cyrilzakka/clinical-trials huggingface dataset:
Intra-Nasal Mechanical Stimulation (INMEST) As a Treatment Method for the Relief of Symptoms of Dry Eye

The purpose of the study is to investigate the degree of symptom relief in people with signs or symptoms of dry eyes after self-treatment at home with the Walther System delivering INMEST (intranasal mechanical stimulation).

A total of 110 subjects are planned to be enrolled and randomized to either use an active device or a sham device. Both groups will also receive standard treatment in mainstream healthcare for symptoms of dry eye. The subject self-administer treatments at home, three times a week for six weeks, with a follow-up period of three months after end of treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18
2. The study subject reports having understood and signed the Informed Consent Form (ICF) and is willing to comply with all investigation visits and assessments
3. History of dry eye in both or one eye, supported by a previous clinical diagnosis or have self-reported history of complaints for at least 4 months prior to enrolment
4. Women of childbearing potential must agree to use a reliable, medically approved form of contraception during the study participation until end of study
5. OSDI score \> 15
6. Non-Invasive tear Break-Up Time (NIBUT) ≤ 10 seconds
7. Anticipated compliance with prescribed treatment and follow-up

Exclusion Criteria:

1. Recently (3 months prior enrolment) undergone nasal or sinus surgery
2. Women who are pregnant as determined by urine test at inclusion and prior to study start (applies to sites in Denmark only)
3. Ongoing acute upper respiratory tract infection, per the Investigator's judgement
4. Bleph-ex treated within 3 months prior to enrolment
5. The study subject has a cognitive incapacity or language barrier precluding adequate understanding or cooperation
6. The study subject is considered by the Investigator to be unsuitable to participate in the investigation for any other reason
7. Any severe diseases interfering with the performance, evaluation, and outcome of the clinical evaluation
8. Previous (within 30 days prior to enrolment/randomization) and concurrent treatment during the treatment phase with another investigational drug/s or device/s
Post-Marketing Surveillance of Gliadel 7.7mg Implant (All-case Observational Study)

Post-marketing surveillance to investigate the clinical safety and effectiveness in patients of all implantation of Gliadel with malignant glioma in the actual medical setting.


Eligibility Criteria:
Inclusion criteria:

* All-patient of Gliadel implantation

Exclusion criteria:

* None
Effectiveness of Graded Motor Imagery to Improve Hand Function in Patients With Distal Radius Fracture

The purpose of this study was to investigate of the effectiveness of Graded Motor Imagery (GMI) on hand functionality in patients with Distal Radius Fracture (DRFx). This study was carried out on 36 patients. These patients were randomly assigned to two groups: classic treatment group (n=19) and GMI group (n=17). Both groups received a 8-week (2 days a week) physical therapy and rehabilitation intervention. Outcome measurements were based on upper extremity functional status (Disability of the Arm Shoulder Hand and Michigan Hand Questionnaire scores), pain (on the rest and during the activity with Visual Analog Scale), range of motion (wrist flexion, extension, ulnar/radial deviation, supination and pronation with goniometer), grip strength (standard grip strength with Jamar hydraulic hand dynamometer; lateral, palmar and pinch strength with pinch meter).


Eligibility Criteria:
Inclusion Criteria:

* ages between 18-65 years
* diagnosed with DRFx which is extra-articular
* managed with pins, internal fixation and/or cast

Exclusion Criteria:

* unwilling or unable to participate
* intra-articular and instable fractures containing other part of the fractures
* fractures related with the malignancy and other neurologic diseases
* existing inflammatory joint condition,
* lack of cognitive function.
The Effects of Pre-extubation Single Recruitment Maneuver on Perioperative Atelectasis

Laparoscopic surgeries may cause atelectasis on the lungs which may stay clinically occult after the surgery. Lung Ultrasound Scoring (LUS) can provide an objective measuring system to understand the condition of the lungs in the perioperative period. In this randomized controlled study, it is aimed to investigate the effects of one single recruitment maneuver (RM) just before emergence and extubation (at the end of surgery) on LUS scores and postoperative recovery room oxygenation in laparoscopic nephrectomy surgeries. Accordingly, the intervention group will be applied single RM before extubation, while the control group will be awaken without RM.

There will be LUS evaluation at 4 different time for intervention group (Group RM) points that are:

T1: 5 min after the intubation T2: At the end of surgery (After skin closure, before recruitment maneuver) T3(RM): After recruitment maneuver, before extubation T4: 30 minutes after extubation in the recovery room

LUS evaluation will be made at 3 different time points in control group (Group NoRM):

T1: 5 min after the intubation T3(NoRM): Before extubation (no recruitment maneuvers will be made) T4: 30 minutes after extubation in the recovery room.

The primary outcome is the comparison of the T3 LUS scores. Assuming a 40% difference in the T3 LUS score, total number of 30 patients were calculated to be included in the study with an alpha value of 0.05 and 95% power. A possible drop-out of 5 patients per group, 20 patients were planned to be enrolled in each group.

Secondary outcomes will include; difference in T4 LUS scores, the effect of RM on postoperative recovery room oxygenation, and the effect of deltaLUS (T3-T2) on postoperative recovery room oxygenation.


Eligibility Criteria:
Inclusion Criteria:

* \>18 years old
* Laporoscopic nephrectomy patients who will be operated in lateral positions
* Elective, semi-elective surgeries

Exclusion Criteria:

* Patients with emphysema
* Patients with documanted heart failure
* Patients requiring intraoperative multiple recruitment maneuver due to hypoxemia
* Patients with hemodynamic instability
* Patients with pneumothorax risk
* Emergency surgery
* Patients requiring intraoperative liberal fluid therapy (\>10 cc/kg/hr)
* Patients requiring blood products
Effect of BM-MSCs on Early Graft Function Recovery After DCD Kidney Transplant.

This study is designed to investigate whether allogeneic bone marrow-derived mesenchymal stem cells (BM-MSCs) can promote function recovery in patients with poor early graft function after kidney transplantation from Chinese Donation after Citizen Death (DCD). DCD kidney transplant recipients with poor early graft function (with or without dialysis) post transplant are equally randomized into MSCs group or control group. Patients in MSCs group are administered MSCs treatment. Allogeneic BM-MSCs (1\*10\^6/kg) from third party are given intravenously for four consecutive doses every week after enrollment. Patients in control group receive placebo. Renal allograft function (eGFR), rejection, patient/graft survival and severe adverse events up to 12 months post enrollment are monitored.


Eligibility Criteria:
Inclusion Criteria:

* Primary kidney transplantation
* Kidneys are from donation after Chinese citizen death
* Poor early graft function with or without dialysis after transplantation
* Patient is willing and capable of giving written informed consent for study participation and able to participate in the study for 12 months

Exclusion Criteria:

* Secondary kidney transplantation
* Combined or multi-organ transplantation
* Women who are pregnant, intend to become pregnant in the next 1 years, breastfeeding, or have a positive pregnancy test on enrollment or prior to study medication administration
* Panel reactive antibody (PRA)\>20% or CDC crossmatch is positive
* Donors or recipients are known hepatitis C antibody-positive or polymerase chain reaction (PCR) positive for hepatitis C
* Donors or recipients are known hepatitis B surface antigen-positive or PCR positive for hepatitis B
* Donors or recipients are known human immunodeficiency virus (HIV) infection
* Patients with active infection
* Recipients with a history of substance abuse (drugs or alcohol) within the past 6 months, or psychotic disorders that are not capable with adequate study follow- up.
* Patients with severe cardiovascular dysfunction
* WBC\<3\*10\^9/L or RBC \<5g/dL
* Highly allergic constitution or having severe history of allergies.
* Patients with active peptic ulcer disease, chronic diarrhea, or gastrointestinal problem affect absorption
* Patients with a history of cancer within the last 5 years
* Prisoner or patients compulsorily detained (involuntarily incarcerated) for treatment or either a psychiatric or physical (e.g. infectious disease) illness
A Study of LY3502970 in Participants With Type 2 Diabetes Mellitus

The main purpose of this study is to evaluate the efficacy and safety of LY3502970 in participants with type 2 diabetes (T2D) who failed to achieve adequate glycemic control on diet and exercise alone or on a stable dose of metformin. This study will last about 30 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Have been diagnosed with Type 2 Diabetes on diet and exercise and/or a stable dose of metformin
* Have a stable body weight for the 3 months prior to randomization
* Have a body mass index (BMI) ≥23 kilogram/square meter (kg/m²)
* Males must agree to use highly effective methods of contraception
* Women not of childbearing potential (WNOCBP) may participate in this trial
* Note: Hormone replacement therapy in post-menopausal women is allowed but women must be on stable therapy for 3 months prior to day 1.

Exclusion Criteria:

* Have Type 1 diabetes mellitus (T1DM) or history of ketoacidosis or hyperosmolar coma
* Have a history of diabetic retinopathy, diabetic maculopathy, or severe non-proliferative diabetic retinopathy that requires immediate treatment intervention
* Have had more than 1 episode of severe hypoglycemia and aware of hypoglycemic symptoms
* Have acute or chronic pancreatitis
* Have obesity induced other endocrine disorders (Cushing's syndrome or Prader - Willi syndrome)
* Have gastric emptying abnormality or chronically take medications impacting GI motility
* Have poorly controlled hypertension
* Have the following heart conditions within the last 6 months: myocardial infarction (MI), unstable angina, coronary artery bypass graft, percutaneous coronary intervention (diagnostic angiograms are permitted), transient ischemic attack (TIA), cerebrovascular accident (stroke)or decompensated congestive heart failure, or IV heart failure
* Have any symptoms of other liver diseases besides nonalcoholic fatty liver disease (NAFLD)
* Have HIV, or Hepatitis B or Hepatitis C
Haplo-SCT vs ASCT With or Without Decitabine in AML CR1

A multicentre, prospective, open-label clinical study, including a randomized controlled study in low or intermediate-risk group patients, and a cohort study of maintenance treatment with decitabine after ASCT.


Eligibility Criteria:
Inclusion Criteria:

* Age \>= 18y
* Diagnosed as AML (except acute promyelocytic leukemia M3) for the first time
* Minimal Residual Disease (MRD) test can be achieved (molecular biology first if applicatable, and/or cytogenetics and/or immunophenotyping)
* Presence of an available haplo-mismatch related donor

Exclusion Criteria:

* Contra-indications of chemotherapy or hematopoietic stem cell transplantation
* Presence of an available identical sibling donor or a 10/10 HLA loci-matched unrelated donor
* Participating in other clinical trials concerning the prophylaxis of disease recurrence after ASCT
* No effective contraception
* Pregnant or lactating females
* Other causes which are not suitable for the trial in investigator's consideration
Masticatory Muscle Activity in Patients With Pain-related Temporomandibular Disorders

The aim of this study was to evaluate masticatory muscle electrical activity in patients with pain-related and pain-free temporomandibular disorders (TMD) as well as in subjects with no TMD. Ninety children with mixed dentition were recruited to the study. Of this total, 30 subjects were diagnosed with pain-related TMD, 30 with pain-free TMD, and 30 without TMD. We used Axis I of the Research Diagnostic Criteria for TMD (RDC/TMD) to assess the presence of TMD in the examined children. The electromyographical (EMG) potentials of the temporalis and masseter muscles were measured with a DAB-Bluetooth Instrument (Zebris Medical GmbH, Germany) at rest and during maximum voluntary clenching (MVC).


Eligibility Criteria:
Inclusion Criteria:

* mixed dentition (the subjects should be aged between 7 and 12 years)
* consent to participate voluntarily in the study

Exclusion Criteria:

* subjects who had undergone orthodontic or masticatory motor system dysfunction treatment, had systemic or rheumatologic diseases, a history of mouth breathing, surgery, traumas or malformations in the head and neck region
Prediction Rules for Low Level Laser on Burn Wounds

The purpose of this study is to investigate whether patients' age, total burned surface area, wound stage and wound depth determine wound healing response to low level laser therapy in burn patients

It will be hypothesized that

1. Age may significantly affect burn wound healing's response to low level laser therapy.
2. TBSA may significantly affect burn wound healing's response to low level laser therapy.
3. Depth of wound may significantly affect burn wound healing's response to low level laser therapy.
4. Wound healing stage may significantly affect burn wound healing's response to low level laser therapy. There will be only one intervention group. The duration of the study will be 6 weeks divided to 18 sessions (three sessions per week). Sixty patients (male and female) will be recruited from the burn units.

Low level laser therapy will be performed for 30 min 3 times per week for 8 weeks on the wound area.

Wound area was irradiated by a red 655 nm light, 150 mW, 2 J/cm2 at the bed of the wound.

Eligibility Criteria:
Inclusion Criteria:

* Partial thickness Burn wound depth.
* Age ranges from 20-50 years.
* TBSA more than 15%
* Sufficient understanding to perform the test

Exclusion Criteria:

* Diabetic patients.
* Burn wound with skin graft
* Infected wounds
* Patients receiving immunosuppressive drugs.
* Patients receiving irradiation or chemotherapy.
* Chronic circulatory diseases
* Severe associated injury with burn.
* Associated co-morbidities, such as neurological diseases, malnutrition, and other inﬂammatory and/or infectious diseases.
Primary Cecal Pathologies Presenting as Acute Abdomen

Background: The importance of cecal pathologies lie in the fact that being the first part of large intestine, any disease involving the cecum affects overall functioning of the large bowel. Primary cecal pathologies presenting as acute abdomen have not been described in any previous study in terms of presentation, management and outcome.

Objectives: The objective of this study was to identify the reported causes of primary cecal pathologies presenting as acute abdomen and the various causes presenting in Indian setting, to discuss morbidity and mortality associated with cecal pathologies and to critically analyse the various management modalities employed in emergency setting.

The importance of cecal pathologies lie in the fact that being the first part of large intestine, any disease involving the cecum affects overall functioning of the large bowel. Primary cecal pathologies presenting as acute abdomen often pose a challenge to their optimal management due to requirement of urgent intervention in most cases and being a common source of misdiagnosis. These pathologies often mimic acute appendicitis and commonly misdiagnosed as one. This misdiagnosis can lead to under-treatment of the underlying pathology and this results in high morbidity and mortality associated with these conditions. So the accurate identification of such conditions is required so that the patients can be optimally managed and patient outcome can be improved.

Eligibility Criteria:
Inclusion Criteria:

* All adult patients presenting in emergency department with acute abdomen were included in study in whom cecal pathology as the cause of acute abdomen was suspected clinically and/or on imaging and further confirmed per-operatively and/or on histopathological examination (HPE) or on imaging. Patients identified with primarily a cecal pathology who had acute pain abdomen as the initial symptom but who didn't presented immediately due to various reasons were also included in the study as it is a well-documented fact that patients in developing countries like India, especially those who live in rural areas or who are illiterate often resort to indigenous methods of treatment or take symptomatic treatment from local practitioners before presenting to a tertiary centre for definitive treatment. Also, only those patients who were operated within 24 hours of index admission in the emergency operation theatre (EOT) by a registrar or faculty member after initial resuscitation were included in the study.

Exclusion Criteria:

* Patients with sub-acute, intermittent or chronic pain; when predominant symptoms were attributable to some other cause even with concomitant presence of a cecal pathology; when predominant pathology was not cecal and patients with cecal pathology operated as an elective case were excluded from this study. Thus patients diagnosed to be having appendiceal stump blowout, perforation of base of appendix, ileocecal tuberculosis or intussusception were not included.
Breakthrough Pain Computer Integrated Patient Controlled Epidural Analgesia

The computer-integrated patient controlled epidural analgesia (CIPCEA) system can automatically adjust the background infusion rate during combined spinal-epidural (CSE) analgesia based on the parturient's need as labour progresses. Analysis of parturients experiencing breakthrough pain may identify associated factors that can also be related to obstetric or foetal outcomes

Computer integrated patient controlled epidural analgesia (CIPCEA) is a novel epidural analgesic delivery system that is currently used in daily practice in KK Women's and Children's Hospital. It has enabled us to monitor the infusion pumps through wireless connection to a central monitoring system and hence, collect pump utilisation data electronically. The CIPCEA system is programmed to analyse the LA usage across the last hour and adjust the background infusion rate according to a preset algorithm.

Breakthrough pain is defined as maternal complaint of pain or pressure that required and was successfully treated with supplemental epidural medications. we investigated the potential factors associated with breakthrough pain in patients who receive CSE epidural analgesia with CIPCEA, with the aim of elucidating the important associated factors.

Eligibility Criteria:
Inclusion Criteria:

* Nulliparous women,
* requested for epidural analgesia

Exclusion Criteria:

* Multiparous women,
* unable to perform combined spinal epidural technique
Apremilast for Chronic Plaque Psoriasis (CPP) Patients Who Have Failed One Course of Biologic Therapy

This is a Phase II, open label, investigator-initiated study to be done at Duke University Medical Center to treat adult patients (ages 18-80) with chronic plaque psoriasis who have failed Biologic Therapy with Apremilast 30 mg BID for 24 weeks. At the time of enrollment, the patient must have received biologic therapy without achieving a response of "almost clear" or "clear" according to PGA or has not responded with a 75% reduction of PASI score. Once deemed eligible, subjects will return for a baseline visit and receive Apremilast therapy and instructions. Subjects will be treated at weeks 0,4,8,12,16,20 and 24; subjects will be evaluated 28 days after last dose of Apremilast for safety and efficacy.

Data Analysis Data will be analyzed and reported after all subjects have completed follow-up phase of study. All subsequent data collected will be analyzed and reported in a follow-up clinical report.

Data \& Safety Monitoring Dr. Murray will be following all laboratory values and adverse events during this trial. In addition, Celgene will provide a study monitor to, at regular intervals, review all data. All data will be reported to Celgene.

Eligibility Criteria:
Inclusion Criteria:

* Subjects 18-80 yrs diagnosed with moderate-to-severe chronic plaque psoriasis with a PGA of 3 or greater and require systemic therapy
* Must have received a biologic therapy for CPP and did not achieve a PGA of 'almost clear' or 'clear'
* Must meet lab criteria per Pg 20-21 of protocol
* All subjects must follow contraceptive measures as described in protocol, Pg 21.

Exclusion Criteria:

* Abnormal Chest x-ray
* Significant abnormality of ECG
* Positive HIV Ab, Hepatitis B \& C
* Subjects with erythrodermic, pustular or guttate psoriasis are ineligible
* Serious local infection or systemic infection, or tuberculosis within 3 mos of first dose of apremilast
A Study of Selpercatinib (LY3527723) in Healthy Participants

The main purpose of this study is to determine how safe and how well tolerated selpercatinib is when given as oral doses to healthy participants. The study will also assess how fast selpercatinib gets into the blood stream and how long it takes the body to remove it. The study will last up to about 6 weeks, inclusive of screening period.


Eligibility Criteria:
Inclusion Criteria:

* Female participants of non-childbearing potential who are agreeable to take birth control measures until study completion
* Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kilograms per meter squared (kg/m²) and had a minimum weight of at least 50 kg at screening
* Have normal blood pressure, pulse rate, electrocardiogram (ECG), and blood and urine laboratory test results that are acceptable for the study

Exclusion Criteria:

* Are currently participating in or completed a clinical trial within the last 30 days or any other type of medical research judged to be incompatible with this study
* Have previously participated or withdrawn from this study
* Have or used to have health problems or laboratory test results or ECG readings that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study
* Had blood loss of more than 500 milliliters (mL) within the previous 30 days of study screening
* Require treatment with inducers or inhibitors of cytochrome P450 (CYP) CYP3A within 14 days before the first dose of study drug through the end of Period 2