cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Band-Loop Space Maintainers Produced with Three-Dimensional Printer and Conventional Technique

Our research is planned as a randomised clinical trial. The main aim of our study is to evaluate the clinical success of band and loop space maintainers produced by three-dimensional printer and conventional technique and the changes they cause in periodontal tissues.

Participants will be selected by simple random selection from systemically healthy children who will need bilateral lower deciduous first molar extraction and space maintainer application from patients who apply to Aydın Adnan Menderes University Faculty of Dentistry, Department of Pedodontics for treatment.

The study will be carried out in a split-mouth design, and it is planned to place a band and loop space maintainer produced by conventional technique on one side and a band and loop space maintainer produced with a three-dimensional printer on the other side in the lower jaw. The clinical success of these two appliances and the changes in periodontal tissues will be compared. In order to evaluate the clinical success, the survival of the appliances and the determined failure criteria (Dissolution of the bonding cement, Separation/breakage from solder area, Embedding of the space maintainer inside towards the gum, Loop distortion/breakage, Inflammation of the gingiva adjacent to/around the space maintainer, Plaque accumulation around the band) will be taken into consideration. In order to evaluate the effects on periodontal tissues, pocket depth, plaque index values, gingival index values will be recorded and PLAP-1 and TNF-a levels in the gingival groove fluid will be examined for more detailed periodontal examination.

The total planned follow-up period is 18 months, with patients invited for follow-up appointments at six-month intervals.

Evaluations will be made at the end of the study with repeated measurements at baseline and control sessions.

Eligibility Criteria:
Inclusion Criteria:

* Systemically healthy children
* Bilateral early loss of deciduous first molar teeth in the lower jaw
* Presence of radiographically confirmed permanent tooth germ under the extracted deciduous tooth
* Radiographically determined 1,5 mm minimum of bone existence above the permanent tooth germ
* Existence of flush terminal plane/mesial step in decidious dentition and Angle class 1 molar relationship in mixed dentition
* Existence of radiographically and clinically healthy abutment teeth
* Frankl score 3 and 4 children

Exclusion Criteria:

* Patients with systemic diseases
* Frankl score 1 and 2 children
Radioscapholunate Fusions After Wrist Trauma

The investigators conduced a clinical trial to evaluate the clinical and radiographic results after radioscapholunate fusion in case of posttraumatic radiocarpal osteoarthritis.

Because of poor clinical result, many authors upgrade the procedure including excision of the distal pole of the scaphoid and later excision of the entire triquetrum.

Only one study compared the three procedures in 17 patients. The investigators performed the same comparison in 85 patients with a mean follow up of 9,1 years (1-23)

The investigators compared three populations: patients with radioscapholunate (RSL) fusion alone, patients with RSLfusion and distal scaphoid excision and patient with RSL fusion, distal scaphoid excision and excision of the triquetrum.

The investigators performed clinical (pain, grasp strength, wrist motion), functional and radiographic (midcarpal osteoarthritis and radiocarpal nonunions) evaluation

Eligibility Criteria:
Inclusion criteria:

* posttraumatic radiocarpal osteoarthritis
* Patients who underwent radioscapholunate fusion

Exclusion criteria:

* Patients with radiocarpal osteoarthritis due to rheumatoid or inflammatory disease and Kienböck disease
* Patients with posttraumatic radiocarpal osteoarthritis managed with other surgery
The Use of Functional Electrical Stimulation in Conjunction With Respiratory Muscle Training to Improve Unaided Cough in Individuals With Acute Spinal Cord Injury

The overall objective of this study is to improve unaided cough with abdominal and latissimus dorsi functional electrical stimulation in conjunction with respiratory muscle training in individuals with acute spinal cord injuries.


Eligibility Criteria:
Inclusion Criteria:

1. Traumatic and atraumatic C2- T12 Spinal cord injury (AIS A, B, and C motor incomplete and complete injuries) currently admitted to inpatient rehabilitation with an injury date \< 12 months prior to enrollment
2. Positive response to electrical stimulation through a palpable contraction
3. Fluent in written and spoken English

Exclusion Criteria:

1. Individuals who do not meet inclusion criteria
2. Prisoners
3. Concurrent traumatic brain injury determined by Rancho level of cognitive functioning \< VI
4. Individuals with open tracheostomy
5. Persons with pacemakers
6. Pregnant women
7. Persons with epilepsy
8. Open wounds or metal implants at site of electrode placement
9. Unresponsive to functional electrical stimulation
10. Current diagnosis or history of thoraco-abdomino-pelvic cancer
Fundus Autofluorescence After Macular Hole Surgery

Funds autofluorescence (FAF) indicates hyper fluorescence at the macular hole in the patients with macular hole. Investigators investigate the association between FAF and visual acuity, recovery of foveal microstructure, and FAF in surgically closed macular holes.

Ultrawide angle FAF images were taken in 27 eyes before and after macular hole surgery and compared with swept source optical coherence tomographic (SS-OCT) images.

Eligibility Criteria:
Inclusion Criteria:

* The patients were followed more than 6 months.

Exclusion Criteria:

* The patient were followed less than 6 months.
Using a Mirror in the Second Stage of Labor: Effects on Duration and Birth Experience

This study aims to investigate the impact of using a labor mirror during the second stage of labor on both the duration of labor and the mother's overall experience. The main questions it aims to answer are:

* Does using a labor mirror in the second stage of labor affect the duration of labor?
* Does the use of a labor mirror in the second stage of labor affect women's total birth experience scale score? To assess the effect of using a birth mirror during the second stage of labor on the duration of labor and mothers' satisfaction with labor, the researchers will give one group a birth mirror and the other group will receive normal midwifery care.
* In the second stage of labor, the birth mirror will be positioned so that the woman can see the progress of the baby as she pushes (lithotomy position).
* Within 24 hours after delivery, mothers will complete the Birth Experience Scale and an opinion form about the use of the mirror.
* The control group will not receive any intervention.

Childbirth is one of the most significant experiences in a woman's life. The second stage of labor, when the cervix is fully dilated and the baby moves through the birth canal, is a crucial phase. Various techniques and tools are used during this stage to assist delivery, one of which is the labor mirror. This tool allows the mother to visually observe the perineum and monitor the progress of labor, especially in water births. Both handheld and bed-mounted options are available, usually made of acrylic, and they can have adjustable angles for better visualization.

The use of a labor mirror offers several benefits. It enables real-time monitoring of the birthing process, allowing midwives to make timely interventions. More importantly, it helps mothers feel more involved in the birth, boosting their confidence and motivation, especially when they see the baby's head. This can lead to more controlled pushing and potentially shorten the duration of labor.

In summary, the labor mirror can enhance the birth experience by allowing mothers to participate actively and by providing emotional support, which may reduce the length of the second stage of labor. However, its use is not widespread in Turkey. This study aims to investigate the impact of using a labor mirror during the second stage of labor on both the duration of labor and the mother's overall experience.

Eligibility Criteria:
Inclusion Criteria:

* between 38-42 weeks of gestation,
* had a healthy fetus,
* had no perinatal and obstetric risk,
* did not have prolonged trauma,
* could understand and speak Turkish

Exclusion Criteria:

* preterm labor onset,
* premature rupture of membranes,
* epidural analgesia,
* amniotic fluid with meconium,
* fetal risk
* intervention delivery
Wellness Coaching for Caregivers of Thoracic Transplant Candidates

Researchers are studying the effects of a health coaching intervention on the stress and burden of caregivers of patients awaiting heart or lung transplant.

This is a randomized trial of health coaching compared to usual care. Caregivers for patients on the adult heart or adult lung transplant waiting list at the Mayo Clinic will undergo informed consent. Consenting participants will be randomized to weekly, 30-minute telephone calls for twelve weeks or usual care. Questionnaires and demographic information will be collected at baseline and after 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older who are the primary caregivers of patients listed (active, deferred, or temporarily inactive) for lung, heart/lung, or heart transplantation at Mayo Clinic in Rochester and Jacksonville, FL

Exclusion Criteria:

* Individuals younger than 18 years
* Non-English speaking, non-verbal, or extremely hard of hearing
A Study of Xeloda (Capecitabine) in Patients With Advanced and/or Metastatic Colorectal Cancer

This study will assess the efficacy and safety of intermittent oral Xeloda administration in combination with irinotecan as a first-line treatment in patients with advanced and/or metastatic colorectal cancer. The anticipated time on study treatment is 3-12 months and the target sample size is \<100 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients \>=18 years of age;
* locally advanced and/or metastatic colorectal cancer;
* \>=1 target lesion.

Exclusion Criteria:

* previous treatment with Xeloda or irinotecan;
* previous systemic therapy for metastatic disease;
* progressive disease during previous adjuvant therapy or within 6 months of completion.
Examining the Effects of Vivo on Physical Function and Glycemic Level in Sedentary Older With Prediabetes.

This is a 12-week randomized, controlled trial that seeks to examine the effect of Vivo on 1) change in lower extremity strength defined as number of chair stands done in 30 seconds and 2) change in average glycemic level (HbA1c) compared to a wait list control.

This is a 12-week randomized, controlled trial that seeks to examine the effect of Vivo on 1) change in lower extremity strength defined as number of chair stands done in 30 seconds and 2) change in average glycemic level (HbA1c) compared to a wait list control. After informed consent and baseline assessments, up to 90 individuals will be randomized in one of two arms: 1) Vivo intervention or 2) waitlist control. Participants in the Vivo 2.0 intervention arm will meet virtually twice a week with their small group and certified trainer for 45 minutes over a 12-week period. Participants will be men and women, ≥60 years old, sedentary, with prediabetes and low function. All participants will undergo baseline and 12-week assessments

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 60 years
* Ambulatory and community-dwelling
* Diagnosis of Pre-diabetes within prior 12 months: fasting glucose between 100 to 126 OR HbA1c between 5.7 and 6.4%
* Low functioning: 1) able to do at least 1 chair stand and 2) number of chair stands done in 30 seconds is below criterion-referenced fitness standards for maintaining physical independence for age and gender
* Sedentary: less than 150 minutes of moderate physical activity OR less than 60 minutes of vigorous physical activity per week
* Have not engaged in resistance training for at least 6 months prior to enrollment
* Access to WiFi in defined exercise space

Exclusion Criteria:

* Inability to complete physical function assessment
* Use of antidiabetic medications
* Use of testosterone supplement or replacement
* Clinical disorder precluding/interfering with participation of assessments

  * Unstable angina, arrhythmia, uncontrolled hypertension
  * End Stage Renal Disease on Hemodialysis
  * Lower extremity amputation or paralysis
  * Neurological condition causing functional or pronounced cognitive impairments
  * Active malignancy except for non-melanomatous skin cancers
* Weight instability (defined as gain or loss of ≥10% over the last 6 months)
* Unable to provide consent
Study of the Long-term Effects of Exercise on Heath Indicators in Older People

Cardiovascular diseases (CVD) represent the most frequent cause of death among the elderly population. Hypertension, unfavorable lipid profile, obesity and physical inactivity are among the main risk factors for CVD. In contrast, mortality from CVD is inversely related to levels of physical activity, and is lower in individuals who exercise and have higher functional fitness levels. Thus, the Centers for Disease Control and Prevention, the American College of Sports Medicine, and the American Heart Association have recommended 20-30 min of moderate-to-vigorous aerobic training for the elderly, preferably every day or at least 3 days a week in the case of vigorous exercise.The same organizations also suggest the inclusion of resistance training in order to improve functional fitness. Therefore, the purpose of this study was to compare different exercise modalities in long-term changes of CVD risk factors and physical fitness among older adults.


Eligibility Criteria:
Inclusion Criteria:

* Older adults living independently;
* medical approval.

Exclusion Criteria:

* Non-smokers;
* Non-morbidly obese;
* No history of severe hypertension;
* No history of falls;
* No orthopaedic, neurological, pulmonary, or cardiac problems.
Pulmonary TELE-REHABilitation Program : Feasibility and Safety Study

Chronic pulmonary disease like interstitial lung disease (ILD) and chronic obstructive lung disease (COPD) are a significant health problem in Canada and around the world. In addition to the respiratory impairment resulting to a progressive dyspnea, these diseases are also characterized by a decrease in exercise tolerance and muscle dysfunction which affect the patient's quality of life. Respiratory rehabilitation is the cornerstone of the management of chronic disease and it includes a set of personalized care mainly delivered in person by a transdisciplinary team and with the objectives of reducing the symptoms felt by the participants and improving their physical and psychosocial condition.

The current containment due to the COVID-19 pandemic increase the sedentary behavior of patients and prevents the holding of any respiratory rehabilitation activity. In this context, tele-rehabilitation appears to be a particularly well-suited solution because it would make it possible to offer a respiratory rehabilitation in a safe and effective manner while minimizing contact with the participants. Although some studies support the feasibility of this intervention, more data is needed to validate its routine clinical application.

The main objective of this study is to verify the safety and the feasibility of delivering pulmonary rehabilitation treatments entirely at home via a telerehabilitation patform developed at the Institut universitraire de cardiologie et de pneumologie de Québec (IUCPQ), and document its effectiveness in people with chronic respiratory disease. The secondary objectives will be: 1) to explore the effects of a telerehabilitation programm on exercise tolerance, muscle function, functional capacity and quality of life, and 2) to assess the satisfaction of participants and health care providers with telerehabilitation.


Eligibility Criteria:
Inclusion Criteria:

* The patient already participate to the telerehabilitation program in the PPMC at IUCPQ
A Study in Patients With Chronic Obstructive Pulmonary Disease

The purpose of the present study is to determine the effects on health status and spirometric values of Foster® 100/6 (two puffs b.i.d.) versus Seretide® 500/50 (one inhalation b.i.d.), over a 12-week treatment period in Chronic Obstructive Pulmonary Disease (COPD) patients.

Chronic obstructive pulmonary disease (COPD) is an incurable, debilitating and progressive disease that can be fatal. The recent Global Burden of Disease Study ranks COPD as the 6th leading cause of mortality and the 12th leading cause of morbidity world-wide. Furthermore, trends in the use of medical care resources indicate that the economic cost of COPD continues to rise in direct relation to the ageing population, the increase in prevalence of disease and the cost of new and existing medical and public health interventions.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female patients aged ≥ 40 years, who have signed an Informed Consent form prior to initiation of any study-related procedure or once applicable written informed consent obtained by legal representative.
2. Outpatients with a diagnosis of COPD and including:

   1. Smoking history of at least 10 pack years defined as \[(number of cigarettes smoked per day) x (number of years of smoking) / 20\], both current and ex-smokers are eligible.
   2. Use of bronchodilators in the previous 2 months to visit 1.
   3. Post-bronchodilator FEV1 \< 60% of the predicted normal value.
   4. Post-bronchodilator FEV1/FVC \< 0.7.
   5. A ≥ 5% response to a reversibility test.
   6. A Baseline Dyspnoea Index (BDI) focal score less or equal than 10 (to be met also at visit 2).
3. History of no more than one COPD exacerbation in the previous 12 months (without considering the last 2 months) to visit 1.
4. A cooperative attitude and ability to be trained to the proper use of pMDI and DPI (Accuhaler®, circular moulded plastic inhaler) inhalers.

Main Exclusion Criteria:

1. Clinically relevant respiratory disorders.
2. Current diagnosis of asthma or respiratory disorders other than COPD.
3. Clinically significant laboratory and ECG abnormalities indicating a significant or unstable concomitant disease which may impact the feasibility of the results of the study according to investigator's judgement.
4. Patients with COPD exacerbation in the 2 months prior to screening and during the study period.
5. Patients requiring long term (at least 12 hours daily) oxygen therapy for chronic hypoxemia.
6. Patients treated with depot corticosteroids in the 2 months preceding the visit 1 and during the run-in period.
Impact of Removable Cast Walker Design on Usability for Patients With Diabetic Foot Ulcers

Within their lifetime, over 30% of people living with diabetes will develop a diabetic foot ulcer (DFU), many of which will never heal and may require amputation. Removable cast walkers (RCWs) are commonly prescribed to offload (treat) DFUs. While RCWs are prescribed to be worn during all weight bearing activities, adherence to this prescription is low. This is a serious concern given that low adherence predicts poor DFU healing. This study will provide pilot/feasibility data to inform a larger clinical trial to evaluate the impact of existing RCW designs on adherence and DFU healing. We will also quantify the effect of RCW form on biomechanical and self-reported measures related to usability. Our working hypothesis is that healing outcomes with a given RCW will be predicted by biomechanical and self-reported measures of RCW usability, with the predictive relationship partly explained by the effect of these measures on adherence.


Eligibility Criteria:
Inclusion Criteria:

* presence of a full thickness plantar (forefoot) diabetic foot ulcer ≥1cm2 that is being treated on an outpatient basis with a University of Texas wound classification of 1A-C or 2 A-C;
* self-reported ability to walk for at least two continuous minutes at a self-selected speed
* confirmation of the presence of diabetic peripheral neuropathy as identified by failure to detect a 10 gram Semmes Weinstein Monofilament on either foot at one of four sites tested (1st, 3rd, 5th metatarsal heads, and plantar surface of hallux) OR a vibration perception threshold value of 25 or more at either hallux.

Exclusion Criteria:

* lower extremity amputation more proximal than transmetatarsal on either limb
* chronic kidney disease stage 4 or higher (i.e., currently undergoing dialysis or eGFR\<30 within last 60 days)
* active Charcot neuroarthropathy
* severe peripheral arterial disease (non-palpable pulse at posterior tibia and dorsalis pedis arteries, and an ankle brachial index\<0.7)
* gait/balance disturbance not attributable to diabetes (e.g. neuromuscular disease or cerebrovascular vascular accident)
* current or previous (within past year) use of an ankle-high RCW or of a contralateral lift to offset an RCW-induced LLD
Staccato® Granisetron Multiple Dose PK

To examine the tolerability and safety of AZ-010 following 7 days of dosing (up to 3 mg) in healthy volunteers To characterize the pharmacokinetics of AZ-010 following 7 days of dosing (up to 3 mg) in healthy volunteers

A Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety and Pharmacokinetic Profile of Staccato Granisetron (AZ-010) in Healthy Volunteers

Eligibility Criteria:
Inclusion Criteria:

* Healthy based on a medical evaluation including history, physical examination, vital signs, electrocardiograms (ECGs) and laboratory tests assessed at the screening visit and prior to the first dose of study drug.
* Body weight ≥ 50 kg and BMI within the range of 18 to 32 kg/m2, inclusive, at screening.
* Negative urine tests for selected drugs of abuse and alcohol breath test at screening and Day 1.

Exclusion Criteria:

* Any significant medical condition
"Electro Acupuncture in the Treatment and Management of Chemotherapy Induced Peripheral Neuropathy"

To evaluate the effectiveness of Electro acupuncture (EA) for treatment of persistent painful CIPN symptoms in patients with stages 1-3 breast cancer treated with docetaxel chemotherapy 6 months prior

A double blind prospective randomized controlled pilot study with cross over.

To assess the effectiveness of EA in improving pain and function for chronic chemotherapy Induced Peripheral Neuropathy (CIPN) 30 participants will be recruited 6 months post-completion of chemotherapy. Fifteen participants will be randomized to the true EA group and 15 to the sham EA group. Those participants randomized to the sham group will cross over to receive true EA after the trial is complete.

Treatment consists of EA or sham EA 1 x per week x 6 weeks. Re-assessment visits occur after the 6 week intervention and again 2 months post trial.

Each assessment visit quantifies the sensory experience of CIPN at that moment in time using Quantitative Sensory Testing (QST) which includes; thermal detection and thermal pain thresholds, light touch detection using nylon monofilament hairs (Semmes Weinstein Monofilaments (SWMF)), static 2-point discrimination, pressure algometry and vibration thresholds. Patient reported outcome measures including the Disabilities of the Arm, Shoulder and Hand (DASH), Lower extremity functional score (LEFS), the Self report Leeds Assessment of Neuropathic signs and symptoms (S-LANSS) pain questionaire will also be used.

Eligibility Criteria:
Inclusion Criteria:

* Any patient diagnosed with stage 1-3 breast cancer who has finished chemotherapy 6 months prior and has residual CIPN symptoms graded as a 3/10 or higher on the numeric rating pain scale.

Exclusion Criteria:

* Patients who have co-morbid conditions that cause peripheral neuropathic symptoms
* patients with heart valve replacements
* patients on prophylactic antibiotics
* patients with severe coagulopathy
* patients who did not receive regular taxane therapy