cyrilzakka/clinical-trials huggingface dataset:
Molar Incisor Malformation in Egypt

The aim of the current study is to assess the prevalence of molar incisor malformation in Fayoum-Egypt.

Localized developmental radicular dysplasia is a rare finding. This radicular formation arrest may be due to traumas, infections, radiation therapy, chemotherapy, or idiopathic.

Molar Incisor Malformation is a condition characterized by arrested or altered radicular development of first permanent molars. Roots may be thin, short, or totally missing. In some patients, there are constrictions located in the cervical part of the crown of the permanent incisors. There are also cases where the roots of the second primary molars are affected.

MIM could also have been mistaken for a consequence of severe root resorption, or dentine dysplasia prior to its initial description.

This unique deformity, regardless of its nomenclature, presents previously undescribed clinical features and it is quite difficult to get a successful conservative treatment result.

The aim of the current study is to assess the prevalence of this rare condition in Fayoum-Egypt.

Eligibility Criteria:
Inclusion Criteria:

* Panoramic radiographs for older than nine-year-old patients, having completely developed first permanent molars

Exclusion Criteria:

* Panoramic radiographs with missing first permanent molars or pathological lesions which may cause root resorption
Experience From the Italian S-ICD Registry

The purpose of this registry is to collect data on implant parameters, early, mid and long-term clinical effectiveness of Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) therapies in order to better understand how to improve the clinical care of patients and effectiveness of S-ICD therapies.

ISIR is an observational, multicentric registry designed to collect implant and follow-up data of consecutive patients implanted with Subcutaneous Implantable Cardioverter Defibrillator (S-ICD).

A number of about 10 enrolling centers is estimated with an overall number of 400 patients.

A minimal follow-up of 6 months is required before analyzing clinical outcomes. The data analysis will focus on implant outcomes and early, mid and long-term effectiveness of S-ICD therapies and safety.

Eligibility Criteria:
Inclusion Criteria:

* Age \>/= 18 years
* Patients successfully implanted with S-ICD
* Patients able to provide written informed consent or have informed consent as provided by a legal representative
Vibration Response Imaging (VRI) in Children With Acute Respiratory Symptoms

The VRI device may provide a complementary diagnostic tool for lung examination and aid the physician in determining whether a chest x-ray should be performed.

This study is a prospective, single center study to determine the value of VRI images as an aid in determining whether a chest x ray is necessary to evaluate children presenting with acute respiratory complaints.

Study participants will be children, selected from the Emergency Department (ED), who were designated to undergo a PA and Left Lateral CXR because of acute respiratory complaints such as a new respiratory condition, acute cough, onset of shortness of breath, or fever.

Patients who meet the study inclusion and exclusion criteria will be enrolled and will be recorded by the VRI device.

A technician will perform a CXR on the enrolled patients. The CXR and the VRI will be performed on the same day within 6 hours of each other.

VRI readers, who are blinded to the patient's CXR, history, and physical exam, will evaluate the VRI recording. The VRI reader will review the VRI images and, using the lexicon of images supplied by Deep Breeze, determine whether the VRI is normal or abnormal.

Certified radiologists will review the patient's CXR and will determine whether the CXR is normal or abnormal based solely on the CXR.

The VRI readers determination of normal or abnormal for each subject will be compared to the radiologists determination of normal or abnormal CXR for each subject.

Eligibility Criteria:
Inclusion Criteria:

1. Subject's parent or legal guardian, is able and willing to read the Informed Consent, understands the Informed Consent, and provides written Informed Consent for the subject; if the minor child is in fact able to give consent, the minor's consent must be obtained in addition to the consent of the minor's legal guardian.
2. Boy or girl in the age range of 3-18 years.
3. Patient presented with acute respiratory complaints, acute cough, onset of shortness of breath, or fever.
4. Patient referred by ED physician and presented for CXR.

Exclusion Criteria:

1. Body habitus or skin condition that might prevent the placement of the sound sensors on the back (e.g. severe scoliosis, kyphosis, chest wall deformation, skin lesion on the back or compression fracture);
2. Potentially contagious skin lesion on the back;
3. Subject has had lung surgery;
4. Subject was prescribed the CXR for monitoring or follow up of a lung condition that pre-existed the current, acute symptoms.
Primary Subtalar Arthrodesis for Calcaneal Fractures

Management of severe injuries to the heel (displaced intra-articular calcaneus fractures) continues to be a major challenge for orthopedic surgeons. Previous studies have demonstrated poor outcomes, and results show that patients experience long-term pain and decreased quality of life postoperatively. Poor outcomes are driven by pain, in particular, which is linked to post-traumatic subtalar arthritis.

The goal of this clinical trial is to compare two surgical options for calcaneus fractures to determine best treatment for returning to work sooner in adults.

Participants will be randomized to one of two treatment options and will be asked to complete patient reported outcome measure surveys.

Researchers will compare Open Reduction and Internal Fixation (ORIF) + Primary Subtalar Arthrodesis (PSTA) to ORIF alone to see which group returns to work at an earlier timepoint.

Eligibility Criteria:
Inclusion Criteria:

* Undergoing operative treatment for displaced intra-articular calcaneus fracture
* Sanders III and IV displaced intra-articular calcaneus fracture OR Sanders II with any of the following criteria: Bohler angle \< 0 degrees, open fracture, pain syndrome, substance use disorder
* Age 18 or older
* Able to follow up at site for 1 year

Exclusion Criteria:

* Planned surgery using extensile lateral approach
* Sanders II displaced intra-articular calcaneus fracture without: Bohler angle \< 0 degrees, open fracture, pain syndrome, or substance
* \<18 years of age
* Body Mass Index (BMI) \>40
* Unable to follow up at site for 1 year
* Patients that speak neither English or Spanish
* Prisoner
Phase I, Open Label,Crossover Food-Effect and Absolute Bioavailability Study of WCK2349 and WCK771 in Healthy Adult Human Volunteers

This study is aimed to ascertain the effect of food on pharmacokinetics of WCK 2349 and determine the absolute bioavailability of WCK 2349 1000 mg (oral, QD dose) with respect to WCK 771 800 mg (intravenous, QD dose).

This study would ascertain/confirm the therapeutically equivalent oral and IV doses of WCK 2349 and WCK 771 respectively, and provide guidance in case of switch over therapy (WCK 771, IV to WCK 2349, oral) in future clinical trials in patients.

All the subjects will be checked-in into the clinical study facility on Day -1, the day prior to dosing. The subjects will be randomly assigned to receive WCK 2349 1000 mg as an oral dose in fed or fasting state (1:1) in the food effect study as per the randomization schedule. The subjects completing the food effect study (i.e., Period 1 and Period 2) will be administered WCK 771 800 mg as an intravenous infusion in fasting state in Period 3 of the study. There will be a washout period of three days between each period. The subjects will continue to remain in the clinical facility for the entire duration of the study (completion of three periods in the study), including wash out period. Prior to check out procedure, detailed clinical examination will be done to confirm that subject has no safety issues.

Eligibility Criteria:
Inclusion Criteria:

* If female, postmenopausal for at least 1 year,surgically sterile or birth control measures.
* Body Mass Index (BMI) between 18 and 32
* No significant diseases
* No recent history of smoking or alcohol

Exclusion Criteria:

* Known history of hypersensitivity or idiosyncratic reaction to quinolones or any other related drugs.
* History or evidence of disease or condition which might compromise the haemopoietic, renal, hepatic,endocrine, pulmonary, central nervous, cardiovascular,immunological, dermatological, gastrointestinal or any other body system.
* No receipt of a prescription drug or non-prescription drug .
To Demonstrate the Relative Bioequivalency of Comparing Single 100 mg Doses Of Cord's 50 mg Desipramine HCL Tablets To Merrell Dow's 50 mg Norpramin Tablets

To demonstrate the relative bioequivalency of comparing single 100 mg doses Of Cord's 50 mg Desipramine Hcl tablets to Merrell Dow's 50 mg Norpramin tablets.


Eligibility Criteria:
Inclusion Criteria:

* No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

Exclusion Criteria:

* Positive test results for HIV or hepatitis B or C.
* Treatment for drug or alcohol dependence.
A Pilot Study of Ultrasound-guided Vacuum-assisted Excision of Breast Cancers

This study is looking into whether the procedure called Vacuum Assisted Excision (VAE) is a safe method for the removal of small and medium sized invasive breast cancers in patients who are unfit or have refused to have surgery to remove cancer.

Recruitment Target: 20


Eligibility Criteria:
Inclusion Criteria:

* The patient is aged 18 years or older.
* Diagnosis on core needle biopsy of invasive cancer of the breast
* Unifocal invasive tumour on imaging (hormone receptor positive or negative)
* T1 or T2 primary or locally recurrent tumour measuring ≤25mm on imaging, excluding any adjacent ductal carcinoma in situ (largest of the measurements on mammography (including digital breast tomosynthesis if performed) and ultrasound)
* The tumour is clearly visible on ultrasound
* Vacuum-assisted excision of the entire ultrasonically visible tumour is deemed to be technically feasible
* The patient is considered to be at high risk of complications or death from a general anaesthetic and therefore surgery under general anaesthesia is not considered appropriate. This must be confirmed by agreement by two named consultant breast surgeons, a multidisciplinary team meeting (including at least one consultant breast surgeon) or by formal anaesthetic assessment. Unsuitability for surgery under local anaesthetic must be confirmed by a consultant breast surgeon.
* or - The patient refuses to undergo surgery. This must be confirmed by a consultant surgeon and breast care nurse following full discussion of the treatment options.
* or - The patient is considered unlikely to benefit from surgical removal of the cancer by virtue of known metastatic disease or other life-shortening condition. This must be confirmed by discussion in a multidisciplinary team meeting which includes an oncologist.
* The patient has given written informed consent for the study Women who are already on primary endocrine therapy for a breast cancer and meet the inclusion criteria will also be eligible.

Exclusion Criteria:

* The patient is on anticoagulants or has a known clotting disorder
* Pregnancy or lactation
* Allergy to local anaesthetic
Stress Management Intervention for Mothers of Children With Cancer

To explore maternal biological (activation of the hypothalamic-pituitary-adrenal axis) and behavioral (smoking, sleep behavior, exercise and alcohol use) pathways of intervention-related decreases in inflammation. Hypothesis: The intervention group will show decreased levels of cortisol and improved health behaviors from pre- to post-intervention when compared with the control group. We will also explore whether intervention-related changes in these parameters predict symptoms of illness. Exploratory Aim 2. To explore psychological pathways of intervention-related decreases in distress among mothers, including the perception of social support and the use of behavioral coping strategies that are components of the intervention. Hypothesis: Increases in perceived social support and use of active behavioral coping strategies will be associated with intervention-related decreases in symptoms of depression, anxiety and psychological stress.


Eligibility Criteria:
Inclusion Criteria:

* biologic, adoptive, or legal guardian mothers of children (birth to 17 years) who are within 6 weeks of being newly diagnosed with any cancer, with the exception of a central nervous system (CNS) cancer or early stage lymphoma, recruited from the Division of Hematology and Oncology, Children's Hospital of Pittsburgh (CHP)
* no reported clinical history of psychotic or bipolar illness, neurological disorder (stroke, transient ischemic attacks, Parkinson's disease, multiple sclerosis) or chronic disease known to influence immune function, including cardiovascular disease, cancer \[within the past 2 years\], or autoimmune disease
* not taking medications that might alter responses to questionnaires or indices of immune function (including major sedatives or glucocorticoid, anti-inflammatory, anti-retroviral, or immunosuppressant medication)
* fluency in English (i.e., have commonly used English in everyday speaking and reading for at least 10 years)
* is at least 18 years of age
* not working nightshifts exclusively.

Exclusion Criteria:

* mothers of children with CNS cancers due to our belief that a psychosocial intervention tailored more specifically to the unique stressors inherent in this diagnosis is warranted
* mothers of children with early stage lymphomas will be excluded because of their child's brief/mild treatment course
* mothers whose child is older than 17 years will not be eligible; the upper age limit (17 years) was established based on referral patterns at the CHP hematology/oncology department.
Comparison of Stapler Line Bleeding Control Techniquessurgery

Introduction RYGB surgeon; Have become increasingly morbid obesity treatment methods with improvements in minimally invasive surgery. Ensuring patient comfort and early return to life are the criteria that should be given priority in this treatment method.The purpose of this study; Emphasizing that the cautery technique of the stapler line bleeding control methods is as successful as the other methods.

The question of the availability of cautery in RYGB surgeons

Eligibility Criteria:
Inclusion Criteria:

* Morbid obese patients

Exclusion Criteria:

* Cirrhotic patients, those under 18 years of age, additional intraabdominal surgeries during LRYGBP and those who had previously undergone obesity surgery (revision surgery)
A Study to Asses Effectiveness and Treatment Management of Oral Venetoclax Tablets + Subcutaneously Injected Azacitidine in Adult Participants Ineligible for Intensive Chemotherapy With de Novo Acute Myeloid Leukemia (AML) in Italy

Acute myeloid leukemia (AML) is a cancer of the blood and bone marrow and is the most common acute leukemia in adults. This study will evaluate how well venetoclax in combination with azacitidine works to treat AML in newly diagnosed adult participants who are ineligible for intensive chemotherapy in Italy.

Venetoclax in combination with azacitidine is approved in Italy to treat Acute myeloid leukemia (AML) in newly diagnosed adults who are ineligible for intensive chemotherapy. All study participants will receive venetoclax in combination with azacitidine as prescribed by their study doctor in accordance with approved local label. Adult participants with a new diagnosis of AML will be enrolled. Around 150 participants will be enrolled in the study at approximately 20-25 sites in Italy.

Participants will receive venetoclax tablets to be taken by mouth in combination with azacitidine given by subcutaneous (SC) injection according to the approved local label. The duration of the study is approximately 18 months.

There is expected to be no additional burden for participants in this trial. All study visits will occur during routine clinical practice and participants will be followed for 18 months.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of primary or secondary acute myeloid leukemia (AML), deemed ineligible for intensive induction chemotherapy because of age, performance status, comorbidities or any other clinical reason as defined by the treating physician.
* Investigator decision on patient treatment with venetoclax + azacitidine must have been reached prior to and independently of recruitment in the study.
* Treatment prescribed in accordance with the applicable approved label and local regulatory and reimbursement policies.

Exclusion Criteria:

* Participants affected by Acute Promyelocytic Leukemia.
* Prior treatment for AML, excluding hydroxyurea.
* Participation in a clinical trial of an investigational drug, concurrently or within the last 30 days. Participation in another post-marketing observational study or Registry is acceptable
Community-based Evaluation of a Pilot PMTCT Project in Kafue District

In this study, the investigators will assess the population effectiveness of using routine HAART as a PMTCT strategy, through a community-based survey. The survey will be done in the catchment areas of four health clinics in rural Zambia both before and after giving routine ART in the clinics, so as to estimate population HIV-free survival among infants born in each target community.

The investigators hypothesize that incorporation of routine ART into PMTCT will increase the HIV-free survival of exposed infants to 75%.

The primary objective is to determine the incremental benefit of a routine ART strategy for PMTCT on a population basis, when compared to short-course Zidovudine and single-dose Nevirapine (the current PMTCT standard of care).

We will take advantage of planned implementation of a pilot project for routine ART across four primary care centres in rural Zambia (Kafue District). Using a community-based survey modeled after the Demographic and Health Survey, we will measure HIV-free survival among children under two years of age in the catchment areas surrounding these pilot sites, both before and after implementation of services. We will use before-after comparisons in each of these four communities to better understand the incremental benefit of providing these services.

Eligibility Criteria:
Inclusion Criteria:

* Household where a child has been born in the past two years.

Exclusion Criteria:

* Household where there no child has been born in the past two years.
Effectiveness of Peer Navigation to Link Released HIV+ Jail Inmates to HIV Care

This study will implement a peer navigation intervention to improve linkage to and retention in HIV care for inmates released from L.A. county jail into the community.

The proposed study has two Primary Specific Aims:

1. To examine individual-level and structural-level barriers to HIV care after release from jail, using formative semi-structured interviews with ex-inmates, case managers, and HIV care providers; and to use the information we obtain to inform the adaptation and tailoring of an intervention designed to improve linkage with and retention to HIV care for HIV+ ex-inmates (Complete);
2. Using a two-group experimental RCT design, to test the adapted peer navigation intervention condition for HIV+ inmates upon release from jail compared to a usual care condition, and to evaluate the intervention's effectiveness at improving linkage with and retention in HIV care, self-reported ART adherence, and HIV RNA viral load suppression;

The intervention is hypothesized to result in greater linkage to care, a greater proportion completing at least three HIV care visits per year, increased self-reported ART adherence, and decreased levels of HIV RNA viral load compared to the usual care control group.

Secondary Aims of the study include assessing the potential moderating effects of substance abuse, the potential mediating effects of substance abuse treatment, and the program's effects on recidivism, and costs.

Active substance abuse is hypothesized to moderate the effect of the intervention, such that the intervention will be less effective among participants who report substance use.

Eligibility Criteria:
Inclusion criteria:

* Age 18 or older
* Men or TGW diagnosed HIV-positive
* English or bilingual Spanish speaking
* Selected for the TCM program (control condition) prior to LINK LA enrollment
* Residing in LA County upon release
* Eligible for ART or incarcerated on ART.

Exclusion criteria:

* Inability to give informed consent
* Parole hold or planned transfer to prison
* Stay in jail \<5 days.
Efficacy and Safety of Oral Tofacitinib in the Treatment of Alopecia Areata

This clinical trial was conducted at the Dermatology department of Services hospital Lahore. Patients of extensive and treatment resistant Alopecia areata were enrolled after ethical approval and informed consent by non-probability consecutive sampling. Inclusion criteria: Treatment with oral tofacitinib citrate was initiated at 5 mg twice daily for six months. Scalp hair loss was calculated at 4, 12 and 24 weeks using the validated Severity of Alopecia Tool (SALT) score, which ranges from 0% to 100%. Regrowth rate: (initial SALT score - final SALT score)/(initial SALT score) × 100 was noted. Response time (time from initiation of treatment to any sign of hair regrowth) was noted. DLQI of patients before and after treatment were noted. Side effects were noted. Pre- and post-treatment photographs were taken. Patients were followed up for another 6 months to look for relapse.

Data were entered and analyzed using SPSS 20. Means were calculated for quantitative variables, frequencies for qualitative data. Data were stratified for the role of effect modifiers.

This clinical trial was conducted at the Dermatology department of Services hospital Lahore. Patients of extensive and treatment resistant Alopecia areata were enrolled after ethical approval and informed consent by non-probability consecutive sampling. Treatment with oral tofacitinib citrate was initiated at 5 mg twice daily for six months after labs and ruling out contraindications. Scalp hair loss was calculated at 4, 12 and 24 weeks using the validated Severity of Alopecia Tool (SALT) score, which ranges from 0% to 100%. Regrowth rate: (initial SALT score - final SALT score)/(initial SALT score) × 100 was noted. Response time (time from initiation of treatment to any sign of hair regrowth) was noted. DLQI of patients before and after treatment were noted. Side effects were noted. Pre- and post-treatment photographs were taken. Patients were followed up for another 6 months to look for relapse.

Data were entered and analyzed using SPSS 20. Means were calculated for quantitative variables, frequencies for qualitative data. Data were stratified for the role of effect modifiers.

Eligibility Criteria:
Inclusion Criteria:

* Either gender Age 18 to 60 years Extensive disease (SALT \> 24)

Exclusion Criteria:

* Patients taking immunosuppressants or DMARDs Recent live vaccination Active or latent TB, Hepatitis B or C, HIV Malignancy Hypersensitivity to the drug Pregnant or lactating mothers