cyrilzakka/clinical-trials huggingface dataset:
Modified Sling and Conventional Suture Techniques in Free Gingival Graft Operations

The aim of this study is to investigate the effects of conventional suture (CS) and modified sling suture (MSS) techniques, applied in free gingival graft (FGG) surgery using gingival unit graft (GUG) and conventional graft (CG) techniques, on clinical parameters and graft dimensions.

Background: The aim of this study is to investigate the effects of conventional suture (CS) and modified sling suture (MSS) techniques, applied in free gingival graft (FGG) surgery using gingival unit graft (GUG) and conventional graft (CG) techniques, on clinical parameters and graft dimensions.

METHODS: 52 individuals having Cairo Type 2 (RT2) and Type 3 (RT3) gingival recessions in mandibular anterior region were divided into four groups as a) GUG+MSS (n=13), b) GUG+CS (n=13), c) CG+MSS (n=13) and d) CG+CS (n=13). Keratinized gingival width (KGW), keratinized tissue thickness (KGT), relative gingival recession height (rGRH), and relative vestibule depth (rVD) measurements were recorded using a digital caliper and periodontal probe UNC 15. Dimensional changes (Δ) of the graft surface area (GSA) was determined by ImageJ software. All measurements were done at baseline and repeated 1st and 3rd months.

Eligibility Criteria:
Inclusion Criteria:

* Systemically healthy individuals
* \<1 mm of attached gingiva on mandibular incisors
* PI and GI scores \<1
* Patients who had not previously undergone soft tissue surgery in the relevant area

Exclusion Criteria:

* Pregnant or lactating women
* Patients younger than 18 years old
* Mandibular incisors with having restoration, probing depth ≥ 3 mm, malposition and/or endodontic problem
* Maxillary premolars with gingival recession in the palatal area and/or prosthetic restoration
An Observational Study to Assess the Quality of Life of the Patients With Multiple Sclerosis and Their Caregivers

This is an observational, non controlled, non-interventional, multicentric, prospective study planned to be conducted in 450 subjects diagnosed with MS and their caregivers in 20 centres of Argentina. The observations from this study will contribute to the awareness of the impact on the Quality of Life (QoL) of the caregivers and, eventually will also provide measures for helping the subjects with multiple sclerosis (MS) without leaving aside the care of the physical and psychic health of those who work as caregivers.

Caregivers of subjects diagnosed with MS have to take care of many activities of MS subjects that they cannot perform themselves, because of their lack of autonomy. The fact of aiding a person with some degree of disability due to a chronic disease in an intense way and for a long time could generate a high level of satisfaction in the caregiver; but at the same time the emotional and physical exhaustion of the caregiver increases as the disease progresses. The QoL of the person who is emotionally bonded to the MS subject as a caregiver has a great chance to be affected; and this is for sure more likely than in the case when the caregiver is a hired professional.

OBJECTIVES

Primary objective:

* To identify the impact of MS on the QoL of the MS subjects and their caregivers

Secondary objectives:

* To establish the correlation between the QoL of the subjects with MS and their caregivers
* To identify the predictors of the QoL in the caregiver group

This is an observational, prospective and non-interventional study planned to be conducted in 20 centers in Argentina. The subjects with diagnosed MS will be managed with the clinical and therapeutic elements that their treating doctors considered appropriate, without modifying their decisions due to the subjects' inclusion into the study. The caregivers will be asked to complete the QoL questionnaire as a part of the normal interview on each and every visit. The total duration of the study is 24 months. A descriptive analysis will be performed for the demographic and clinical characteristics of the investigation subjects, as well as for the characteristics of the treatments they receive when they start their participation in this study. For the qualitative variables, treatment modifications, frequency tables and the percentages will be performed.

Eligibility Criteria:
Inclusion Criteria:

* MS subjects and their caregivers, \>21 years of age of both sexes
* Subjects who have signed informed consent
* Subjects with established MS diagnosis according to the revised Mc Donald criteria - 2005 with at least 1 year of evolution
* Subjects with MS that have an identified caregiver

Exclusion Criteria:

* Subjects with other(s) associated neurological, psychiatric or systemic disease(s)
Efficacy of Web-based Cognitive Behavioural Treatment for Adolescents With Chronic Fatigue Syndrome

The aim of this study is to determine the efficacy of FITNET (web-based cognitive behavioural treatment) for adolescents with Chronic Fatigue Syndrome (CFS) in The Netherlands. The second goal of the study is to establish predictors of outcome. It is very important to know the characteristics of patients who will benefit from Cognitive Behavioural Treatment (CBT) and who will not. Possible predictors of outcome are: age, depression, anxiety, fatigue of the mother, parental bonding, self-efficacy, body consciousness of child and mother, physical activity (Actometer).

All participants will be randomized to one of the two treatment arms:

1. Intervention with web-based cognitive behavioral treatment
2. Usual care

The duration of the cognitive behavioural program is limited to 6 months. The adolescents who have been assigned to the usual care will get the opportunity to attend the program after these 6 months. The total follow-up time is 12 months after the start of the web-based program.

The web-based program is developed for both the adolescents and the parents. The program consists of two parts, a psycho-educational part and a cognitive behavioural part consisting of 21 treatment modules. The therapist activates one or more treatment modules per week, dependent on the progress of the participant. Within a treatment module the participant will keep several journals, answer questions and do several assignments. All answers are sent to the therapist, with whom a weekly email contact will be realized.

Efficacy of the web-based program will be determined after 6 months. There will be a follow-up measurement at 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Adolescents (12 - 18 years) with Chronic Fatigue Syndrome

Exclusion Criteria:

* Score greater than or equal to 44 on the Stait-Trait Anxiety Inventory for Children
* Score greater than or equal to 20 on the Children's Depression Inventory
* No availability of computer and/or internet
* Risk of suicide
* Mental retardation
MMR and MMRV Vaccines: Effect of Age at First Dose on Safety and Immunogenicity of the Measles Component.

Healthy children who received two doses of GlaxoSmithKline (GSK) Biologicals' live attenuated measles-mumps-rubella vaccine (MMR) or measles-mumps-rubella-varicella vaccine (MMRV) in their second year of life.The purpose of this study is to assess the effect of the age at administration of the first dose on the reactogenicity and immunogenicity of the measles component of these vaccines.

In addition, this study will evaluate if the effect of the age at first dose is modified by the type of vaccine administered.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female subject between 11 to 22 months at the time of first vaccination.
* Written informed consent obtained from the parent/guardian of the subject.

Exclusion Criteria:

* History of previous measles, mumps, rubella and/or varicella vaccination or disease or known exposure to any of these diseases within 30 days prior to the inclusion in the study.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, included the chronic administration (defined as more than 14 days) of immune-suppressants or other immune-modifying drugs within six months prior to the firs vaccine dose.
* History of any neurologic disorders or seizures.
* History of allergic diseases or reactions likely to be exacerbated by any component of the vaccines.
* Planned administration of a vaccine not foreseen by the study protocol from 30 days prior to each vaccination until 42-56 days after each vaccination
VET Evaluation: Healthy

The study involving healthy participants aims to validate the Virtual Eggs Test (VET) as a tool for measuring hand dexterity and grip force control. This part of the study focuses on determining the test's reliability and validity in a population without motor impairments. Healthy participants will perform the VET using both their dominant and non-dominant hands across two sessions. The purpose is to establish baseline performance metrics for comparison with stroke patients and to assess the test's usability in clinical settings.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 85 years.
* No motor deficits.
* Adequate cognitive and language abilities to understand the experiment and follow instructions.
* Signed informed consent.

Exclusion Criteria:

* Significant visual or oculomotor impairments.
* Comorbidities or disabilities that may interfere with the study, such as multiple sclerosis, Parkinson's disease, or muscle tone disorders.
* Cardiopulmonary or circulatory pathologies.
* Pregnancy or breastfeeding.
* Psychiatric comorbidities.
* Difficulty understanding the Italian language.
* Lack of cooperation.
* Consumption of alcohol or diuretics before the test
Study of NRX 195183 Therapy for Patients With Relapsed or Refractory Acute Promyelocytic Leukemia

The purpose of this study is to determine whether NRX 195183 is effective in the treatment of relapsed or refractory Acute Promyelocytic Leukemia

A common current therapeutic approach to APL uses oral ATRA and chemotherapy in induction and consolidation. This approach has significantly improved survival in newly diagnosed APL patients. However, approximately 30% of patients relapse. Recently, an approach involving the combination of oral ATRA and arsenic trioxide has been tested. The prognosis for relapsed patients is very poor. This study seeks to investigate NRX 195183 monotherapy in patients who have failed or are resistant to or are intolerant of any prior therapy.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of APL morphology or FAB M3 variant confirmed by RT-PCR assay or chromosome analysis/FISH showing t(15:17) translocation. Patients must also have relapse from, resistance to or intolerance of any one or more of the following therapies:

  * ATRA
  * Cytotoxic chemotherapy
  * Arsenic trioxide
* Patients must be 18 or older.
* Bilirubin equal or less than 1.5 times the upper limit of normal.
* Creatinine equal or less than 1.5 times the upper limit of normal.
* Patients entered into this study should be non-pregnant and non-nursing and should not plan on becoming pregnant while on treatment. Treatment under this protocol would expose an unborn child to significant risks. Women and men of reproductive potential should agree to use an effective means of birth control. There is an extremely high risk that a severely deformed infant will result if NRX 195183 is administered during pregnancy.

Exclusion Criteria:

* Non-APL, AML patients should be excluded from the study.
* Other serious illnesses which would limit survival to 6 months.
* Psychiatric conditions which would prevent compliance with treatment or informed consent.
* Uncontrolled or severe cardiovascular disease. This would include history of a recent acute myocardial infarction, uncontrolled congestive heart failure, or active angina.
* AIDS or HIV positive patients, although HIV test is not required for accrual.
An Observational Study on Predicting the Efficacy of Immunotherapy for NSCLC Based on LIRAscore

This is a multi-center, observational clinical study to explore the role of LIRAscore in predicting immunotherapy monotherapy and combination with chemotherapy efficacy and prognosis in locally advanced or metastatic non-small-cell lung cancer. The study plans to enroll 108 patients. The primary endpoint of this study was ORR, and secondary endpoints were PFS, OS, DoR, DCR, and safety.


Eligibility Criteria:
Inclusion Criteria:

1. Patients voluntarily participated in the study, signed the informed consent, and had good compliance;
2. Histologically and/or cytologically confirmed previously untreated, locally advanced or metastatic non-small-cell lung cancer (stage IIIB/IIIC or stage IV) without driver gene mutation;
3. Patients are willing to receive immunotherapy monotherapy or immunotherapy combined with chemotherapy;
4. The patient agrees to provide the remaining tissue samples after clinical routine diagnosis during the baseline period for LIRA score and PD-L1 immunohistochemical testing;
5. The Eastern Organization for Oncology (ECOG) physical fitness score is 0 or 1;
6. The patient has at least one measurable or unmeasurable but evaluable lesion.

Exclusion Criteria:

1. According to clinical routine, patients do not meet the criteria for receiving standard anti-tumor treatment;
2. Patients with known EGFR mutations, ALK rearrangements or ROS1 rearrangements are not eligible to participate in this study;
3. According to the researcher's judgment, the patient is not suitable to participate in this study.
High-Dose Sequential Therapy and Single Autologous Transplantation for Multiple Myeloma

This study uses a sequence of high-dose chemotherapy drugs and a stem cell transplant to treat multiple myeloma. The study is being performed to evaluate the efficacy and side effects of treatment. Specifically, the study is designed to reduce the risk of interstitial pneumonitis.

Analysis of 196 previously treated patients demonstrated a median event-free survival (EFS) of 36 months with a median overall survival of more than 6 years. The main toxicity of this therapy is related to carmustine-induced pneumonitis or interstitial pneumonitis (IP). This complication is related to the dose of carmustine. Institutional experience in myeloma patients using this dose of carmustine indicates an incidence of IP of34%.

There have been recent studies evaluating the role of tandem autologous transplants for patients with multiple myeloma. These trials were based upon the hypothesis that performing tandem high-dose therapy regimens would lead to increased tumor cell kill, decreased tumor burden and an improvement in overall survival. Our results with high-dose sequential therapy including the dose-intense carmustine/melphalan transplant demonstrates similar median EFS and overall survival (OS) when compared with the results of tandem transplant approaches.The proposed trial will continue to use a high-dose sequential transplant approach, however, we will use a reduced dose of carmustine which we expect to be associated with a lower incidence of IP.

Eligibility Criteria:
INCLUSION CRITERIA

* Stage II to III multiple myeloma, or progression after initial treatment of Stage I disease; early or relapsed
* Age 18 to 75 years.
* Pathology reviewed and the diagnosis confirmed at Stanford University Medical Center.
* Patients with amyloidosis may be eligible for this trial, with approval by the Principle Investigator.
* Patients must have a Karnofsky performance status \> 70%.
* Aspartate aminotransferase (AST) must be \< 2 x upper limit of normal (ULN)
* Alanine aminotransferase (ALT) must be \< 2 x ULN
* Total bilirubin \< 2 mg/dL.
* Serum creatinine \< 2.0 or 24-hour creatinine clearance ≥ 60 mL/min.
* Patients must be HIV-negative.
* Patients must provide signed, informed consent.

EXCLUSION CRITERIA

* Severe psychological or medical illness
* Prior autologous hematopoietic cell transplantation
* Pregnant
* Lactating women
* Smoldering multiple myeloma,
* Monoclonal gammopathy of unknown significance or primary amyloidosis will be excluded from this study
Low Dose Aspirin Studied With the AggreGuide

This study is to determine whether the AggreGuide platelet aggregometer can discern the effect of low dose aspirin on subjects platelet aggregation using arachidonic acid as the agonist.


Eligibility Criteria:
Inclusion Criteria:

* adults

Exclusion Criteria:

* aspirin contraindications
* anticoagulants
* aspirin past week
Heparin-Induced Thrombocytopenia - Retrospective Analysis of Data on Incidence and Outcomes Study

HIT-RADIO is a study of patients who had a positive heparin PF-4 antibody test between 1/21/2008 and 9/25/2008 at selected hospitals. The study will collect and analyse information that is already in the patients' medical records. Information about laboratory values (such as platelet counts), treatments (such as medications), and outcomes (such as blood clots, amputation, and death) will be included.

HIT-RADIO is a retrospective chart-review study of patients who had a positive heparin PF-4 antibody test between 1/21/2008 and 9/25/2008 at selected hospitals associated with the Transfusion Medicine/Hemostasis Clinical Trials Network .

Heparin-induced thrombocytopenia (HIT) is a major complication of the administration of heparin and can result in life-threatening thrombosis with or without thrombocytopenia (HIT-T) or can produce thrombocytopenia without clinically symptomatic thrombosis ("isolated" HIT). Isolated heparin-induced thrombocytopenia is defined as a fall in platelet count associated with a positive heparin PF-4 antibody test, in the absence of clinically overt thrombosis. While the treatment of HIT-T (HIT with thrombosis) with anticoagulation is well established, the risks and treatment of isolated HIT are unclear.

It is anticipated that this data analysis will provide a current overview of the implications of a positive heparin PF-4 antibody test in clinical practice. It should determine the percentage of positive heparin PF-4 antibody tests that are associated with thrombocytopenia and thrombosis (HIT-T) or "isolated" HIT at diagnosis and the subsequent major clinical outcomes of death, limb amputation/gangrene, and new thrombosis. No "snapshot" of such HIT patients has been conducted in the past decade and the results will be important in assessing the impact of HIT in current medical care as well as documenting current treatment strategies.

Eligibility Criteria:
Inclusion Criteria:

* All subjects with a positive heparin PF-4 antibody test occurring between 1/21/2008 and 9/25/2008
* Medical record available for the admission during which the positive heparin PF-4 antibody test was obtained

Exclusion Criteria:

* None
Urinary Retention Rates in Clinical Practice After Treatment With OnabotulinumtoxinA for Idiopathic Overactive Bladder

This study is a retrospective chart review of patients treated with BOTOX® for idiopathic Overactive Bladder (OAB) as standard of care in clinical practice. The study will determine the rate of post procedural urinary retention requiring catheterization and identify factors that may predict urinary retention.


Eligibility Criteria:
Inclusion Criteria:

-Patients treated with BOTOX® for Overactive Bladder.

Exclusion Criteria:

* Received botulinum toxin formulations other than BOTOX® in the bladder.
* Had symptoms of OAB associated with a neurological condition.
* Had a history of chronic urinary retention treated with Clean Intermittent Catheterization (CIC) or indwelling catheter.
A Comprehensive Approach to Head and Neck Cancer Prehabilitation

Head and neck cancer accounts for 3% of malignancies in the United States. However, the diagnosis and treatment for head and neck cancer is considered to be debilitating. Not because of its morbidity, but due to the extremely rigorous treatment course which has a profound impact on patients physical, social, and emotional functioning. Disfigurement and sensorimotor deficits further compound this impact. Head and neck cancer patients contend with treatments that can significantly affect their quality of life. Treatment regularly results in decreased functional capacity and decreased quality of life. Physical impairments are manifested through, but not limited to, disfigurement, deconditioning, communication issues, "swallowing, speech, breathing, and cancer-related fatigue". Premorbid factors such as preexisting anxiety and depression, chemical dependency, financial barriers, and lack of social support system are unique obstacles to the head and neck cancer population impacting treatment and outcomes. Due to these factors, patients experience higher rates of anxiety and depression, psychological distress, and fear of cancer recurrence. In fact, "compared with other survivors of cancer, head and neck cancer survivors are almost 2 times more likely to die from suicide". In view of the aforementioned research, Roger Maris Cancer Center's head and neck cancer will implement a prehabilitation program that evaluates each patient using standardized screening tools and provide personalized education and interventions. This project evaluates a more comprehensive and proactive multidisciplinary approach to improve treatment and outcomes in head and neck cancer patients.


Eligibility Criteria:
Inclusion Criteria:

* Equal to or greater than 18 years of age
* Diagnosis of head and neck cancer
* Actively pursuing cancer treatment with a curative intent
* Willing and able to provide written consent

Exclusion Criteria:

* Patients with cardiac arrhythmia with implanted pacemaker
* Patients with other implanted electronic equipment/device
* Patients undergoing external defibrillation
* Pregnant women (per BIS instructions for use, pregnant women should not participate)
* Patient weight exceeding 375 lbs.
* Patient has a metal allergy