cyrilzakka/clinical-trials huggingface dataset:
Mixed-Methods Evaluation of Short-, Medium-, and Long-Term Outcomes Following Hip Treatment

This study, titled "Mixed-Methods Evaluation of Short-, Medium-, and Long-Term Outcomes Following Hip Treatment," aims to assess the long-term effectiveness of treatments for pediatric hip conditions, including hip dysplasia, Legg-Calve-Perthes disease, SCFE, and avascular necrosis.

Conducted at Mayo Clinic, the study combines retrospective chart reviews and prospective follow-up to gather data on clinical outcomes, radiographic measures, and patient-reported outcomes (PROs) like functional status, pain, and quality of life.

The retrospective component analyzes records from 1975 to 2024, while the prospective component includes follow-up surveys using validated PRO measures (e.g., HOOS, SF-12, VAS). This study seeks to identify recurrence rates and complications associated with hip treatments, providing insights to improve future care standards for pediatric hip conditions. Data will be securely stored, with confidentiality maintained throughout.

Eligibility Criteria:
Inclusion Criteria:

* Patients over the age of 18 seen for a concern of hip pathology at Mayo between 1975 and 2024
* Patients over 18 who can be contacted for follow-up and are willing to participate.

Exclusion Criteria:

* Patients presenting over age 18 for hip dysplasia
* Patients who are unwilling to complete follow up surveys.
Adapting MHealth Technology to Improve Patient Activation

Persons with disabilities (PwD) commonly experience fatigue, which often negatively impacts their everyday lives. Management of this symptom can be challenging. Satisfaction with current interventions to manage fatigue is low among PwD and there is a desire for more personalized approaches. The purpose of this study is to develop and test a fatigue self-management intervention using mobile phones that is personalized to each person's needs.

Persons with disabilities (PwD) commonly experience fatigue, which adversely impacts their everyday lives. Information to manage and improve fatigue can be complicated and overwhelming. Little has been done to link mobile health (mHealth) approaches with patient activation and self-management to effectively address fatigue for PwD. The purpose of this study is to develop and pilot-test a fatigue self-management short message service (SMS) text intervention using mobile phones to target patient activation levels in PwD. The proposed study will: (1) develop content for a fatigue self-management intervention using SMS tailored to patient activation levels in persons with multiple sclerosis, spinal cord injury, and stroke. An advisory board made up of one physical medicine and rehabilitation physician and six PwD will provide input on the content and format for the developed content. (2) test the feasibility and acceptability of SMS to improve patient activation for fatigue self-management in PwD. The long-term goal is to improve the health of PwD by increasing their skills, confidence, and knowledge to manage fatigue and other chronic symptoms that affect their daily life.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* had disability for at least one year
* score of less than 10 on the Modified Fatigue Impact Scale 5 question (MFIS-5)
* ability to read and speak English at the 6th grade level
* willing to use their own phone and SMS

Exclusion Criteria:

* evidence of acute condition (e.g. relapse)
* sleep apnea
* inability to answer interview questions or provide consent
* terminal cancer
Low Intensity Shock Wave Therapy in the Rehabilitation Treatment of Erectile Dysfunction After Robotic Radical Prostatectomy.

The study deals with the hypothesis that LiESWT in addition to the administration of PDE5i can improve sexuality rehabilitation with faster recovery of a valid erection and higher IIEF-5 scores in the short and medium-term follow-up.

Prospective randomized controlled trial (RCT) designed to provide high level evidences describing the role of Low-intensity Extracorporeal Shock Wave Therapy LiESWT plus early introduction of PDE5i vs early PDE5i alone on penile rehabilitation of erectile dysfunction ED after treatment of post-Robot-Assisted (RA) Radical Prostatectomy (RP) RARP

Eligibility Criteria:
Inclusion Criteria:

* Patients aged ≤75 yrs;
* Low-risk PCa (PSA \<10 ng/mL and GS \<7, ISUP grade 1, and cT1-2a) undergoing nerve sparing RARP;
* preoperative IIEF-5 score ≥ 17;
* First PSA (45d after surgery) \<0.2
* compliants patients able to follow the study protocol and fill in IIEF-5 scores and EORTC quality of life questionnaires;
* patients able to provide a written informed consent for the trial.

Exclusion Criteria:

* anaesthesiologic contraindications to robotic surgery;
* patients submitted to pelvic radiotherapy or androgen deprivation;
* patients reporting major postoperative complications (CD≥3);
* cardiovascular contraindications to PDE5i medical treatment.
Fanconi Syndrome Due to ARVs in HIV-Infected Persons

Cross-sectional cohort study of participants with HIV with or without protocol-defined Fanconi syndrome (confirmed creatinine clearance \[CLcr\] decline and evidence of proximal tubulopathy).


Eligibility Criteria:
Inclusion Criteria - Fanconi Cases

Subjects must meet all of the following inclusion criteria to be eligible for participation in this study.

* Adult (greater than or equal to 18 years) HIV-1 infected subjects regardless of race or ethnicity.
* Subjects must be on a stable ARV regimen for greater than or equal to 1 month prior to study entry.
* Evidence of protocol-defined Fanconi syndrome
* TDF subjects must be on TDF-containing regimen at the time of onset of Fanconi syndrome.
* Negative serum pregnancy test (females of child-bearing potential only).
* Less than two years post-menopausal women of child-bearing potential (TDF subjects only) agree to follow an adequate birth control barrier method or agree to abstain from heterosexual intercourse while participating in the study.
* The ability to understand and sign a written informed consent form, which must be obtained prior to initiation of any study procedures.

Exclusion Criteria - Fanconi Cases

Subjects who meet any of the following exclusion criteria are not to be enrolled in this study.

* Non TDF subjects who have received any TDF within the prior 6 months, or those who have received greater than 2 weeks cumulative treatment.
* TDF subjects who have previously served as a TDF control for this protocol.
* History of current alcohol or substance abuse judged by the investigator to potentially interfere with laboratory results.

Inclusion Criteria - Controls

Subjects must meet all of the following inclusion criteria to be eligible for participation in this study.

* Adult (greater than or equal to 18 years) HIV-1 infected subjects regardless of race or ethnicity.
* No evidence of protocol-defined Fanconi syndrome
* On a TDF-containing regimen matched to a Fanconi case by clinic location, duration on TDF and age.
* Negative serum pregnancy test (females of child-bearing potential only).
* The ability to understand and sign a written informed consent form, which must be obtained prior to initiation of any study procedures.

Exclusion Criteria - Controls

Subjects who meet the following exclusion criteria are not to be enrolled in this study.

• History of current alcohol or substance abuse judged by the investigator to potentially interfere with laboratory results.
ToleroMune Ragweed Exposure Chamber Study

It is believe that ragweed is the primary cause of autumn allergies and 87% of patients with ragweed allergy suffer rhinoconjunctivitis. ToleroMune Ragweed is a novel, synthetic, allergen-derived peptide desensitising vaccine, currently being developed for the treatment of ragweed allergy.

This study will look at the efficacy, safety and tolerability of two doses of ToleroMune Ragweed in ragweed allergic subjects following challenge with ragweed in an EEC.

This study is designed as a randomised, double-blind, placebo-controlled, parallel group study to evaluate the safety and tolerability of ToleroMune Ragweed in ragweed allergic subjects with allergic rhinoconjunctivitis,subjects may also have controlled asthma. The efficacy of ToleroMune Ragweed will be explored in subjects using an(Environmental Exposure Chamber)EEC.

The study will consist of 3 study periods. In Period 1, Screening will be performed up to a maximum of 12 weeks before randomisation and may consist of one or two visits to the clinic, at the Investigator's discretion. Baseline Challenge will consist of 4 visits to the EEC at least 3 days before randomisation.

In Period 2, subjects in each cohort complying with the inclusion/exclusion criteria will be randomised to one of five groups and will receive treatment every 2 weeks (±2 days) for 14 weeks.

In Period 3, Post Treatment Challenge will consist of 4 visits to the EEC 18-22 weeks after the first administration in the treatment period and assessments will be performed identical to those at the baseline challenge. Follow-up will be conducted 3-10 days after PTC.

Eligibility Criteria:
Inclusion criteria

* Male or female, aged 18-65 years.
* Minimum 2-year documented history of rhinoconjunctivitis on exposure to ragweed. \[Subjects may also have controlled asthma
* Positive skin prick test to ragweed allergen.
* Minimum qualifying rhinoconjunctivitis symptom scores

Exclusion criteria

* History of asthma.
* A history of anaphylaxis to ragweed allergen.
* Subjects with an FEV1 \<70% of predicted.
* Subjects who cannot tolerate baseline challenge in the EEC.
* Subjects for whom administration of epinephrine is contra-indicated (e.g. subjects with acute or chronic symptomatic coronary heart disease or severe hypertension).
* A history of severe drug allergy, severe angioedema or anaphylactic reaction to food.
* A history of any significant disease or disorder (e.g. cardiovascular, pulmonary, gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, neoplastic/malignant, psychiatric, major physical impairment).
Brain and Coordination Changes Induced By Robotics and FES Treatment Following Stroke

The long-range goal of this work is to identify how to target treatment so that the brain is functionally re-organized to produce movement. This study will compare treatment response to robotics versus functional neuromuscular stimulation.

Methods. Up to ninety-six chronic stroke subjects (\> 12 months post stroke) will be randomized to one of the treatment groups: Wrist/hand Functional Electrical Stimulation (FES)+whole arm motor learning group; shoulder/elbow robotics + whole arm motor learning group; and whole arm motor learning group. For all groups, treatment will offered 5 hrs/day, 5 days/week, for 12 weeks. All three treatment groups will receive motor learning therapy. For the Wrist/hand FES+whole arm motor learning group, there will be the addition of FES during treatment. For the Shoulder/elbow robotics + whole arm motor learning group there will be the addition of robotics training. Outcome measures will be collected at weeks 1, 6, 12, and three months after the end of treatment. Measures will include muscle strength (Manual Muscle Testing); coordination of joint movement (Fugl-Meyer Coordination Scale); motor control of target acquisition, pathway maintenance; and smoothness of movement (robotics measures); performance of 13 functional tasks (Arm Motor Ability Test); and quality of life (Stroke Impact Scale). Measures of brain function will be non-invasive and will include cognitive planning time, cognitive effort level, and location of brain activity during simple shoulder and arm movements. Changes in brain function measures will reflect plasticity or adaptability in response to treatment.

Eligibility Criteria:
Inclusion Criteria:

* Medically stable and at least 12 months post stroke.
* Difficulty using upper limb for functional tasks.
* Age \>21 years

Exclusion Criteria:

uncontrolled, chronic medical condition
Newer Therapeutic Targets in Head and Neck Cancers

Based on the recently identified mutations in HNSCCs, the major pathologic pathways implicated in the tumorigenesis of HNSCC include dysregulation of four processes:

1. cellular survival and proliferation (e.g., TP53, EGFR, MET, and PIK3CA);
2. cell-cycle control (e.g., CDKN2A and CCND1);
3. cellular differentiation (e.g., NOTCH1); and
4. Adhesion and invasion signaling (e.g., FAT1).7 TP53, EGFR, PIK3CA, CDKN2A, CCND1, and MET participate in several common signaling pathways.

Alterations of these genes are most frequently seen in alcohol and tobacco-related HNSCC. However their role in prognostication and selection of therapeutics is not known

Sample size:

Patients with squamous cell carcinoma of oral cavity fulfilling the inclusion and exclusion criteria and willing to participate will be included in this study.

Method:

Comprehensive history and physical examination of the patients will be carried out and all the details will be recorded in the preset proforma. All routine investigations as indicated including a biopsy to establish a diagnosis and CT of the head and neck to measure the tumor dimensions and stage the disease before initiation of treatment will be recorded. The paraffin embedded tissue will be studied for expression of various genetic mutations using NGS platform. Brush cytology will be collected in liquid medium for HPV typing using PCR.

The Ion AmpliSeq™ Cancer Hotspot Panel v3 will be used to detect hotspot regions of 161 oncogenes and tumor suppressor genes This research panel, with improved primer design, contains 4,648 total 4 pools (DNA pool 1: 1,891 amplicons. DNA pool 2: 1,890 amplicons. RNA pool 1: 447 amplicons. RNA pool 2: 420 amplicons.), enabling researchers to sequence challenging samples of formalin-fixed, paraffin-embedded (FFPE) tissue. Copy Number Variants (CNVs), Gene Fusions, Insertions-Deletions (indels), Single Nucleotide Polymorphisms (SNPs), Somatic Variants are identified.

HPV DNA PCR METHODOLOGY

DNA will be isolated by using QIAamp DNA mini kit (Qiagen, Hilden, Germany). The presence of HPV will be detected by using the digene® HC2 HPV DNA Test- The digene HC2 HPV DNA Test uses Hybrid Capture 2 technology to detect high-risk and low-risk HPV genotypes. It uses in vitro microplate assay based on signal-amplified nucleic acid hybridization that uses chemiluminescence for the qualitative detection of 18 types of human papillomavirus (HPV) (13 high risk and 5 low risk) DNA in cervical specimens. The test uses an RNA probe cocktail that detects 13 high-risk HPV types (16/18/31/33/35/39/45/51/52/56/58/59/68) and 5 low-risk types (6/11/42/43/44).

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven cases of primary head and neck cancers.

Exclusion Criteria:

* Patients under 18 years of age
* Pregnant and lactating women
* Multiple cancers or patients with cancer of other sites.
Evaluation of the Clinical Efficacy of Moxibustion With Regulating Yin and Yang in the Treatment of Menopausal Obesity

This study is designed as a two-dummy randomized controlled trial to evaluate the safety and superiority of Yin and Yang regulating moxibustion in the treatment of menopausal obese patients.

The study will be a multicenter, randomized, controlled trial, conducted from January 2021 to December 2022, including 216 menopausal obese patients who meet the inclusion criteria. The subjects will be randomly divided into 2 treatment groups: Yin and Yang regulating moxibustion group and mild moxibustion group. Each group of treatment will last for 12 weeks, with a follow-up period of 12 weeks. The main outcome indicator is waist circumference. The secondary outcome indicators include subjects related to obesity, TCM clinical syndrome score and modified Kupperman score, weight impact on quality of life scale (IWQOL-Lite), quality of life assessment health survey summary (SF-36). During the intervention period, adverse events will be recorded.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who meet the diagnostic criteria for menopausal syndrome and obesity;
2. Patients with BMI≥25 and waist circumference≥80cm;
3. Female patients between 40-60 years old;
4. Have not taken any hormone drugs or weight loss related drugs in the past 3 months;
5. Sign the informed consent and voluntarily accept the intervention methods of this project.

Exclusion Criteria:

1. Unexplained vaginal bleeding, or unnatural menopause;
2. Have used hormone replacement therapy or other drugs related to this disease in the past 3 months;
3. Combined with serious organic diseases, endocrine diseases, heart, liver and kidney, and respiratory diseases;
4. Secondary obesity caused by hypothalamic lesions, hypothyroidism, glucocorticoid therapy, etc.;
5. Combined with organic uterine diseases, such as polycystic ovary syndrome, malignant tumors, severe cervical erosion, after total hysterectomy, etc.;
6. There are contraindications to moxibustion, such as moxibustion intolerance, skin allergies, scars, and other serious skin diseases;
7. Poor compliance and unable to adhere to treatment.
Aneurysm Wall Histology Registry

The purpose of this prospective registry is to determine if patients harboring intracranial aneurysms have any predictive markers between aneurysm wall tissue, cerebrospinal fluid and blood plasma.

To design a registry to evaluate the wall of intracranial aneurysms during open surgical clipping by direct photographic appearance, wall biopsy samples, CSF and blood plasma fluid collection (Interleukins; IL-8/ Matrix Metalloproteinase; MMP-9) for complete evaluation and comparison.

The focus of the registry will be to determine the presence of aneurysmal wall defects, mural clot, atherosclerotic and atheroma, wall permeability and delamination. These findings will then be correlated to the collected CSF and blood values to determine if there is any direct features of the aneurysm wall that would predict any of the reported post embolic syndromes. The collected data can also be correlated to the peroperative imaging, (MRI, CT and Angiogram).

Eligibility Criteria:
Inclusion Criteria:

* Patient \> 18 years but \< 80 years of age
* Patient with an unruptured Intracranial aneurysm 8mm or larger
* Patient that surgical exposure and clipping will be the primary treatment option

Exclusion Criteria:

* Any patient that has a ruptured intracranial aneurysm
* Any Pediatric patients
* Any patient presenting with any pre-treatment intracranial lesions

  * Vascular malformations
  * Hemorrhage
  * Normal Pressure Hydrocephalus
  * Obstructive Hydrocephalus
  * White matter disease
  * Tumors
  * Trauma
  * Other vascular type lesions
* Any meningitis type symptoms
* Medical or surgical co-morbidities such that the patient's life expectancy is less than 1 year
* Inability to obtain consent
Assessment of the Safety of ABT-308 in Healthy Volunteers and Subjects With Asthma

The primary purpose of this study is to determine the safety, tolerability and pharmacokinetics of ABT-308 in healthy volunteers and patients with mild to moderate controlled asthma.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers:

  1. A condition of good health based upon the results of medical history, physical examination, vital signs, laboratory profile and ECG.
  2. BMI 18 to 29, inclusive.
* Mild asthma patients:

  1. Diagnosis of well-controlled, mild to moderate asthma by GINA guidelines for \> or = to 6 months
  2. A condition of good health (than mild to moderate asthma) based upon the results of medical history, physical examination, vital signs laboratory profile and EDG.
  3. BMI 18 to 34, inclusive.

Exclusion Criteria:

1. Asthma exacerbation within 8 weeks of Study Day 1.
2. Clinically significant allergic reaction to any drug, biologic, food, or vaccine.
3. History of allergic reaction or significant sensitivity to constituents of study drug.
4. Receipt of any investigational product within 30 days or 5 half-lives (whichever is longer) prior to study drug administration.
5. Subject is a smoker or has a history of smoking within the 6-month period preceding study drug administration.
6. Current enrollment in another clinical study.
Head and Neck Cancer in Children: A Retrospective Study

The aim of the study is to identify demographic characteristics, various histopathologies, and site preferences for each disease entity of malignant head and neck tumors in pediatric oncology patients \& treatment outcomes in these patients, according to experience at South Egypt Cancer Institute which is the largest referral site in Upper Egypt.

Background:

Although head and neck masses represent a common entity in children, malignancy is uncommon. Only very limited data are available in the literature on the incidence of childhood cancer of the head and neck worldwide.

Data from the United States National Cancer Institute database suggest that the head and neck are involved in 12 % of all childhood malignancies. The most common pediatric head and neck malignancies include Non Hodgkin lymphomas, Hodgkin lymphomas, rhabdomyosarcomas, thyroid malignancies, nasopharyngeal carcinomas (NPCs), salivary gland malignancies, and neuroblastomas.

Patients \& Methods:

A hospital-based study, involving Pediatric cancer patients, those diagnosed with malignant tumors of the head \& neck, in the period from 2001 January till 2015 December, and received treatment at the pediatric oncology department, their medical records will be retrospectively reviewed for data collection.

Clinico-laboratory data for each hisopathologic disease entity of various head \& neck malignancies will be gathered. The demographic distribution for each disease entity in accordance with gender \& age, and site preferences in these disease entities will be recorded. Treatment received \& treatment outcomes will be verified and absolute frequencies \& relative incidence of these disease entities will be calculated.

Eligibility Criteria:
Inclusion Criteria:

* Patients whose age less than 19 years.
* Patients diagnosed with a primary malignant tumor of the head \& neck.

Exclusion Criteria:

* Patients whose age more than 18 years.
* Patients diagnosed with a malignant disease primarily arising from the bone marrow.
* Patients diagnosed with tumors of the central nervous system.
* Patients diagnosed with retinoblastoma.
Benefits of Breast MRI for Predicting of Histopathologic Cell Type of Small Breast Cancer

This study examines the additional benefits of magnetic resonance imaging (MRI) with Gadovist in early breast cancer with poor prognostic features.

Dedicated Contrast-enhanced Magnetic Resonance Imaging (DCE-MRI)

Eligibility Criteria:
Inclusion Criteria:

* Patients with invasive ductal carcinoma
* Patients undergoing DCE-MRI scan which are assessed according to BI-RADS lexicon
* Breast cancer patients with pathological diagnosed invasive ductal carcinoma with hormonal receptor (ER, PR and HER-2) response
* Patients who have signed on informed consent form Patients will undergo MRI imaging and the physicians will practice according to practice guidelines.

Exclusion Criteria:

* Patients under 18 years old or during pregnancy
* Patients with MRI's contraindications e.g. patients with cardiac pacemaker or are allergic to MRI contrast agent Patients with unstable clinical abnormality and might get unexpected clinical treatment