cyrilzakka/clinical-trials huggingface dataset:
Effect of Wearing a Compression Sock During Running on Muscle Soreness in Distance Runners.

Running is the most popular physical activity worldwide. Although running provides many health benefits, it is often associated with injuries and symptoms such as delayed onset muscle soreness. There is still a paucity of interventions that can effectively minimise these symptoms in distance runners.

Our primary aim is to explore the effect of compression socks during running on delayed onset muscle soreness after running. Our secondary aims are to explore the effects of compression socks during running on perceived recovery, perceived exertion, affective response, and heart rate after running. This is a randomised, double-blind, sham-controlled crossover trial. Forty-four participants will be recruited via social media, running clubs and the running coaches' network of the research team. Participants will be randomised to complete a running protocol under two conditions (compression socks or sham socks). After that, there will be a wash-out period of 7 to 10 days, and participants will repeat the running protocol under the other conditions. Primary outcome: lower limb muscle soreness will be collected, using a 0-100 numerical pain scale, immediately, 24 hours and 48 hours after the running protocol, with 24 hours post-protocol being the primary timepoint. Secondary outcomes: perceived recovery will be collected, using a 0-10 scale immediately, 24 hours and 48 hours after the running protocol. Perceived exertion, affective response, and heart rate will be registered only immediately after the protocol. Between-group differences will be explored using linear mixed models.

Eligibility Criteria:
Inclusion Criteria:

* Run consistently in the last six months (at least three times a week and at least 10 kilometres per week);
* Runners who did not run further than 42 kilometres in the last month.

Exclusion Criteria:

* Pregnancy;
* Any lower limbs fracture in the last 12 months;
* History of lower limb arthroplasty or osteotomy, previous venous thrombosis, kidney disease;
* Any running-related injury in the last six months. A running-related injury will be considered the presence of lower limb pain that caused restriction, stoppage of running (distance, speed, duration, or training) for at least seven days or three consecutive scheduled training sessions or the need for a health professional treatment
Women First: Preconception Maternal Nutrition

Multi-country three-arm, individually randomized, non-masked, controlled trial to ascertain the benefits of ensuring optimal maternal nutrition before conception and providing an evidence base for programmatic priority directed to minimizing the risk of malnutrition in all females of reproductive age.

The objective is to determine the benefits to the offspring of women in poor, food-insecure environments of commencing a daily comprehensive maternal nutrition supplement (with additional balanced calorie/protein supplement for underweight participants) ≥ 3 months prior to conception versus the benefits of commencing the same supplement at 12 weeks gestation and also to compare offspring outcomes with those of a control group which receives no supplement.

Eligibility Criteria:
Inclusion Criteria:

* 16-35 years of age;
* expectation to have first or further pregnancy without intent to utilize contraception
* Hb \>8 g/dL

Exclusion Criteria:

* Nulliparous women who do not agree to hospital delivery (equipped for caesarian section) or/and do not have ready access to such a facility.
Effect of Aromatherapy on Venopuncture Pain and Anxiety

The effect of aromatherapy with lavender essential oil on pain and anxiety during venipuncture will be evaluated.

The anxiety and pain during venipuncture may be cause to the avoidance of the medical therapy in patient as well as adult. Aromatherapy with lavender was shown that beneficial effects on chronic pain and anxiety. It's effect on acute pain and anxiety is not exactly known. In this study, the aromatherapy with the lavender will be compared with placebo to evaluate the analgesic and anxiolytic effect during peripheral venous cannulation before surgery.

Eligibility Criteria:
Inclusion Criteria:

* be scheduled for elective surgery
* be accepted to inhale lavender

Exclusion Criteria:

* age \<18 years \>65 years
* preoperative pain or consumption of analgesic medication
* anxiety disorders or consumption of anxiolytic medications (i.e. SSRI, benzodiazepine)
* pregnancy or breastfeeding
* asthma, chronic obstructive pulmonary disease
* poor sense of smell
* allergy to the lavender essential oil
Nicotine Patch Bioequivalence Study

The purpose of this study is to compare the relative bioavailability of nicotine following single application of a new transdermal formulation to that of a reference formulation.

4 single 24hour applications separated by 48hour intervals.


Eligibility Criteria:
Inclusion Criteria:

* Healthy subject aged 18 to 45 years (inclusive)
* Current Smoker of \>or = 5 and \< or = 15 cigarettes/day
* Fagerström score \< or =5 at selection
* Absence of any clinically significant abnormal finding at physical, vital sign, Electrocardiogram ECG, biological examinations in the investigator's opinion.

Exclusion Criteria:

* Presence of any significant medical finding or significant history (in particular any cardio-vascular disease, severe renal or hepatic insufficiency, current gastric or duodenal ulcer) that may impact the safety, the interpretation of the results and/or the participation of the subject in the study according to the opinion of the investigator
* Any visible skin disorder, abnormal skin pigmentation or dermatologic disease liable to interfere with use or assessment of transdermal patch
Study of ONTAK (Denileukin Diftitox) in Previously Treated Cutaneous T-Cell Lymphoma Patients

The purpose of this study is to provide an opportunity for patients who exhibit progressive disease while receiving placebo on the companion 93-04-11 study to receive ONTAK. It is also designed to determine the effectiveness of ONTAK in Cutaneous T-cell Lymphoma (CTCL) patients whose tumors do not express CD25.


Eligibility Criteria:
Inclusion Criteria:

* Patient must have been previously enrolled in Protocol 93-04-11 and randomized to the placebo arm; or the patient met all eligibility criteria for protocol 93-04-11 other than the expression of CD25 on CTCL tumor cells.
* CTCL disease Stage Ia - III.
* History of less than or equal to 3 previous therapies. Repeated use of the same agent is considered to be 1 therapy unless it is part of a different combination regimen. Only 1 prior combination cytotoxic chemotherapy regimen is permitted. Topical or systemic steroids are not considered a therapy.
* Patient must have evaluable or measurable disease. Lymph node involvement no greater than LN2. No CTCL involvement of bone marrow.
* No significant pulmonary or cardiac disease. No active CNS, kidney, or liver disease.
* No systemic infections.
* ECOG performance status of 0 or 1.

Exclusion Criteria:

• The 93-04-14 study is no longer open to subjects previously enrolled in 93-04-10 or 92-04-01.
In-Patient Study In Schizophrenic Patients

This study is a placebo-controlled study to assess the safety and tolerability of a novel antipsychotic medication, (773812) when given to schizophrenic patients for twenty-eight days. Assessments include blood sampling to determine drug concentrations, psychiatric assessments while under treatment, and movement assessments to evaluate potential side effects.


Eligibility Criteria:
Inclusion Criteria:

* Must have schizophrenia that has been stable for at least three months.
* Willing to discontinue current anti-psychotic medications (under supervision) prior to the study.
* Willing to live at the study center for a total of 38 days and then return for three follow-up visits.

Exclusion Criteria:

* Taking medications for conditions other than schizophrenia.
* History of alcohol or drug abuse within six months of the study, and their alcohol consumption must meet moderate guidelines.
Ovarian Function After Hysterectomy With or Without Fimbriectomy or Salpingectomy

The impact of Hysterectomy with preservation of the ovaries on ovarian function has long been controversial. studies have shown conflicting data regarding ovarian function after simple Hysterectomy.

In recent years, there is a growing evidence that Salpingectomy or Fimbriectomy may have preventive value reducing Ovarian and Primary Peritoneal carcinoma, but the safety and the consequences regarding ovarian function have yet to be established.

The aim of this study is to evaluate ovarian function after Hysterectomy alone Vs. Hysterectomy combined with salpingectomy or fimbriectomy


Eligibility Criteria:
Inclusion Criteria:

* Women undergoing Hysterectomy for Benign In dication (eg. Uterus Myomatous) before menopause

Exclusion Criteria:

* Menopause
* known or suspected malignancy
Lifestyle Redesign For Schizophrenia

This study aimed to investigate the effects of lifestyle redesign program plus treatment as usual versus treatment as usual on cognition, psychiatric symptoms, quality of life, and occupational engagement for schizophrenia.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of schizophrenia, based on the ICD-10 diagnostic criteria for research (World Health Organization, 1992)
* age from 20 to 65
* attending day care center regularly for at least 1 month and taking stable dose of medication

Exclusion Criteria:

* comorbid other mental disorder (e.g. depression, anxiety, ADHD...etc.)
* comorbid mental retardation
* lacking the reading and writing skills
Study of Weekly Genexol®-PM Plus Gemcitabine in Subjects With Recurrent and Metastatic Adenocarcinoma of the Pancreas

Phase II Study of Weekly Genexol®-PM Plus Gemcitabine in Subjects With Recurrent and Metastatic Adenocarcinoma of the Pancreas.

The aim of the this phase II study is to assess the efficacy and safety of a combination treatment of Genexol®-PM plus gemcitabine in patients with recurrent and metastatic adenocarcinoma of the pancreas.

Eligibility Criteria:
Inclusion Criteria:

1. Patient has definitive histologically or cytologically confirmed recurrent and metastatic adenocarcinoma of the pancreas. The definitive diagnosis of recurrent and metastatic pancreatic adenocarcinoma will be made by integrating the histopathological data within the context of the clinical and radiographic data. Patients with islet cell neoplasms are excluded.
2. Initial diagnosis of recurrent and metastatic disease must have occurred ≤6 weeks prior to randomization in the study.
3. Patient has one or more lesions measurable by CT scan or MRI (if patient is allergic to CT contrast media).
4. Male or non-pregnant and non-lactating female, and ≥ 20 years of age.
5. Patient must meet the following blood counts at Baseline (obtained ≤14 days prior to randomization):

   * Absolute neutrophil count (ANC) ≥ 1.5 × 10\^9/L
   * Platelet count ≥ 100,000/mm3 (100 × 10\^9/L)
   * Hemoglobin (Hgb) ≥ 9 g/dL.
6. Patient has the following blood chemistry levels at Baseline (obtained ≤14 days prior to randomization):

   * AST (SGOT), ALT (SGPT) ≤ 2.5 × upper limit of normal range (ULN), unless liver metastases are clearly present, then ≤ 5 × ULN is allowed.
   * Total bilirubin ≤ULN
7. Patient has a Karnofsky performance status (KPS) ≥ 70. Two observers will be required to assess KPS. If discrepant, the one with the lowest assessment will be considered true.
8. Patient has voluntarily agreed to participate in the study, and signed the Informed Consent Form (ICF) prior to participation in any study-related activities.

Exclusion Criteria:

1. History of malignancy in the last 5 years. Patients with prior history of in situ cancer or basal or squamous cell skin cancer are eligible. Patients with other malignancies are eligible if they were cured by surgery alone or surgery plus radiotherapy and have been continuously disease-free for at least 5 years.
2. Patients have uncontrolled bacterial, viral, or fungal infections
3. Patient has known historical or active infection with HIV, hepatitis B, or hepatitis C.
4. Patients have a history of allergy or hypersensitivity to any of Paclitaxel, Gemcitabine, or Cremophor EL.
5. Patients with high cardiovascular risk, including recent coronary stenting or myocardial infarction in the past 6 months.
6. History of Peripheral Artery Disease (e.g,. claudication, Leo Buerger's disease).
High-Dose Vitamin D Deficiency in Burn Injury

High dose Vitamin D (50,000IU) therapy may increase bone mineral density/bone mineral content after large burns.


Eligibility Criteria:
Inclusion Criteria:

* 5+ yrs
* Burn size 40% or greater
* Patient can remain around Shriner Hospital for Children area for 16 weeks
* Agree to take Vitamin D

Exclusion Criteria:

* Age less than 5yrs
* Burn size less than 40%
* Pre-existing bone disease or healing fractures
* Underlying chronic disease-endocrine or cancer
* Kidney failure
ART Compared to the Hall Technique for Management HSPM

Aims: Evaluation of treatment success on HSPM-affected molars after ART and Hall technique.

comparison of pain during treatment with ART and Hall technique in HSPM. comparison of child and parent satisfaction with restorations used by ART and Hall technique.

Design: A randomized, controlled, crossover clinical study including thirty children.

Background and Aims:

Despite the widespread prevalence of HSPM:

there are no comparative studies yet between ART and Hall technique in the restoration of HSPM.

there are no studies yet on the success of ART in the treatment of HSPM.

Design:

A randomized, controlled, crossover clinical study including thirty children Each child will apply both of ART and Hall technique to him.

Eligibility Criteria:
Inclusion Criteria:

* Absolute positive, positive or negative behavior according to the Frankel Scale.
* Healthy, both physically and mentally.
* Do not take medications that interfere with the assessment of pain within 24 hours prior to treatment.
* A child with HSPM-affected primary second molars on the right and left side in one jaw.
* The HSPM affected teeth from 2-6 degree in Ghanim scale.
* Teeth with atypical carious lesions.
* Teeth with post-eruption destroyed
* The presence of a clear, intact dentinal bridge between the caries and pulp radially.

Exclusion Criteria:

* Allergy to the substances used in restoration.
* Presence of general or developmental medical conditions.
* Teeth with pulpitis inflammation or apical lesion or non-restorable.
* Teeth closed to being replaced.
Enhanced Medical Rehabilitation in Older Adults

The purpose of this study is to provide evidence that Enhanced Medical Rehabilitation is an effective treatment for older adults after disabling medical events.

The intervention involves physical and occupational therapy for patients who have been admitted to a skilled nursing facility for therapy following a disabling medical event.

Participants in this study will be randomly assigned to receive either Enhanced or standard of care therapy, meaning they will either receive their PT (Physical Therapy)\& OT(Occupational Therapy) from therapists who have been specially trained in the study intervention or from therapists with normal training. Participants will be assessed at baseline, 30, 60, and 90 days after baseline, and at the date of their discharge from the skilled nursing facility.

Eligibility Criteria:
Inclusion Criteria:

* 65 and older
* Admitted to a skilled nursing facility for post-acute care from PT and OT for 2 weeks or more.

Exclusion Criteria:

* Language, visual or hearing barriers to participation
* Medical illness preventing study participation or accurate data collection
* Moderate-severe dementia (demonstrated by chart diagnosis and/or short blessed score greater than 13)
* Progressive neurological condition such that recovery of function is not feasible
* Patient did not have the ability to walk prior to hospitalization (e.g. paraplegic)
* Schizophrenia or other chronic or current psychotic disorder.
Cognitive Decline in Asymptomatic Intracranial Stenosis Patients: A 1-Year Follow-Up Study

To investigate the cognitive decline after standard medical treatment without stenting in Asymptomatic Intracranial Stenosis patients and the underlying neural mechanism by fMRI.

All participants underwent a medical evaluation that included routine laboratory studies before and after 1-year standard medical treatment. Upon meeting the inclusion criteria and providing informed consent, each participant will complete a battery measure of neuropsychological tests and Magnetic Resonance imaging scan in multimodalities within 7 days after admission and after 1-year when patients received standard medical treatment at the First Affiliated Hospital of AnHui Medical University. participants were randomly allocated to patient group and the control group.There are about 20 patients and 20 healthy controls in this study.

Firstly, a series of neuropsychological tests were obtained by a trained investigator to assess baseline. Each assessment will involve a set of assessment tools, the memory as the primary outcome measure and various other tasks and questionnaires to measure cognition (including MoCA,MMSE, DS, Stroop test, TMT, VFT), memory (CAVLT), emotion (HAMA-17,HAMD-14), behavioral and psychological symptoms(NPI). All the tests are conducted in two days. The patients had receiving a magnetic resonance imaging scan in multi-modalities.

After 1-year standard medical treatment,the patients participants were interviewed to obtain the same assessment and magnetic resonance imaging scan in multi-modalities as before. Patients are instructed to focus their answers on the past 15 days. The clinical symptom of participants were followed 6 and 12 months after the admission. Afterwards, they were unblinded by the study coordinator.

Eligibility Criteria:
Inclusion Criteria:

* Patients with intracranial stenosis which was defined as stenosis of 50% or more in Intracranial segment of internal carotid artery and middle cerebral artery (MCA).
* The degree of stenosis was measured by transcranial doppler, computed magnetic resonance angiography (MRA),tomography angiography (CTA) and digital subtraction angiography (DSA).

Exclusion Criteria:

* History of stroke,transient ischemic attack,seizures or unexplained loss of consciousness.
* Organic brain defects on T1 or T2 images.
* Any history or clinical signs of other severe psychiatric illnesses (like major depression,psychosis or obsessive compulsive disorder).
* Implanted pacemaker,medication pump,vagal stimulator,deep brain stimulator. History of substance abuse within the last 6 months.
The CorCinch - Functional Mitral Valve Regurgitation (FMR) Study

This is a multi-center, non-randomized, prospective Early Feasibility Study to evaluate the AccuCinch® Ventricular Restoration System in patients with symptomatic heart failure and concomitant functional mitral regurgitation that have stable symptoms on guideline-directed medical therapy

Device name changed from AccuCinch® Ventricular Repair System to AccuCinch® Ventricular Restoration System, FDA Approval Date 08Aug2020

Eligibility Criteria:
Inclusion Criteria:

* Study patient is at least 18-years old
* Severity of FMR: ≥ Moderate (i.e., 2+, according to Stone et al Clinical Trial Design Principles and Endpoint Definitions for Transcatheter Mitral Valve Repair and Replacement: Part 1: Clinical Trial Design Principles. A Consensus Document from the Mitral Valve Academic Research Consortium11; and 2003 ASE Guidelines for grading mitral regurgitation10)
* Ejection Fraction: ≥20 to ≤60%
* Symptom Status: NYHA II-IV (i.e., ambulatory)
* Treatment and compliance with optimal guideline directed medical therapy for heart failure for at least 1 month
* Surgical risk: Subject is eligible for cardiac surgery (specific risk score or comorbidities should demonstrate high risk features, as determined by the Heart Team)
* Completion of all qualifying diagnostic and functional tests and agrees to comply with study follow-up schedule

Exclusion Criteria:

* Patients with significant organic mitral valve pathology (e.g. myxomatous degeneration, mitral valve prolapse or flail leaflets)
* Myocardial infarction or any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery within 30 days
* Prior surgical, transcatheter, or percutaneous mitral valve intervention
* Untreated clinically significant coronary artery disease (CAD) requiring revascularization
* Hemodynamic instability: Hypotension (systolic pressure \<90 mmHg) or requirement for inotropic support or mechanical hemodynamic support
* Any planned cardiac surgery or interventions within the next 6 months (including right heart procedures)
* NYHA class IV (i.e., non-ambulatory) or American College of Cardiology (ACC)/American Heart Association (AHA) Stage D heart failure
* Fixed pulmonary artery systolic pressure \>70 mmHg
* Severe tricuspid regurgitation (per ASE guidelines and graded by the Echo Core Lab)
* Modified Rankin Scale ≥ 4 disability
* Hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, or any other structural heart disease causing heart failure other than dilated cardiomyopathy of either ischemic or non-ischemic etiology.
* Anatomical pathology/constraints preventing appropriate access/implant of the AccuCinch® Ventricular Restoration System (e.g., femoral arteries will not support a 20F system)
* Renal insufficiency (i.e., eGFR of \<30ml/min/1.73m2; Stage 4 or 5 CKD)
* Moderate or severe aortic valve stenosis or regurgitation or aortic valve prosthesis
* Fluoroscopic or echocardiographic evidence of severe aortic arch calcification, mobile aortic atheroma, intracardiac mass, thrombus or vegetation
* Active bacterial endocarditis
Sirolimus With Tacrolimus for Graft-vs-Host Disease Prophylaxis After Related Stem Cell Transplantation

The purpose of this study is to evaluate the ability of sirolimus to prevent graft versus host disease (GVHD) in patients following stem cell transplant from a related donor.

* Therapy to prevent GVHD will consist of an infusion of tacrolimus intravenously and sirolimus orally once per day starting 3 days before stem cell infusion. This will take place in the hospital where the patient will remain for the duration of the transplant.
* Sirolimus will continue for 9 weeks at at stable dose, then will be tapered by 1/3 on week 9 and 1/3 on week 17. It will be stopped on week 26 if there is no significant evidence of GVHD. These dose modifications will occur at home and patients will be seen weekly for the first 2 months after discharge.
* If GVHD is present, the tapering schedule wil be slower and based upon the patient's clinical condition.
* Tacrolimus will be given orally once the patient is discharged from the hospital and will be tapered at the same schedule as sirolimus. Blood levels of both tacrolimus and sirolimus will be monitored and the dose adjusted accordingly.
* During the year following stem cell transplant, blood work will be performed to evaluate the immune system and GVHD.

Eligibility Criteria:
Inclusion Criteria:

* Patients with hematologic malignancies who will undergo allogeneic HSCT from matched family-members.
* Age greater than 18
* ECOG performance status 0-2
* Total bilirubin \< 2.0 mg/dl
* AST \< 90 IU
* Serum creatinine \< 2.0 mg/dl

Exclusion Criteria:

* Active, uncontrolled infection
* Ejection fraction \< 45% by echocardiogram or MUGA scan
* Forced vital capacity \< 60%
* Uncontrolled hypertension
* Second transplantation
* Evidence of HIV infection
* Cholesterol \> 300 mg/dl
* Relapsed aggressive Burkitt's or Burkitt's-like lymphoma