cyrilzakka/clinical-trials huggingface dataset:
Efficacy of Manuel Therapy and BETY in Patients With Temporomandibular Dysfunction Related Headache

The aim of the study is to investigate the effects of Manual Therapy and the Cognitive Exercise Therapy Approach treatment in patients with TMD-related headaches.

60 subjects with TMD-related headaches, according to ICHD-3, will be included in the study after the voluntary consent form will be filled out. Subjects will randomly be divided into 3 groups according to the order.

Group 1: Patient education and exercise group: The patients in this group will be taught an exercise program after general education. Education training program about parafunctional activities of TMD and active exercises for masticatory and neck muscles. Patients will be asked to complete and follow-up home exercises for 30-45 minutes once a day, 5 days a week for 8 weeks. The continuity of the exercises will be ensured by sending reminder messages to this group of patients about doing their exercises once a week by the physiotherapist.

Group 2; Manuel Therapy group: This group will receive the same patient education and exercises additionally manual therapy program which is planned to last 45 minutes will be applied twice a week, for 8 weeks.

Group 3; BETY group: This group will receive the same patient education and exercises in addition BETY approach, which is the Cognitive Exercise Therapy Approach treatment, will be applied in 2 sessions a week for 45 minutes and a total of 8 weeks of treatment.

Eligibility Criteria:
Inclusion Criteria:

* Ages between 18 and 60 years old
* Getting a diagnosis of TMD-related headache
* Not having received FTR and manual therapy in the last 3 months
* Having pain ≥ 50 or more according to the headache impact test (HIT 6)
* Patients who have not received medical treatment in the last 3 months and will not receive medical treatment during the treatment
* Patients who describe pain in the jaw, face, temporal region or ear for at least 6 months and who have pain in the chewing muscles with palpation

Exclusion Criteria:

* Ages under 18 and over 60 years old
* Patients with disc displacement and/or attachment degeneration
* Patients with dental infection
* Patients who have undergone facial and ear surgery in the last six months
* Patients undergoing orthodontic treatment
* Patients using regular analgesics or anti-inflammatory drugs
* Patients with a history of trauma (whiplash injury, condylar trauma, fracture),
* Patients who have undergone any surgery related to the cervical and/or TMJ
* Patients with facial paralysis
* Patients with missing teeth in the upper jaw
* Patients with cognitive deficits
* Participation rate lower than 80% of the program schedule
Does Oral Intake Decreases Postoperative Pain Score in Children

Pain score after inguinal hernia repair surgery in children decreased as time passed in previous studies. Postoperative oral intake is usually resumed two hours after minor surgery in most of institutions, that may influence children's behavior and pain score.

A recent study suggest that oral intake one hour after minor surgery does not increase the incidence of postoperative nausea and vomiting.

The investigators primary endpoint is to clarify whether postoperative oral intake influences postoperative pain score in children.


Eligibility Criteria:
Inclusion Criteria:

* 18 month to 12 years old children undergoing elective unilateral inguinal hernia repair surgery

Exclusion Criteria:

* neurological disease, developmental delay
ID-Cap System Under Direct Observation

The ID-Cap System is classified as an ingestion event marker (IEM), a Class II medical device. The system is intended to record time-stamped ingestions with the ingestible sensor, ID-Tag which transmits a signal to a wearable device, the ID-Cap Reader. In this study, 36 subjects will ingest capsules containing ingestible sensors while wearing the Reader and being observed in a clinic setting.


Eligibility Criteria:
Stratification for gender and Body Mass Index is performed.

The BMI-Gender categories will be: Normal/Underweight (BMI\<25), Overweight (BMI 25.0 to \<30), and Obese (BMI\>30.0); and Male/Female.

Inclusion Criteria:

* Men and women 18 years of age or older.

  * Enroll at least one subject and less than four subjects 65 years of age or older
  * Enroll at least one subject and less than four subjects 18 to 21 years of age
* For females of childbearing potential, negative urine pregnancy test at time of entry and assurance that a medically-accepted means of contraception will be used for the duration of the study. Able and willing to provide informed consent.
* Willing to adhere to all protocol requirements and study procedures.
* Adequate organ function at screening (defined for investigator in protocol)

Exclusion Criteria:

* Unable to take oral medications.
* Women who are pregnant, breast-feeding, or plan to become pregnant during the study, and females of childbearing potential who are not using a medically-accepted means of contraception.
* Medical condition which may affect passage through the gastrointestinal tract
* Known hypersensitivity to any component of the ingestible ID-Capsule
* Significant medical condition, psychiatric condition, current alcohol or drug abuse, or other condition which may preclude the study participant from being able to follow study procedures or to safely participate in the opinion of the investigator..
* Participation in an investigational product study (e.g., medical device or drug study) within 30 days prior to screening, or prior participation in an Ingestion Event Marker study.
* Presence of an active implantable electronic medical device.
* Positive screen for drugs of abuse (detection of drug for which a valid prescription exists is not exclusionary)
Laser Acupuncture Therapy in Postpartum Low Back Pain

Over half of women after giving birth have low back pain (LBP), however, LBP is often accepted as a normal part of postpartum. Unsolved low back pain undoubtedly affects women's physical health and may be negatively affect their psychological health. This study was aimed to investigate the efficacy of laser acupuncture therapy (LAT) in postpartum LBP. Postpartum women with LBP admitted at a postpartum care center were recruited and randomly assigned to the intervention group or the control group. The participants in the intervention group underwent 10 sessions/2 weeks of LAT and received standard obstetric care. The participants in the control group only received standard obstetric care. Primary outcome measurements were Visual Analogue Scale (VAS) for pain and salivary cortisol values. Secondary outcome measurements were Chinese versions of the Roland and Morris Disability Questionnaire (RMDQ), Oswestry Disability Index (ODI) version 2.1and the Perceived Stress Scale (PSS).


Eligibility Criteria:
Inclusion Criteria:

1. Age not less than 20 years
2. Women postpartum within one month
3. Low back pain with visual analogue scale (VAS) score ≧1
4. Low back pain was not relieved by rest for 30 minutes.

Exclusion Criteria:

1. with systemic diseases
2. with cancers
3. with psychiatric diseases
4. under treatment for severe pain by a physician.
The Bioavailability of Iodine in Plant-based Milk Alternatives

Iodine is a mineral commonly found in seafood and dairy products such as milk and cheese. Iodine is important as it is required to make thyroid hormones which regulate growth and metabolism at all stages of life. The UK population has been iodine-sufficient for many years, however, there is now concern that iodine deficiency may be more prevalent than previously thought. This is a concern because iodine deficiency during pregnancy can result in cognitive impairment and developmental delays in children.

This study will to measure the ability to absorb iodine from plant-based milk alternatives fortified with iodine and compare with cow's milk in adults. Knowing the actual iodine bioavailability from plant-based alternatives is important because plant-based milk alternatives are becoming increasingly popular, especially in young adults, and are used as a replacement for cow's milk.

In this study, participants will consume three test drinks (cow's milk, soya milk and oat milk), one per week. The study will start with the cows' milk and the other two drinks will be administered in a random order with a crossover design. We will ask participants to follow a low iodine diet for three days leading up to the test day where they will drink one of the test drinks. Participants will then keep a food diary and collect their urine for the following 24 hours. Participants will then go back to their usual diet for at least four days before starting the next arm of the study with another test drink. This data will be used to calculate how much iodine was absorbed.


Eligibility Criteria:
Inclusion Criteria:

* Self-reported healthy adults
* Aged 18+
* English speakers
* Signed consent form
* No allergies or intolerances to the study drinks
* Not following a vegan diet (participants will be required to drink cow's milk)

Exclusion Criteria:

* Pregnancy or lactating (according to the participants own statement)
* Living outside of the UK
* Involvement in another research study where diet is restricted or modified
* History of thyroid disease (according to the participants own statement)
* Any metabolic, gastrointestinal or chronic disease such as diabetes, hepatitis, hypertension, or cancer (according to the participants own statement)
* Use of iodine containing supplements within 1 week prior to study start
* Inadequate (\<70 µg/day) or excessive (\>500 µg/day) iodine intake from food (assessed during screening with previously validated iodine-specific FFQ)
* Use of iodine-containing disinfectants (betadine)
* Exposure to iodine-containing X-ray/ computed tomography contrast agent within the last month
Anidulafungin During Continuous Venovenous Hemofiltration (CVVHF)

The purpose of this trial is to study the pharmacokinetics of anidulafungin during continuous venovenous hemofiltration.

Background: Anidulafungin is a cyclic lipopeptide antifungal agent of the echinocandin class. Members of this class of antifungal agents are known to inhibit the synthesis of glucan polymers in fungal cell walls. The spectrum of activity of anidulafungin includes Candida (all species, including strains resistant to fluconazole), Aspergillus, and Pneumocystis.

In intensive care patients continuous venovenous haemodiafiltration (CVVHF) is a well-established extracorporal renal replacement therapy with a high clearance rate.

Pharmacokinetic studies of antifungal agents in critically ill patients treated with CVVHF are rare. No data about anidulafungin in CVVHF are available although intensive care patients are perfect candidates for anidulafungin treatment due to their high risk profile for systemic fungal infections.

Study objective: The study is conducted to investigate the pharmacokinetics of anidulafungin during CVVHF in critically ill patients.

Study design: open, 1 arm

Study population: 10 critically ill adult patients administered to the ICU with acute renal failure and suspected or proven fungal infection.

Treatment/Dosage/Route: On the first day 200 mg of anidulafungin will be administered intravenously over 3 hours (loading dose). The following days 100 mg of anidulafungin will be administered intravenously over 1.5 hours.

Main outcome variables: The following pharmacokinetic parameters will be determined: area under the curve (AUC), half-live (t1/2), maximum plasma concentration (Cmax) and elimination fraction.

Methods: High pressure liquid chromatography (HPLC) will be used to determine anidulafungin concentrations.


Eligibility Criteria:
Inclusion Criteria:

* Age 19 to 70 years
* Suspected or proven infection requiring parenteral antifungal therapy.
* Continuous venovenous hemofiltration because of an acute renal failure.

Exclusion Criteria:

* Known history of hypersensitivity to echinocandins.
* An expected survival of less than three days.
* Known alcohol dependency, epilepsy, pregnancy or liver failure.
* Neutropenic patients
Guiding Dose Increases in Patients Incompletely Responsive to Usual Doses of Atomoxetine

The purpose of this trial is to test the value of dose increases in patients with residual ADHD symptoms after treatment with the usual target dose of atomoxetine


Eligibility Criteria:
Inclusion Criteria:

* Outpatients who are at least 6 years of age and not more than 16 years of age at Visit 1
* Patients must meet DSM-IV diagnostic criteria for ADHD (any subtype)
* Patients must have laboratory results showing no significant abnormalities (significant would include laboratory deviations requiring acute medical intervention or further medical evaluation)
* Patients must be of normal intelligence as assessed by the investigator (that is, without a general impairment of intelligence and likely, in the investigator's judgment, to achieve a score of greater than or equal to 70 on an IQ test)
* Patients must be able to swallow capsules

Exclusion Criteria:

* Patients who weigh less than 25 kg or greater than 70 kg at study entry
* Patients with current or past Bipolar I or II disorder, psychosis, autism, Asperger's syndrome, or pervasive developmental disorder
* Patients with a history of any seizure disorder (other than febrile seizures) or patients who have taken (or are currently taking) anticonvulsants for seizure control
* Patients with a history of severe allergies to more than 1 class of medications or multiple adverse drug reactions
* Patients with cardiovascular disease or other conditions that could be aggravated by an increased heart rate or increased blood pressure
Safety and Efficacy of Multiple Dosing Regimens of BPS804 in Post Menopausal Women With Low Bone Mineral Density

This study is designed to provide information on the safety, tolerability, pharmacokinetics (PK) and bone biomarker response following multiple BPS804 administration in multiple dosing regimens. This information will permit a comparison of the possible risks and benefits of different dosing regimens of the study drug to enable optimal doses and dose intervals to be tested in subsequent studies.

This study was conducted and previously posted by Novartis. The record was transferred to Ultragenyx in February 2021.

Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women (natural or surgically induced menopause)
* Low bone mineral density (BMD), as defined by a T score or equivalent BMD absolute value (g/cm2) for lumbar spine of between -2.0 and -3.5, inclusive
* Body mass index (BMI) must be within the range of 18 to 35kg/m2. Subjects must weigh between 45 and 120kg inclusive to participate.
* 25-(OH) vitamin D serum level of ≥ 15ng/ml
* Serum calcium within normal limits

Exclusion Criteria:

* Subjects with suspected neural foraminal stenosis (e.g., cervical, spinal, lumbar), or history of Bell's palsy, cranial nerve disorders, temporomandibular joint and muscle disorders.
* Subjects who have an increased baseline risk of osteosarcoma: Paget's disease of the bone or unexplained and clinically significant elevations of alkaline phosphatase and/or subjects who have received radiation therapy involving the skeleton.
* Subjects with any known bone diseases other than postmenopausal osteoporosis.
* Subjects with a history of an osteoporotic fracture (e.g., vertebral fracture, fragility fracture of the wrist, radius, humerus, hip, or pelvis).
* Subjects who are regularly using or have regularly used agents affecting bone metabolism:

  * Calcitonin, estrogen, SERMs (raloxifene, Tamoxifen, etc.), Tibolone progestin, or androgens within the last three (3) months prior to screening.
  * Any oral bisphosphonate, lithium chloride, fluoride or systemic glucocorticosteroids (p.o. or i.v.) where the total dose exceeds 750 mg of prednisone or equivalent within the last year prior to screening.
  * Any previous use of denusomab (ProliaTM), parathyroid hormone (ForteoTM), and/or PTH analogs, strontium ranelate, or parenteral formulations of bisphosphonates.
* Current disease(s) known to influence calcium metabolism including hyperparathyroidism, hypoparathyroidism, hypocalcemia or hypercalcemia.
* Any disease, abnormality or deformation of the spine (e.g., scoliosis, ankylosing spondylitis, osteophytes) or hip (e.g., joint prosthesis) which would preclude the proper acquisition of a lumbar spine DXA (L1-L4) or femur DXA, respectively.

Other protocol-defined inclusion/exclusion criteria may apply
Shoulder RFA Pilot Study

Through this prospective, single-arm cohort pilot study, we plan to explore the safety and effectiveness of Shoulder Radiofrequency Ablation (SRFA) in patients with non-operative chronic shoulder pain due to shoulder osteoarthritis with or without rotator cuff tears.

This will be one of the first collaborative prospective, single-arm cohort using a standardized selection protocol and comprehensive SRFA protocol to treat chronic, refractory shoulder pain due radiographically confirmed glenohumeral joint OA with or without RTC pain, in patients deemed non-surgical candidates by a board-certified orthopedic shoulder surgeon. Upon completing the proposed research, we expect our contribution to fill the knowledge gap on whether SRFA is a potentially viable treatment option for this patient population. This contribution is expected to be substantial because SRFA may be a safe and effective treatment option for many people suffering shoulder pain and debility who are sub-optimal surgical candidates and have historically either been undertreated to have less than ideal treatments options, including opioid-based pain management in particular.

Eligibility Criteria:
Inclusion Criteria:

1. ≥50 years old capable of understanding and providing consent in English, and capable of complying with the outcome instruments used
2. ≥3 months of shoulder pain refractory to conventional treatment (i.e., physiotherapy, medication, steroid injections)
3. Persistent shoulder pain ≥ 4/10 in intensity on a 7-day average
4. Shoulder pain refractory to conventional treatment (i.e., physical therapy, oral analgesics, steroid injection)
5. Prior consultation with a board-certified orthopedic shoulder surgeon, deemed a non-surgical candidate for the primary diagnosis of glenohumeral joint pain +/- rotator cuff pain
6. ≥80% pain relief for at least 30 minutes after a single fluoroscopically-guided block of the sensory branches of the SN, AN, and LPN with 0.5 mL of lidocaine at each nerve
7. Scheduled for procedure of interest

Exclusion Criteria:

1. Infection
2. Allergy to any medication needed to participate in this study
3. Previous partial/total/reverse shoulder arthroplasty. Participants with a history of RTC repair will not be excluded.
4. Neurologic disorders including radiculopathy, connective tissue/inflammatory joint disease/widespread soft tissue pain disorder
5. Severe, uncontrolled psychiatric disorder requiring hospitalization within 6 months
6. Intraarticular or subacromial injection to the study shoulder within 3 months before C-SRFA
7. Uncontrolled bleeding diathesis
8. Pregnancy
9. Pacemaker, neurostimulator, or other implanted device potentially sensitive to RF energy
10. Active Worker's compensation claim, litigation, or other possible reason for secondary gain.
11. Prior shoulder radiofrequency ablation
12. Daily opioid use
Trial of Asthma Self-Management Education in Patients With Depressive Symptoms

Although depressive and anxious symptoms are common in asthma patients and are associated with worse clinical and resource utilization outcomes, there have been no studies focusing on the particular challenges of improving asthma self-management in this population. The investigators hypothesize that a tailored intervention to improve asthma self-management in patients with a known history of depressive and anxious symptoms will be effective in improving asthma-related quality of life.

Depressive and anxious conditions are common during the lifetime of asthma patients and have been shown to be associated with worse asthma as defined by more symptoms, more hospitalizations and greater use of medications. There have been few studies trying to improve asthma outcomes in patients with known depression. One method to improve outcomes is to instruct patients in ways to better self manage asthma. The goal of this study is to test a comprehensive intervention to improve asthma self-management by increasing knowledge and self-efficacy in patients with a known history of a positive screen for depression. Patients will be randomized to two groups - a control group and an intervention group. Patients in the control group will receive an asthma workbook, will make a contract to adopt behaviors they think will improve asthma, and will receive telephone follow-ups approximately every week for 8 weeks and then approximately every 2 months. Patients in the intervention group will receive these components plus they will be taught how to use a peak flow meter and specific chapters of the workbook will be used as templates for focused instruction during telephone follow-ups. The primary outcome will be a comparison of within-patient change in asthma-related quality of life between groups.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* known history of depressive or anxious symptoms

Exclusion Criteria:

* pregnant
* has cognitive deficits
* no access to telephone
Effect of Phacoemulsification on Ocular Blood Flow in Human

* To investigate ocular haemodynamics after phacoemulsification surgery
* To evaluate the influence in people with different autoregulation of ocular blood flow


Eligibility Criteria:
Inclusion Criteria:

* age-related cataract
* no complications during surgery

Exclusion Criteria:

* complications during surgery
* have other complications