cyrilzakka/clinical-trials huggingface dataset:
rhBMP-2 Versus Vivigen in Lumbar Fusion Procedures

This study is aimed at comparing the overall efficacy (clinical and radiographic) of Vivigen, a novel cellular allograft product, and rhBMP-2 when utilized in lumbar fusion procedures.

The purpose of this study is to compare the overall efficacy (clinical outcome and radiographic fusion) of Vivigen (cellular allograft product) and rhBMP-2 in patients who undergo a single level lumbar instrumented fusion. Specifically, when compared to their control group counterparts treated to rhBMP-2, we hypothesize that the intervention group administered Vivigen would, following surgery, experience:

1. Comparable mean postoperative leg/back pain score, where the pain scores are obtained using the numeric rating scale of 0-no pain, to 10-worst pain possible
2. Comparable inpatient length of stay (LOS)
3. Comparable postoperative Oswestry Disability Index (ODI) score (0-no disability, to 100-maximum disability possible), two weeks, 6 weeks, 3 months, 6 months, and 1 year postoperatively
4. Comparable fusion rates, evaluated via CT scan I year postoperatively

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 or older;
2. Diagnosed with lumbar degenerative/isthmic spondylolisthesis, degenerative disc disease with axial low back pain and neurologic symptoms, failed conservative treatment and eligible for a single level lumbar instrumented fusion;
3. Willing to provide informed consent, participate in study, and comply with study protocol.

Exclusion Criteria:

1. Pregnant or contemplating pregnancy prior to surgery;
2. Serious spinal conditions (e.g. spinal cord compression, cauda equina syndrome, spinal infection, spinal tumor, spinal fracture, inflammatory or systemic spinal arthritis);
3. Surgery involving more than 2 vertebral levels;
4. Worker's compensation or personal injury related to lumbar spine (treatment outcomes may be affected by patient's personal interests; could also run into potential issues with reimbursement).
5. Lactating women
6. Patients who have a known or suspected allergy to Gentamicin Sulfate, Meropenem, Vancomycin, Dimethyl Sulfoxide (DMSO), and Human Serum Albumin
7. Immune compromised patients
Anti-Scarring Efficacy and Safety of Intradermal Juvista (Avotermin) in Healthy Males

This study was undertaken to investigate safety and scar-improvement activity of different applications of Juvista (avotermin), administered to surgical incisions made to the skin of a healthy population of male volunteers aged 18-45 years. The study addressed two issues: whether Juvista (avotermin) administered at 200ng/100μl/linear cm wound margin is more effective than 50ng/100μl/linear cm for scar improvement and, secondly, whether dosing once only (before wounding) or twice (before and after wounding) is optimal for scar improvement.


Eligibility Criteria:
Inclusion Criteria:

* Clinically healthy, male subjects aged 18 to 45 years (inclusive)
* Body weight between 40kg and 150kg or a body mass index within the range 15-55kg/m2, calculated using Quetelet's index

Exclusion Criteria:

* Subjects with history or evidence of hypertrophic or keloid scarring, or with tattoos or previous scars in the area to be biopsied.
* Subjects with tattoos or previous scars within 3cm of the area to be incised during the trial.
* Afro-Caribbean volunteers, because of their increased susceptibility to hypertrophic and keloid scarring.
* Subjects who, on direct questioning and physical examination, have evidence of any past or present clinically significant disease.
* Subjects with a chronic or currently active skin disorder, which would adversely affect the healing of the acute wounds or involved the areas to be examined in this trial.
* Subjects with a history of clinically significant allergies.
* Subjects with any clinically significant abnormality following review of pre-trial laboratory data and physical examination.
* Subjects taking, or who had taken, certain prescribed drugs in the 4 weeks before to Day 0 and, in particular, topical or systemic steroids, anti-inflammatory, anti-coagulant, anti-proliferative drugs, and antibiotics.
* Subjects who have taken part in a clinical trial within 3 months before admission to this trial, or who are currently participating in a clinical trial, whether an investigational drug was involved or not.
* Subjects with any clinical evidence of severe ongoing, or prolonged, depression or mental illness.
* Subjects smoking more than 20 cigarettes a day.
* Subjects drinking more than 28 units of alcohol per week (1 unit = ½ pint of beer \[285ml\], 25ml of spirits, or 1 glass of wine).
* Subjects showing evidence of drug abuse.
* Subjects known to have, or to have had, serum hepatitis or who were carriers of the hepatitis B surface antigen (HbsAg) or hepatitis C antibody.
* Subjects previously testing positive for HIV antibodies, or who admit to belonging to a high-risk group.
* Subjects with pre-existing clinically significant neurological conditions.
* Subjects who, in the opinion of an investigator, are not likely to complete the trial for whatever reason.
Effect of Back Massage on ınfertılıty Stress, Sexual satısfactıon and marrıage Harmony ın ınfertılıty Couples

This study aimed to investigate the effect of back massage on infertility stress, sexual satisfaction and marital harmony in infertile couples.

It aims to answer the question "Does back massage increase sexual satisfaction and marital harmony in infertile couples?" They will apply infertile chirt back massage and then answer survey questions about sexual satisfaction and marital harmony.

Infertility is defined as the inability to become pregnant despite regular, unprotected sexual intercourse for 12 months. Infertility can cause decreased sexual satisfaction, deterioration of marital harmony and separation in couples. Massage with contact and touch can increase harmony between couples, reduce stress and contribute to increased sexual satisfaction. This study aimed to investigate the effect of back massage on infertility stress, sexual satisfaction and marital harmony in infertile couples.

The couples included in the study were divided into two groups: study and control groups. All patients completed the demographic information scale, The COMPI Coping Strategy Scales, Golombok Rust Sexual Satisfaction Scale and Marital Adjustment Scale. Back massage was taught to the couples in the study group and the spouses were allowed to perform back massage during the infertility treatment. No intervention was applied in the control group. A month later, the COMPI Coping Strategy Scales, Golombok Rust Sexual Satisfaction Scale and Marital Adjustment Scale were repeated on the fences. Mann Whitney u test, ki kare test and wilxon test used to analyze data.

Marital harmony and sexual satisfaction were found to be higher and stress levels were lower in couples who received back massage.

As a result, it has been shown that back massage has positive effects on infertility stress, sexual satisfaction and marital harmony in infertile couples.

Eligibility Criteria:
Inclusion Criteria:

Being 18 years or older, Being diagnosed with infertility, Being married and spouses living together, Being literate, There is no mental or psychological disorder/disability that would affect understanding and perception, Not having a problem that prevents massage (must not be an extremity amputee, should not have a fracture or dislocation, should not have an open wound)

Exclusion Criteria:

* Unable to communicate,
* Couples who do not want to participate in the research will not be included in the research.
* Those who have conditions that prevent massage (those with fever, wounds on their backs, individuals with tumors, the presence of an incomprehensible mass, those with orthopedic disorders, etc.) Exclusion Criteria for the Control Group
* Individuals who cannot be contacted and do not want to participate in the research will not be included in the research.
Combination of Antiplatelet and Anticoagulation for AIS Patients Witn Concomitant NVAF and Extracranial/Intracranial Artery Stenosis

The goal of this clinical trial is to compare the safety and effectiveness of anticoagulation combined with antiplatelet therapy in acute ischemic stroke (AIS) patients with concomitant non-valvular atrial fibrillation (NVAF) and extracranial/intracranial artery stenosis. Participants will be 1:1 randomized into anticoagulation alone or anticoagulation combined with antiplatelet therapy. The primary endpoint is composite events 3 months after enrollment.

Concomitant NVAF and extracranial/intracranial artery stenosis will greatly increase the risk of stroke, even with standard anticoagulation. However, clinicians may be concerned with the high risk of bleeding complications of anticoagulation combined with antiplatelet therapy. The goal of this clinical trial is to evaluate the safety and effectiveness of anticoagulation combined with antiplatelet therapy in acute ischemic stroke (AIS) patients with concomitant non-valvular atrial fibrillation (NVAF) and extracranial/intracranial artery stenosis. Participants will be 1:1 randomized into anticoagulation alone or anticoagulation combined with antiplatelet therapy. The primary endpoint is composite events 3 months after enrollment.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years old
* Acute ischemic stroke or TIA with onset \< 7 days
* Have a history or newly diagnosed as NVAF
* Concomitant stenosis (\>50%) of carotid artery/intracranial artery, of which the ischemic lesion located within the territory

Exclusion Criteria:

* Chronic renal dysfunction (GFR \< 30ml/min) or severe hepatic injury
* Have a history or newly diagnosed as valvular heart disease
* Mural thrombus in heart
* Contraindications of anticoagulation or antiplatelet therapy, e.g. severe intracranial hemorrhage
* Myocardial infarction within 6 months before enrollment or received percutaneous coronary intervention in the past
* Have or plan to receive CEA or CAS in the following 3 months
* Life expectancy less than 1 year
* Plan to receive invasive surgery in the following 3 months and have high risk of uncontrollable bleeding
* Pregnant or lactating women
* Individuals identified by researchers as unsuitable for participation in the study due to other reasons.
Modified Thoracoabdominal Nerve Block(M-TAPA) in Pediatric Laparoscopic Appendectomies

To compare the effect of M-TAPA block and port-site local anesthetic infiltration on postoperative pain in pediatric laparoscopic appendectomies. The main questions it aims to answer are:

* Is M-TAPA block more effective in reducing pain?
* How M-TAPA block affects the use of rescue analgesics in the postoperative period? Participants will have the same anaesthetic agents during surgery, before extubation they will have same analgesic agent for postoperative pain. Participants in the M-TAPA group will undergo USG-guided M-TAPA block bilaterally with % 0.025 Bupivacaine max dose of 2 mg/kg by the same experienced anesthesiologist before extubation. Participants in the LAI group will be administered 0.025% Bupivacaine at a maximum dose of 2mg/kg divided equally and administered by the surgeon at 3 port entry sites before the patient is extubated.


Eligibility Criteria:
Inclusion Criteria:

* Patients with American society of Anesthesiologists (ASA) physical status I-II,
* Patients which will undergo Laparoscopic appendectomy due to the diagnosis of acute appendicitis,
* Patients whose parents or legal heirs have consented to participate in the study

Exclusion Criteria:

* Patients with Society of Anesthesiologists (ASA) III-IV status,
* Patients whose parents or legal heirs' disapproval,
* Patients inability to cooperate,
* Patients who have allergy to any of the medications used in the study,
* Patients with perforated appendix
* When the Laparoscopic surgery returns to open shape
Mental Status and Quality of Life of Post-COVID-19 Patients

The current SARS-CoV-2 virus pandemic has already affected the lives of every person on earth. Most of the information given in the media on a daily basis focuses on the pandemic aspects. Fear of getting sick arises in the population, and once infection occurs, numerous concerns arise over the course of the disease. For some patients, hospitalization and subsequent rehabilitation is needed due to complications from the disease. Besides the aspect of treating patients physically from the disease, the psychological aspects that often accompany patients during and after the disease are not addressed. Depressive and anxiety symptoms can follow patients for many years and can affect their quality of life. Thus, the purpose of this project is to assess the mental status of patients prior to the inpatient rehabilitation program

Patients with COVID-19 or post-COVID-19 will have a need for rehabilitation during and directly after hospitalization. Data on safety and efficacy are lacking, as the number of COVID-19 survivors has increased rapidly. The Convergence of Opinion on Recommendations and Evidence process was used to make interim recommendations for the in-hospital rehabilitation and post-hospital phase in patients with COVID-19 and post-COVID-19 patients, respectively. The International Task Force (ITS) was established, including the European Respiratory Society (ERS) and key opinion leaders from the American Thoracic Society (ATS), as well as key opinion leaders in the field of lung rehabilitation. In its report, the ITS identified recommendations for the rehabilitation of patients with COVID-19 and post-COVID-19 patients. Majority of the experts recommended strongly (71%) or conditionally (24%) for COVID-19 survivors with symptoms of psychological distress at 6-8 weeks after discharge from the hospital receiving a formal psychological assessment. Therefore, this project aims to evaluate the mental status and quality of life of patients admitted to the rehabilitation unit, after COVID-19 hospitalization.

In our project, we intend to answer the following questions:

* What is the severity of depressive symptoms in individuals who have suffered COVID-19 ?
* What is the severity of anxiety symptoms in individuals who have suffered COVID-19 ?
* What is the level of perceived stress in individuals who have suffered COVID-19 ?
* What is the quality of life of people in individuals who have suffered COVID-19 ?

Eligibility Criteria:
Inclusion Criteria:

* Previously hospitalized for SARS-CoV-2 infection;
* Pulmonary rehabilitation conducted in ward settings

Exclusion Criteria:

* Inability to self-complete the research questionnaires;
* Presence of the following issues at the time of the examination or in the medical data: disturbances of consciousness, psychotic symptoms or other serious psychiatric disorders
* Initiation of psychiatric treatment during the research project;
* Patient's refusal at any stage of the research project.
Acupuncture as the Therapeutic Modalities of Acute Toxicity in the Radiotherapy of Head and Neck Tumors

The aim of the study is to evaluate the benefit of the acupuncture as healing modalities in the therapy of acute toxicity of radiotherapy.

The study will enroll 100 patients in current radiotherapy of the head and neck cancer with acute radiotoxic symptoms at least of G1. The patients will be randomized (by ticket) in two regimens 1:1.

Regimen A (control regimen): standard support treatment of adverse events of the radiotherapy.

Regimen B (acupuncture regimen): standard support treatment of adverse events of the radiotherapy and acupuncture.

Due to the disease and patients differences, treatment will be individualized. Used acupuncture points will be documented. The patients difficulties will be observed and their medication and will be recorded in the patient diary.

Possible skin toxicities wil be documented by the photography.

Before the randomization, all subjects will sign the voluntary informed consent. After the achievement of 50 enrolled subjects in any regimen, the enrollment will continue only to the other regimen.

Head and neck cancer therapy will include only curative and adjuvant radiotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Curative and adjuvant radiotherapy for head and neck tumors;
* PS 1-2;
* Patient collaboration in evaluation of the toxicity diary.

Exclusion Criteria:

* Palliative radiotherapy in the head and neck tumor;
* PS 3;
* Non-compliance of the patient.
The Effect of Guided Imagery and Music Therapy on Post-Operative Recovery After Gynecological Oncology Surgery

This pilot study will be a prospective, randomized trial which will take place at the University of Minnesota Medical Center (UMMC). Eligible patients will be identified at the time of their first clinic visit. If selected to be involved in the study, the patients will be randomized to one of three different groups: a Guided Imagery and Music therapy group (GIMT) or one of two control groups.

The GIMT group will undergo a standardized regimen of peri-operative guided imagery and music therapy guided by CDs. As there are no studies which discuss whether the act of listening to any therapy will affect outcomes, we will also explore whether white noise can affect outcomes as well. Therefore, one control group (WN) will abide by the same regimen and will listen to a CD with white noise; the other control group (CP) will have no intervention at all and will follow our current peri-operative procedures.

Eligibility Criteria:
Inclusion Criteria:

* Subjects will include women who are being seen at the Women's Health Center by the Gynecological Oncology group at the University of Minnesota (UMMC). These women will be considered for inclusion based on their projected surgery: exploratory laparotomy. Subjects will have to have their surgery at the UMMC within 1 month of their clinic visit. Patients may be undergoing surgery for either known cancer (ovarian or uterine) or high suspicion for malignancy.

Exclusion Criteria:

* \< 19 years old
* pregnant
* undergoing a procedure other than laparotomy
* scheduled to be discharged the same day of surgery
* chronic narcotic pain medication users
* if they are currently using or planning on using other complementary alternative medicine (CAM) therapies prior to or after surgery.
Use and Harm Exposure in New Low Nicotine Cigarettes

The proposed research extends previous research on Quest® cigarette smoking behavior by testing whether compensatory smoking occurs as cigarette nicotine level decreases, and whether, as a result, biomarkers of harm exposure increase. This hypothesis will be tested in 210 smokers who report smoking at least 15 cigarettes per day and have been smoking for at least five years and are not currently interested in quitting, but interested in trying a new cigarette product. Participants will be randomized to one of three conditions: 1) smoke their own preferred brand (control group); 2) smoke Quest® cigarettes in progressively decreasing cigarette nicotine level (step-down); or 3) Quest® cigarette non-step-down condition, where they will smoke Quest® cigarettes in a random order. The study will consist of 4 stages beginning with a 5-day preferred own brand cigarette smoking phase for all participants, followed by one of the three cigarette conditions. For those smoking Quest® cigarettes, cigarette nicotine level will change every 10 days, either in a step-down or random fashion. The primary behavioral outcome is smoking topography, a quantitative measurement of smoke exposure. Alveolar carbon monoxide (CO), a validated assessment of smoke exposure, and urine samples to assess carcinogen exposure, specifically NNAL (4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol) and 1-HOP (1-hydroxypyrere), and exhaled breath condensate will also be collected at the laboratory visits. At the initiation of the study, participants will view the Quest® print advertisement and complete a survey related to product expectations in order to determine the impact marketing and advertisement has on beliefs, attitudes and behaviors related to Quest® cigarettes.


Eligibility Criteria:
Inclusion Criteria:

* Self-report smoking \> 15 daily cigarettes.
* Self-report smoking only non-menthol cigarettes.
* Not currently trying to quit smoking, or planning to quit in the next 2 months.
* Interested in trying a new cigarette-like product.

Exclusion Criteria:

* Not meeting any of the inclusion criteria.
* Self-report drinking \> 25 alcohol-containing drinks per week.
* Self-report currently using any nicotine replacement products.
* Self-report substance use disorders (abuse or dependence involving alcohol, cocaine, or stimulants, benzodiazepines, not nicotine) in the last 5 years.
* Self-report past history of Axis I psychiatric disorders other than depression
* Self-report myocardial infarct within the past year.
* Females must not be currently pregnant, planning a pregnancy during the study, or currently breastfeeding/lactating.
* Provide a baseline CO reading \< 10 ppm
Assessment of Strength Outcomes After Use of the PrimusRS for Specificity of Training in a Cardiac Rehabilitation Setting

The purpose of this study is to determine if performed force measurements yield a different recommended weight lifted during the sternotomy healing process than the traditional gold standard of 5 pounds. A secondary endpoint data obtained will be scores from the pre and post-activity questionnaires.

In a prospective study involving 130 cardiac rehabilitation patients muscular strength will be measured with a force dynamometer (PRIMUS) on six commonly performed activities. During the first session of cardiac rehabilitation, each subject's date of birth, height, and weight will be recorded. To ensure safety, cardiovascular nurse specialists and exercise physiologists will monitor the patients for hypertension (blood pressure \>240/110 mm Hg), arrhythmias, angina, dizziness, pain, shortness of breath, and perceived exertion. The subjects will be asked to complete a pre-activity confidence survey. On the second day of cardiac rehabilitation, a clinical exercise specialist will the PRIMUS equipment to obtain force measurements on the six activities including: rising from a bed, rising from a chair, opening a door, lifting an object from the floor and/or placing an object overhead. Following the performance of the activities, the patients will be asked to complete a post-activity confidence survey.

Eligibility Criteria:
Inclusion Criteria:

* CABG through median sternotomy
* Valve repair or replacement through median sternotomy
* Any ethic of socio-economic status

Exclusion Criteria:

* Refusal to participate
* Sternal dehiscence
* Permanent pacemaker
* Permanent defibrillator
* Unstable angina
* History of heart transplant
* History of hernia
* History of aneurysm
* Physical disability that limits resistance training
* Uncontrolled hypertension (systolic 160 mmHg or diastolic \> 100 mmHg)
* Symptomatic dysrhythmias
* History of aortic dissection
Study Evaluating Etanercept on Skin and Joint Disease in Psoriatic Arthritis

The purpose of the study was to compare the efficacy of 2 different Etanercept regimens for the treatment of skin and joint manifestations of psoriatic arthritis.


Eligibility Criteria:
Inclusion Criteria:

Inclusion Criteria:

* 18 years of age or older at time of consent
* Active Psoriatic Arthritis
* Clinically stable, plaque psoriasis involving more than 10% of the body surface area

Exclusion Criteria:

Exclusion Criteria:

* Evidence of skin conditions other than psoriasis that would interfere with skin examinations.
* Systemic anti-psoriasis therapy or DMARD within 28 days of study drug initiation
* Prior exposure to any TNF-inhibitor, including etanercept