cyrilzakka/clinical-trials huggingface dataset:
Pharmacological Recruitment of Endogenous Neural Precursors to Promote Pediatric White Matter Repair: Establishing Correlations Between Visual Outcomes, Saccadic Function and MEG Oscillations in Children With Demyelinating Disorders in Comparison to Healthy Control Children

The neural circuits in our brains require a layer of insulation in order to transmit signals in a rapid and efficient fashion. This insulation is called White Matter and is comprised of a specific type of brain cell called an oligodendrocytes. Damage to brain white matter occurs following injury and in disorders like Multiple Sclerosis and results in sensory, motor, and cognitive problems. Currently there are no effective medical therapies to promote brain repair and reduce disability following damage to white matter. In this project, we hope to change the situation by encouraging the brain itself to generate new oligodendrocytes and thus new white matter. Our first step is to find measures sensitive to white matter growth.


Eligibility Criteria:
Inclusion Criteria:

* Experienced a demyelinating event (Only applicable to patient subjects)
* Between the ages of 5 years to 18 years and 11 months of age
* Has either English as his or her native language or has had at least two years of schooling in English

Exclusion Criteria:

* Children with non-demyelinating etiologies of white matter dysfunction (i.e., metabolic disorders, vasculitis, and non-specific MRI abnormalities
* Is younger than 5 years of age
* Is 18 years and 11 of age or older
* Has a prior history of traumatic brain injury, neurological disorder, cerebral palsy, developmental delay, or learning disability
* Requires sedation for brain scanning
* Is claustrophobic, as brain scanning requires children to enter a tunnel in the MRI machine
Kinesio Taping Versus Compression Garments for Breast Cancer-Related Lymphedema

Breast cancer-related lymphedema (BCRL) tends to become chronic and progressive. Current therapies have modest results for this condition. Compression garments (CG) prevent the worsening of lymphedema and even improve it, during periods between treatments of physical therapy. Kinesio Taping(KT) is being recently used for lymphedema, although little evidence backs it. The aim of this study is to compare the reduction of lymphedema volume with both therapies.

Primary end points: to evaluate whether the decrease in BCRL volume is different for a 4-week treatment with KT than with CG.

Research design:

Randomized quasi-experimental clinical pilot study: initial sample randomly balanced into two groups . The initial sample was selected among the patients of "Breast Pathology Rehabilitation" at Hospital Universitario 12 de Octubre . The planned sample size was 30.

Cross Design: it made possible to evaluate two different treatments in the same patient, cancelling intragroup variability.

Open design: it was impossible to blind patients and physiotherapist researcher because of patent visual differences between the two therapies, CG or KT, both during application and while being worn, and even in the hours after its removal, due to the marks left on the skin. However, at least one external evaluator suitably trained was implemented and performed the randomisation of the groups and collected all patient data. Statistical study was also made by others (staff of the "Clinique Investigation Unit (i+12)" of Hospital Universitario 12 de Octubre) with coded variables to blind the analyst.

Eligibility Criteria:
Inclusion Criteria:

1. Suffering from clinically significant breast cancer-related lymphedema at least since three months ago.
2. Having a Compression Garment suitable for the lymphedema arm

Exclusion Criteria:

1. Physiotherapy treatment for lymphedema during the 4 weeks before study start (pre-wash phase).
2. Metastasis breast cancer or other tumour.
3. Treated with systemic chemotherapy and /or radiotherapy at that time
4. Heart Failure or Renal Failure.
5. Using Diuretics.
6. Bilateral axillary lymphadenectomy.
7. Cognitive impairment or delay that impedes understanding the study's instructions.
Sensory Retraining Facilitates Sensory Recovery After Mandibular Nerve Injury

The purpose of this study is to determine whether sensory retraining exercise could improve lip numbness caused by bilateral sagittal split of mandible.

The study is a prospective randomized controlled trial. The patients receiving bilateral sagittal split osteotomy and having lip numbness or paraesthesia will be included in this study. 80 patients will be included and randomized into two groups and there are 40 patients in each group. The control group is to maintain follow up in clinic and do not receive any sensory retraining exercise. The experimental group is requested to perform sensory retraining at home by themselves.

Eligibility Criteria:
Inclusion Criteria:

1. Taiwanese adult (18-40 y/o)
2. Developmental dentofacial disharmony (Class III)
3. Patients received orthognathic surgery (BSSO alone or with maxillary procedure)

Exclusion Criteria:

1. Medical condition associated with systemic neuropathy
2. Unwilling to sign informed consent
3. Congenital anomaly or acute trauma affecting the face
4. Previous facial surgery
5. Positive pain sensation at first week of post-surgery
6. Altered sensation before OGS as numbness or unusual feeling
7. Cleft lip and palate
Effect of Nesiritide Infusion on Insulin Sensitivity in Healthy Obese Insulin Resistant Subjects

The purpose of the study is to compare the effects of nesiritide to placebo administered by a continuous IV infusion over 48 hours for the treatment of insulin resistance in healthy, obese, insulin resistant individuals.


Eligibility Criteria:
Inclusion Criteria:

1. Age 40-65 years inclusive
2. Men and women
3. Able to provide written, informed consent
4. Weight stable (± 3 kg) during the 3 months prior to enrollment
5. BMI ≥ 30 kg/m2; body weight ≤ 106 kg
6. Resting blood pressure ≥ 110/60 mmHg and ≤ 150/100 mmHg

Exclusion Criteria:

1. Known coronary artery disease, angina or heart failure
2. Type 1 or Type 2 Diabetes (A1c ≥ 6.5% and/or fasting plasma glucose \>125mg/dL)
3. Bleeding disorders
4. Hemoglobin level \< 12.5 g/dL for women; \< 13.0 g/dL for men
5. Acute or chronic infections
6. Hepatitis and/or cirrhosis (AST or Alanine Aminotransferase 2.5 times upper limit of normal)
7. Severe asthma or chronic obstructive pulmonary disease
8. Renal insufficiency (creatinine \> 1.6 mg/dL)
9. Prior bariatric surgery
10. Inflammatory bowel disease or malabsorption
11. Cancer within the last 3 years (except non-melanoma skin cancer or treated cervical carcinoma in situ)
12. Psychiatric or eating disorders
13. Untreated or inadequately controlled thyroid (abnormal TSH) or other endocrine disorders
14. Active rheumatoid arthritis or other inflammatory rheumatic disorder
15. Pregnant or nursing women
16. Presence of clinically significant abnormalities on electrocardiogram
17. Smoking (within the last 3 months)
18. Known hypersensitivity to nesiritide or any of its excipients
19. Poor intravenous access
20. Use of medications: a) nitrates, b) beta-blockers, c) digoxin, d) anti-diabetic agents, e) oral, injected or chronic topical steroids (inhaled steroids for mild asthma are acceptable), f) chronic use of aspirin or other non-steroidal anti-inflammatory drugs, including cyclooxygenase-2 inhibitors, g) other drugs known to affect immune or metabolic function and h) orlistat, phenteramine or other weight loss or anorectic agents.
GoalKeeper: Intelligent Information Sharing for Children With Medical Complexity

This proposal addresses the major challenge of improving health outcomes for children with cancer and other complex conditions, for whom the effectiveness of outpatient care depends on care coordination across a diverse group of caregivers that includes parents, community support organizations and pediatric care providers. The investigators have developed GoalKeeper, a prototype system for supporting care coordination across multiple care providers. The primary aim of the clinical trial is to assess the potential for this new system, GoalKeeper, to improve meaningful use of goal-centered care plans in the care of children with cancer and other complex chronic conditions.

The overarching aim of the research is to improve care coordination and goal setting for children with medical complexity (CMC). Specific aims of the pilot clinical trail are as follows: (1) To assess the efficacy of GoalKeeper on goal-setting in the health care encounter. (2) To examine the roles of parent health literacy and parent activation in moderating the effect of the intervention.

Study Population: Stanford's Primary and Subspecialty Care Clinics at Stanford Children's Health will serve as the setting for study recruitment.

The pilot randomized controlled trial will enroll 60 parents of children with medical complexity and their health-care providers. Eligibility criteria for participants will be age 18 years or older, English-speaking, and (for parents) child\<12 years old. Exclusion criteria are parent with known mental illness or neurocognitive impairment. A stepped wedge approach by provider will introduce families to GoalKeeper at different time points in the study. A pre-intervention period will occur at least 1 month before the trial start where clinical observations and baseline survey information will be obtained of each providers' practice.

Each family will be given training and 4-month access to the GoalKeeper application and participate in an exit interview at the end of study.

Eligibility Criteria:
Inclusion Criteria:

* Parent-child dyads and their medical provider
* Parent and provider age 18 years or older
* Parent English- or Spanish-speaking
* Child \> age 12 months and \<12 years old

Exclusion Criteria:

* Parent with known mental illness or neurocognitive impairment.
Does it Make Sense to Give Postoperative Antibiotics to Patients With an Uncomplicated Acute Cholecystitis

Each patient is preoperatively treated once profylactic with intraveneous antibiotics. Postoperatively, one group will be treated with intraveneous antibiotics during 5 days. The other group will receive no antibiotics.


Eligibility Criteria:
Inclusion Criteria:

* Uncomplicated acute cholecystitis \< 5 days(confirmed by echography and blood sample)
* \> 18 years old

Exclusion Criteria:

-
Glucocorticoids With Antihistamines Versus Antihistamines in Acute Urticaria in Emergency

Acute urticaria is common and affected 12% of population. 400 patients come in department emergency of Toulouse each year and there aren't many studies in literature which evaluate the glucocorticoids treatment. The standard treatment of urticaria is antihistamines H1, but glucocorticoids treatment administered orally for short course would permit to increase quickly acute urticaria uncomplicated. Clinical trial, prospective randomized double blinded of adults with acute urticaria less 24 hours duration and no take treatment urticaria before.

Acute urticaria is common and affected 12% of population. 400 patients come in department emergency of Toulouse each year and there aren't many studies in literature which evaluate the glucocorticoids treatment. Acute urticaria is pruritic and incapacitating for daily life. The standard treatment of urticaria is antihistamines H1, but glucocorticoids treatment administered orally for short course would permit to increase quickly acute urticaria uncomplicated. Clinical trial, prospective randomized double blinded of adults with acute urticaria less 24 hours duration and no take treatment urticaria before. One group randomized received 40mg of cortancyl and 1 pill of citerizine and another group randomized received 1 pill citerizine and placebo like cortancyl. Pharmacy hospital takes care of randomization. Pruritus evaluated with icth score and rash evaluated with nine rule of Wallace, the patient is evaluated in T0, one hour after and contacted by telephone at J2, J5, J15, J 21 itch score, Wallace extension, observance, side effects are asked him.

Eligibility Criteria:
Inclusion Criteria:

* adults
* urticaria rash no more 24 h duration and no take treatment for urticaria

Exclusion Criteria:

* patients were presented severe anaphylaxis or taken antihistamines or glucocorticoids within 5 days of arrival at ED,
* severe infection
* pregnancy
* patients BPCO
* diabetics
* allergy corticosteroids
* refusal to comply
* participate an other study
A Study of Imlunestrant Versus Standard Endocrine Therapy in Participants With Early Breast Cancer

The main purpose of this study is to measure how well imlunestrant works compared to standard hormone therapy in participants with early breast cancer that is estrogen receptor positive (ER+) and human epidermal receptor 2 negative (HER2-). Participants must have already taken endocrine therapy for two to five years and must have a higher-than-average risk for their cancer to return. Study participation could last up to 10 years.


Eligibility Criteria:
Inclusion Criteria:

* Have a diagnosis of ER+, HER2- early-stage, resected, invasive breast cancer without evidence of distant metastasis.
* Participants must have received at least 24 months but not more than 60 months of any adjuvant ET, from time of adjuvant ET initiation.
* Participants may have received (neo) adjuvant chemotherapy and/or targeted therapy with a CDK4/6- or PARP- inhibitor.
* Must have an increased risk of disease recurrence based on clinical-pathological risk features.
* Have a Performance Status of 0 or 1 on the Eastern Cooperative Oncology Group scale.
* Have adequate organ function.

Exclusion Criteria:

* Have any evidence of metastatic disease (including contralateral ALN) or inflammatory breast cancer at primary breast cancer diagnosis.
* Participants with more than a 6-month consecutive gap in therapy during the course of prior adjuvant ET.
* Participants who have completed or discontinued prior adjuvant ET \>6 months prior to screening.
* Participants with a history of previous breast cancer are excluded, with the exception of ipsilateral DCIS treated by locoregional therapy alone ≥5 years ago.
* Pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 180 days after the last dose of study intervention.
* Participant has previously received ET of any duration for breast cancer prevention (tamoxifen or AIs) or raloxifene.
* Participants with a history of any other cancer.
* Have serious preexisting medical conditions that, in the judgment of the investigator, would preclude participation in this study.
Accuracy of Digital Three-Dimensional Root Position Prediction Via Digitized Models

Measuring the accuracy of a new technique by which root positions can be predicted at the pre-finishing stage of the comprehensive orthoodntic treatment

A CBCT is taken Pre-Treatment

Segmentation of teeth is done from the CBCT exported as STL files and kept aside.

Routine comprehensive orthodontic treatment is done till pre-finishing stage.

Impression for teeth is taken at this timepoint.

A cast is poured and laser scanned.

Now the investigators have segmented teeth and a cast with new crown positions

The investigators will superimpose the teeth on the crowns of the digital cast to obtain the " Predicted Root Position" (PRP)

To check accuracy of this Prediction a CBCT is taken and compared to the prediction to check its accuracy.

Eligibility Criteria:
Inclusion Criteria:

* Patients requiring orthodontic treatment
* Adult set of permanent dentition
* Non-extraction cases

Exclusion Criteria:

* Syndromic patients
Muscle Strength Evaluations in Ankylosing Spondylitis

This study evaluates how the trunk and proximal girdle muscles are affected in male patients with ankylosing spondylitis, compared to healthy controls.

Ankylosing spondylitis is a chronic, inflammatory rheumatic disease with an unclear etiology which causes back pain and affects the functionality of axial skeleton. Besides the effect upon axial skeleton, the disease also affects the peripheral joints. In most patients, tenuous affection of peripheral joints occurs however, in some others the disease causes impaired spinal mobility and articular instability. This causes proximal girdle muscles and trunk muscles of the patients to be exposed to excessively stress and in conclusion deformities develop. Maximum force generated by a muscle or muscle group directly effects the physical ability of an individual, and manual muscle dynamometers are used to directly evaluate the muscle strength. In this manner the investigators aim to evaluate trunk and proximal girdle muscles' powers in male patients with ankylosing spondylitis and analyze the correlation between muscle powers, and functionality and disease activity.

Eligibility Criteria:
Inclusion Criteria:

1. Having a diagnosis of ankylosing spondylitis according to Modified NewYork criteria
2. Being male
3. Aged ≥18

Exclusion Criteria:

1. Severe cardiac or pulmonary or renal disease
2. Accompanying fibromyalgia
3. Severe psychiatric disorder
4. Other disease limiting spinal, shoulder or hip range of motion
5. Myopathy, neuropathy or radiculopathy that may cause muscle weakness
6. Using high dose steroids
7. Endocrinological disorders
8. Malignancy
9. Pregnancy
Gestational Immunity for Transfer

This is a study prospective cohort study at an urban academic centre, with two parts:

1. Health outcomes, and maternally transferred antibodies, in babies born to mothers who had antenatal COVID-19 and convalesced before delivery, followed up until 12 months of age
2. Safety and protective properties of breast milk after lactating women are vaccinated against COVID-19

This proposal aims to provide a multi-faceted approach to study how immunity may be transferred - both transplacentally and through breastfeeding, from mother to child, in the context of COVID-19.

We first recruit all babies delivered to mothers convalescent from antenatal COVID-19, to 1) follow up their growth and development, and 2) study the protective effects of antibodies transferred from mother to child transplacentally during pregnancy, as well as postnatally through breastfeeding. We compare these to a cohort of healthy controls whose mothers did not have COVID-19 during pregnancy.

Next, we compare the protective effects of antibodies transferred during breastfeeding from mother to child after lactating mothers are vaccinated against COVID-19, to that of natural infection. We also study the safety of breastfeeding after vaccination by looking for vaccine components in the breast milk.

Eligibility Criteria:
Inclusion Criteria:

Lives in Singapore

Exclusion Criteria:

Prematurity Congenital abnormalities Primary immunodeficiencies Autoimmune disorders
Cognitive-psychophysiological Treatment for Tics in Young People With Tourette's Syndrome With or Without Biofeedback

The goal of this clinical trial is to compare the effectiveness of CoPs therapy with or without the therapeutic component of biofeedback in treating tics in Tourette Syndrome with emerging young adults.

Hypotheses:

1. The CoPs+Biofeedback treatment will improve the severity of tics (YGTSS) and the Clinical Global Impression, surpassing the clinical significance threshold of CoPs treatment alone.
2. We expect that the identified variables (psychosocial, neurocognitive, biological) will predict the improvement of tics.

Researchers will compare if the biofeedback treatment will improve the severity of tics.

* In the pre-test, participants will undergo two interviews, each lasting 3 hours. These interviews will assess (through a battery of tests) the severity of tics as well as the psychosocial, biological, and neurocognitive aspects of functioning. A general assessment of intelligence and executive functions will also be conducted.
* They will next attend 10 to 12 therapy sessions, with or without biofeedback. (The biofeedback component is explained in more detail in the ''Study Design'' section).
* The post-test follow-ups consist of two evaluations: one 3 months after the end of the treatment and the other 6 months after. The evaluation will be done using the same battery of tests as during the pre-test interview.

\* The project explanations are in English for everyone's ease of understanding, but our study is conducted in French. \*

Eligibility Criteria:
Inclusion Criteria:

* Have a diagnosis of TS as the main issue, as reported by the participant;
* Be aged 14 to 21 years inclusive at the start of therapy.

Exclusion Criteria:

* Present a sensorimotor impairment;
* Have a diagnosis of intellectual disability (intelligence quotient below 75);
* Alcohol or drug abuse;
* A neurological issue (e.g., hemifacial spasms, Huntington's disease);
* Change medication one month or less before step 1 and up to step 4 (last measurement time) without informing a member of the research team;
* Simultaneously receive another intervention for tics (e.g., psychologist, massage therapist) without informing a research team member.
Tooth Graft of Two Different Particle Sizes in Extraction Sockets

The primary objective of the present study is to clinically and radiographically evaluate the efficacy of autogenous tooth graft obtained from bone mill and dental grinder to preserve alveolar ridge dimensions in extraction sockets.

Accordingly, teeth will be used as a test material to allow for comparative tests after processing it in the automated milling system (AMS). The material will be moistened and then placed in toto into the extraction sockets to generate particles at settings 1 (500 RPM for 30s) or 2 (900 RPM for 30s) to generate MS and SS respectively ((SS group; 0.5-0.8 mm) and medium size (MS group; 1.0-1.2 mm)).

Eligibility Criteria:
Inclusion Criteria:

* Systemically healthy individuals within the age group of 20-50 years with presence of teeth with hopeless prognosis requiring extraction

Exclusion Criteria:

* Medically compromised patients.
* Subjects who underwent radiotherapy or chemotherapy in the past 12 months.
* Patients having uncontrolled periodontal disease or having an active sinus infection.
* Smokers
A Personalized Trunk Stability Exercise Program Study With Brain Disease Patients

To investigate the effect on improving trunk stability and satisfaction with the program when a customized trunk stabilization exercise program personalized to the subject's functional level is applied to patients with brain disease.


Eligibility Criteria:
Inclusion Criteria:

1. Adults over 19 years old
2. Brain disease patients hospitalized in the rehabilitation medicine department of our hospital and receiving exercise therapy 5 times a week
3. Patients with a functional ambulatory category (FAC) score of 0-4
4. After receiving a detailed explanation of this study and fully understanding it, the subject or legal representative voluntarily decides to participate and agrees in writing to follow the precautions.

Exclusion Criteria:

1. Those who have suffered prior to participating in the study
2. Those in good physical condition, such as unstable conditions in the state system, coordination system, problem system, and endocrine system, and those with cerebrovascular disease
3. Other cases of investigation without participation in this study
To Demonstrate the Relative Bioavailability of Atenolol Tablets, 100 mg

To demonstrate the relative bioavailability of atenolol tablets, 100 mg.


Eligibility Criteria:
Inclusion Criteria:

* No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

Exclusion Criteria:

* Positive test results for HIV or hepatitis B or C.
* Treatment for drug or alcohol dependence.