 10-meter walk test and six-minute walk test.

Eligibility Criteria:
Inclusion Criteria:

* Able to achieve adequate fit within the exoskeleton
* Diagnosis of CVA or motor incomplete SCI (AIS C or D)
* Sufficient range of motion to attain normal, reciprocal gait pattern, and transition from normal sit to stand or stand to sit
* Intact skin on all surfaces in contact with device and load-bearing surfaces
* Weight \<220 pounds

Exclusion Criteria:

* Pregnancy
* Spinal instability
* Unhealed limb or pelvic fractures or any condition restricting weight-bearing in limbs
* Diagnosis of other neurological injuries other than CVA or SCI
* Uncontrolled spasticity (≥3 on Modified Ashworth Scale)
* Colostomy
* Decreased range of motion or contractures in legs (\>10° at hips, knees, or ankles)
* Uncontrolled autonomic dysreflexia
* Unresolved deep vein thrombosis
* Inability to tolerate standing due to cardiovascular issues or orthostatic hypotension
* Inability to follow 3 step commands
* Severe comorbidities: active infections, heart, lung, or circulatory conditions
* Pressure sores, impaired skin integrity
* Use of mechanical ventilation for respiratory support
Clinical Trial Readiness for the Dystroglycanopathies

The purpose of the study is to describe the early signs and symptoms of the dystroglycanopathies, and to gather information that will be required for future clinical trials.

Muscular dystrophies are a diverse group of inherited disorders characterized by progressive muscle weakness and wasting. The disorders are caused by mutations, or changes, in genes. Genes are tiny pieces of inherited material (DNA) that direct the body to make certain kinds of proteins.

In this study, researchers will examine the clinical presentation of muscular dystrophy caused by abnormal glycosylation of alpha-dystroglycan. Patients with dystroglycanopathies could have mutations in any one of the more than 20 currently identified genes, or evidence of dystroglycanopathy in biopsied muscle tissue . Symptoms range from congenital muscular dystrophy that may involve the brain and eye, through an adult-onset limb girdle muscular dystrophy.

The study involves a clinical evaluation at the University of Iowa. The evaluation includes muscle strength and motor ability testing, lung function testing, quality of life and activity assessment, and a review of past medical history. Portions of this evaluation will be repeated on a yearly basis. Financial assistance is available for travel to Iowa City. Support is also available for genetic testing for people with a dystroglycanopathy diagnosis based on muscle or skin biopsy analysis.

Knowledge gained from this study will improve healthcare recommendations for people with dystroglycanopathies, and provide a baseline for further study, including potential treatment options.

Eligibility Criteria:
Inclusion Criteria:

* Elevated CK (creatine kinase)
* Evidence of a dystroglycanopathy as determined by review of muscle pathology OR documented mutation in one of the known genes OR abnormal alpha-dystroglycan glycosylation in cultured fibroblasts
* Dystroglycanopathies are predicted to affect all racial and ethnic backgrounds, and all patients with dystroglycanopathies will be eligible for participation.
* Participants may be of any age, including children, and males and females will be recruited equally.
* Patients will have varying degrees of muscular weakness, but otherwise should be in relatively good health.

Exclusion Criteria:

* There are no exclusion criteria.
Study of AROSOD-1 in Adult Participants With Amyotrophic Lateral Sclerosis (ALS)

In this Phase 1 adult symptomatic patients with amyotrophic lateral sclerosis (ALS) carrying a superoxide dismutase 1 (SOD1) gene mutation thought to be causative of ALS, will receive single ascending doses of ARO-SOD1 administered by intrathecal (IT) infusion. The study is primarily intended to evaluate safety, but will also evaluate the effect of ARO-SOD1 on SOD1 cerebrospinal fluid (CSF) levels as a biomarker of pharmacodynamic (PD) effect, therefore lumbar punctures will be required at timepoints throughout the study. After each participant has completed their individual final visit, participants whose SOD1 CSF levels have recovered to a satisfactory level may rescreen and enroll into higher dose cohorts; or if unable or unwilling to rescreen may enroll into an open-label study to be added by amendment when supported by nonclinical data for multidose administration.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of ALS based on source-verifiable medical record and meets the Gold Coast Criteria
* Pathogenic or likely pathogenic SOD1 mutation based on source-verifiable medical records or genetic testing during Screening
* Slow Vital Capacity (SVC) ≥ 50% of predicted value adjusted for sex, age, and height (from a sitting position) at Screening
* Body Mass Index (BMI) ≥ 18.0 kg/m2 at Screening
* Able to complete at least 6 months of follow-up
* If taking any medication or supplement to treat ALS or ALS symptoms, must be on stable dose for ≥ 4 weeks prior to Day 1 and expected to remain at that dose until final study visit and not expected to start these medications after the first dose of ARO-SOD1
* Able and willing to provide written informed consent and to comply with all study assessments
* Participants of childbearing potential must agree to use highly effective contraception in addition to a condom during the study and for at least 90 days following the end of study or last dose of study drug, whichever is later. Males must not donate sperm and females must not donate eggs during the study and for at least 90 days following the end of the study or last dose of study drug, whichever is later.

Exclusion Criteria:

* Current or anticipated need of a diaphragm pacing system (DPS) during the study
* Participants using tofersen can be enrolled only after a washout period of approximately 20 weeks from the last tofersen dose to the first planned dose of ARO-SOD1
* History of having received stem cell therapy for ALS treatment
* Any current or anticipated contraindications to lumbar puncture (LP)
* The presence of an implanted shunt for drainage of CSF or an implanted central nervous system (CNS) catheter
* Human immunodeficiency virus (HIV), seropositive for hepatitis B virus (HBV), seropositive for hepatitis C virus (HCV)
* Uncontrolled hypertension
* Severe cardiovascular disease
* History of drug abuse or alcoholism within 6 months of study enrollment
* Inability to comply with study requirements

Note: additional inclusion/exclusion criteria may apply per protocol
Study in Healthy Volunteers to Prove That 2 Rotigotine Patches From Different Manufacturing Processes Deliver Equivalent Drug Amount to the Body.

The major aim of this study is to investigate and compare the drug amount delivered to the body after sequential application of 2 rotigotine transdermal patches from 2 different manufacturing processes.


Eligibility Criteria:
Inclusion Criteria:

* Healthy White, male volunteers between 18 and 55 years of age (inclusive).
* BMI between 19 and 28 kg/m² (inclusive).

Exclusion Criteria:

* Previous participation in a clinical study with rotigotine
* History or current condition of epilepsy and/or seizures.
* Known clinically relevant allergy or known/suspected clinically relevant drug hypersensitivity.
* History of significant skin hypersensitivity to adhesives or other transdermal products or recently unresolved contact dermatitis.
* History or present condition of an atopic or eczematous dermatitis, psoriasis, and/or an active skin disease.
* Clinically relevant abnormality in physical examination, ECG, vital signs or safety laboratory examinations.
* Positive HIV, hepatitis B or C test or positive alcohol or drug test.
* Relevant hepatic or renal dysfunction
* Intake of medication that might interfere with the test drug within 2 weeks prior to dosing.
* Thickly hair-covered abdomen resulting in difficulties in finding appropriate patch application sites
Therapeutic Effect of Two Muscle Strengthening Programs in Patients With Patellofemoral Pain Syndrome

Introduction: The patellofemoral pain syndrome (SPF) is one of the most frequent pathologies generated by the knee joint. Conservative treatment with physiotherapy exercises reduces pain and improves functional capacity in the short and medium term. The purpose of this study was to evaluate the therapeutic effect of combining a program of muscle strengthening exercises for the core, hip and knee on anterior knee pain in non-athletic patients with SPF. Materials and methods: Randomized controlled trial clinical trial, designed to evaluate the effect of two muscle strengthening programs in people with SPF (Group A: exercises for core, hip and knee, Group B: exercises for hip and knee), during eight weeks of intervention in people between 15 and 40 years of age, with a clinical diagnosis of SPF, with a level of mild to moderate physical activity. The Kujala test was used to measure pain and quality of life.

Experimental study: controlled clinical trial, designed to evaluate the effect of two muscle strengthening programs in people with patellofemoral pain syndrome.

Young adults between 15 and 40 years old, with clinical diagnosis of patellofemoral pain syndrome (by means of Computerized Axial Tomography and medical concept of a specialist Orthopedist in knee), in the last three years, non-athletes with a level of physical activity between mild and moderate, affiliated to the health care institution CAFAM (Caja de Compensación Familiar is a compensation fund of Colombia that has pharmacies, hotels, Convention Center, Recreation Club, School, among others and offers Subsidy Services, Credits, Insurance, Tourism, Health, Education, Housing).

All the procedures developed within the study had as a reference the standards of good clinical practice and ethical principles for medical research in humans. The participants signed the informed consent where they accepted their participation in the present study.

The participants were randomized with the SNOSE (sequentially numbered, opaque sealed envelopes) method to two protocols of muscular strengthening (Group A: Exercises for core, hip and knee and Group B: Exercises for Hip and Knee).

Eligibility Criteria:
Inclusion Criteria:

* Patients with a clinical diagnosis of patellofemoral misalignment with knee CT, aged between 15 and 40 years.
* Patients with clinical signs of retropatellar pain at rest or in the following activities: going up or down stairs, jumping, running, doing squats, kneeling, or sitting for a long time.
* Pain or apprehension to the mobilization of the patella.
* Crepitus with pain when performing squats.
* Confirmatory CT of unilateral or bilateral patellofemoral misalignment.

Exclusion Criteria:

* Clinical history or clinical evidence of patellofemoral dislocation, subluxation or osteoarthrosis of the knees.
* Dysfunction of the ligaments, bursa, meniscus, patellar tendon or synovial plica of the knee.
* Traumatic lesions of ligaments or meniscus or patients with osteoarthrosis secondary to congenital conditions.
* Clinical history of orthopedic surgery in lower limbs.
Weight Loss in Diabetic, Older Obese Adults

This study examines the effects of weight loss and aerobic exercise training on sugar metabolism and other risk factors for heart disease in obese older individuals.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 50 years,
* Body mass index (BMI) \> 27kg/m(2),
* No prior history of diabetes or coronary disease,
* Sedentary
The Role of Vitamin D in Predicting Response to Neoadjuvant Therapy in Patients With Rectal Cancer

It has been reported that better local control is achieved and sphincters are preserved at a higher rate with curative resections performed after neoadjuvant chemoradiotherapy in patients with locally advanced rectal cancers. In addition, it has been reported that local recurrence is reduced and survival is prolonged in patients with complete pathological response to neoadjuvant therapy. Therefore, the importance of predicting patients with pathological complete response has increased.

It has been reported that data obtained from PET-CT scans and clinical information such as tumor size, T stage, and N stage may be useful in predicting the response to neoadjuvant therapy in patients with locally advanced rectal cancer.

Consideration of blood biomarkers in predicting neoadjuvant response can be a very attractive option. Because samples are easily collected, relatively inexpensive to measure, and contain information about different aspects of tumor biology. There are a limited number of blood biomarkers such as CEA and IL-6 that have been studied in the literature.

Experimental studies show that vitamin D suppresses inflammation and protects against cancer by triggering differentiation. In 1980, Cedric and Frank Garland stated for the first time that vitamin D may affect the survival of the patient after the diagnosis of colorectal cancer. In later studies, a positive relationship was reported between the serum level of 25-hydroxyvitamin D - 25 (OH) D and survival rates for colorectal cancer, breast and prostate cancer. In addition, 25 (OH) D serum concentration has been shown to be inversely related to colorectal cancer progression.

In the light of all these information, the role of serum vitamin D levels before neoadjuvant treatment in predicting pathological response in patients with rectal cancer is investigated in this study.


Eligibility Criteria:
Inclusion Criteria:

* • All patients with locally advanced rectal cancer

Exclusion Criteria:

* • below 18 years old

  * patients who did not received neoadjuvant therapy
Gabapentin as Adjunctive Treatment for Postoperative Pain Control

The specific aims of this research study are to use 600 mg gabapentin as an adjunctive treatment for acute postoperative pain control in order to reduce postoperative opiate consumption and improve postoperative pain control.

After consent has been obtained for the study and the cesarean has been completed, when the participant is in the recovery room, she will take the first pill of the study drug. This will occur approximately 30-60 minutes after the cesarean is completed. The time of first dose will be noted on the data capture form. The following will then occur:

* Participants will take study capsules (either 600 mg gabapentin or placebo) every 8 hours for the first 48 hours after beginning the study. The nurse on the unit will be sent the study drug in a blinded capsule by the Investigational Pharmacy.
* Participants will be asked about postoperative pain on a Visual Analog Scale by the care nurses or study personnel before each dose of study drug, before receiving any opioid medication, 2-4 hours after study drugs are consumed, at 24, 36 and 48 hours post surgery, and any other times during routine postoperative clinical care would warrant. Women record pain postoperatively on a similar scale as part of routine clinical care. Prescription pain medication will be given per clinical routine care. Study personnel will note how many pills were sent home.
* One week (6-9 days) after the cesarean delivery, participants will be contacted by phone or other preferred method and asked about pain score, somnolence scores, dizziness, nausea, depression, any problems they are experiencing, and asked how many pain pills are left in their prescriptions given when they went home. These data will be recorded.

An Edinburgh Depression Scale will also be administered upon consent, at 48 hours, and again at one week after delivery. If the scores meet the specified criteria, the provider will by notified or if the subject has already been discharged from the hospital, she will be given contact information for follow up care.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women at least 18 years of age
* Singleton gestation
* Gestational age equal to or greater than 30 weeks
* Women undergoing a non-emergent (often scheduled) repeat cesarean delivery
* Spinal anesthesia utilized during cesarean

Exclusion Criteria:

* History of opiate abuse
* Women on opiates during pregnancy
* Women requiring treatment with magnesium sulfate postpartum
* Preexisting Fibromyalgia, chronic pain syndrome, or rheumatologic disorder
* General anesthesia required for cesarean
* Plans to breastfeed
* History of major depression or postpartum depression requiring medication
* Planned classical cesarean section
Evaluation Study of L-T3 Utility in the Follow-up of Patients With Thyroid Cancer

To compare the hypothyroid state in patients with thyroid cancer prepared either by placebo or L-T3 following L-T4 withdrawal in preparation for whole body scintigraphy. To evaluate the time needed for TSH elevation (\> 30 mUI/L) on placebo vs. L-T3.

Patients with well differentiated thyroid cancer (DTC) need whole-body scintigraphy (WBS) and thyroglobulin (Tg) measurement in order to detect recurrence. Classically, withdrawal from levothyroxine (L-T4) during 4-6 weeks is needed for TSH elevation (\> 30mUI/L), to allow iodine uptake and Tg production. As a result, patients become hypothyroid with impaired quality of life and a potential for tumour flare-up. Recombinant hTSH before WBS prevents hypothyroidism but is not yet approved for radioiodine treatment and is an expensive therapy. L-T3 substitution during the first 2-3 weeks of withdrawal is an alternative used empirically to prepare patients; however, no data exists to prove its benefit upon reducing hypothyroidism.

Objectives: 1) To compare the hypothyroid state in patients prepared either by placebo or L-T3 following L-T4 withdrawal. 2) To evaluate the time needed for TSH elevation (\> 30 mUI/L) on placebo vs. L-T3.

Method: At the time of L-T4 withdrawal or after thyroidectomy, patients with DTC awaiting WBS or radioiodine treatment were randomized in two groups (double-blind): L-T3 (50 mg qd) or an identical placebo for 3 weeks, after which treatment was stopped for 2 weeks. A validated questionnaire of signs and symptoms of hypothyroidism (Billewicz's scale) was administered every 2 weeks until the WBS. TSH, fT4 and fT3 were measured weekly.

Eligibility Criteria:
Inclusion Criteria:

* Patients with well-differentiated thyroid cancer, with total thyroidectomy
* 18 y.o. or older

Exclusion Criteria:

* Use of rhTSH for Whole Body Scintigraphy preparation
* Non stable cardiac arrythmias
* Any condition impairing TSH elevation(glucocorticoid use, hypopituitarism)
* Allergy to Liothyronine
* Inability to give a consent