cyrilzakka/clinical-trials huggingface dataset:
Bone Volume Changes After Socket Preservation Using Geistlich Bio-Oss Collagen and Mucograft Seal

Evaluation of Bone volume Changes after socket preservation using Geistlich Bio-Oss® Collagen and Geistlich Mucograft® Seal compared to natural healing after tooth extraction

In the last decade dental implants have become widely used for oral rehabilitation. But, the usage of dental Implants might be difficult in cases of alveolar bone deficiencies.

Different ridge preservation techniques were successfully used, using membrane with or without bone substitutes.new grafting material is Mucograft Seal, a collagen matrix graft, which originally used as an alternative to the connective tissue graft for the treatment of gingival recessions. Mucograft has demonstrated a good tissue reaction with high biocompatibility and a low shrinkage tendency, in order to increase the amount of keratinized gingiva in the augmented area.

Study Hypothesis: The observed changes in ridge dimensions when using Geistlich Bio-Oss® Collagen and Geistlich Mucograft® Seal as ridge preservation will be less pronounced in comparison to natural healing after tooth extraction.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent.
* Patients of 18 years or older.
* Patients in need of a tooth extraction in the area of premolars, canines or incisors due to periodontal and/or dental reasons, provided that the socket walls are intact (bone dehiscence of max. 4mm limited to one bone wall).
* Patients who need implant placement at the site of extraction.

Exclusion Criteria:

* Inability to complete or understand the informed consent process.
* Bone dehiscence at extraction socket of more than 4 mm or 4 mm at more than one bony wall.
* Pregnant or lactating women.
* Patients who use medications that affect bone metabolism such as IV bisphosphonates.
* Heavy smokers (more than 10 cigarettes per day).
* Patients with removable prosthesis, which might compress the treated site.
506U78 in Treating Patients With Recurrent or Refractory Cutaneous T-cell Lymphoma

Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Phase II trial to study the effectiveness of 506U78 in treating patients who have recurrent or refractory cutaneous T-cell lymphoma

PRIMARY OBJECTIVES:

I. Determine the response rate, failure-free survival, and progression-free survival of patients with recurrent or refractory cutaneous T-cell lymphoma treated with 506U78.

II. Determine the toxicity of this drug in these patients. III. Study the pharmacokinetics of this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive 506U78 IV over 2 hours on days 1, 3, and 5. Treatment continues every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 6 months.

PROJECTED ACCRUAL: A total of 12-35 patients will be accrued for this study within 3 years.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed relapsed or refractory cutaneous T-cell lymphoma

  * Large cell transformation of cutaneous T-cell lymphoma allowed
* No active CNS disease
* Performance status - Zubrod 0-2
* Absolute neutrophil count at least 1,000/mm\^3\*
* Platelet count at least 100,000/mm\^3\*
* Bilirubin no greater than 1.5 times upper limit of normal (ULN)
* SGPT no greater than 2.5 times ULN
* Creatinine clearance greater than 50 mL/min
* No history of symptomatic cardiac dysfunction
* No history of pericardial effusion
* HIV negative
* No grade 2 or greater sensory or motor neuropathy
* No history of seizures
* No other malignancy within the past 5 years except curatively treated basal cell carcinoma of the skin of carcinoma in situ of the cervix
* No medical, psychiatric, or social condition that would preclude study
* No other concurrent serious illness or active infection
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No prior stem cell or bone marrow transplantation (BMT)
* No more than 1 prior immunotherapy regimen
* No more than 3 prior systemic regimens with denileukin diftitox
* At least 3 weeks since prior biologic therapy
* No concurrent BMT
* No prior 506U78
* No more than 3 prior systemic chemotherapy regimens comprising any of the following:

  * Oral methotrexate
  * Topical mechlorethamine
* At least 3 weeks since prior chemotherapy
* No other concurrent chemotherapy
* At least 3 weeks since prior anticancer endocrine therapy
* No concurrent topical or systemic steroids
* At least 3 weeks since prior radiotherapy
* No more than 3 prior systemic regimens comprising any of the following:

  * Total skin electron beam therapy
  * Spot radiotherapy
* No more than 3 prior systemic regimens comprising any of the following:

  * Oral retinoids
  * Ultraviolet therapy (PUVA)
* At least 3 weeks since prior anticancer therapy
COVID-19 Plasma Collection

Patients who are severely ill with COVID-19 may benefit from receiving plasma infusions from donors who have recovered from the disease and are proven to no longer be infected. Efforts to initiate the collection and infusion of these products to high risk patients have been initiated around the world and the FDA has recently provided information about how this could be accomplished. As the Jefferson Blood Donor Center already has processes to collect, test and process blood, investigators are planning to make efforts to collect plasma for this use should it be necessary. The purpose of this study is to describe the process for identifying and collecting convalescent plasma from donors previously infected with the virus. The research portion on top of this standard blood product collection will the process of identification of subjects and processes by which blood products are processed in this special population. This protocol does not involve the administration of blood products to patients with COVID-19 infection.

As described by the FDA on 3/24/2020, convalescent plasma has been used for a variety of infectious diseases including Ebola, SARS, MERS and H1N1 flu. Given that there is no current medical treatment beyond supportive care for COVID-19, there is a great deal of interest in using convalescent plasma for patients with COVID-19. As a first step in this process, investigators are proposing to identify donors and collect plasma with antibodies against COVID-19. While the intention is to use this for patients in the near future, the purpose of this study will be to see if this is feasible and a separate application will be submitted related to the treatment of patients with these products.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years and older
* Prior diagnosis of COVID-19 documented by a laboratory test approved by the FDA
* Either: Complete resolution of all COVID-related symptoms for 14-28 days at the time of blood donation AND negative repeated SARS-CoV-2 test OR Complete resolution of all COVID-related symptoms for \> 28 days
* Male donors, never-pregnant female donors, or previously pregnant female donors negative for HLA antibodies
* Meet all criteria for volunteer blood donation per Jefferson Blood Donor Center and the FDA

Exclusion Criteria:

* Failure to pass standard volunteer blood donor screening criteria required by the Jefferson Blood Donor Center and the FDA
* Female donors with HLA antibodies (per FDA requirements for convalescent plasma donors)
* Inadequate venous access for phlebotomy
* Currently pregnant
Implementation Strategy of Bio-molecular Techniques for Early Diagnose of Congenital Syphilis and Chagas Diseases

Chagas disease and syphilis are considered a mayor public health problem worldwide. Both pathologies affect socio-economic vulnerable population and they are both transmitted congenitally, causing an alarming increasing number of infected newborns. The current diagnostic methods for these diseases are based on serology follow-up until 8 to 10 months from birth, which considering the population usually involved and their scarce resources, usually translates in loosing continuity in their controls and follow-up.

Chagas prevalence in pregnant women is 4% with an incidence of Congenital Chagas disease of 1500 annual cases. From those, only 1 third are diagnosed. In the investigators and other authors experience, the detection of DNA of Trypanosoma cruzi by PCR shows an elevation of parasitemia at birth, with a peak at the first month of life.

Syphilis is a re-emergent pathology, preventable and curable when diagnose is achieved early at the beginning of pregnancy.. The cost-effectiveness of performing screening for this infection is widely demonstrated, preventing high morbi-mortality for children when applied to pregnant women.

For both syphilis and Chagas diagnosis, there are some studies comparing PCR follow-up with conventional serology, but none were validated and there is still need to bring more evidence in order to modify current practice. The investigators propose a sequential study of PCR for Tryipanosoma cruzi and Treponema pallidum from birth, believing this will increase sensitivity of congenital Chagas and syphilis diagnose and improve follow-up of these patients.


Eligibility Criteria:
Inclusion Criteria:

* Child under 1 year of age, born from mother positive for syphilis not treated or inadequately treated during pregnancy
* Patients with acquired syphilis
* Child under 1 year of age, born from mother with positive serology test for Chagas

Exclusion Criteria:

* Patients who had received treatment for syphilis or Chagas previously
* Patients who are not able to complete scheduled visits
* Other diseases that could difficult implementation of this protocol or results interpretation.
HYDEAL-D® Application for Promoting the Restoration of Sexual Function in the Postpartum Period

During postpartum and lactation, vaginal epithelium tends to have an impaired degree of hydration and lubrication. This may lead to vaginal dryness, burning sensation dyspareunia or itching, which negatively affect the sexual function of puerperal women.

This study aimed to evaluate the efficacy of HYDEAL-D® vaginal gel (HYALOGYN®, Fidia Farmaceutici, Abano Terme, Italy) application on promoting the restoration of sexual function in the postpartum period.


Eligibility Criteria:
Inclusion Criteria:

* Women from 18 to 40 years old;
* Women in the puerperium period (after vaginal delivery or cesarean section);
* Women that are breast-feeding, that are not breast-feeding or that are breast-feeding partially;

Exclusion Criteria:

* Allergy to hyaluronic acid gel;
* Women non-Italian speaking;
* Women with signs of vaginal infection;
* Women with a history of cancer of any site with recent genital bleeding of unknown origin; and patients with acute hepatopathy, embolic disorders, severe primary disease of kidney;
* Women who are attending or have attended other clinical trials within previous two weeks;
* Women with mental disorder and no insight
The Effect of Computerized Alcohol Screening and Brief Intervention (CASI) on Alcohol Consumption in Adolescent Patients in the Emergency Department

The purpose of this research is to examine the effectiveness of the Computerized Alcohol Screening and Brief Intervention (CASI) in adolescent patients in the Emergency Department at the UC Irvine Medical Center. This research study will evaluate the effectiveness of the brief intervention compared to standard of care (no intervention). Brief interventions have a high potential impact in ED. Computerized alcohol screening and brief intervention (CASI) is a fast and easy to use tool for patients and healthcare providers. CASI provides the Alcohol Use Disorders Identification Test (AUDIT-C)4, from the World Health Organization and CRAFFT3, followed by a brief intervention and customized alcohol intake recommendations for the patient. This study will also determine the effectiveness of the brief intervention in reducing alcohol use/abuse in adolescents between 12-17 years of age.

The overall goal of this study is to identify at risk alcohol use/abuse in adolescents and provide an intervention at an early stage. The current data to support alcohol and screening and brief intervention in adolescents is limited. The researchers hope that this research study will add to the overall body of knowledge in support of using the emergency department as a tool in public health, as it relates to the individual patients morbidity and mortality (pancreatitis, cirrhosis) and to the societal costs of alcohol use (lost days of work, motor vehicle collisions).


Eligibility Criteria:
Inclusion Criteria:

- Ages 12-17

Exclusion Criteria:

- Intoxicated
The Effect of Bathing and Moisturizers on Skin Hydration in Atopic Dermatitis: an in Vivo Study

The purpose of this study is to determine the hydration effect of various regimens of skin bathing and moisturizer application on atopic dermatitis


Eligibility Criteria:
Inclusion Criteria:

* male or female;
* Age range 18-45 years;
* Subjects have history and physical findings consistent with mild to moderate AD with SCORAD score ≤ 40;
* Stop using some drugs such as oral corticosteroid for at least 4 weeks, topical corticosteroid and calcineurin inhibitor for at least 2 weeks, food supplement such as evening primrose oil, wheat extract Flax seed oil sunflowerseed oil, borage oil and fish oil for at least 3 months;
* Subjects who have signed the written informed consent.

Exclusion Criteria:

* Subjects who have medical histories such as zinc or essential fatty acid deficiency, end stage renal disease, hypothyroidism, human immunodeficiency virus (HIV), malignancies, obstructive biliary disease, diabetes mellitus and in those who have had radiation or other medical histories that may interfere the outcome;
* Subjects who ingest drugs that could interfere with the study results such as diuretics, antiandrogens, lipid reducing agents, isotretinoin cimetidine;
* Subjects cannot enroll until the end of the project;
* Subjects who have allergy to any ingredient in the moisturizer or cleanser that will be used in the protocol;
* Pregnant woman or lactating woman.
Consolidation Chemotherapy After Autologous Stem Cell Transplantation for Lymphoid Malignancies

To imporve the outcome of patients with relapsed/refractory lymphoma, we conduct a clinical trial to test the efficacy and feasibility of consolidation chemotherapy after autologous stem cell transplantation

Patients with relapsed or refractory lymphoma will be included. All patients will undergo PBSC mobilization with CTX and G-CSF. After sucessful collection of CD34+ over 1x109/L, autologous stem cel ltransplantation with Bu-Cy-E conditioning will be given. Two months after auto-HSCT, a PET-CT will be performed and all patients with CR, CRu and PR will recieved 3 cycles of mini-Bu-Cy-E as consolidation 3, 6 and 9 months after auto-HSCT. For patients with SD or PD after auto-HSCT will refered to the allogeneic transplantatio program and take off the study.

Eligibility Criteria:
Inclusion Criteria:

* Patients with relapsed or refracotry NHL or HD: PR or SD after first line salvage chemotherapy;
* ECOG: 0-2
* Tbil \< 1.5x ULN and AST/ALT \<2.5x ULN
* With informed consent

Exclusion Criteria:

* Life expectancy \< 3 months
* Women in pregnancy
* uncontrollable infection disease
* serum Cr \>400mmol/l
* uncontroled diabetis and heart disease
The Snack Study: The Feasibility of Changing Night-time Food Choices to Improve Glucose Tolerance in Pregnancy

Obesity during pregnancy increases the risk for high glucose and diabetes in the mother, and for obesity and comorbid metabolic disease in the offspring. Results of previous intervention studies designed to improve the metabolic health of obese mothers, and thereby reduce the risk to their offspring, have been modest at best. Furthermore, few studies have proved to be efficacious among low income African American women who have high risk for the transmission of obesity to future generations. The purpose of this study is to examine the feasibility of changing the types of foods and drinks that are consumed at night during late pregnancy in order to improve maternal glucose tolerance and reduce the risk for future obesity in the child.

Obesity during pregnancy increases the risk for high glucose and diabetes in the mother, and for obesity and comorbid metabolic disease in the offspring. Results of previous intervention studies designed to improve the metabolic health of obese mothers, and thereby reduce the risk to their offspring, have been modest at best. Furthermore, few studies have proved to be efficacious among low income African American women who have high risk for the transmission of obesity to future generations. The purpose of this study is to examine the feasibility of changing the types of foods and drinks that are consumed at night during late pregnancy in order to improve maternal glucose tolerance and reduce the risk for future obesity in the child. We hypothesize that women who replace their usual night-time foods and drinks with lower glycemic load options will have more stable night-time glucose and lower glucose following an oral glucose load. This intervention will be assessed in a cohort of African American women of low income, who were obese at their first prenatal care visit.

Eligibility Criteria:
Inclusion Criteria:

* African American race
* Healthy, singleton pregnancy
* ≤ 28 weeks' gestation at enrollment
* BMI of 30.0 - 45.9 kg/m2 at first prenatal visit
* Reports regular food consumption after 8pm at night that is not attributable to work schedule or other constraints.

Exclusion Criteria:

* pre-gestation or gestational diabetes
* current smoker
* presence of any medical condition or the use of any medication known to affect fetal growth
* previous delivery of a small-for-gestational age infant (\<10th percentile)
* previous delivery of a pre-term infant (\<36.0 weeks' gestation)
* inability to communicate in both verbal and written English
* unwilling or unable to consume study-provided foods.
Growth Hormone Treatment of Children Diagnosed of Intrauterine Growth Retardation

This trial is conducted in Europe. The aim of this trial is to assess and compare the efficacy and safety of two dose levels of somatropin over a long period (till final height is reached). This trial is an extension to trials GHRETARD/BDP/14/NL (a 2-year initial trial) and GHRETARD/BPD/20/NL (a 2-year extension trial).


Eligibility Criteria:
Inclusion Criteria:

* Completion of the GHRETARD/BPD/20/NL trial
* Written informed consent from child and/or parents/guardians before continuation in the extension trial
A Study of Erlotinib in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

This open-label, multi-center study will evaluate the progression-free survival and safety of erlotinib in participants with locally advanced or metastatic non-small cell lung cancer with activating mutations in the tyrosine kinase domain of the epidermal growth factor receptor (EGFR). Participants will receive daily oral doses of erlotinib until disease progression or unacceptable toxicity.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of locally advanced or metastatic non-small cell lung cancer with activating mutations in the tyrosine kinase domain of the EGFR
* Measurable disease according to RECIST
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Life expectancy greater than or equal to (\>/=) 12 weeks
* Adequate hematological, liver and renal function
* Participants with asymptomatic and stable cerebral metastases receiving medical treatment

Exclusion Criteria:

* Previous chemotherapy or treatment against EGFR for metastatic disease
* Treatment with an investigational agent less than 3 weeks before enrollment
* History of neoplasm other than non-small cell lung cancer (except carcinoma in situ of the uterine cervix, basal cell skin carcinoma, or prostate carcinoma)
* Participants with symptomatic cerebral metastases
* Any significant ophthalmologic abnormality
* Unstable systemic disease
* Coumarins use
* Evidence of any other disease, neurological or metabolic dysfunction, physical examination or laboratory finding contraindicating the use of an investigational drug
* Participants with pre-existing parenchymal lung disease such as pulmonary fibrosis, lymphangiosis carcinomatosis
* Participants with known infection with human immunodeficiency virus (HIV), Hepatitis B (HBV), Hepatitis C (HCV)
A Study of Epacadostat (INCB024360) in Combination With Durvalumab (MEDI4736) in Subjects With Selected Advanced Solid Tumors (ECHO-203)

The purpose of this study is to explore the safety, tolerability, pharmacokinetics, immunogenicity and preliminary efficacy of INCB024360 administered in combination with MEDI4736 in subjects with selected advanced solid tumors.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects, age 18 years or older
* Histologically or cytologically confirmed diagnosis of selected locally advanced or metastatic solid tumors
* Must have failed at least 1 prior treatment regimen for locally advanced or metastatic disease or be intolerant to treatment or refuse standard treatment

Exclusion Criteria:

* Laboratory and medical history parameters not within protocol-defined range
* Participation in any other study in which receipt of an investigational study drug occurred within 28 days or 5 half-lives (whichever is longer) prior to first dose
* Prior treatment with immune checkpoint inhibitors (eg, anti-CTLA-4, anti-PD-1, anti-PD-L1, and any other antibody or drug specifically targeting T-cell co-stimulation) or an IDO inhibitor (exception is tumor types in which a PD-1 pathway targeted agent is approved, e.g. melanoma, non-small cell lung cancer.)
* Receipt of any anticancer medication in the 21 days prior to receiving the first dose of study medication
* Has an active or inactive autoimmune process
* Evidence of interstitial lung disease or active, non-infectious pneumonitis
* Prior radiotherapy within 2 weeks of initiating treatment; Must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis
* Untreated central nervous system (CNS) metastases or CNS metastases that have progressed
* Currently pregnant or breastfeeding
A Comparison of Specialized Versus Standard Compression After Saphenous Ablation

The purpose of this study is to determine if the use of specialized compression garments, in comparison to standard compression, improves early patient outcomes after endovenous ablation.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years and above
* CEAP Class C2 or C3 disease
* Incompetence of the great saphenous vein defined a reflux persisting\>0.5 seconds in the upright position
* Planned endovenous ablation of the great saphenous vein

Exclusion Criteria:

* Inability of patient or legal guardian to provide informed consent
* Previous history of DVT
* Clinical evidence of significant chronic venous disease (CEAP classes C4, C5, C6)
* Planned concomitant phlebectomy or sclerotherapy within 4 weeks of endovenous ablation
* Documented allergy or intolerance to compression stockings
* Arterial insufficiency as documented by an ankle-brachial index \<0.5
* Known prothrombotic condition
* Life expectancy less than 1 year
* Inability to return for follow-up due to geographic inaccessibility, concurrent medical conditions or substance abuse
* Weight greater than 220 pounds or height \> 6'4"