cyrilzakka/clinical-trials huggingface dataset:
The Course of Hip Flexion Weakness Following LLIF or ALIF

The purpose of this study is to assess the course of hip weakness after LLIF or ALIF procedures. These outcomes include measures of hip strength using a dynamometer, which is a device used to measure muscle strength. While it is known that people experience temporary hip and leg weakness after an LLIF or ALIF, the exact timing of when hip and leg strength is regained after an LLIF or ALIF is not known.


Eligibility Criteria:
Inclusion Criteria:

* 1-, 2-, or 3-level L2L3, L3L4, or L4L5 LLIF or ALIF for degenerative pathology including radiculopathy, neurogenic claudication, intervertebral disc disease, facet joint disease, degenerative spondylolisthesis, degenerative myelopathy degenerative kyphosis, and scoliosis
* Back and/or leg pain
* Failed at least 6 months of conservative treatment

Exclusion Criteria:

* Older than 65 years of age
* Prior spinal fusion surgery
* Greater than Grade 2 spondylolisthesis
* Greater than 10° scoliosis
* History of spinal infection
A Community Pharmacist-led Intervention to Improve Adherence to Lipid-lowering Treatment

The objective of the study is to test the effectiveness of a community pharmacist-led intervention to increase adherence to lipid lowering treatment.

Medication non-adherence represents an important threat to the health of the Western people. A large number of pharmacy records based studies demonstrated that adherence to lipid lowering treatment in daily practice is substantially worse compared to adherence observed in the controlled setting of randomized controlled trials. In addition, the relationship between non-adherence with statin-treatment assessed with pharmacy records and cardiovascular outcomes has been convincingly demonstrated. This implies that pharmacy records can and should be used to identify non-adherent patients and thus patients at risk for major cardiovascular events. Using this data, community pharmacists can play a more substantive role in developing the concept of pharmaceutical care. The objective of the study is to test the effectiveness of a community pharmacist-led intervention to increase adherence to lipid lowering treatment.

Eligibility Criteria:
Inclusion Criteria:

* Suboptimal adherent to statin treatment
* Older than 65 years
* Responsible for own medication intake

Exclusion Criteria:

* Life expectancy shorter than 6 months
* Institutionalized
* User of medication blisters
Ph2a Study to Evaluate IW-3718 in Patients With Gastroesophageal Reflux Not Completely Responsive to Proton Pump Inhibitors

This study is meant to assess the effect of IW-3718 as an added treatment to ongoing once-daily protocol pump inhibitor (PPI) treatment for patients who continue to experience symptoms of their gastroesophageal reflux disease (GERD).


Eligibility Criteria:
Inclusion Criteria:

* Patient is between 18 and 65 years of age at the Screening Visit; females must not be pregnant or must not be breastfeeding;
* Patient has a confirmed diagnosis of gastroesophageal reflux disease, must be currently taking a proton pump inhibitor (PPI), and must be experiencing GERD symptoms as specified by the protocol.

Exclusion Criteria:

* Patient may not meet any of the excluded conditions specified in the protocol;
* Patient is experiencing alarm symptoms such as GI bleeding, anemia, vomiting, dysphagia, or unexpected weight loss;
* Patient has a clinically significant hypersensitivity or allergies to any of the active ingredients or excipients in the study medication.
Healthy Eating ASD

Most studies which have addressed food selectivity among children with autism spectrum disorders have been conducted in either clinic or home settings. School-based research has been conducted to increase healthy eating, but this research was largely conducted with children without special needs or if children with special needs did participate, they were not identified.

This study will focus on increasing consumption of fruits and vegetables among children with an Autism Spectrum Disorder in a school setting.

Food Preference Inventory: A survey of food preference and eating habits, developed by the experimenter, will be provided to the parents/guardians of prospective participants. The Food Preference Inventory is anticipated to take between 10 and 20 mins to complete. The parent/guardian of the prospective participant is asked to return toe inventory to the school if 1) the parent/guardian gives permission for his/her child to participate and 2) if the child does not have a food allergy.

General Procedures: Each day of the study (1-5 days per week), school staff will offer participants a small portion of a fruit or vegetable (about 1/8 cup) to eat during lunch time. The participant will have about 5 min to consume the item before it is recollected by school staff.

Baseline: The fruit or vegetable is presented with the participants lunch. Eating the item produces no programmed consequences.

Single Item Presentation: The fruit or vegetable is presented before the participants lunch (about 5 min). Eating the item produces no programmed consequences.

Single Item Presentation + Modeling: The fruit or vegetable is presented before the participants lunch (about 5 min). School staff will model eating the food item.

Single Item Presentation + Token Economy: The fruit or vegetable is presented before the participants lunch (about 5 min). Eating the item will produce a token (e.g., a sticker or hole punch). Once the student collects a few tokens (e.g., 3-5), he/she can exchange the tokens for a small price (e.g., pencil or crayon).

Data Collection: Data will be collected by school staff. Staff will record whether each participant consume the fruit or vegetable item.

Safety Procedures: School staff will monitor lunch - as they typically do.

Eligibility Criteria:
Inclusion Criteria:

* Participants will be students in a private school with a diagnosis of an autism spectrum disorder and between 6-14 years of age.

Exclusion Criteria:

* Parents who report their children have food allergies of any kind will be excluded.
Propylene Glycol-Free Melphalan Hydrochloride (Evomela) in AL Amyloidosis Patients

This is a single arm, open label study designed to evaluate the safety and efficacy of propylene glycol-free melphalan hydrochloride in patients with AL amyloidosis. Treatment will be comprised of propylene glycol-free melphalan hydrochloride administered intravenously at a dose of 70-100 mg/m2/day on Days -3 and -2 as conditioning prior to autologous stem cell transplantation.

After giving written informed consent, subjects will be evaluated for eligibility for enrollment in the study. Baseline evaluations will be performed as outlined in Section 7. Subjects who satisfy all inclusion and exclusion criteria will begin the study drug. Subjects will be monitored from the time of the medication administration until discharge from the transplant program for safety. Organ function and hematologic status will also be measured at 6 and 12 month follow-up visits.

Standard response criteria for AL amyloidosis hematologic and organ response will be used. Overall response rate will be measured and participants will be categorized into complete response, very good partial response, partial response and progressive disease. Progression free survival, organ response, and safety and tolerability of propylene glycol-free melphalan hydrochloride will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Eastern Cooperative Oncology Group Performance Status 0-2
* Histologic diagnosis of primary systemic (AL) amyloidosis based on:

  * Deposition of amyloid material by Congo red stain showing characteristic apple green birefringence AND
  * Evidence of a clonal plasma cell dyscrasia with monoclonal protein in the serum or urine by immunofixation electrophoresis AND/OR abnormal serum free light chain assay AND/OR clonal plasma cells in the bone marrow exam demonstrated by immunohistochemistry, flow cytometry, or in situ hybridization AND
  * Evidence of organ involvement
* Eligible for treatment with high dose melphalan and stem cell transplantation per institutional guidelines
* Ability to understand and willingness to sign informed consent
* Pulmonary Function Test demonstrating a diffusion capacity of lung for carbon monoxide ≥ 50%
* Left ventricular ejection fraction ≥40%
* Systolic blood pressure \>90 mm Hg (supine position)
* Eastern Cooperative Oncology Group Performance status of 2 or better (unless patient is diagnosed with AL amyloidosis involving the gastrointestinal and peripheral/autonomic nervous systems, then performance status of 3 is acceptable)

Exclusion Criteria:

* Previous high-dose melphalan and stem cell transplant
* Previous total cumulative dose of oral melphalan \> 300 mg
* Cytotoxic chemotherapy within the previous 28 days
* New York Heart Association ≥3
* Decompensated or uncontrolled heart failure
* Oxygen dependence
* epidermal growth factor receptor \< 30 ml/min
* Active infection (i.e HIV, Hepatitis B or C)
* Pregnancy or breastfeeding
* Exposure to another investigational drug within 3-4 weeks prior to start of study treatment
* Ongoing alcohol or drug addiction
* Unable or unwilling to comply with the protocol
A Study of NE3107 in Early Parkinson's

The goal of this clinical trial is to learn if bezisterim can treat movement symptoms of Parkinson's disease in patients that are 45 to 80 years old, in generally good physical and mental health, and are nearing the need for treatment to relieve their symptoms but have not yet been prescribed any form of levodopa or drug with similar activity. The main questions it aims to answer are:

* Will bezisterim decrease movement symptoms of Parkinson's disease?
* What medical problems do participants have when taking bezisterim?

Researchers will compare the effects of bezisterim treatment to placebo (a look-alike substance that contains no drug) to see if bezisterim works to treat movement symptoms of Parkinson's disease.

Participants will

* have a physical examination that includes an electrocardiogram
* take drug or placebo twice daily for four months
* visit a clinical site or receive an at home visit seven times over the course of five months


Eligibility Criteria:
Inclusion Criteria:

* 45 years to 80 years of age
* diagnosed with idiopathic Parkinson's Disease (PD) within 18 months
* nearing the need for symptomatic therapy
* agree to use birth control measures
* provide voluntary consent
* willing to allow blood collection for DNA methylation analysis
* pass all screening tests and procedures

Exclusion Criteria:

* has taken levodopa or another similar drug for the motor symptoms of PD
* a known or strongly suspected familial cause for PD diagnosis
* major mental health or physical illness
* medical history of major mental or physical illness
Study on the Prevention of Dermal Toxicity Caused by Regorafenib by Traditional Chinese Medicine TDX105

this is an preventive study to evaluate the preventive effect of traditional chinese medicine TDX105 on Regorafenib induced Dermatologic Toxicities

this is an double blinded controlled preventive study to evaluate the preventive effect of this is an preventive traditional chinese medicine TDX105 plus Urea Ointment compared with placebo plus Urea Ointment on Regorafenib induced Dermatologic Toxicities

Eligibility Criteria:
Inclusion Criteria:

1. Clinically confirmed colorectal cancer patients;
2. It is planned to use the targeted drug regorafenib for the first time, and the initial dose is 120mg/d;
3. Performance Status score ≤3;
4. Age ≥18; 5, no intellectual and mental disorders, normal language expression ability, ability to judge their own symptoms

6. Understand and agree to accept the treatment, and sign the informed consent.

Exclusion Criteria:

1. Patients with skin reactions affected by simultaneous use of other targeted drugs (sorafenib, sunitinib, fruquintinib, etc.), chemotherapy drugs (capecitabine, doxorubicin, etc.) or hand-foot radiotherapy;
2. Patients with skin diseases such as eczema, psoriasis and tinea pedis at observed skin sites (namely hands and feet); Patients with skin allergic diseases;
3. Patients in the study who cannot cooperate with the continuation of this treatment;
4. Sudden changes in the patient's condition affected and interfered with the researcher
Polyhexamethylene Biguanide Increases the Regression Rate of Human Papillomavirus (HPV) Infection

Human papillomavirus (HPV) infection is a worldwide problem strictly linked to the development of cervical cancer. Persistence of the infection is one of the main factors responsible for the invasive progression and women diagnosed with intraepithelial squamous lesions are referred for further assessment and surgical treatments which are prone to complications. Despite this, there are several reports on the spontaneous regression of the infection.

In this study the investigators will evaluate the effectiveness of a long term polyhexamethylene biguanide (PHMB)-based local treatment in improve the viral clearance reducing the time exposure to the infection and avoiding the complications associated with the invasive treatments currently available.

Women diagnosed with HPV infection were randomly assigned to receive six months of treatment with a PHMB-based gynaecological solution (Monogin®) or to remain untreated for the same period of time.

The administration of Monogin® has been performed every three days for fifteen days and then every fifteen days for the subsequent six months.


Eligibility Criteria:
Inclusion Criteria:

* pathologic Pap smear
* positive "high risk" HPV DNA test
* positive colposcopy examination

Exclusion Criteria:

* patients who had undergone wart therapy in the previous six months
* pregnancy
* invasive disease
* immunosuppression
* previous HPV vaccination
Clinical Study of Double-Endoscopic Combined With Minimally Invasive Treatment for Early Gastric Cancer at Clinical Stage T1b

For patients diagnosed with early gastric cancer involving submucosal invasion, super-ESD indications, or lymph node metastasis, a combination of preoperative endoscopic ultrasound and abdominal contrast-enhanced CT was utilized to ascertain the depth of tumor invasion and to identify any suspicious metastatic lymph nodes in the vicinity of the stomach. Subsequently, a local full-thickness resection, coupled with or followed by individualized precise lymph node dissection, was conducted to fulfill the following objectives: ① To investigate the safety, feasibility, and efficacy of local resection for patients meeting super-ESD criteria; ② To offer a clinical foundation for the individualized and precise lymph node dissection treatment of early gastric cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18-70 years old;
2. Endoscopic pathological diagnosis: adenocarcinoma;
3. Enhanced abdominal CT combined with endoscopic ultrasound clinical staging: T1bN0-1M0.
4. Has not received other treatment;
5. No other serious comorbidities;
6. Agree to participate in the study and sign the informed consent form.

Exclusion Criteria:

1. Pregnant or breastfeeding women
2. History of previous abdominal surgery
3. History of other previous malignancies
4. Can patients with severe heart, lung, brain diseases tolerate surgical treatment
Prospective Trial for Examining Hematuria Using Computed Tomography

The primary objective is to evaluate whether one-phase nephrographic CT (experimental) is sufficient to detect urothelial cell carcinoma in patients with hematuria compared to the traditional four-phase CT (control).

Responsible centers Oslo University Hospital, Aker. Division of Radiology and Nuclear medicine.

Study type: Prospective clinical trial

Study design: One sample paired proportion, non-inferiority study with a 7.5% non-inferiority limit.

Investigational product: One phase nephrographic CT (experimental arm) vs. Four-phase CT (control arm)

Objective:The primary objective is to evaluate whether one-phase nephrographic CT (experimental) is sufficient to detect urothelial cell carcinoma in patients with asymptomatic macroscopic hematuria compared to the traditional four-phase CT (control).

Primary endpoints: The difference in accuracy between the experimental- and control arm.

there will also be a secondary reading in order to asses interobserver variability for both the experimental and the control arm

Sample size: 250 patients

Eligibility Criteria:
Inclusion Criteria:

* Asymptomatic macroscopic hematuria referred to CTU before cystoscopy
* \>18 years old

Exclusion Criteria:

* Symptomatic urinary tract infection relieved by antibiotics
* Patients referred to CTU after cystoscopy
* Cystoscopy within the last 6 months
* Symptomatic stone disease
* Macroscopic hematuria after recent catherization or instrumentation
* Microscopic hematuria
* Previous history of Urothelial cell carcinoma
* Known staghorn calculi
* Allergy to iodine contrast media
* Impaired renal function (eGFR \< 30m/min/1.73m2)
* Unable to provide consent for any reason
* For any reason, do not wish to participate in the study
A New Anthrax Vaccine Administered by the Intramuscular (IM) Route in Healthy Adults

This study will provide preliminary safety and comparative immunogenicity data for the E.coli derived rPA vaccine administered by intramuscular (IM) injection at Day 0 and Month 1.Doses will range from 5 μg to 100 μg rPA, and at each dose-level, rPA will either be combined with phosphate-buffered saline (PBS) or adsorbed to Alhydrogel.

This is a safety study with an open-label part (2 groups), followed by a dose-ranging part evaluating safety and immunogenicity using a double-blind, sequential-group design with randomization and placebo-control within each of the 6 groups. Volunteers in each dose group will receive two IM injections at Day 0 and Month 1

Eligibility Criteria:
Volunteers are eligible for this study if they meet all the following criteria:

* Citizens of the U.S.
* Age 18 to 40 years.
* For women, a negative serum pregnancy test will be required at study entry and within 24 hours prior to each vaccination, as well as verbal assurance that adequate birth control measures are applied prior to initial vaccination and for 3 months after the last vaccination.
* Good health as determined by medical history, physical examination, and clinical judgment.
* Normal Baseline Clinical Laboratory Values at screening including:

  * Complete Blood Count (CBC) including:
  * White Blood Cell Count: 3.8 -10.8
  * Red Blood Cell Count (Mill/MCL)
  * Male: 4.20 - 5.80
  * Female: 3.80 - 5.10
  * Hemoglobin (G/DL)
  * Male: 13.2 - 17.1
  * Female: 11.7 - 15.5
  * Hematocrit (%)
  * Male: 38.5- 50.0
  * Female: 35.0 - 45.0
  * Platelet Count: 140 - 440 (THOUS/MCL)
  * Differential
  * Urine dipstick for protein and blood: negative or trace. If either is ≥ 1+, obtain complete urinalysis (UA). If microscopic UA confirms evidence of hematuria or proteinuria ≥ 1+, the volunteer is ineligible.
  * Negative serology for HIV infection (ELISA test).
  * CPK within normal limits
  * Hepatic Function Tests including AST, ALT, ALK PHOS.
  * Total bilirubin, BUN, serum creatinine, serum electrolytes
* Availability for at least 13 months of follow-up from the time of the screening visit.
* Successful completion of the Test of Understanding defined as 90% correct with three opportunities to take test. Errors will be reviewed with volunteer after each test.
* Commitment for trial participation and signature of the approved consent form.
Computer-Assisted Counseling in Helping African American Smokers Stop Smoking

RATIONALE: Stop-smoking plans using a nicotine patch, in-person counseling, and computer-assisted counseling may help people stop smoking.

PURPOSE: This randomized clinical trial is studying how well computer-assisted counseling helps African American smokers stop smoking.

OBJECTIVES:

* Develop and evaluate the efficacy of an interactive, culturally sensitive, individualized, palmtop computer-delivered smoking cessation intervention for African American smokers.
* Examine how hypothesized treatment mechanisms mediate the effects of computer-delivered treatment on abstinence.

OUTLINE: This is a randomized study. A subset of 20 participants are assigned to arm II for pilot testing. All other participants are randomized to 1 of 2 intervention arms.

* Arm I (standard care \[SC\]): Participants receive nicotine patch therapy on days -5 to 31. Participants also receive a Pathways to Freedom self-help guide and undergo 5 in-person counseling sessions based on the Treating Tobacco Use and Dependence Clinical Practice Guideline. The counseling sessions occur at 12 and 5 days prior to the quit smoking date and at 3, 10, and 31 days after the quit smoking date.
* Arm II (computer-delivered treatment \[CDT\]): Participants receive the same intervention as in arm I. Participants also undergo CDT for 6 weeks comprising 5 modules (quitting strategies; motivation and support; general smoking information; calendars and fun stuff; and daily tips) beginning 12 days prior to the quit smoking date and continuing for 31 days after the quit smoking date.

All participants complete questionnaires at baseline, during the counseling sessions, and then at approximately 6 months after the quit smoking date.

After completion of study intervention, participants are followed at approximately 6 months.

PROJECTED ACCRUAL: A total of 500 participants will be accrued for this study.

Eligibility Criteria:
Inclusion Criteria:

1. African American
2. Age 21 to 65 years
3. Current Smoker (history of at least 5 cigarettes/day for the last year)
4. Motivated to quit within the next 14 days
5. Participants must provide a viable home address and functioning home telephone number
6. Can speak, read, write in English at a sixth-grade literacy level
7. Provide viable collateral contact information
8. Register "8" or more on a carbon monoxide breath test

Exclusion Criteria:

1. Contraindication for nicotine patch use
2. Active substance dependence (exclusive of nicotine dependence)
3. Regular use of tobacco products other than cigarettes (cigars, pipes, smokeless)
4. Use of bupropion or nicotine products other than nicotine patches supplied by the study
5. Pregnancy or lactation
6. Any active illness that precludes full participation in the study protocol
7. Another household member enrolled in the study
Detection of Intravascular Injection Between Blunt and Sharp Needles During Cervical Transforaminal Epidural Block.

This study evaluates the incidence of intravascular injection during cervical transforaminal epidural block using blunt needle, compared to the sharp needle. The investigators will performed cervical transforaminal epidural block using blunt-type block needle in half of participants or sharp-type block needle in the other half.

Cervical transforaminal epidural block is an effective treatment option of radiating pain. There are potential risks associated with transforaminal epidural block such as infection, dural puncture, bleeding, and intravascular injection. Although the risk is low, intravascular injection should be carefully monitored because intravascular injection of particulate steroids can cause fatal neurologic deficits such as spinal infarction and cerebral infarction.

The incidence of intravascular injection during transforaminal epidural block with real time fluoroscopy guidance depends on spinal level. The previous studies using real time fluoroscopy demonstrated that the incidence of intravascular injection of cervical transforaminal epidural block is higher than that of lumbosacral transforaminal epidural block.

In this study, therefore, the investigators investigate the incidence of intravascular injection during cervical transforaminal epidural block using blunt needle, compared to the sharp needle.

Eligibility Criteria:
Inclusion Criteria:

* Patients with radiating pain from cervical spinal stenosis and herniated nucleus pulposus.

Exclusion Criteria:

* Pregnancy, allergic to contrast media, patient refusal, and patients with persistent contraindication to nerve block such as coagulopathy and infection of the injection site.