cyrilzakka/clinical-trials huggingface dataset:
Bioequivalence Study of Generic Tretinoin 0.04% Microsphere Gel, 0.04% Retin-A Micro® and Placebo

The objective will be to assess clinical bioequivalence of 0.1% Retin-A Micro® Gel and Spear Pharmaceutical's generic 0.1% Tretinoin Microsphere Gel with a placebo arm.

Acne study

Eligibility Criteria:
A subject will be eligible to participate if they meet all of the following inclusion criteria:

* Normal, healthy male and female children and adults.
* Age 12 to 40 years.
* Written and verbal informed consent must be obtained. Subjects age 12 to 17 (inclusive) must sign an assent for the study and a parent or a legal guardian must sign the informed consent (per FDA letter 8.21.07).
* Women of child-bearing potential must be non-pregnant and non-nursing, and must be willing to avoid pregnancy during the course of the study and during the menstrual cycle following completion of their participation in the study, adequate contraception is defined as regular use of any two of the following: oral, injectable contraceptives, condoms, spermicides, diaphragm, IUD, implantable and contraceptive patches. (oral contraceptives if used for at least three months and injectable contraceptives if used for at least 6 months)- prior to enrollment in the study, or abstinence.
* Have at least 20 inflammatory (papules and pustules) and 25 non-inflammatory (open and closed comedones) lesions with a maximum of 2 nodulocystic lesions on the face (per FDA letter 8.21.07).
* Global severity score from 2-4
* Able to refrain from the use of all other topical acne medications or antibiotics during the treatment period.
* Considered reliable and capable of understanding their responsibility and role in the study.

Exclusion Criteria

A subject will be eligible to participate if they meet none of the following exclusion criteria:

* Subjects with active cystic acne as evidenced by more than 2 facial nodules.
* More than 40 papules and/or pustules (inflammatory lesions)
* More than 60 open and or closed comedones/milia (non-inflammatory lesions)
* Overall severity grade of less than 2 or greater than 4,
* History of allergy or hypersensitivity to tretinoin.
* Significant history or clinical evidence of auto-immune, cardiovascular, gastrointestinal, hematological, hepatic, neurological, pancreatic, or renal disease
* Use of systemic retinoid treatment within six months prior to study initiation.
* Oral contraceptives should not be started or changed within 3 months prior to study initiation or planned to change during the study.
* Pregnant or breast-feeding.
* Participation in a clinical study for acne within 4 months preceding study initiation.
Treatment of Desmoid Fibromatosis With Arterial Embolization

Desmoid fibromatoses are rare and locally aggressive mesenchymal tumors. The current scientific evidence regarding the efficacy and safety of the treatment of desmoid fibromatosis by arterial embolization is constituted by several retrospective and prospective studies. These studies report promising results through the use of chemoembolization, that is, arterial embolization using particles loaded with chemotherapy.

Instead, the type of treatment we propose would consist of injection of embolizing material without the use of chemotherapy, based on the positive results we have consistently reported over the years on arterial embolization of musculoskeletal tumors.

Desmoid fibromatoses are rare (1-2 cases/million per year) and locally aggressive, characterized histologically by monoclonal myoblasts present in abundant stromal tissue.The current therapeutic strategy has abandoned primary resection, as recurrences after resection are common and often their phenotype is more infiltrative. Nonsurgical approaches remain suboptimal. For asymptomatic disease, current guidelines suggest an initial period of active surveillance. The current scientific evidence regarding the efficacy and safety of the treatment of desmoid fibromatosis by arterial embolization is constituted by several retrospective and prospective studies. These studies report promising results through the use of chemoembolization, that is, arterial embolization using particles loaded with chemotherapy.

Instead, the type of treatment we propose would consist of injection of embolizing material without the use of chemotherapy, based on the positive results we have consistently reported over the years on arterial embolization of musculoskeletal tumors.

Doxorubicin is routinely used in the treatment of soft tissue sarcomas and other mesenchymal malignancies. Its use against desmoid fibromatosis is effective but associated with hematologic, gastrointestinal, and cardiac toxicity. Consequently, this drug is reserved for symptomatic, nonresponsive, rapidly growing, or life-threatening fibromatoses.

Eligibility Criteria:
Inclusion Criteria:

* Patients of both sexes aged ≥ 12 years
* Fibromatosis demsoid symptomatic and in active phase (documented growth at last follow-ups)
* Patients not eligible for surgery or cryoablation
* Patients who have had embolization surgery for fibromatosis desmoide from 01/01/2023 to date and all new patients listed for this type of treatment.
* Signature of informed consent to the study

Exclusion Criteria:

* Patients with life expectancy \<3 months or severely impaired status functional status (ASA 4)
* Patients with fibromatosis not in active phase, documented clinically and by investigations imaging (MRI, CT)
* Patients with coagulation deficiency or plateletopenic disease
* Patients with documented active infection
* Incompatibility to performing MRI examination.
Role of Complete Blood Picture in Predicting the Etiology of Extrahepatic Cholestasis

Cases with extrahepatic cholestasis are common and faced during day to day clinical practice, however reaching the final etiology is sometimes challenging and needs investigations which are usually expensive, may carry hazards to the patients, or inaccessible so we are in need for a method which is easily available, affordable and safe for aiding in the differential diagnosis of extrahepatic cholestasis. our study aiming to evaluate the role of complete blood count in predicting the etiology of extrahepatic cholestasis.

Extrahepatic cholestasis has various etiologies including benign causes (benign stricture, chronic pancreatitis, choledochal cyst, mirizzi syndrome, etc...), choledocholithiasis, malignant causes (cancer pancreas, gallbladder cancer, cholangiocarcinoma, etc....), parasitic infestations (fasciola hepatica, ascaris lumbricoides, etc......) and other causes. it is essential to detect the exact cause of extrahepatic cholestasis in order to determine treatment options. diagnosing such conditions depends on clinical examination, laboratory investigations, imaging studies, endoscopic procedures, biopsy and even surgical intervention. some of these investigations are expensive, not available, or carry risk to the patients. moreover non of them is accurate 100%. Complete blood count is already available, easy to obtain, not invasive investigation. In these study we are trying to evaluate the role of complete blood count parameters namely RDW, MPV, PDW, PCT, NLR, PLR in the differential diagnosis of extrahepatic cholestasis.

Eligibility Criteria:
Inclusion Criteria:

* patients with extrahepatic cholestasis

Exclusion Criteria:

* age under 14 years
* previous bilio-pancreatic interventions
* hemoglobinopathy
* splenomegaly
* myeloproliferative disorders
* diabetes mellitus
* recent blood transfusion in less than one month
An Enhanced Protein (Dairy) Weight Loss Intervention for Dynapenic Obesity: Impact on Muscle Quality and Composition

The purpose of the trial is to assess the effects of combining regular, generous intakes of high quality protein (primarily from dairy and other animal source proteins) with calorie restriction and low-intensity exercise on muscle quality and muscle adipose infiltration (along with bone mineral density \[BMD\] and a number of secondary outcomes) in frail, obese, older adults participating in a 6 month intervention. The investigators will compare these effects to those of a traditional control regimen of calorie restriction and low-intensity exercise over the same duration.

Obese older adults (≥60 yrs) with moderate functional impairment will be randomized to 1 of 2 study arms. Outcomes to be measured at 0, 3 and 6 months are as follows: Primary outcomes- (1) Muscle Quality (MQ): muscle power (time to perform ten chair rises, height of the chair, leg length, body mass, and acceleration of gravity) in relation to muscle mass (CT-scan) and (2) Muscle adipose infiltration (MAI) (CT-scan). Secondary outcomes- Bone Mineral Density (BMD; DXA scan) physical function (Short Physical Performance Battery (SPPB); 6 minute walk; 8-foot up and go; and 30 second chair stands; handgrip strength; body weight; fat mass; waist circumference; activity (accelerometers); mental health (sleep, depression, quality of life); and feasibility factors (adherence, protein intake, nutrition adequacy). BMD will only be accessed at 0 and 6 months.

Study Arms:

* Weight loss plus low-intensity exercise intervention (WL-LoEX; n = 35): Subjects follow a calorie-reduction diet for a weight loss of ≥10%, protein\~0.8g/g/d. Subjects will also participate in three 30-minute low-intensity exercise sessions weekly. One serving of dairy protein/day will be provided to WL-LoEX participants.
* High protein weight loss plus low-intensity exercise intervention (PRO-WL-LoEX; n = 35): Subjects follow a calorie-reduction diet for a weight loss of ≥10%, with a high proportion of high quality protein at each meal. Intakes of \> 30g of protein will be achieved three times a day by subjects in this group, with all or predominantly all from animal sources (high quality) and 60-70% of animal protein from dairy foods that will be provided. Subjects will also participate in three 30-minute low-intensity exercise sessions weekly.

Eligibility Criteria:
Inclusion Criteria:

* BMI \>30;
* SPPB score of ≥4 to \<10;
* GFR \<45 mL/min

Exclusion Criteria:

* Body weight \>495 lbs. (BodPod limits);
* estimated glomerular filtration rates (eGFR) less than 45 mL/min;
* symptomatic cardiac disease;
* receiving chemotherapy;
* hemophilia;
* presence of unstable or symptomatic life-threatening illness;
* neurological disease or disorder causing functional impairments;
* inability to walk,
* dementia;
* prescription weight loss medications;
* use of monamine oxidase inhibitors (MAOIs); or
* primary medical provider advises against participation.
Breastfeeding Practice Evaluation in Taiwan

This project aims to analyze and compare the prevalence of breastfeeding at one hour after delivery, discharge from hospital, one month, two months, four months, and six months after delivery and to examine factors associated with breastfeeding between baby-friendly hospitals and non baby-friendly ones. Employing a prospective cohort design, the study population is mothers who gave lived births in Taiwan area from August, 2009 to March, 2010. At least 11 hospitals both in non baby-friendly and baby-friendly hospitals from northern, middle, southern and east areas will be asked for permission to join this study (totally 22 hospitals). The research assistants will contact each eligible participant in the hospitals and explained the purposes and procedure of the study. Once permission was obtained, mothers will be asked to write a questionnaire and their telephone numbers as well as address for future contacts. After the individual case returned home, the collection of data was mainly via telephone interviews. However, if the individual case could not be contacted more than two times via telephone, she would be surveyed by questionnaire. The collection of data showed the state of mother milk feeding one month, two months, four months, or six months after delivery. 1, 000 effective questionnaires were expected to be returned (500 ones from baby friendly hospitals; 500 ones, from non baby-friendly hospitals.) The survey include questions on breastfeeding experiences (one hour after delivery, discharge from hospital, one month, two months, four months, and six months), planned duration of breastfeeding, socio-demographic information, perceived baby-friendly practices at hospital, social support regarding breastfeeding, prior infant feeding method, maternal and infant health conditions, mother's working plan, receipt of formula samples and commercial message during perinatal period. The researcher hopes that based on the research results we can have a better understanding of the influencing factors of promoting mother milk feeding in non baby-friendly hospitals, and that we know how to raise the breastfeeding rate in Taiwan area, which can serve as references for the governmental policies.


Eligibility Criteria:
Inclusion Criteria:

* Postpartum women who gave lived births in Taiwan area from August, 2009 to March, 2010.
* Be able to understand the content of questionnaire
Internet Stop Smoking Study - Phase VI

The purpose of this study is to determine the percentage of English- and Spanish-speaking smokers worldwide who can stop smoking using an Internet stop smoking site.

Latinos and non-Latinos are welcome to participate.

We will stop recruitment on March 19, 2011. Participants will be able to use the site until May 19, 2011.

This is Phase VI of a series of clinical trials comparing various Internet methods to help smokers quit via the Internet.

Our previous trials have involved randomized assignment. This trial is a participant preference trial, in which English- and Spanish-speaking smokers will be able to choose the elements of the site which they would like to use to stop smoking.

Smokers who find our link via search engines or listing on other Web sites may choose to enter the study.

Participants must be 18 years old to enter the study. Participants will be followed up at 1, 3, 6, and 12 months after entry into the study to determine whether they have stopped smoking. They will receive an email reminder with a link to our follow-up surveys. We will stop sending these email reminders on May 19, 2011, when the current Website will close.

Participation is totally voluntary. Participants are free not to provide data or to stop participating at any time.

Eligibility Criteria:
Inclusion Criteria:

* Adult (18 years old or above)
* must have email
* logging on to our stop smoking Internet site
* providing consent to enter stop smoking study

Exclusion Criteria:

* Younger than 18 years old
Building Healthy Children

This study will evaluate the effectiveness of providing a combination of evidence-based behavioral health treatments for mothers who gave birth to their first child prior to the age of 21 and who meet eligibility requirements and their children on prevention of child maltreatment and promotion of positive socioemotional development.

Building Healthy Children is a collaboration of social service and health care agencies, each providing evidence-based services to intervention families in a seamless package. Low-income parents who gave birth to their first child when they were under 21 and who were not involved in the child welfare system were targeted as an at-risk group for whom home visitation services would offer optimal preventive and cost-efficiency outcomes. Services include Interpersonal Psychotherapy \[IPT\] for maternal depression and Child Parent Psychotherapy \[CPP\] for maternal-child relationship development and trauma treatment, and Parents As Teachers \[PAT\]. Families are provided a tiered complement of BHC services based upon risk and current need.

Case management and outreach services are key to assure family engagement and full program participation. An assigned community outreach worker provides a consistent, nurturing relationship that helps retain families in the program and readies parents for the evidence-based treatments, movement towards goals, and behavior change. Outreach workers help to stabilize families and ensure compliance with medical appointments and recommended care.

Most importantly, BHC home-based services are integrated with primary care practices: pediatric, family medicine, and federally qualified neighborhood health center. These comprehensive services are compared with a screening and referral only group in a randomized design. Integration with the child's medical home is an all-inclusive approach to improve child health and well-being and to achieve desired program outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Participants will include patients drawn from Strong Pediatrics, Anthony Jordan Health Center, Rochester General Hospital, or Highland Family Medicine
* residents of Monroe County,
* Temporary Assistance for Needy Families (TANF) eligible,
* are neither currently active nor have had an indicated CPS report,
* have a mother who is or was under 21 at the birth of her first child, and
* has a maximum of two children under the age of three.

Exclusion Criteria:

* Children who have indicated Child Protective reports or who are in foster care at the time of recruitment
* Any children or mothers who are not able to complete the research protocol also will be excluded.
* Potential subjects suffering from extreme medical or psychiatric conditions (such as severe brain injury or psychosis) or serious cognitive impairments (such as mental retardation) that would render them incapable of completing research measures validly will be excluded.
* Mothers with thought disorder, severe depression or suicidality requiring hospitalization, severely limited intellectual functioning (IQ less than 70), and current maternal incarceration.
Safety and Effectiveness of Giroctocogene Fitelparvovec or Fidanacogene Elaparvovec in Patients With Hemophilia A or B Respectively

A study to learn about the long-term safety and efficacy of giroctocogene fitelparvovec or fidanacogene elaparvovec in patients with hemophilia A or hemophilia B respectively, who have received treatment through prior participation in a Pfizer-sponsored clinical trial. Data collection and participant visits will be based on standard of care.


Eligibility Criteria:
Inclusion Criteria:

-Only participants who received investigational giroctocogene fitelparvovec or fidanacogene eleparvovec and were enrolled in a Pfizer-sponsored study (C0371002, C0371003, C0371005, C3731001, C3731003) are eligible.

Exclusion Criteria:

-None
Nerve Growth Factor for the Treatment of Cornea Disease

To determine the efficacy and safety of nerve growth factor in the treatment of limbal stem cell deficiency (LSCD) associated with neurotrophic cornea.

This is a prospective open-label pilot study evaluating the role of cenegermin-bkbj for the treatment of LSCD with associated neurotrophic keratopathy. Patient diagnosed with LSCD with neurotrophic cornea who have failed conventional treatment such as artificial tears are enrolled in the study after a 2 week washout period. Patient are then treated with cenegermin-bkbj over an 8 week period.

Eligibility Criteria:
Inclusion Criteria:

Patients diagnosed with LSCD and neurotrophic cornea confirmed by testing with Cochet-Bonnet aesthesiometer

Exclusion Criteria:

1. Active ocular infection
2. Anticipated need for bandage contact lens, amniotic membrane graft, or tarsorrhaphy during the study period
3. Unable to discontinue the use of contact lens
4. Visual acuity worse than 20/200 in the better eye
Early Assisted Discharge for COPD Exacerbations With Telemonitoring.

To determine if an early assisted discharge program for acute exacerbations of COPD (AECOPD), with telemonitoring and telephone control, is equally effective and more efficient in terms of use of health care resources, that a home care provided by hospital respiratory nurses and pulmonologists.

This study seeks to improve the health of patients with AECOPD by home care after discharge from the Hospital using the technology of the information and the communication. The investigators want evaluate the efficiency, satisfaction (patients, keepers) and effectiveness of a program of early discharge with home care in patients with AECOPD with telemonitoring and telephone control, in relation to the traditional protocol of home care based on nurse and pulmonologist visits.

Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to the hospital with COPD exacerbation
* No concomitant serious unstable diseases
* Without fever in 48 hours
* Aerosol treatment at the most every 6 hours
* Treatment with glucocorticoid intravenous \< 40 mg twice a day
* A thoracic radiograph without new disease
* Subjective improvement of the patient
* Familiar suitable environment

Exclusion Criteria:

* Neoplasias and other chronic diseases in terminal situation
* Alcoholism
* Intravenous medication
* Disability to understand and take part in the program
* Admitted to intensive care unit (ICU) or non invasive mechanical ventilation during the exacerbation
* Unstability hemodynamic
* To be an institutionalized patient.
Post-lesion Administration of Dexamethasone to Prevent the Development of Neuritis After Radiofrequency Ablation

Chronic neck and back pain has become one of the leading causes of disability and loss of productivity. For many patients with facet or sacroiliac joint mediated pain who have responded to diagnostic nerve blocks, radiofrequency ablation of the nerves innervating the joints can provide long term relief. Radiofrequency ablation (RFA) is a relatively safe procedure with minimal risk of adverse events. However, with any procedure involving damage to the peripheral nervous system, there is risk of post-procedure neuropathic pain. The investigators will test the hypothesis that dexamethasone injection delivered at the time of lesion effectively prevents the development of post-ablation neuritis through a placebo-controlled, double-blind, randomized trial in patients undergoing cervical, thoracic, lumbar, and sacroiliac joint radiofrequency denervations


Eligibility Criteria:
Inclusion Criteria:

* patients with a diagnosis of either cervical, thoracic, or lumbar facet or sacroiliac joint pain who have responded to medial branch blocks and are already scheduled for bilateral radiofrequency ablations
* age greater than 18 years old
* English speaking

Exclusion Criteria:

* patient not previously scheduled for radiofrequency ablation of the cervical, thoracic, or lumbar facets, or sacroiliac joints
* on anticoagulation
* have a pacemaker
* age less than 18 years old
* non-English speaking