cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy Study of Q301 in Mild to Moderate Adolescents and Adults Atopic Dermatitis Patients

This is a randomized, double-blind, vehicle-controlled, parallel-group comparison study to evaluate the safety and efficacy of Q301 Cream vs. vehicle in adolescent and adult subjects with mild to moderate AD. Study drug (Q301 Cream or vehicle) will be administered topically twice a day for 8 consecutive weeks.


Eligibility Criteria:
Inclusion Criteria:

* Patient, for a period of at least three months, has had a clinical diagnosis of AD according to the Hanifin and Rajka Criteria by a board certified/eligible dermatologist.
* Patient has an Investigator's Global Assessment (IGA) score of 2 or 3 corresponding to mild or moderate AD
* Patient is in good general health and free of any disease state or physical condition that might impair evaluation of AD or which, in the investigator's opinion, exposes the patient to an unacceptable risk by study participation.

Exclusion Criteria:

* Patient has used within four weeks prior to randomization, systemic treatment with: 1) corticosteroids, 2) cyclosporine, 3) other immunosuppressive treatment or any medication known to affect AD (e.g., JAK inhibitors, etc.).
The Effects of Resourcefulness Intervention Group

The purpose of this study is to analyze the effects of resourcefulness interventions on interpersonal competence, relationship adjustment, and negative emotion in young adults. An interventional and longitudinal study design will be used to design resourcefulness intervention groups and examine the effects of resourcefulness group interventions on interpersonal competence, relationship adjustment, and negative emotion in young adults.

Purposes: To analyze the effects of resourcefulness interventions on interpersonal competence, relationship adjustment, and negative emotion in young adults.

Methods: The interventional and longitudinal study design will be used in this study. The resourcefulness intervention groups will be built up and the effects of resourcefulness group interventions on interpersonal competence, relationship adjustment, and negative emotion in young adults will be examined.

Anticipated results: the study results will be important references for interpersonal and intimate relationship counseling for college students.

Eligibility Criteria:
Inclusion Criteria:

Participants who have ever had at least one experience in the relationship.

Exclusion Criteria:

1. The ones who are taking continuous education in the evening.
2. The ones who have been diagnosed with major depressive disorder, panic disorder, or other psychotic diseases which influenced cognitive functions.
"Blind" vs. Fluoroscopy-Guided Steroid Injections for Knee Osteoarthritis

To compare relative efficacy of intraarticular steroid injection using anatomic landmarks vs. fluoroscopy guided technique in decreasing knee osteoarthritis pain 1 month after the procedure.


Eligibility Criteria:
Inclusion Criteria:

- Adults with knee OA clinically deemed to qualify for steroid injection

Exclusion Criteria:

- Children Non-English Speakers Pregnant
Reduction of Concussion Symptoms Through the Use of Osteopathic Manipulative Therapy

Concussion incidence in high school and collegiate sports is high, especially in football. Once diagnosed, return to play is dependent on recovery from symptoms followed by a specific protocol for clearance; the sooner the symptoms subside the sooner the protocol is initiated. Osteopathic Manipulative Therapy (OMT) is a low risk procedure that has minimal side effects and has been used to decrease both headache intensity and frequency. With the main subjective symptom tracked for concussion being headache, OMT may be used to decrease the severity and the duration of this symptom.

Concussion incidence in high school and collegiate sports is high, especially in football. These injuries have become the focus of the sports world, as coaches, trainers, and medical personnel are more vigilant than ever in screening for concussions. Once diagnosed, return to play is dependent on recovery from symptoms followed by a specific protocol for clearance; the sooner the symptoms subside the sooner the protocol is initiated. Osteopathic Manipulative Therapy (OMT) is a low risk procedure that has minimal side effects and has been used to decrease both headache intensity and frequency. With the main subjective symptom tracked for concussion being headache, OMT can be used to decrease the severity and the duration of this symptom. In a prospective superiority comparison between standard of care for concussion (rest and return to play protocol) and a single OMT treatment in combination with standard therapy, we hypothesize that OMT decreases symptom duration and severity of headache in concussion management.

Eligibility Criteria:
Inclusion Criteria:

1. Patients referred to the Geisinger sports medicine clinic or athletic training room for concussion evaluation and management
2. Age less than 25 years old
3. Enrolled in high school or college
4. Participating in a sport at either collegiate or high school level

Exclusion Criteria:

1. Diagnosis does not meet criteria for concussion
2. Symptoms of concussion not present on initial visit
3. Patient unable to tolerate the OMT treatment
4. Patient needs intervention beyond standard concussion management
5. Patients not able to provide consent to be a part of the study
Feasibility and Effectiveness of Colonic Irrigation

This study will allow investigators to determine whether colonic irrigation may allow for a non-oral, same-day alternative to traditional oral bowel prep regimens. This in turn could lead to more persons able to undergo screening colonoscopy for colorectal cancer and thus increased cancer prevention and early detection.

The primary endpoints for this study are:

* Overall quality of bowel cleansing for each of the three segments of the colon (ascending, transverse, and descending) as measured by the Boston Bowel Preparation Score (BBPS), a validated numerical scale for bowel cleanse (0-3 for each colon segment; 0-9 total score) (6).
* Patient satisfaction, as measured by a questionnaire administered by a study investigator via follow-up phone call after completion of the colonic irrigation and subsequent colonoscopy.

Eligibility Criteria:
Inclusion Criteria:

* Outpatients age 50-84 years old, who require a screening or surveillance colonoscopy
* Ability to give consent

Exclusion Criteria:

* Pregnancy
* History of ulcerative colitis or Crohn's disease
* History of surgical ostomy
* History of colorectal surgery
Effectiveness, Safety and Immunogenicity of GSK Biologicals' HPV Vaccine GSK580299 (Cervarix) Administered in Healthy Adolescents

Genital infections with oncogenic human papillomaviruses (HPV) are common in both men and women. The most important disease associated with oncogenic HPV infection is cervical cancer, currently the second leading cause of cancer-related death among women globally. The current study is designed to evaluate the overall impact of HPV immunization in adolescents 12-15 years of age.


Eligibility Criteria:
Inclusion Criteria:

* Study participants who the investigator or delegate believes that they and/or their parents/legally acceptable representative can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits) should be enrolled in the study.
* A male or female between, and including, 12 and 15 years of age at the time of the first vaccination.

A written informed assent must be obtained from all study participants prior to enrolment. In addition, a written informed consent must be obtained from the study participants' parent or legally acceptable representative.

Note: As according to the Finnish law legal age of consent is 15 years, a written informed consent form can be obtained from study participants aged 15 years old and their parent(s)/legally acceptable representative(s) will receive a letter informing them of their child participation to the study.

* Healthy male and female study participants as established by medical history before entering into the study. If needed, a history-directed clinical examination will be performed by the investigator or delegate (e.g. study nurse).
* Study participants must not be pregnant. Absence of pregnancy should be verified (e.g. urine pregnancy test) as per investigator's or delegate's clinical judgement.
* If the study participant is female, she must be of non-childbearing potential, i.e. be abstinent, have a current tubal ligation, hysterectomy, ovariectomy or be post-menopausal or pre-menarcheal, or if she is of childbearing potential, she must use adequate contraception for 30 days prior to vaccination and continue for 2 months after completion of the vaccination series.

Exclusion Criteria:

* Previous vaccination against HPV or Hepatitis B virus.
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
* Acute disease at the time of enrolment. (Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory infection with or without low-grade febrile illness, i.e. Oral temperature \<37.5°C (99.5°F) / Axillary temperature \<37.5°C (99.5°F) / Rectal temperature \<38°C (100.4°F).)
* Pregnant or lactating female.
The Impact of a Web-Based Naloxone Intervention Under Standing Orders to Patients Prescribed Chronic Opioid Therapy

In the setting of naloxone standing orders, this study will assess the impact of a targeted, web-based overdose prevention and naloxone intervention for patients prescribed chronic opioid therapy. Outcomes are changes in opioid risk behaviors, naloxone uptake, and knowledge about overdose and naloxone.

This is a patient level randomized study of a targeted, web-based overdose prevention and naloxone intervention for patients prescribed chronic opioid therapy. This study will be conducted in a health system which has implemented naloxone standing orders. Adults prescribed chronic opioid therapy will be identified in the electronic health record, outreached, and recruited for participation. Once enrolled, participants will be randomized to usual care or the intervention. The web-based intervention is an animated video which provides education on what is an opioid overdose, how to prevent and recognize an opioid overdose, and how to respond with naloxone. This video also encourages patients to pick up naloxone from a pharmacy under standing orders. Participants will be given knowledge and risk surveys over the follow-up. The primary outcome is opioid risk behavior. Secondary outcomes include knowledge about overdose and naloxone, substance use, and pain intensity. Patients will also be followed in the electronic health record for naloxone dispensings, changes in opioid dose, aberrant urine toxicology results, and overdose events.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or greater
* Prescribed chronic opioid therapy
* Have a health plan which covers the formulation of naloxone available at the pharmacy they received their opioid prescriptions from.

Exclusion Criteria:

* Non-English speaking, hospice enrollment, do-not-resuscitate order, no internet access
Comparison Between Two Concentration of Hypertonic Saline in Intestinal Obstruction Surgery

Background and Rationale :

Perioperative fluid management is a challenging issue in surgical care especially in a procedure specific model. Recently hypertonic saline (HS) has the advantage of using the patient's own total body water by drawing interstitial space. Although it still controversial whether HS is associated with benefits in specific patient populations, particularly with respect to site of lesion and illness severity; these data provide insight into therapeutic modalities to curtail ileus formation.

Objectives :

* Measurement of total volume of fluid infused, the need of inotropic or vasopressor to maintain adequate hemodynamic parameters with assessment of electrolyte disturbances and S.lactate
* The incidence rate of surgical complications; infection and anastomotic dehiscence

Study population \& Sample size :

There were no previous trials comparing the two studied groups of the current trial. We expected a small standardized effect size of 0.2. Based on this effect size, 25 subjects will be needed to elicit the difference between the two groups at an alpha level of 0.05 and power of 0.9 (Whitehead et al; 2016).


Eligibility Criteria:
Inclusion Criteria:

* Age: 20-70 years old
* ASA≤III
* BMI 25-40kg/m.

Exclusion Criteria:

* Severe CVS diseases (EF\<50%)
* Severe pulmonary diseases (Pulmonary function test ≤ 50% of predicted)
* Neurological disorders; Psychological diseases, demyelinating lesions, Parkinsonism, motor or sensory disorders.
* Pregnancy.
* Severe chronic renal disease (s. Creatinine\> 2gm/dl or patients on dialysis).
* Severe hepatic impairment (Child \& Pugh classification class C).
* Acid-base and electrolytes disturbances.
Percutaneous Pin Removal in Children - is Analgesia Necessary?

This is a simple randomised clinical trial to study if non-narcotic analgesia reduces the pain score and pulse rate of children who undergo removal of percutaneous pins in the outpatient clinic.

Inclusion criteria:

* 5-12 years of age
* 2 or 3 percutaneous pins in either elbow

Exclusion criteria:

- documented or suspected allergies to acetaminophen, ibuprofen

Patients enrolled in the study are instructed not take additional analgesia prior to the clinic visit (risk of overdosage explained). This is verified by clinic nurses conducting the trial.

At the clinic visit, they are randomized into one of three groups

1. acetaminophen; 2. ibuprofen; or 3. Vitamin C (Placebo).

They are served the 'medication' (weight-appropriate dose) and the pins are removed in the clinic an hour later.

Pain score (Wong-Baker scale) and pulse rate are measured before pin removal, immediately following pin removal, and 10 minutes after pin removal.

The study hypothesis is that non-narcotic analgesia (such as acetaminophen and ibuprofen) do not decrease pain score and pulse rate associated with the pin removal procedure.

See Brief Summary

Eligibility Criteria:
Inclusion Criteria:

* age: 5-12 inclusive
* 2 or 3 percutaneous pins in either elbow

Exclusion Criteria:

* documented or suspected allergies to acetaminophen or ibuprofen
A Multi-National, Prospective, Observational Study in Patients With Unresectable or Metastatic Melanoma

The purpose of this study is to examine the safety of Ipilimumab and patterns of use in the treatment of unresectable or metastatic melanoma in the post-approval setting

Time Perspective: this study does have a retrospective component involving a subset of patients

Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

* Diagnosis of unresectable or metastatic melanoma
* Age of 18 years or older at time of entry into the study
* Patients who have initiated treatment for unresectable or metastatic melanoma at medical practice (e.g. community-based, office-based, hospital-based, academic setting)within 21 days before informed consent for this study OR in the case where treatment has not yet been initiated, documentation that the treatment strategy was determined before informed consent for this study, and treatment must be initiated within 28 days after informed consent
* Ipilimumab-treated patients must be receiving treatment for the indication(s) approved in their country of residence or where they are receiving treatment

Exclusion Criteria:

* Current or pending participation in a clinical trial examining therapy for the treatment of any cancer (including unresectable or metastatic melanoma)
* Current use of therapy to treat a primary cancer other than melanoma
Carbohydrate Counting in Adults With Type 1 Diabetes Treated With Continuous Subcutaneous Insulin Infusion

The investigators postulate that carbohydrate (CHO) counting in adult patients with type 1 diabetes mellitus (T1DM) treated with continuous subcutaneous insulin infusion (CSII) may improve glycemic control, glycemic variability and quality of life.

This study was designed as a randomized, controlled (versus standard education), open, one-center trial. Patients in group 1 were taught carbohydrate counting to estimate insulin preprandial bolus, while the patients in group 2 followed standard education. Primary outcome (glycosylated hemoglobin, HbA1c) and secondary outcomes (fasting glucose, glycemic variability, insulin requirement, body mass index (BMI), waist circumference, quality of life) were measured at baseline, 3, and 6 months.

Eligibility Criteria:
Inclusion Criteria:

* type 1 diabetes mellitus
* age 18-65
* continuous subcutaneous insulin infusion for at least 3 months

Exclusion Criteria:

* patients who have already been trained in carbohydrate counting
* known hypothyroidism not on replacement therapy
* renal disease (serum creatinine \>1.4 mg/dl in females and \>1.7 mg/dl in males)
* patients with celiac disease
* pregnancy
* serious diseases or disabilities which may interfere with study assessments
Employment-Based Depot Naltrexone Clinical Trial

The purpose of this study is to determine whether employment-based naltrexone treatment proves effective in promoting depot naltrexone adherence and drug abstinence.

A randomized study is planned over 5 years to evaluate the effectiveness of the Therapeutic Workplace in promoting naltrexone adherence in opiate-dependent adults. An extended-release depot formulation of naltrexone will be used. Participants will be offered an inpatient opioid detoxification and naltrexone induction. Participants who complete the oral naltrexone induction will be randomly assigned to one of two groups. Both groups will be invited to work in the Therapeutic Workplace and will be prescribed depot naltrexone for 6 months. Patients in the "Work Plus Naltrexone Contingency" condition will earn access to working and earning salary by taking depot naltrexone once per month. "Work Plus Naltrexone Prescription" participants will be encouraged to take depot naltrexone monthly, but access to working and earning salary will not be contingent on doing so.

Eligibility Criteria:
Individuals were eligible if they:

* met the Diagnostic and Statistical Manual of Mental Disorders, 4th. Edition (DSM-IV) criteria for opioid dependence,
* reported using heroin on at least 21 of the last 30 days while in community,
* were unemployed,
* were aged 18-65 years,
* were medically approved for naltrexone
* lived in or near Baltimore, MD.

Individuals were excluded if they

* had current DSM-IV major Axis I disorders,
* had current suicidal or homicidal ideation,
* expressed interest in methadone treatment,
* were required to use opioids for medical purposes,
* earned more than $200 in taxable income over the previous 30 days,
* had physical limitations that would prevent them from using a keyboard,
* were pregnant or breastfeeding,
* had serum aminotransferase levels more than three times over normal.
Treatment for Symptomatic Peripheral Neuropathy in Patients With Diabetes

The purpose of this protocol is to determine if an investigational drug is effective in treating nerve malfunction in diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Patients must have type I or type II Diabetes Mellitus.
* Have clinically diagnosed positive sensory symptoms such as numbness, lancinating pain, burning pain, aching pain, allodynia and prickling sensation that have been present not greater than 5 years but stable for 6 months.
* Has a HbA1C less than or equal to 12%. Patients with HbA1C greater than 9% must be on insulin therapy.
* Must be 18 years or older.
* Be able to visit the doctor's office approximately 3 times over a maximum of a 6-week period to determine if you can continue in the study.

Exclusion Criteria:

* History of significant liver problems.
* Have poor kidney function.
* Drink an excess of alcohol or abuse drugs.
* Have recently participated or currently participating in a Medical study in which you receive an experimental drug.
* Are a woman and are pregnant or breastfeeding, intend to become pregnant within the next 2 years or a woman not using effective birth control.
A Novel Combination Oral Agent to Treat Acne Vulgaris

The purpose of this study is to evaluate a novel, combination product for the treatment of acne vulgaris in females


Eligibility Criteria:
Inclusion Criteria:

* Healthy females 13 years of age or older
* Non-pregnant, non-lactating females
* Signed written informed consent form
* Must be able to understand and be willing to follow all study instructions
* Have a clinical diagnosis of acne vulgaris

Exclusion Criteria:

* Female subjects who are pregnant or nursing
* Any concomitant dermatologic condition that may affect outcome measures
* Concurrent use of any other medication to treat acne vulgaris
* Have a history or clinical evidence of any other active acute or chronic medical disease or condition considered by the principal investigator as unsuitable for the study
* Are currently using any other investigational agent or device
* Have participated in any other clinical study within 90 days prior to enrollment
* Employees or family members of sponsor or research site
Respiratory Muscle Training in Malnourished Patients Undergoing Abdominal Surgery

Malnutrition affects 50% of hospitalized patients around the world and causes changes in respiratory muscles predisposing the development of pulmonary complications probable, because of the ineffectiveness of cough. How the training of respiratory muscles can improve the effectiveness of cough, malnourished patients could benefit from this train however, the training of the muscles in malnourished patients has not been tested for safety or efficiency. So, the aim of this study is to assess the safety and efficiency of respiratory muscle training to improve the potency of cough in malnourished patients.


Eligibility Criteria:
Inclusion Criteria:

* hospitalized malnourished patients (BMI ≤ 20 Kg/m2, loss of body weight ≥ 10% unintentional, or serum albumin \<3.5 g/dL)
* candidate to elective abdominal surgery
* ability to perform all evaluations and training

Exclusion Criteria:

* previous respiratory disease
* necessity of over than 48h of mechanical ventilation
* reoperation
Functional MRI Use in Prostate Radiation Treatment Planning

This study is being done to evaluate the use of MRI during radiation treatment planning to identify areas of tumor within the prostate to aid in future treatment planning and targeting of prostate cancer. This study will be conducted at the University of Pennsylvania Health System. The study is projected to run for 18 months. Subjects will be male 18 or older with a prostate cancer diagnosis and treatment plansat the Department of Radiation Oncology.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Male
* Biopsy proven prostate cancer without evidence of metastatic disease
* Planned definitive external beam RT with daily ERB and implanted Visicoil fiducial markers.
* Prior fMRI-ec documenting an IPL 25 mm2 in axial bidimensional diameter product, concordant with intraprostatic tumor location as documented on transrectal ultrasoundbiopsy
* Subject capable of giving informed consent for standard external beam RT and for the study.
* No current contraindication that would prevent MRI or gadolinium contrast.

Exclusion Criteria:

* Metastatic disease
* Lack of fMRI-ec documeneting an IPL 25 mm2 in axial bidimensional product, concordant with intraprostatic tumor location as documented on transrectal untrasound biopsy
* Neoadjuvant androgen deprivation therapy greater than 10 weeks, defined from date of LHRH analog injection to date of fMRI-sim
* Contraindication that would prevent MRI or gadolinium contrast
* GFR 30 mL/min/1.73m2 per Crockoft-Gault formula.