cyrilzakka/clinical-trials huggingface dataset:
Impact of Aligner Replacement Protocols on Predictability of Planned Dental Movements: Evaluation of Double Aligner

The study will evaluate the impact of replacing aligners after 7 days with new aligners made of different materials on the predictability of planned dental movements. Three groups of participants will follow different aligner protocols, and the planned movements will be compared with the achieved ones. The study aims to provide relevant data for clinical practices with orthodontic aligners and assess participants' satisfaction with the treatment.

This prospective clinical trial aims to determine whether replacing an aligner after 7 days with a new aligner of a different material affects the predictability of planned dental movements. A total of 114 adult patients undergoing orthodontic treatment with aligners-requiring bilateral tooth movements (extrusion, intrusion, rotation, tipping, or mesiodistal translation)-will be recruited and randomized into three groups with distinct aligner exchange protocols.

Group 1: 10 days of exclusive FLX aligner use. Group 2: 7 days of FLX aligner use followed by 3 days of FLX35 use. Group 3: 7 days of FLX aligner use followed by 3 days of a new FLX aligner. Within each group, patients will be further categorized into subgroups based on horizontal, vertical, and rotational movements. Digital study models, radiographs, and standardized clinical photographs will be used to compare planned versus achieved tooth movements. The primary outcome is the predictability of movement, defined as the difference and percentage of planned versus actual movement. Secondary outcomes include participant satisfaction measured via the OHIP-14 questionnaire. Data will be analyzed using descriptive statistics and paired tests appropriate for the split-mouth design. The study is conducted in accordance with the Declaration of Helsinki, and all treatment costs will be covered by the sponsor, NeoDent (JJGC Industria e Comercio de Materiais Dentarios S.A.).

Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18 years or older, with full permanent dentition.
* Interested in orthodontic treatment with aligners.
* Planned movements include extrusion, intrusion, rotation, tipping, or mesiodistal translation.
* Signed informed consent.

Exclusion Criteria:

* Contraindications to aligner use, including allergies to polyurethane or PETG.
* Poor oral hygiene or active periodontal disease.
* Malocclusions involving multiple missing teeth or short clinical crowns.
Home Therapy for Stroke Rehabilitation Using the HandSOME Exoskeleton

This research will evaluate the potential for a novel hand orthosis (HandSOME) to help stroke victims regain functional use of their hand and regain independent living. Participants will use the HandSOME at home regularly for 8 weeks. Clinical evaluations will measure changes from the intervention after the 8 weeks and also at a 3 month followup.

After stroke, individuals often have great difficulty with using the affected hand in functional tasks. The hand frequently suffers from finger flexor hypertonia as well as finger extensor weakness. This leads to increased difficulty in grasp and release of objects. HandSOME is a light weight wearable hand orthosis that increases range of motion and decreases effort during grasping tasks. The goal of this study is to evaluate the HandSOME device's effectiveness in the rehabilitation of stroke patients through an 8 week intervention. Eligible subjects will use the device daily at home for 8 weeks with one visit per week to the clinic to evaluate progress and troubleshoot problems with the device. The hypotheses are that the gains from the 8 weeks of training will be statistically significant and clinically important (defined as gains of greater than 10% of full scale) in the domains of impairment, function and amount of arm use.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of stroke more than six months prior to entry into the study
2. Impaired ability to open affected the hand
3. At least trace ability to extend the wrist and fingers

Exclusion Criteria:

1. Have cognitive deficits that could negatively affect their ability to complete the protocols as evidenced by a score of 24 or less on the Folstein Mini-Mental State Examination
2. Have excessive pain in any joint of the affected extremity that could limit ability to cooperate with the protocols
3. Have serious uncontrolled medical problems as judged by the project therapist
4. Receiving oral or injected antispasticity medications during study treatment
5. MCP and IP passive extension limit \> 30 degrees from full extension
6. Excessive tone in the fingers and thumb as determined by Ashworth scores \>=3
Depression in Chronic Airways Diseases

Chronic airways diseases involve alterations in the person's social roles, relationships and self-perception so demands continual psychological adjustment .

Also Kunik studied patients with chronic breathing disorders for depression and anxiety and found that 65% of patients were positive for depression and anxiety.

Shackell found that patients' anxiety and fears of breathlessness and dying extended into the night and were aggravated by feelings of isolation and frustration. One patient reported that they often thought 'am I going to see the next morning?'

This fear and sense of helplessness can lead to panic and evidence suggests that patients with chronic breathlessness often call for emergency assistance during the night According to GOLD report 2017, anxiety and depression in chronic obstructive pulmonary disease patients are both associated with poor prognosis.

Much of the evidence explored so far relates to chronic obstructive pulmonary disease. While other chronic lung diseases have received less attention In addition to, several studies have been found relationship between asthma and psychological disturbance .One review of literature describes an increased prevalence of psychological co-morbidity in asthmatic adults and another research suggests that anxiety and depression are more common in patients with moderate to severe asthma than in the general population Gift. found significantly greater self-reported depression scores among patients with chronic obstructive pulmonary disease receiving prednisone compared to patients not receiving any steroids.

Interestingly, the psychiatric sequel of steroid treatment are often sudden in onset and appear to generally occur within 2 weeks after steroid introduction

Eligibility Criteria:
Inclusion Criteria:

* Chronic airways diseases as chronic obstructive pulmonary disease, bronchial asthma, bronchiectasis

Exclusion Criteria:

* Diabetes Mellitus and Hypertension.
* Cardiac diseases.
* Chronic renal and liver diseases.
Community-based Post-exposure Prophylaxis for COVID-19

Specifically identified Ayurvedic preparations is recommended by ministry of AYUSH as post-exposure prophylaxis to efficaciously prevent a negative person who has come into contact with COVID-19-positive. Traditionally, recommended Ayurvedic preparations have been used as antioxidants, antimicrobial and anti-inflammatory properties. Particularly, Guduchi Ghanvati has been recognised with its ability to control viral attachment, viral replication and induce immune response in pre clinical settings, and found to be one among the most important drugs in Ayurveda to fight against COVID-19.

However, known gap in guideline implementation and its impact on preventing active infection in exposed cases is unclear. Study aimed to increase the use of recommended AYUSH guidelines by having registered AYUSH physicians provide these medications, when indicated, in community based participants after known exposure to the SARS-CoV-2 coronavirus.


Eligibility Criteria:
Inclusion Criteria:

* Men or women 18 to 60 years of age
* Household contact residing with the index case in the 14 days prior to index diagnosis within a residence without maintaining social distance
* Access to device and internet for telephonic appointments and follow up

Exclusion Criteria:

* Currently hospitalised
* Symptomatic with fever, cough, or shortness of breath
* Use of anti-malarial treatment or chemoprophylaxis
* Moderately or Severely ill for any co-morbid condition requiring medical assistance.
* Cognitive impairment
Effect of the Combination of Methotrexate and Adalimumab on Reduction of Immunization in Ankylosing Spondylitis (COMARIS)

The purpose of this study is to determine if association of methotrexate with adalimumab leads to decrease immunogenicity beside adalimumab alone in Ankylosing Spondylitis.


Eligibility Criteria:
Inclusion Criteria:

* Subject 18 years of age or older
* Able and willing to give written informed consent and to comply with the requirements of the study protocol
* Subject met the definition of Ankylosing Spondylitis (AS) based on ASAS Criteria
* Subject with active AS, has had an inadequate response, an intolerance or an to one or more nonsteroidal anti-inflammatory drugs

Exclusion Criteria:

* Previous adalimumab treatment or previous treatment with more than one anti TNF alpha therapy.
* Previous methotrexate treatment, not stopped 3 month before inclusion
* Surgery scheduled during study
* Female subject without method of contraception
* Contraindication to adalimumab or methotrexate
Intervention to Improve Asthma Management/Prevention

To implement and evaluate a comprehensive asthma education and prevention program in all 54 public elementary schools in the predominantly minority Birmingham, Alabama school system.

BACKGROUND:

The study was part of an initiative "Interventions to Improve Asthma Management and Prevention at School". The Broad Agency Announcement was released in June, 1994.

DESIGN NARRATIVE:

The study had several objectives. The first was to demonstrate that a comprehensive school-based asthma education program could be implemented, using existing resources, in a largely poor, inner city educational environment. The second objective was to provide broad information on asthma and its management to elementary school faculties in order to help reduce fear and anxiety due to lack of knowledge about asthma. The third was to provide curriculum-based information about asthma to the general student bodies of elementary schools. The fourth objective was to institute a cost effective screening program that would identify elementary school students with asthma. The fifth was to provide an education program designed to improve knowledge and prevention. The sixth was to develop an individual asthma action plan for students with asthma that would improve their management and prevention skills and to coordinate the individual asthma action plan with school personnel and activities in order to improve support for the students in following their management plans.

The program was evaluated through a randomized controlled design with the schools as the unit of randomization and the students the unit of analysis. The Birmingham public schools were divided into three cohorts of 18 schools each on the basis of geographic location. Schools were randomly assigned within cohorts so that nine schools were experimental and nine were control. The research protocol was implemented in the first cohort in the fall of 1995, in the second cohort in the fall of 1996, and in the third cohort in the fall of 1997. Students with asthma were followed for three school terms following collection of baseline data and implementation of the education program. Outcomes were assessed in terms of school absences and performance, health care utilization, quality of life and asthma morbidity during school.

Eligibility Criteria:
No eligibility criteria
Ameliorating Effects and Mechanisms of TaVNS on Constipation in PD Patients.

The investigators intend to conduct a randomized, double-blind, sham-stimulation-controlled experiment, incorporating various clinical scales, gastrointestinal electrogram, and high-resolution anorectal manometry (HRAM), to investigate the improvement effect of taVNS on constipation symptoms in PD patients.

The investigators intend to conduct a randomized, double-blind, sham-stimulation-controlled experiment, incorporating various clinical scales, gastrointestinal electrogram, and high-resolution anorectal manometry (HRAM), to investigate the improvement effect of taVNS on constipation symptoms in PD patients. Meanwhile, the investigators aimed to verify mechanistic effects by investigating changes in proteins and cytokines related to inflammation and intestinal barrier function in serum and feces to verify mechanistic effects.

Eligibility Criteria:
Inclusion Criteria:

1. aged 40-70 years;
2. had a PD diagnosis designated by movement disorder neurologists (Ke-zhong Zhang and Yong-sheng Yuan) according to Movement Disorder Society Clinical Diagnostic Criteria;
3. fulfilled Rome IV criteria for functional constipation, including having \< 3 spontaneous bowel movements (SBM; i.e., not induced by rescue medication) per week for the past 3 months with symptom duration of at least 6 months;
4. stable initiation of PD medications, leastways 3 month before this investigation; (5) provided written informed consent.

Exclusion Criteria:

1. a history of previous abdominal surgery (other than appendectomy);
2. the presence of carcinoma;
3. any organic diseases causing constipation or neurologic diseases such as multiple sclerosis, rachischisis, or spinal cord injury;
4. taking antidepressant agents including tricyclic antidepressants and selective serotonin reuptake inhibitors;
5. a serious concomitant disease of the heart, liver, kidney, or diabetes;
6. pregnancy or lactation;
7. participating in another trial or enrolled in a trial during the past month;
8. an allergic reaction to surface electrodes.
Gene and Protein Expression Patterns in Predicting Response to Cetuximab in Patients With Recurrent and/or Metastatic Head and Neck Cancer

RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how will patients respond to treatment.

PURPOSE: This research study is looking at gene and protein expression patterns in predicting response to cetuximab in patients with recurrent and/or metastatic head and neck cancer.

OBJECTIVES:

* To identify 100 patients from the Head and Neck Tumor Tissue Repository and Clinical Database treated with cetuximab monotherapy or cetuximab-containing combination therapy as a standard of care for recurrent and/or metastatic head and neck squamous cell carcinoma at Vanderbilt University Medical Center.
* To assay the diversity of gene and protein expression patterns seen in these patients.
* To identify predictive patterns associated with treatment response and survival of these patients by correlating the laboratory data with clinical data.

OUTLINE: Tumor tissue specimens and clinical data are obtained from the Head and Neck Tumor Tissue Repository and Clinical Database protocol VU-VICC-HN-0356. Specimens are analyzed for patterns of gene and protein expression predictive of cetuximab treatment response and survival by DNA microarray, tissue microarray, reverse transcriptase-PCR, and mass spectroscopy.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of recurrent and/or metastatic head and neck squamous cell carcinoma

  * Enrolled on the Head and Neck Tissue Repository and Clinical Database protocol VU-VICC-HN-0356
  * Previously treated with cetuximab monotherapy or cetuximab-based combination therapy
* Sufficient biological material available for analysis

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Impact of IPT With Sulfadoxin Pyrimetamin on Pregnant Women and Their Babies Outcomes in Peri-urban Areas of Bobo-Dioulasso(Burkina Faso)

The purpose of this is to determine the impact of intermittent preventive treatment (IPT) with sulfadoxine-pyrimethamine (SP) on the morbidities associated with malaria in pregnant women and newborns in rural peri-urban areas of Bobo-Dioulasso, 5 years after its implemented.

Malaria in pregnant women is a crucial issue in Burkina Faso. Faced with this problem, a strategy based on the use of treated nets and intermittent preventive treatment (IPT) based on sulfadoxine-pyrimethamine (SP) was adopted in 2005. Five years after its implementation, the investigators will check whether this strategy is still effective in the preventing maternal and congenital malaria on the one hand and maternal anemia, low birth weight and prematurity on the other hand.

Eligibility Criteria:
Inclusion Criteria:

* Residing in the health area of Lafiabougou or secteur 24
* Having agreed to give free and informed consent

Exclusion Criteria:

* Bleeding from during the pregnancy
* eclampsia
Hemodynamic Management Following Acute Traumatic Spinal Cord Injury

The purpose of this study is to assess the effect of various hemodynamic management strategies on functional neurologic outcomes and non-neurologic adverse events in the first 5 days following acute spinal cord injury (SCI). The hemodynamic management strategies assessed include targeting a mean arterial blood pressure (MAP) goal of 85-90 mmHg, targeting a spinal cord perfusion pressure (SCPP) goal of ≥65 mmHg, or targeting normal hemodynamics, which is a MAP goal of ≥65 mmHg.


Eligibility Criteria:
Inclusion Criteria:

* Traumatic spinal cord injury

Exclusion Criteria:

* Patients with an injury from a trauma that penetrates the spinal cord (i.e., gunshot or knife wound resulting in cord transection)
* Preexisting neurologic or spinal cord injury
* Severe traumatic brain injury as measured by a best resuscitated Glasgow Coma Scale (GCS) score of \<8 at 24 hours following injury
* Presence of traumatic injuries that preclude spine surgery within 24 hours of presentation
* Concomitant injury/illness requiring targeted blood pressure management (e.g., injury to the aorta, aortic dissection, hemorrhagic stroke)
* Preexisting history of neuromotor disorders (i.e., cerebral palsy, Parkinson disease, etc.)
* Not expected to survive \>24h
* Cord transection identified by radiologist and agreed upon by the spine surgery team
* Injury below spinal cord level L1
* Prisoners
* Pregnant women
Enhancing Well-Being Through Exercise During Old Age

Determine the feasibility of adapting Fit \& Strong!, an evidence-based group physical activity and health education program, to include affect and mood-related content and of employing this intervention among older adults with a range of depressive symptoms.

The specific aims of this pilot are to use a small randomized controlled trial (RCT) with a wait list control design to: 1) Determine the feasibility of adapting Fit \& Strong! to include affect and mood-related content and of employing this intervention among older adults with a range of depressive symptoms. 2) Begin to determine whether Fit \& Strong! is efficacious as an approach for improving positive affect, reducing negative affect, decreasing symptoms of depression, and improving cognition among older adults. 3) Explore the relationship between negative/positive affect and symptoms of depression and maintenance of physical activity between baseline and 2 months, in order to determine whether improved positive affect and reduced negative affect and depression and improved cognition are associated with an increase in physical activity.

Eligibility Criteria:
Inclusion Criteria:

* ages 60+;
* Sufficient visual and hearing capacity to follow instructions;
* a score of at least 1 on the Patient Health Questionnaire-8 (Kroenke et al., 2001);
* Six Item Screener (Callahan, 2002) score \> 4;
* pass screening with the Exercise Assessment and Screening for You (EASY) scale \[Cardinal et al., 1996\] or have doctor's clearance to participate;
* no recent (\<6 months) joint replacements;
* physically inactive (\<150 minutes of exercise per week);
* able to walk at least 20 feet (with or without the aid of a cane or walker);
* speak English proficiently.

Exclusion Criteria:

* Non-proficient in English;
* 0 on the Patient Health Questionnaire-8 (Kroenke et al., 2001);
* Six Item Screener \< 5 (Callahan, 2005);
* fail screening with the EASY scale and does not have doctor's clearance to participate;
* joint replacement in last 6 months;
* 150+ minutes of exercise per week;
* unable to walk at least 20 feet;
* severe medical illness (i.e., metastatic cancer, brain tumors, unstable cardiac, hepatic, or renal disease, myocardial infarction or stroke) within the 3 months preceding the study;
* Other brain/neurological disorders (i.e., dementia or delirium according to Diagnostic and Statistical Manual (DSM-IV) criteria, history of severe head trauma, Parkinson's disease or Parkinson's plus syndromes, multiple sclerosis, epilepsy);
* Conditions often associated with depression (i.e., endocrinopathies other than diabetes, lymphoma, and pancreatic cancer).

Potential participants for the optional MRI component will be excluded for the following:

* cardiac pacemaker or defibrillator
* metal parts in head, spinal cord, eyes, or chest
* past operation or radiation therapy with skull or brain: e) aneurysm clips
* dentures that have been surgically implanted with magnets, braces:
* claustrophobia:
* heart valve replacement:
* history of work with metal resulting in an injury:
* eye injury with metal:
* history of strokes/seizures:
A Study to Evaluate the Efficacy and Safety of Rosnilimab (ANB030) in Treatment of Subjects With Moderate-to-Severe Alopecia Areata

Efficacy and safety of rosnilimab (ANB030) in subjects with moderate-to-severe Alopecia Areata

This is a Phase 2, randomized, double-blind, placebo-controlled, parallel-group,multicenter study to evaluate the safety, tolerability, and efficacy of rosnilimab in subjects with alopecia areata (AA).This study also will evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of rosnilimab and evaluate the immunogenicity of rosnilimab in subjects with AA.

Eligibility Criteria:
Inclusion Criteria:

* Male or nonpregnant, nonlactating female subject aged 18 to 75 years (inclusive) at the time of informed consent.
* Subjects with a clinical diagnosis of AA defined as having a SALT score ≥ 50 and in which the current episode of hair loss is \> 24 weeks (without evidence of spontaneous terminal hair regrowth ≥ 10% within 24 weeks at the time of screening and baseline), but ≤ 8 years (from onset of current episode).

Exclusion Criteria:

* Concomitant active systemic diseases (except stable thyroid diseases) that may cause hair loss (eg, lupus erythematosus, systemic sclerosis, celiac disease) that could interfere with the Investigators' ability to evaluate the subject's response to therapy.
* Subject's cause of hair loss is indeterminable and/or in addition to AA they have concomitant causes of alopecia, such as traction alopecia, cicatricial alopecia, lichen planopilaris, frontal fibrosing alopecia, advanced androgenetic alopecia (ie, Ludwig Type III or Norwood-Hamilton Stage ≥ V), telogen effluvium, trichotillomania, or diffuse AA (alopecia areata incognita).
* Known or suspected congenital or acquired immunodeficiency state, or condition that would compromise the subject's immune status (eg, history of splenectomy).