cyrilzakka/clinical-trials huggingface dataset:
Uddevalla Skövde Transscleral Micropulse Study

Micro pulse transscleral laser treatment (MP-TLT) is a relatively new method to reduce the intraocular pressure (IOP) in glaucoma. New recommendations regarding the treatment protocol has recently been developed and was published 2022.

The overall objective is to evaluate the efficacy and safety of the proposed treatment method in an independent study. In addition, the outcome of MP-TLT in patients with pseudoexfoliation glaucoma, which is relatively common in the Nordic countries, and primary open angle glaucoma will be studied separately.

The IOP change over the course of one year will be monitored, as well as success rate and survival. Further, patient-reported discomfort from the treatment and the occurrence of any adverse events or complications will be studied.

Forty patients scheduled for MP-TLT by their ophthalmologist will be recruited. One eye per patient is included, based on randomization, even if both are treated. MP-TLT will be performed according to the current recommendations.

Baseline IOP will be calculated as the mean of three separate measurements taken on different days preoperatively. IOP will then be measured 1 week, 1 month, 3 months, 6 months and 12 months after MP-TLT.

The central corneal thickness (CCT), the central retinal thickness (CRT), anterior chamber flare and the visual field (HFA 24-2 faster) will also be measured preoperatively and during follow up.

In accordance with the World Glaucoma Association guidelines, no adjustment for multiple comparisons is planned in this study.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of primary open angle glaucoma (POAG) or pseudo exfoliative glaucoma (PXFG)
* Age ≥ 18 years
* The patient is expected to be able to adequately undergo and cooperate in the treatment and follow-up as described in the study protocol.
* The patient is judged to have good compliance with already prescribed pharmacological glaucoma treatment.

Exclusion Criteria:

* Allergy or hypersensitivity to tetracaine or lidocaine
* Prior transscleral laser or cryo treatment.
* Prior eye surgery (including intravitreal injection) or pressure-lowering laser treatment (SLT/ALT/MDLT) during the last 2 months.
* Planned or expected eye surgery (eg., cataract surgery or intravitreal injection) in the coming year.
* History of macular edema.
* History of corneal edema.
* History of uveitis during the past year.
* Existing thinning in the sclera of a greater extent than 30 degrees (one "clock-hour") of the circumference.
An Investigational Study of ESK-001 in Participants With Normal Liver Function and Participants With Mild, Moderate, and Severe Liver Damage

This a phase 1, open label, single dose, parallel cohort study to determine the pharmacokinetics (PK) of study drug (ESK-001) in healthy volunteer participants, and participants with mild, moderate, and severe hepatic impairment.

This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.)

Eligibility Criteria:
Key Inclusion Criteria for All Participants:

* Body mass index between 18.0 and 40.0 kg/m2

Key Inclusion Criteria for Participants with Hepatic Impairment:

* Diagnosis of chronic (\> 6 months), stable hepatic impairment with no clinically significant changes within 30 days prior to dosing, as determined by medical history

Key Exclusion Criteria for All Participants:

* Uncontrolled treated/untreated hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 105 mmHg), or uncontrolled treated/untreated hypotension (systolic blood pressure \< 90 mmHg and/or diastolic blood pressure \< 50 mmHg), or resting pulse rate \< 45 or \> 100 bpm. Measurements may be repeated once in order to determine eligibility

Key Exclusion Criteria for Healthy Volunteer:

* Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator or designee.
* Positive hepatitis panel and/or positive human immunodeficiency virus test.

Key Exclusion Criteria for Participants with Hepatic Impairment:

* History of any uncontrolled or unstable renal, hematological, gastrointestinal, neurological, endocrine, or psychiatric disorder, as determined by the investigator or designee, within 6 months prior to screening.
* History or current diagnosis of uncontrolled or significant cardiac disease indicative of a significant risk of safety for participation in the study.
* Liver function tests outside the appropriate reference ranges that are not consistent with hepatic dysfunction, as determined by the investigator or designee.
* QTcF \> 480 ms for males or \> 490 ms for females at screening or check-in, as confirmed from the mean of the original value and 2 repeats.
Reducing Frailty for Older Cancer Survivors Using Supplements

The purpose of the study is to examine the feasibility and safety of twelve weeks oral supplementation of Epigallocatechin-3-gallate (EGCG) in older survivors of cancer


Eligibility Criteria:
Inclusion Criteria:

1. Be age 65 or over.
2. Be diagnosed with stage I-III Cancer.
3. Have completed curative intent treatment ≤10 years prior to screening. (Patients on endocrine therapies are allowed to enroll.)
4. Have a Fried's Frailty Score (FFS) of ≥ 2.
5. Able to provide informed consent, or have consent given by patient-designated health care proxy per institutional policies and University of Rochester Cancer Control guidelines.

Exclusion Criteria: Study subjects must not:

1. Have chemotherapy planned for the during of the study.
2. Have abnormal liver function tests (ALT, AST and bilirubin ≥3 times institutional upper limit of normal) per most recent available lab test (within 3 months of screening).
3. Have uncontrolled or unmanaged liver disease.
4. Consume more than 6 cups of green tea per day.
5. Have known allergies to caffeine.
6. Be diagnosed with a major psychiatric illness requiring hospitalization within the last year.
7. Be diagnosed with dementia.
8. Cannot provide informed consent due to lack of decision making capacity (as determined by the patient's oncologist) and has no patient-designated health care proxy per institutional policies and University of Rochester Cancer Control URCC guidelines.
A Phase 1 Pharmacokinetic Bioequivalence Study of DMB-3113 and Adalimumab in Healthy Japanese Adult Male Subjects

To determine the pharmacokinetic bioequivalence of DMB-3113 and adalimumab and to confirm the safety of the study drug in healthy Japanese adult male subjects


Eligibility Criteria:
Inclusion Criteria:

1. Healthy Japanese male adults;
2. The Body Mass Index (BMI) of the subjects must be from 17.6 to 26.4 kg/m2 at the time of the screening test;and
3. Subjects must take a screening test within the 4 weeks before the date of administration of the study drug; subjects must take a screening test before the date of administration of the study drug and exhibit no clinically abnormal findings in the judgment of the investigator or any of the subinvestigators

Exclusion Criteria:

1. Concurrent or history of potentially fatal infections such as opportunistic infections, including sepsis, pneumonia, and fungal infection;
2. Individuals with history of tuberculosis or diagnosed with tuberculosis by interview, chest X-ray examination, or interferon-gamma release assay;
3. Concurrent or history of demyelinating disease (multiple sclerosis, etc.);
4. Concurrent or history of congestive cardiac failure;
5. Concurrent or history of allergic symptoms such as asthma bronchial, drug-induced rash, and urticaria, which, in the judgment of the investigator or any of the subinvestigators, may affect participation in this clinical study; or
6. Concurrent or history of cardiac, hepatic, renal, gastrointestinal, respiratory, and/or hematological function disorders, which, in the judgment of the investigator or any of the subinvestigators, may affect participation in this clinical study
Study Comparing Plate Stabilization to Conservative Treatment in Midshaft Clavicle Fractures

The purpose of this study is to find whether to operate or treat conservatively dislocated midshaft clavicle fractures.

Midshaft clavicle fractures are common comprising 2% of all fractures and 35% to 45% of all shoulder girdle injuries in adults. Old-established treatment practices, based on no randomised controlled trials, are used for clavicle fractures. By tradition, midshaft clavicle fractures have been treated conservatively with arm immobilized to a sling for few weeks. The goal of treatment is to restore painless function of the upper extremity.

There have been some recommendations for operative treatment, such as skin compromising in fracture area, open fracture, floating shoulder, neurovascular symptoms in upper extremity, or multiple injuries. Recently, increasing interest has emerged in the surgical treatment.

Eligibility Criteria:
Inclusion Criteria:

* a completely displaced middle third clavicle fracture, no cortical contact between main fragments
* fresh fracture, treatment within seven days after injury
* age between 18 and 70 years
* provided informed consent

Exclusion Criteria:

* fracture was not dislocated
* multiple injured patient
* associated neurovascular injury, or suspicion of it
* reduced cooperation
* cancer or any severe illness impairing health
* pathological fracture
* treatment seven days after injury
* open fracture
* corticosteroid or immunosuppressive medication
* upper extremity fracture at same time
* an earlier clavicle or shoulder region fracture
* pregnancy
* lack of consent
Traditional Chinese Medicine as Preventive Method for Osteoporosis Induced by Adjuvant Endocrine Therapy

To test the efficacy of two Traditional Chinese Medicine in preventing osteoporosis in patients receiving adjuvant endocrine therapy.

Breast cancer is the most common malignant tumor in female wolrdwide. Results from clinical trials like ATAC trial have demonstrated the efficacy of AIs in postmenopausal breast cancer patients. Meanwhile it may cause a certain rate of osteoporosis in postmenopausal patients. The aim of this trial is to test the efficacy of two traditional Chinese medicine in preventing osteoporosis in patients receiving adjuvant endocrine therapy.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed invasive breast cancer;
* Post-surgery, primary lesion been removed;
* Post-Menopausal patients or pre-menopausal patients who will receive ovarian function suppression;
* Histologically confirmed ER and/or PR positive ;
* Receiving adjuvant AIs therapy in the following one years;
* Leukocyte ≥ 3\*10(9)/L; Platelets ≥ 75\*10(9)/L;
* Serum glutamate oxaloacetate(AST/SGOT) or serum glutamic-pyruvic transaminase(ALT/SGPT) \<2.5 times of upper limit of normal range;
* Serum creatinine/blood urea nitrogen(BUN) ≤ upper limit of normal (UNL) range;
* Written informed consent according to the local ethics committee equirements;

Exclusion Criteria:

* Metastatic Breast Cancer;
* Received Neo-Adjuvant Endocrine Therapy;
* History of pelvic fracture or bone metabolic disease;
* Received drugs interfering bone metabolism in the last 12 months;
* Baseline Bone Mineral Density: T \< -2SD;
* With other primary malignant disease;
* With severe non-malignant co-morbidity that will influence long-term follow up;
* Known severe hypersensitivity to any drugs in this study;
Nurse-Led, Symptom-Based Screening of Household Child Contacts of Tuberculosis Index Cases

To assess implementation of a nurse-led, symptom-based screening program in local, decentralized clinics for tuberculosis (TB) screening of child contacts less than 5 years old who were exposed to tuberculosis in the home. This will allow nurses in decentralized clinics to either start IPT for those asymptomatic patients and refer symptomatic patients for evaluation of TB disease and possible antituberculous therapy (ATT).

Retrospective review of routine program data for child contacts less than five years of adult TB index cases who are receiving TB care at local, decentralized clinics in the Matlosana district of Northwest Province will be assessed. 16 clinics will be stratified and randomized in 1:1 fashion to either TST-based screening, the current standard of care, or symptom-based screening, the newly recommended standard of care in South Africa. Those who are TST positive in the TST-based group and those who are symptomatic in the symptom-based group will be referred to Klerkdorp Hospital for further evaluation of tuberculosis. Nurses in the decentralized clinics will initiate those who are TST negative or asymptomatic on IPT. Their clinical course will be monitored throughout treatment and adherence to therapy measured. The investigators will compare clinic-level outcomes including percentage of patients initiated on, adherent to, and completing IPT.

Eligibility Criteria:
Inclusion Criteria:

* Child less than five years old
* Household contact of a drug-sensitive pulmonary or extrapulmonary TB index case (drug sensitivity is define as culture-confirmed OR absence of rifampin resistance on gene Xpert) admitted to one of the public clinics in the Matlosana sub-district on or after October 1, 2015.

Exclusion Criteria:

* Household contact of a drug-resistant TB index case. (Drug resistance defined either by culture or by presence of rifampin resistance on gene Xpert).
The Effect of Mindfulness Meditation and Loving-kindness and Compassion Meditation on Psychological Distress

The purpose of the study is to explore the effect of of mindfulness meditation and loving-kindness and compassion meditation on psychological distress (i.e., anxiety, depression, stress), and explore the mechanism from the perspective of reinforcement sensitivity theory.

Participants were randomly assigned to three groups: mindfulness meditation group (MM, n = 51), loving-kindness and compassion meditation group (LKCM, n = 51), and waitlist group (n = 50). Participants in MM group and LKCM group received four weeks intervention, and data was collected before the intervention and after the intervention.

Eligibility Criteria:
Inclusion Criteria:

(1) have not attended structured meditation intervention; (2) have not diagnosed psychiatric diseases; (3) not currently receiving or has never received psychological counseling; (4) not currently taking or has never taken psychotropic medication; (5) age is less than 18.

Exclusion Criteria:

(1) have attended structured meditation intervention; (2) have diagnosed psychiatric diseases; (3) receiving or have received psychological counseling; (4) taking or have taken psychotropic drugs; (5) age is more than 18.
Irisin Hormone Levels in Endometrial Hyperplasia

The purpose of the study is to determine serum irisin hormone levels an its relation between endometrial hyperplasia

The study consisted of two groups. The first group was formed of the patients diagnosed endometrial hyperplasia histopathologically , and the controls were healthy women admitted to the clinic just for annual examination without any complain and symptoms. Patients in the 35-50 age range in both groups were included in the study. The histopathologic diagnosis of patients was established for Kayseri Education and Research Hospital Pathology clinics. Demographic parameters such as age, menopausal status, body mass index (BMI), body weight and known familial cancer story were registered.

Pregnancy, liver function disorders, cardiovascular disease, metabolic disease, diabetes, chronic kidney disease, central nerves system disease, immunosuppressive drug use, another known malignancy and excessive exercises in among one month were all exclusion criteria for the patients.

3 cc peripheral venous blood samples were taken in the patients' diagnosed endometrial hyperplasia in the course of evaluation the biopsy results and in controls during their examinations just for only once. Blood samples were centrifuged in 3200 rpm speed for 10 minutes, and stored in -80 'C until the analysis. Blood samples were evaluated on the same day after four mounts for stored first blood sample. Serum Irisin levels were evaluated with enzyme- linked immunosorbent assays kit (Catalog number: K4761-100 Biovision USA) in Kayseri Research and Education Hospital Biochemical Clinics.

Eligibility Criteria:
Inclusion Criteria:

* between 35-50 years of age
* İn endometrial hyperplasia group; patients who were diagnosed endometrial hyperplasia histopathologically

Exclusion Criteria:

* Pregnancy
* Liver function disorders
* Cardiovascular disease
* Metabolic disease
* Diabetes
* Chronic kidney disease
* Central nerves system disease
* Immunosuppressive drug use
* Another known malignancy
* Excessive exercises in among one month
AutoVPAP Versus VPAP; Assessment of Sleep and Ventilation

The aim of the study is to compare the effects of a modified form (AutoVPAP) of the VPAP non-invasive ventilator versus standard VPAP ventilation on sleep quality and breathing during sleep in stable patients with nocturnal hypoventilation due to restrictive ventilatory disorders (eg. neuromuscular disease or chest wall disorder).


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18-80 years
* Nocturnal hypoventilation (nocturnal peak transcutaneous PCO2 \> 6.5 kPa when breathing spontaneously) with
* Congenital neuromuscular disease (eg. Duchenne muscular dystrophy, congenital muscular dystrophy), acquired neuromuscular disease (eg. old polio, bilateral diaphragm paralysis) or chest wall disease (eg. idiopathic scoliosis, thoracoplasty)
* Recruited from 1300 patients attending Royal Brompton Hospital Lind ward ventilator clinic.
* All patients will be familiar with non-invasive ventilation use but currently using a ventilator which is not a VPAP model eg. BiPAP Harmony, Breas PV403.
* Able to understand treatment and protocol

Exclusion Criteria:

* Unstable respiratory failure (PaO2 \< 7.5 kPa, PaCO2 \> 8.0 kPa,
* Uncontrolled heart failure or arrhythmia
* Moderate or severe bulbar weakness.
* Unable to understand treatment or protocol
Predictor of Advanced Sub-Clinical Atherosclerosis (PASA) Study

The study will evaluate the clinical utilization of skin Cholesterol (SC) for cardiovascular risk assessment in asymptomatic individuals at low, intermediate and high risk based on Framingham global risk estimates.

Preliminary studies have suggested that SC is an easy to measure, noninvasive marker of cardiovascular risk. This study is intended to provide further data in support of broader clearance by the Food and Drug Administration for the use of SC as a tool to identify asymptomatic patients at increased risk of cardiovascular disease. Currently, SC testing is cleared for use as part of risk assessment in subject suspected of having significant multi-vessel disease.

The current study data will be used to support the use of SC testing as part of cardiovascular risk assessment in subjects without suspected coronary artery disease (CAD).

* The primary objective of the study will be to determine the relationship between skin cholesterol levels and carotid artery intima-media thickness (CIMT), a surrogate marker for atherosclerotic burden used as the "gold standard" comparator.
* Secondary objectives of the study will be to compare the skin cholesterol levels with other markers of CAD as HDL cholesterol, Apo B, hsCRP, and lipoprotein-association phospholipase A2.
* Another objective is to determine the relationship between skin cholesterol levels and the presence of carotid plaques detected by ultrasound.

Eligibility Criteria:
Inclusion Criteria:

* Informed written consent from the subject prior to testing.
* Males or females 30-80 years of age

Exclusion Criteria:

* 1. Known coronary heart disease, (history of myocardial infarction, coronary bypass surgery, coronary angioplasty, or angina pectoris with a positive stress test or angiographic documentation)
* Known peripheral vascular disease (claudication with ankle-brachial index \< 0.9, angioplasty, or peripheral artery bypass procedure)
* Known cerebrovascular disease (stroke or TIA with documented carotid or aortic atherosclerosis)
* History of carotid artery endarterectomy or carotid artery surgery
* Diabetes mellitus (fasting glucose \> 126 mg/dL, on on insulin-reducing medications)
* 10-year Framingham risk of cardiac death or MI using ATP III calculator \>20%
* Subjects taking cholesterol-lowering medications
* Known hepatitis
* Known pregnancy
* Skin disease on either hand (e.g. eczema psoriasis, rash or broken skin)
Pretherapeutic Paraaortic Lymphadenectomy in Women With Locally Advanced Cervical Cancer Versus Definitive Chemoradiotherapy

This is an international, prospective, multicenter and randomized phase III study designed to determine if patients with locally advanced cervical cancer have longer overall survivals with pretherapeutic paraaortic surgical staging when compared to radiologic staging.

All eligible patients will be equally randomized between the 2 following treatment groups:

* Standard of care arm: standard chemoradiation (whole pelvis chemoradiation therapy).
* Experimental arm: pretherapeutic paraaortic lymphadenectomy followed by tailored chemoradiation. Pretherapeutic lymphadenectomy will be performed via the laparoscopic extraperitoneal or transperitoneal approach using either traditional laparoscopy or robotically-assisted laparoscopy.

The surgery (extraperitoneal or transperitoneal laparoscopic lymphadenectomy) is considered investigational.

Chemoradiation treatment (with either pelvis or tailored radiation) is considered as standard treatment approved in France for the treatment of cervical cancer.

Eligibility Criteria:
Inclusion Criteria:

1. Women with clinical stage from 1B2 to 4A cervical squamous cell carcinoma, adenosquamous, or adenocarcinoma.
2. Women with FDG-PET positive or indeterminate pelvic lymph nodes or indeterminate low common iliac nodes (see addendum below) and negative paraaortic nodes.
3. Women with planned treatment of primary definitive chemoradiation therapy.
4. Patient information and written informed consent form signed.
5. Age ≥ 18 years old.
6. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤ 2.
7. Life expectancy ≥ 3 months.

Exclusion Criteria:

1. Women with stage 1A or 1B1 cancer.
2. Women with prior radiotherapy to the pelvis or retroperitoneal surgery.
3. Women with neuroendocrine histologies, or histologies other than squamous, adenosquamous or adenocarcinoma.
4. Women with FDG PET positive high common / paraaortic lymph node metastasis confirmed by biopsy (see addendum below).
5. Women who have undergone simple or radical hysterectomy prior to radiotherapy.
6. Women with planned treatment of radiotherapy only (without chemotherapy).
7. Women with planned treatment of palliative radiotherapy.
8. Women with metastatic disease outside of pelvis.
9. Women who have completed treatment for other malignancies (except non-melanomatous skin cancer) \< 5 years from their new diagnosis of cervical cancer.
10. Women who are pregnant, women who are likely to be pregnant or are breastfeeding.
11. Women with any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with patient's safety, provision of informed consent or compliance to study procedures.
12. Women not affiliated with Social Security System in France.
13. Women deprived of liberty or under guardianship.