cyrilzakka/clinical-trials huggingface dataset:
Thoracic Re-irradiation For Locoregionally Recurrent Non-small Cell Lung Cancer

This prospective phase II study is to assess the efficacy and safety of thoracic re-irradiation for locoregionally recurrent non-small cell lung cancer using hypofractionated technique.

This prospective phase II study is to assess the efficacy and safety of thoracic re-irradiation for locoregionally recurrent non-small cell lung cancer using hypofractionated technique.

1. For peripherally located recurrent tumors, stereotactic body radiation therapy is used at 5000-6000 cGy in 10 fractions.
2. For centrally located recurrent tumors, adaptive hypofractionated radiation is used: Patients are irradiated at 3000-4000cGy in 6-10 daily fractions in the first course. After a four-week interval, patients who have non-progressive disease and an adequate pulmonary function undergo adaptive re-planning, and are irradiated at 2400-3500cGy in 4\~7 daily fractions as a boost. Concurrent chemotherapy consists of weekly docetaxel and nedaplatin.

Eligibility Criteria:
Inclusion Criteria:

* loco-regionally recurrent NSCLC after thoracic radiotherapy (confirmed by pathology or continuous enhanced CT imaging);
* chemotherapy, targeted or immunotherapy are allowed before enrollment;
* \>=6 months from previous chest radiotherapy;
* presence of measurable disease according to RECIST criteria;
* ECOG performance score is 0-1;
* organ and bone marrow functions meet the following criteria:

  * forced expiratory volume in 1 second (FEV1) ≥ 0.8L;
  * percentage-predicted single-breath carbon monoxide diffusing capacity (DLCO %) \> 60%;
  * absolute neutrophil count ≥1.5×10\^9/L;
  * platelet ≥80×10\^9/L;
  * hemoglobin ≥9.0g/dL;
  * serum creatinine clearance was ≥50 mL/min calculated based on the Cockcroft-Gault formula
  * serum bilirubin ≤1.5 times normal upper limit (ULN)
  * AST and ALT≤2.5 times ULN

Exclusion Criteria:

* previous or concurrent with other malignant tumors, except for non-melanoma of the skin or carcinoma in situ of the cervix;
* loco-regional recurrence with distant metastasis;
* any other disease or condition contradicted to radiotherapy (e.g., active infection, within 6 months after myocardial infarction, symptomatic heart disease, including unstable angina, congestive heart failure or uncontrolled arrhythmia, immunosuppressive therapy);
* women who are pregnant or breastfeeding, women who have not undergone a pregnancy test (within 14 days before first administration), and women who are pregnant;
* pregnancy, lactation, or fertility but no contraceptive measures;
* those with bleeding tendency;
* participate in other clinical trials within 30 days before enrollment;
* drug and other drug addiction, chronic alcoholism and AIDS patients;
* having uncontrollable seizures or loss of self-control due to psychosis;
* a history of severe allergies;
* participants considered unfit to participate in this study.
Effects of Bevespi on Ventilation and Gas Exchange Abnormalities in COPD Assessed by 129Xe MRI

The purpose of this study is to determine whether the new inhaler, Bevespi improves lung function. Magnetic resonance imaging (MRI) using inhaled hyperpolarized 129Xe gas, that can provide useful images of the functioning of the lung will be used as a new measure to determine change in function. The investigator anticipate these images will provide more specific information about lung disease than standard lung function tests in response to treatment.

The study will characterize ventilation and gas transfer distributions in GOLD II and III COPD patients and assess the potential for these physiological parameters as a novel phenotyping method using Magnetic resonance imaging (MRI) using inhaled hyperpolarized 129Xe gas.

The study will additionally quantify regional ventilation and gas transfer response to glycopyrrolate/formoterol in GOLD II and III COPD patients.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of COPD confirmed by post-bronchodilator spirometry demonstrating (forced expiratory volume at 1 second(FEV1)/forced vital capacity (FVC) \< 0.70 and forced expiratory volume at 1 second (FEV1) in GOLD 2 or 3 stage (30%≤ (forced expiratory volume at 1 second \[FEV1\] \< 80%)
* Willing and able to give informed consent and adhere to visit/protocol schedules
* Women of childbearing potential must have a negative urine pregnancy test

Exclusion Criteria:

* Upper respiratory tract infection within 6 weeks
* Chronic systemic corticosteroid use \> 10 mg/day of prednisone

  * Chronic oxygen use (intermittent or continuous)
  * Previous lung resection surgery or decortication
  * Previous history of pneumothorax
  * Evidence of interstitial, occupational or chronic infectious lung disease by imaging studies
  * History of exposure to occupational or environmental hazards that are known to cause lung diseases
  * For women of child bearing potential, positive pregnancy test
  * Major chronic illnesses which in the judgement of the study physician would interfere with participation in the study
  * Patients who are not willing to withhold COPD inhalers for the run-in period.

    * MRI is contraindicated based on responses to MRI screening questionnaire
    * Subject is pregnant or lactating
    * Respiratory illness of a bacterial or viral etiology within 30 days of MRI
    * Subject has any form of known cardiac arrhythmia
    * Subject does not fit into 129Xe vest coil used for MRI
    * Subject cannot hold his/her breath for 15 seconds
    * Subject deemed unlikely to be able to comply with instructions during imaging
Phase I/II Trial rHuKFG for the Treatment of Steroid Refractory Gastrointestinal Acute GVHD

Phase II efficacy evaluation, phase I/II efficacy and toxicity trial of recombinant human keratinocyte growth factor for the treatment of steroid refractory gastrointestinal graft versus host disease.

There are two processes that cause diarrhea as the clinical manifestation of graft versus host disease. The first is the obvious immunologic attack on the colonic epithelium of the recipient. Once this immunologic attack has been abated the recipient is left with a colonic mucosa that is devoid of microvilli and has a smooth intestinal boarder. This is frequently subject to superinfections from bacteria all of which cause the diarrhea to continue. Researchers only endpoint to measure clinical response of immunosuppression is the resolution of diarrhea. The human recombinant keratinocyte growth factor stimulates the growth of colonic epithelium. The growth of colonic epithelium will in turn probably ameliorate some of the diarrhea associated with graft versus host disease.

Eligibility Criteria:
Inclusion criteria:

* Patients post allogeneic bone marrow transplant with watery diarrhea progressed on 2mg/kg of steroids after 3 days or failed to improve after 5 days.
* Patients may have skin or liver involvement with graft versus host disease.
* Patients should not have any infections etiology for diarrhea.

Exclusion criteria:

* None
Phase 3 Safety and Efficacy Study of I.V. Iclaprim v Linezolid in cSSSI (ASSIST-1)

This is a multi-center, investigator-blind, comparative Phase 3 study. Patients will receive either iclaprim or linezolid for 10 to 14 days. Patients will be evaluated daily for the first four days of study treatment and then every other day, for up to 14 days of the treatment period, at End of Therapy, the Test Of Cure visit (7 to 14 days post treatment), and a Late Follow-up (F/U) visit (7 to 14 days after the TOC visit).

Primary Objective:

The primary objective of this study is to compare the clinical cure rates of iclaprim and linezolid at the test of cure (TOC) visit (7 to 14 days after the end of treatment).

Secondary Objectives:

The secondary objectives of this study are to compare iclaprim with linezolid regarding:

* Clinical efficacy at the end of study medication treatment;
* Time to resolution of systemic and local signs and symptoms of complicated skin and skin structure infection (cSSSI);
* Clinical outcome in the microbiologically evaluable (ME) population;
* Bacteriologic outcome in the ME population;
* Bacteriologic eradication rates of Baseline (BL) pathogens;
* Clinical outcome in the modified intent-to-treat (MITT) population;
* Bacteriologic outcome in the MITT population;
* Baseline in vitro susceptibility of isolated pathogens in the ME population; and
* Safety and tolerability of iclaprim treatment.

Eligibility Criteria:
Inclusion Criteria -Diagnosis of an infection consistent with complicated skin and skin structure infection due to a gram positive pathogen.

Exclusion Criteria: - Known or suspected hypersensitivity to any study medication or other related anti-infective medication - Any known or suspected condition or concurrent treatment contraindicated by the prescribing information - Previous enrollment in this study - Treatment with any investigational drug within 30 days before enrollment
Study to Evaluate The Analgesic Efficacy and Safety of Intravenous Paracetamol in Subjects With Postoperative Pain After Total Hip Arthroplasty

The main purpose is to evaluate the analgesic efficacy of 1g of intravenous (Iv) paracetamol versus i.v. placebo, administered every 6h, as measured by the reduction of the 24-hour cumulative dose of the opioid tramadol in the treatment of postoperative pain following total hip arthroplasty.


Eligibility Criteria:
Inclusion Criteria:

* Spinal anesth
* BMI 10-35
* No pain conditions/concom med may alter pain quantif.

Exclusion Criteria:

* Other add. surgery
* Liver/Renal function altered
* coagulation alterations
* Respir / Cardiac insufficiency
* Agents affecting microsomal syst
Utilizing Helpline for Opioid Dependence Treatment

The investigator propose to develop an opioid telephone helpline, where trained counselors and educators provide referral, educational and targeted interventions and support to individuals interested in addressing their addiction or needing help with managing their pain. The proposed application builds on "tobacco quit line" efforts, a nationally-adopted telephone-based service, providing education materials, access to cessation medication and counseling against tobacco use. Similar to tobacco quit line; the proposed telephone based services will remove barriers to treatment as they help individuals at the exact time of need. The helpline will also educate individuals with new onset pain about pain expectations, relaxation techniques, use of pharmacology and psychotherapy for treatment in addition to providing support for coping and reducing dependency on prescription opioids. It will be a low cost, easily accessible and utilizable technology to augment the clinical outcome of medication assisted treatment of opioid use disorder and pain management.

The proposed specific aims are to:

1. Test if the helpline is a resourceful tool for patients with opioid use disorder looking for referrals and support to access treatment. The opioid helpline will provide individuals with opioid use disorder seeking treatment, direct access to a live person who can answer questions regarding referrals and various treatment programs. The helpline will also follow-up on treatment compliance and offer support and motivational techniques for these individuals to stay engaged in treatment
2. Test if the helpline is a resourceful tool for patients with new onset of pain or chronic pain being prescribed opioids. The opioid helpline will provide these individuals the necessary educational materials on managing pain safely while avoiding misuse. It will offer free imagery guided meditation and other non-pharmacological tools to help with pain management.
3. Test if providers find the opioid helpline helpful and resourceful for their practice and are willing to refer patients to the helpline.

Eligibility Criteria:
Inclusion Criteria:

Participant Criteria:

1. Age greater than or equal to 18 years.
2. A formal diagnosis of Opioid Use Disorder (OUD) by a health care provider or
3. If no formal diagnosis of OUD, having a self-reported concern with opioid use or addiction.
4. An individual seeking to reduce opioid use.
5. An individual concerned about opioids prescribed for management of new-onset pain or chronic pain.

Provider Criteria:

1. University of Virginia: Providers of any specialties within VA including dentists that prescribes opioids.
2. County of Wise: Providers of any specialties including dentists that prescribes opioids.

Exclusion Criteria:

Participant Criteria:

1. Individuals under 18 years of age.
2. Individuals seeking treatment for non-opioid substance use disorders
3. Individuals who have no pain issues
4. Individuals located outside of Virginia.

Provider Criteria:

Providers outside the designated regions.
Phase 1 Naltrexone-Bupropion-Methamphetamine Interaction Study

The study is to primarily measure safety and interactions between oral doses of Naltrexone/Bupropion and i.v. Methamphetamine.


Eligibility Criteria:
Inclusion Criteria:

* Are MA experienced but not dependent, males or females aged 21-to-50 years.
* Reported use of MA during the past six months without experiencing an adverse consequence plus a life time MA or amphetamine use history of at least four occasions of use.
* Have a body mass index (BMI) between 18 and 30.
* Are willing and able to give written consent.
* Are not currently a subject (including still in the follow-up period) of another drug research study.
* Have no medical contraindications determined by the following: an adequate medical history, a physical examination including vital signs, 12-lead ECG, hematology, blood chemistry, and urinalysis.
* Have a negative drug test for barbiturates, benzodiazepines, opiates, cocaine, amphetamines and ethanol at the time of hospital admission (Day 0).
* Are females who have a negative pregnancy test at hospital admission.
* Are of either non-childbearing (tubal ligation or total hysterectomy) or of childbearing potential using one or more of the following barrier methods of contraception: male or female condoms (with/without spermicide), diaphragm (with spermicide) and/or copper containing intrauterine device (with/without spermicide). No other contraceptives are acceptable.

Exclusion Criteria:

* Please contact site for more information
Reliability and Validity of the Kinesthetic and Visual Imagery Questionnaire in Acute Stroke Patients

This study was planned to investigate the validity and reliability of the Kinesthetic and Visual Imagery Questionnaire in patients with acute stroke.

The objectives of the research are:

1. To evaluate the validity of the Kinesthetic and Visual Imaginery Questionnaire in acute stroke patients aged 50-75 years
2. To evaluate the test-retest reliability of the Kinesthetic and Visual Imaginery Questionnaire in acute stroke patients aged 50-75 years

Motor imagery (MI) is the mental representation of movement without any real body movement. MI is a complex and cognitive process involving the use of sensory and perceptual memories related to motor movements.Various studies using brain imaging techniques have found that during motor imagery, brain areas similar to voluntary movement are activated or the motor cortex can be stimulated. These findings suggest that stroke patients who cannot physically move their limbs can stimulate brain regions responsible for motor movements using motor imagery. The Kinesthetic and Visual Imaginery Questionnaire (KVIQ) is a motor imagery questionnaire developed for people who need to be guided for different reasons and cannot perform complex movements. Evaluate both visual and kinesthetic dimensions of motor images. This study was planned because of the need for evaluation of motor imagery for stroke patients, who mostly have motor and sensory problems.

Eligibility Criteria:
Inclusion Criteria:

* First stroke and ischemic stroke
* Being in the 50-75 age range
* At least 24 hours after stroke
* Absence of apraxia and aphasia
* Get at least 15 points on the Glasgow Coma Scale
* Score of 24 or more from Mini Mental Test
* Stable vital signs and no improvement in symptoms for 48 hours
* No signs of depression (score 15 or less from the Beck Depression Scale)
* Sitting without support for 1 minute
* Not participating in another concurrent study
* Agree to participate in the study

Exclusion Criteria:

* Other known neurological diseases
* Neglect of the body half
* Presence of cerebellum or mesencephalon lesion
* Drug use affecting cognition
* Patients with epilepsy, seizure attacks
* Those with severe heart and lung disease that may interfere with the study
* Patients with visual or auditory disabilities that might interfere with the study
Pain Relief During Repair of Postpartum Perineal Tears

The aim of our study is to compare the analgesic effect of topical application of lidocaine-prilocaine cream and lidocaine infiltration during repair of postpartum perineal tears.


Eligibility Criteria:
Inclusion Criteria:

1. Gestational age \> 37 weeks
2. Uncomplicated pregnancy
3. Single vertex fetus
4. Normal vaginal delivery
5. Women who will accept to participate in the study

Exclusion Criteria:

1. Women received epidural analgesia
2. Women required episiotomy
3. Women with intact perineum
4. Operative vaginal delivery
5. Allergy to the used drugs
Kinematic Parameters to Predict Knee Diseases.

There is no study to explore the prediction of knee diseases using kinematic parameters of knee during gait. The aim of this study is to explore the possibility of predicting knee diseases by gait parameters.


Eligibility Criteria:
Inclusion Criteria:

1. age\> 18 years
2. body mass index\<30;
3. confirmed radiographically or by surgery to have knee injuries/arthritis;
4. knee pain in their knees at least one months;
5. able to walk unaided

Exclusion Criteria:

1. history of other lower limbs' surgery/injuries/arthritis (hip or ankle);
2. Corticosteroid or Sodium Hyaluronate injection within 6 months;
3. neuropathic arthropathy or rheumatoid arthritis;
4. any other muscular or neurological diseases that affected the condition of the lower limbs;
5. unable to walk independently;
6. history of heart disease;
7. body mass index\> 30;
8. age\> 90 years;
9. unable to finish the procedure
Efficacy of Angiographic Embolization vs Non-embolization of Moderate/Poor Vascularized Vertebral Metastases on Intraoperative Bleeding During Surgery Decompression and Vertebral Stabilization.

Although angiographic embolization has been introduced for preoperative management of spine metastases in 1975 and is suggested today by many authors in the management of such pathologies, it needs to be confirmed by RCT. It is a minimally invasive procedure, not free from complications. The recent meta-analyzes, due to the limited number of patients included are not exhaustive about the effectiveness of embolization in the reduction of the intraoperative bleeding, especially in the context of poor / moderate metastasis vascularization. We want to evaluate the efficacy of preoperative angiographic embolization of intermediate / poor vascularized spine metastases in reducing intraoperative blood loss during excision surgery.


Eligibility Criteria:
Inclusion Criteria:

* Male, Female aged 18 years and 75 years
* prognosis \>6 months (Tokuhashi score ≤ 11)
* patients with lesions with moderate vascularization (grade 2)
* time between embolization and intervention \>/= 48-72 h

Exclusion Criteria:

* congenital and iatrogenic hemocoagulative disorders (PT INR\> 1.5, aPTT ratio\> 1.25 with documented coagulation factor deficiency, PLT \< 80,000 / microL or known coagulation pathologies);
* renal failure (creatinine ≥ 1.2);
* MDC iodized allergy;
* pregnancy / lactation;
* chronic ischemic heart disease;
* precluded arterial access by angiography;
* indication to emergency surgery;
* time between embolization and surgery\> 72 h;
* refusal by the patient.
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MRG-110 Following Intradermal Injection in Healthy Volunteers

MRG-110 is intended to promote the growth of new blood vessels by inhibiting a molecule called miR-92a. MRG-110 is being studied to determine if it can accelerate healing of wounds by improving blood flow into the wound area. The primary objective of this study is to investigate the safety and tolerability of MRG-110 when injected into the skin at the site of a small skin wound in normal healthy volunteers. Another objective is to study the pharmacokinetics of MRG-110 (the movement of a drug into, through and out of the body). Participants in the clinical trial will receive either a single dose or multiple doses of MRG-110 and/or placebo. Blood samples, urine samples and skin biopsies will be collected to measure how MRG-110 is processed by the body, and how the body responds when exposed to MRG-110.


Eligibility Criteria:
Key Inclusion Criteria:

* Normal healthy volunteers.
* Females must be of non-childbearing potential.
* If engaged in sexual relations with a female of child-bearing potential, males must be surgically sterile or must be willing to use a highly effective method of contraception throughout their study participation and for at least 6 months after the last dose of study drug.
* Must have 2 regions on lower back/upper buttocks that are free of striae, scars, tattoos, or other skin pathologies.
* Must have no conditions that could increase risk of abnormal or delayed healing.

Key Exclusion Criteria:

* Clinically significant abnormalities in medical history or physical examination.
* Clinically significant abnormalities in laboratory tests at screening.
* History of cutaneous disorder.
* Hemangioma, history of hemangioblastoma, or other known vascular disorder.
* Positive for bloodborne pathogen (hepatitis B, hepatitis C, HIV).
* Use of an investigational drug or device within 28 days prior to Day 1, or use of an investigational biological or oligonucleotide drug within 90 days of Day 1.
Open-label Extension Study to Evaluate the Safety and Tolerability of WVE-120102 in Patients With Huntington's Disease

WVE-HDSNP2-002 is an open-label extension (OLE) study to evaluate the safety, tolerability, PK, PD, and clinical effects of WVE-120102 in adult patients with early manifest HD who carry a targeted single nucleotide polymorphism, rs362331 (SNP2). To participate in the study, patients must have completed the Phase 1b/2a clinical study WVE-HDSNP2-001.


Eligibility Criteria:
Inclusion Criteria:

1. Patient successfully completed the Phase 1b/2a study with WVE-120102, WVE-HDSNP2-001.

Exclusion Criteria:

1. Received an investigational drug other than WVE-120102, including an investigational oligonucleotide, within the past 1 year or 5 half-lives of the drug, whichever is longer.
2. Inability to undergo brain MRI (with or without sedation).
3. Clinically significant medical finding on the physical examination other than HD that, in the judgment of the Investigator, will make the patient unsuitable for participation in and/or completion of the study procedures.