cyrilzakka/clinical-trials huggingface dataset:
Effect of Extraction Versus Non-extraction Orthodontic Treatment on the Third Molars

What is the effect of extraction orthodontic treatment in comparison to non- extraction treatment on the position, inclination and incidence of impaction of the third molars?

Data regarding the personal information (name, age and gender), chief complaint, medical and dental history will be taken. Medical history questionnaire will be filled by the patient to exclude the presence of any systemic conditions.

complete set of orthodontic records will be taken; Pre- operative records including (standardized intra- and extra-oral photographs, primary impression for study model, panoramic \& lateral cephalogram). After formulating the best treatment plan for each patient, All patients will be enrolled into one of two groups: Intervention Group (I) : Extraction treatment group. Comparator group (C): Non-extraction group. Following the end of treatment, Post-treatment records including (standardized intra- and extra-oral photographs, primary impression for study model, panoramic \& lateral cephalogram) will be taken.

Primary outcome: The angulation of the mandibular third molars.Secondary outcomes:

1. space available for the upper and lower third molar.
2. Angulation of the third molar.
3. The vertical position of the third molars.
4. the mineralization status of the third molars

Eligibility Criteria:
Inclusion Criteria:

* Adolescent males and females (14-18 years) with Bilaterally unerupted developing third molars. Not more than two thirds of the root development of the third molars had taken place.

  * Dental Class I malocclusion cases requiring four premolar extraction with a moderate anchorage requirement.
  * low or increased vertical dimension.

Exclusion Criteria:

* Premolar extraction cases requiring maximum anchorage preparation.

  * Low vertical dimension.
  * patients without dentofacial deformities, severe facial asymmetries, or missing teeth.
A Study to Assess Changes in Clinical Management After DaTSCAN Imaging of Subjects With Clinically Uncertain Parkinsonism or an Illness With Similar Symptoms

Patients come to their doctor showing possible symptoms of a movement disorder. It is possible that these symptoms may get worse over time. There is more than one disease that can cause such symptoms. The most common movement disorder illnesses are Parkinson´s Disease and Essential Tremor. Sometimes it is difficult for doctors to make the right diagnosis because the symptoms caused by these illnesses are almost the same. On the other hand the correct treatment for Parkinson´s Disease is different from the correct treatment for Essential Tremor. This study aims to see whether having pictures of the brain taken with DaTSCAN can affect the way the doctor treats these patients and whether it can affect their quality of life directly.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with clinically uncertain Parkinsonian Syndromes or monosymptomatic, atypical or incomplete presentation of tremor, rigidity, bradykinesia or postural instability.
* Onset of clinical manifestations within the last 5 years

Exclusion Criteria:

* Differential diagnosis between Parkinsons´s Disease and Progressive Supranuclear Palsy or between Parkinson´s Disease and Multiple System Atrophy
* Subjects with an established/certain movement disorder clinical diagnosis
* Presence of known causes of tremor
Well-Formulated Ketogenic Diet Polycystic Kidney Disease

This is a prospective study to determine ketogenic diet effect on htTKV, GFR, microalbuminuria. This is a single-center study of 20 patients with ADPKD and deemed high risk for progression to ESRD. This determined by combination of features of ADPKD and htTKV as assessed by prior computed tomography (CT) or MRI. Patients will be recruited from the Polycystic Kidney Disease (PKD) Clinic at Ohio State University Wexner Medical Center. Enrolled patients will have MRI for htTKV, urinary studies, blood tests at baseline, 6 months, and 52 weeks. Blood for GFR will be assessed three times over the course of the study including baseline, 6 months, and 1 year. Participants will follow ketogenic diet for 52 weeks. Investigatory diet team will manage the ketogenic diet.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-65 years old
* Diagnosis of ADPKD by imaging and/or genetic testing
* GFR ≥ 25 mg/dl
* Patients at risk for rapid progression of ADPKD: Mayo Class 1C-1E along with any other high risk features including early decline in GFR, hypertension onset ≤ 35 years of age, urologic events ≤ 35 years of age, PKD 1 truncating mutation and PROPKD score of 4 or higher as determined by the treating physician
* No changes of medications within the last three months.
* Able to comply with dietary intervention
* Ability to sign informed consent

Exclusion Criteria:

* Patients currently being treated with Tolvaptan
* Diagnosed with diabetes.
* Pregnancy
* Contraindications to MRI
* Ketogenic diet within the last three months
* Severe kidney disease with GFR \< 25 mg/dl
* Unable to purchase food for the diet intervention
* Gastrointestinal disorders that will interfere with diet intervention
* Chronic alcohol or drug abuse
The Role of Amnion Membrane Allografts in Nipple Preservation

The overall objective of this proposal is to conduct a randomized-controlled study to determine whether treatment with dehydrated human amnion/chorion membrane (dHACMs) allografts can improve NAC viability in patients undergoing nipple sparing mastectomy (NSM). dHACM allografts are commercially available tissue membranes with biocompatible extracellular matrix and growth factors that have been shown to improve wound healing in patients with chronic and lower extremity wounds. To date, no study has evaluated the impact of dHACMs on NAC preservation following NSM. Investigators hypothesize that subareolar surgical implantation of dHACM allografts at time of NSM will reduce NAC necrosis and improve viability.

This proposal will be the first clinical trial to evaluate the clinical efficacy of dHACM allografts in NSM. The topic of study not only addresses a critically unmet need in the field of plastic surgery, but also maintains exceptional scientific and clinical merit. This study would be the first to establish dHACM allografts as a novel, innovative, and biologically-based adjunctive mechanism to improve vascularity and wound healing following NSM. Such findings would not only provide the evidence-base for widespread implementation of dHACM allografts in the surgical management of breast patients, but also serve as a catalyst to study the clinical efficacy of these allografts in other plastic surgical patient cohorts. Overall, this proposal aims to serve as a successful translational model incorporating scalable, biologically-based regenerative therapies in a surgical population.

Nipple necrosis is a major complication after nipple sparing mastectomy, a procedure that is commonly performed in the human population for gender reassignment surgery and for breast cancer prevention. This study will assess the efficacy of dHACMs can improve nipple viability after NSM.

Eligibility Criteria:
Inclusion Criteria:

* Biologically female with documented diagnosis of gender dysphoria, desire to undergo gender affirming surgery (female-to-male) NSM, and age 15 years of age or older.
* Biological female, age 18 to 75 years old, who desire to undergo bilateral prophylactic NSM for nonmalignant breast conditions or to reduce the risk of breast cancer.

Exclusion Criteria:

* Current steroid use
* Known connective tissue disorder
* Known neuropathy
* Known history of breast cancer
* History of breast radiotherapy
* Pregnant or nursing
Impact of Exercise Combined With Inulin Propionate Ester on Fat Oxidation

There is evidence to suggest that responsiveness to exercise training programmes can be expected to be influenced by changes in resting fat oxidation, an important factor in the aetiology of obesity. Our previous work has shown that oral supplementation with inulin propionate ester (IPE) reduces intra-abdominal fat and prevents weight gain and that oral propionate intake enhances resting fat oxidation. The effects of IPE combined with exercise training on resting fat oxidation and body fatness are unknown. The aim of this study was to investigate the impact of 4-weeks IPE supplementation, in combination with a moderate intensity exercise training programme, on whole body fat oxidation and on plasma GLP-1 and PYY.

Participants: Healthy overweight females with BMI \>25 kg/m2 and 25-45 years of age were recruited through advertisements and word of mouth on the campus of the University of Glasgow or from other public places. Participants were required to be sedentary, non-smokers, with stable body weight for two months prior to the study enrollment, not pregnant, free of medication, nutritional supplementation or following any specific diet and with no antibiotic use for the past three months. Participants with chronic illness, eating disorders and history of gastrointestinal operations were excluded.

Study Design: This is a randomized study with a parallel design. Study participants underwent 4 week supervised moderate intensity exercise training combined either with IPE (EX/IPE) or cellulose as placebo (EX/Placebo) supplementation at doses of 10g / day. Supplements were provided as sachets containing white powder and participants were asked to consume one sachet per day with breakfast in a way convenient for each participant. Before the start of the study and at the end of the 4-week intervention, participants were asked to conduct a submaximal exercise test. Prior to the first and after the second submaximal exercise test, participants of both groups conducted a 7-hour experimental trial which involved collection of expired air and blood samples in fasted and postprandial states. Body weight and body composition were measured in the fasted state. Prior to the first 7-hour experimental trial, participants were asked to record their diet for 3 days and replicate this intake prior to the second 7-hour experimental trial.

Eligibility Criteria:
Inclusion Criteria:

Healthy, sedentary and overweight females with BMI \>25 kg/m2 and stable body weight for two months prior to the study.

Exclusion Criteria:

Acute or chronic illness, eating disorders, history of gastrointestinal operations, smoking, pregnancy, taking supplements, and being on specific diet for the past three months.
Safety, Tolerability, Biological Effects and Pharmacokinetics of BIIL 284 BS in Healthy Males

Study to obtain information about the safety and tolerability of BIIL 248 BS, to find the pharmacologically active dose range for the two formulations PSE 1% and WIF tablets by determination of the surrogate marker CD11b (= Mac-1) and to obtain preliminary pharmacokinetic data as well as first information on food effects after administration of the 75 mg WIF tablet in healthy male volunteers


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects as determined by results of screening
* Age ≥ 21 and ≤ 50 years
* Broca ≥ - 20% and ≤ + 20%
* Signed written informed consent in accordance with Good Clinical Practice and local legislation

Exclusion Criteria:

* Results of the medical examination or laboratory tests that are judged by the clinical investigator to differ significantly from normal clinical values
* Known gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Diseases of the central nervous system (such as epilepsy) or with psychiatric disorders
* Known history of orthostatic hypotension, fainting spells or blackouts
* Chronic or relevant acute infections
* History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
* Intake of a drug with a long half-life (≥ 24 hours) within at least one month or less than ten half-lives of the respective drug before enrolment in the study
* Intake of any other drugs which might influence the results of the trial during the week previous to the start of the study
* Participation in another study with an investigational drug within the last two months preceding this study
* Smokers (\> 5 cigarettes or 2 cigars or 2 pipes/day)
* Volunteer who is not able to refrain from smoking on study days
* Alcohol abuse (more than 60 g of alcohol per day)
* Drug abuse
* Excessive physical activities (e.g. competitive sports) within the last week before the study
* Blood donation within the last 4 weeks (≥ 100 ml)
Evaluating Error Augmentation for Neurorehabilitation

This is a sub-project of a larger NIDRR Grant. One promising form of robotic training that leverages the power of neuro-plasticity is error augmentation. In this paradigm the computer singles out and magnifies a stroke survivor's movement errors from a desired trajectory, thus forcing the subjects to strengthen their control. Using the VRROOM, a state-of-the-art system which uses haptics (robotic forces) and graphics (visual display) interfaces, a subject's desired trajectory can be determined and the movement errors can be amplified in real-time with dramatic results. This project evaluates a practical approach of error augmentation, using therapist-driven trajectories. The investigators intend to determine clinical efficacy of several types of therapist-assisted error augmentation on retraining the nervous system in functional activities. The investigators will test two experimental treatments in a crossover design. The investigators hypothesize that combined haptic and visual error augmentation will lead to the best functional recovery.


Eligibility Criteria:
Inclusion Criteria:

* adult (age \>18)
* survived a single cortical stroke at least 6 months previously involving ischemia or hemorrhage of the middle cerebral artery (MCA),
* demonstrated the presence of some active shoulder and elbow movement (characterized by Fugl-Meyer Assessment Upper Extremity scores ranging from 15-50 for ARM 1; 25-50 for ARM 2).

Exclusion Criteria:

* diffuse or multiple lesion sites or multiple stroke events
* bilateral paresis
* severe spasticity or contracture (Modified Ashworth ≥3
* severe concurrent medical problems
* severe sensory deficits
* cerebellar strokes resulting in severe ataxia
* significant shoulder pain
* focal tone management with Botulinim Toxin (Botox®) injection to the hemiparetic upper extremity (UE) within the previous four months,
* aphasia that would influence the ability to perform the experiment
* cognitive impairment (Mini Mental State Examination \< 23/30)
* affective dysfunction that would influence the ability to perform the experiment
* depth perception impairment (\< 3 on Stereo Circle Test)
* visual field cut or hemispatial neglect that would influence the ability to participate in the activity
* inability to provide informed consent
Immunization Services Model for Adult Rate Improvement

ImmuSMART is a study of personalized telephonic prompts to community pharmacy patients to improve adult vaccination rates for pneumococcal and herpes zoster vaccines.

This study will investigate immunization rate improvement among adult patients in 250 northeastern US community pharmacies as a result of telephonic prompts during regular automated outbound communiqués. There will be three projects assessing different forms of these appended prompts-appointment-based medication synchronization automated prompts, refill ready automated prompts, and refill reminder automated prompts. Each intervention will occur in one of three pharmacy chains, each with approximately 10,000 patients randomized to control or intervention (receive prompt or no).

Prior to the outbound automated call to the patient, a third-party technology vendor (Scientific Technologies Corporation) will perform an automated immunization status assessment of the patient by submitting a query the state immunization registry to compare the adult patient's existing immunization record to the CDC Recommended Adult Immunization Schedule. Gaps in immunizations that fall within pharmacy scope of practice will be identified. During the automated call (performed by VoicePort, a pharmacy telephonic support vendor) to the patient, they will be prompted to receive identified immunization gap vaccines upon their next pharmacy visit, with priority on pneumococcal, influenza, and herpes zoster vaccinations. If the patient accepts, the vaccination will be delivered when next the patient comes to visit the pharmacy.

After 6 months of running the trial, statistical modeling will be employed to assess vaccination rate differences between control and intervention patients.

Eligibility Criteria:
Inclusion Criteria:

* Patient at least 19 years of age at date of enrollment
* Patient not in long-term care, hospice or otherwise identified as unable to come to pharmacy for receipt of vaccine
* Patient currently missing a record of receipt of at least one of three vaccinations: flu, pneumonia, or shingles
* Patient enrolled in telephonic pharmacy reminder service
Rituximab in Children and Adolescents With Relapsed and Refractory B-Cell NHL/L3ALL

This is a multicentric phase II study of Mabthera (rituximab) in children and adolescents with relapsed and refractory B-cell NHL/L3ALL. The primary objective is to determine the response rate of Rituximab as single agent in relapsed or refractory Burkitt lymphoma, L3 acute leukemia, large B-cell lymphoma and non subclassified aggressive B-cell NHL

This is a multicentric phase II study of Mabthera (rituximab) in children and adolescents with relapsed and refractory B-cell NHL/L3ALL. The primary objective is to determine the response rate of Rituximab as single agent in relapsed or refractory Burkitt lymphoma, L3 acute leukemia, diffuse large B-cell lymphoma and non subclassified aggressive B-cell NHL. The secondary objectives are to assess the toxicity profile of Rituximab in children and adolescents as single agent, and when followed by chemotherapy, to study pharmacokinetics of Rituximab in serum and in CSF and to determine the overall duration of response, time to progression and survival in patients responders to antiCD20 initially alone and followed by chemotherapy.

Patients will receive Rituximab (Mabthera) at 375 mg/m2, once a week during 4 weeks, administered in IV infusion starting at 50mg/h and increasing by steps of 50 mg/h every 30mn until the speed of 400 mg/h. Patients with combined CNS relapse will receive an intrathecal injection of MTX+HC+Ara-C 48 h after each injection of rituximab First assessment will be done prior to receiving the 3rd course of rituximab. Responding patients (CR, PR) and patients with objective effect (OE) will receive the 3rd and 4th injections of rituximab before starting the salvage chemotherapy (COPADM, CYVE/CC course or ICE, depending on previous chemotherapy regimen received by the patient, followed by HDCT+ hematopoietic stem cell rescue). A second evaluation will be done after the 4th course if performed.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically proven B-cell malignancies, either Burkitt NHL or L3 ALL or large B-cell lymphoma or aggressive B-cell NHL, with the exception of diffuse large B-cell lymphoma arising in the mediastinum.
* Immunohistochemistry showing CD20 positivity
* Measurable (at least one bi-dimensionally measurable lesion) or evaluable (bone marrow, bone involvement) disease in progression since the last evaluation
* First relapsed or refractory disease after LMB or BFM protocol, except the isolated CNS relapses
* Life expectancy \> 4 weeks
* Performance status (Karnofsky) \> 30
* Adequate hepatic, renal and cardiac functions
* Wash out of 3 weeks in case of recent chemotherapy
* Complete initial work-up within 8 days prior to treatment
* Able to comply with scheduled follow-up and with management of toxicity
* Written inform consent form from adult patients and from parents and legal guardians for minor children

Exclusion Criteria:

* Active viral infection, especially chronic hepatitis B
* previous salvage therapy for relapse
* Prior or current history of severe allergy
* Primary large B-cell lymphoma of the mediastinum
* Isolated CNS relapse
Patients With Chemotherapy-induced Polyneuropathy Are Treated With an Integrated Program Including Massage, Mobilization in Posture and Transport Layers, Physical Exercises or With Whole-body Vibration Platform Training

In a Phase-III Study Patients With Chemotherapy-induced Polyneuropathy (NCI CTC Grade 2/3) Are Randomized for an Integrated Program (IP) Including Massage, Mobilization in Posture and Transport Layers, Physical Exercises (Standard) or With Whole-body Vibration (WBV) Platform Training (Experimental).

Subjects with a haematological malignancy or solid and a diagnosis of a chemotherapy-induced polyneuropathy. In a phase-III study patients with chemotherapy-induced polyneuropathy (NCI CTC grade 2/3) are randomized for an integrated program (IP) including massage, mobilization in posture and transport layers, physical exercises (standard) or with whole-body vibration (WBV) platform training (experimental). 15 training sessions in a time period of 12 to 15 weeks were intended. Evaluation included locomotor and neurological tests and self-assessment-tools. The primary objective of the study was the physical fitness and coordination assessed by the chair-rising test (CRT).

Eligibility Criteria:
Inclusion Criteria:

Patients 18 to 70 years of age with solid and hematological neoplasms suffering from chemotherapy-induced polyneuropathy grade II-III according to National Cancer Institute Common Toxicity Criteria (NCI CTC, version 3.0) and pathological chair-rising test (CRT)28 ( ≥10 s) were eligible

Exclusion Criteria:

* psychiatric disorders
* plasmatic coagulation disorders
* thrombotic/thromboembolic events within 6 months before randomization
* severe neurological disorders like seizures
An Evaluation of Innerview™, a Web-based Tool to Support the Integration of Mental Health in the Primary Care Setting

Innerview can address some of the challenges of integrating mental health and primary care by accurately and reliably collecting mental health evidence and activities directly from patients, and then organizing and automating that evidence and activity into reports for providers and care teams that support diagnosis, treatment planning and monitoring of the mental health issues within a practice population.

To deliver integrated quality care, innovative strategies are needed to efficiently collect, understand, monitor and manage mental health evidence and its contribution to the primary care office visit. Computer applications can provide solutions to providers by helping their processes to be feasible, manageable, and sustainable. We hypothesize that by both providing patients the opportunity to reflect on their physical, emotional and behavioral symptoms and functioning, and giving providers accurate, reliable, current, symptom-based mental health evidence in an accessible organized format prior to the face-to-face visit, Innerview will enhance diagnostic and treatment processes from both a patient- and population-based perspective, as well as enhance communication between patient and provider.

Eligibility Criteria:
Inclusion Criteria:

* In order to be eligible to participate in this study, a subject must meet all of the following criteria:

  * Provide signed and dated informed consent form
  * Be aged 18 or older
  * Be willing to comply with all study procedures and be available for the duration of the study
  * Be able to read English at an 8th grade level (as determined by physician)
  * Have internet access to email with a computer and/or tablet

Exclusion Criteria:

* Patients are excluded from study participation if they meet any of the following criteria:

  * Inability to provide consent due to guardianship issues
  * Currently experiencing psychotic symptoms (as determined by physician)
  * Anything that, in the opinion of the Investigator, would preclude the subject's full compliance with or completion of the study.