cyrilzakka/clinical-trials huggingface dataset:
Suprascapular Neuropathy in the Setting of Rotator Cuff Tears: Results of Arthroscopic Treatment

Aim of this prospective double blind randomized clinical trial is to understand the correlation of suprascapular neuropathy in the setting of large and massive tears of the shoulder rotator cuff and to investigate whether arthroscopic dissection of the superior transverse scapular ligament is positively related to the improvement of this neuropathy.

The suprascapular nerve originates from the upper trunk of the brachial plexus with participation from the A5 and A6 spinal nerve roots and occasionally from the A4 root. It is treading behind the clavicle and to the upper border of the scapula and then enters through the scapular notch of the shoulder and below the transverse superior transverse ligament to the rear surface of the scapula. This entry point is an important factor of pressure and surgical dissection of the ligament enlarges the space through which the nerve travels.

The rotator cuff consists of the tendons of subscapularis, supraspinatus , infraspinatus and minor teres muscles. Cadaveric studies have shown that tears in the cuff , particularly massive ruptures a gap more than 5cm, change the path of the suprascapular nerve and create conditions that pressure.

Until now, there are no prospective studies that compare the improvement of suprascapular neuropathy after arthroscopic dissection of the superior transverse scapular ligament in patients with rotator cuff tears , or that study the degree of neuropathy compared with the extent of the rupture .

Eligibility Criteria:
Inclusion Criteria:

- Large of Massive repairable rotator cuff tears combined suprascapular neuropathy

Exclusion Criteria:

* Suprascapular neuropathy of another cause (eg. brachial plexus neuropathy)
* Other surgery at the same shoulder region
Short Practices Well-being Study

The goal of this research study is to better understand the effects of short practices on well-being.

Participants will be asked to complete a task that will take 5-10 minutes, followed by a set of surveys. They will also be invited to complete a second set of surveys \~7 days later.

The aim of this study is to better understand the effects of short practices on well-being. In the initial part of the study, participants will be required to complete a set of surveys assessing their health along with demographic measures. Participants will also be asked to complete a brief task. They will be asked sensitive questions (e.g., about your psychological state, mental health). To have their submission accepted, participants must correctly answer questions designed to check if they are paying attention. This part of the study will take approximately 24 minutes to complete. Anonymized data may be made available to other researchers. One week after completing this study, participants will be invited to complete a second set of surveys.

Eligibility Criteria:
Inclusion Criteria:

* United States and United Kingdom residents 18 year or older

Exclusion Criteria:

* Inability or unwillingness to complete the study
* Fail to pass the attention check embedded in the survey
Endometrial Shedding Prior to Ovulation Induction Pilot Study

This is a pilot study examining the feasibility of implementing a large randomized control trial looking at the effect of endometrial shedding with medroxyprogesterone acetate compared to no pre-treatment in women taking clomiphene citrate for ovulation induction for infertility due to oligo-ovulation or anovulation.

The purpose of this pilot study is to assess the feasibility of implementing a randomized controlled trial assessing the effect of giving medroxyprogesterone acetate (MPA) to induce a withdrawal bleed compared to a control group of women not receiving MPA on pregnancy rates prior to ovulation induction with clomiphene citrate in oligo-ovulatory and anovulatory women. The primary outcome measure is the effective implementation of the study including a measure of time to recruit 50 patients, physician, nursing and patient compliance rate with the study protocol, and patient satisfaction. Secondary outcome measures include the pregnancy rate per ovulation (where pregnancy is defined as a positive fetal heart rate on ultrasound 2 weeks after a positive pregnancy test), the ovulation rate per cycle started, conception rate per cycle started (where conception is defined as a positive beta-human chorionic gonadotropin level), conception rate per ovulation, time to complete 3 stimulation cycles and endometrial thickness at time of luteinizing hormone surge.

Eligibility Criteria:
Inclusion Criteria:

* Oligo-ovulation defined as having less than or equal to 8 menstrual cycles in the past year or inter-menstrual periods of 45 days or longer
* general good health
* ability to have timed intercourse or intrauterine insemination
* no evidence of tubal dysfunction
* no evidence of a uterine cavity abnormality
* no evidence of male factor infertility

Exclusion Criteria:

* a baseline ultrasound showing an endometrial lining greater than 1.0 cm
* a baseline ultrasound showing an endometrial lining of less than 0.5 cm
* a positive progesterone level at baseline bloodwork
* a positive beta human chorionic gonadotropin level at baseline bloodwork
* body mass index of greater than 40
* women who have previously taken clomiphene citrate for ovulation induction within the last 6 months
* women who are taking metformin
* women who are taking a progestin for luteal phase support.
The Role of Inflammation and Vasodilatation in PACAP38-induced Headache Using MRI on Healthy Subjects

Studying Pituitary adenylate cyclase-activating peptide 38 (PACAP38) induced headache effects on extra- and intracerebral arteries and pre-posttreated by sumatriptan and ketorolac assessed by magnetic resonance imaging (MRI) on healthy volunteers.

The purpose of this research project is to investigate the importance of blood vessel (vasodilatation), vessel wall inflammation and blood flow in arteries of headaches triggered by PACAP38 and for headache treated with sumatriptan (migraine medicine) and ketorolac (NSAID). In addition, we will investigate headache-related changes in the brain's network connectivity.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers
* Aged 18-50
* 50-100 kg

Exclusion Criteria:

* Tension type headache more than 5 dag /month
* Other primary headaches
* Daily medication except contraceptives
* Drug taken within 4 times the half-life for the specific drug except contraceptives
* Pregnant or lactating women
* Exposure to radiation within the last year
* Headache within the last 24 hours before start of trial
* Hypertension
* Hypotension
* Respiratory or cardiac disease
* Primary relatives with current or previous migraine
Clinical Study Evaluating the Safety of Lactobacillus Probiotic in Children With Drug Resistant Epilepsy

Animal and human studies have brought up evidence supporting Gut microbial disbalance, namely dysbiosis, as a causative factor of epilepsy, especially the refractory form. thus, probiotics might constitute a safe, low-cost, and effective supplementary therapy in patients with DRE.

The Lactobacillus population is probiotic bacteria that have a beneficial role in epilepsy. Lactobacillus can influence brain function through the modulation of GABA, as shown in rodent models. Moreover, it has been demonstrated in animal models of epilepsy and in human epileptic patients that probiotic treatment aimed at restoring gut microbiota equilibrium has beneficial effects on epileptic symptoms by increasing GABA in animals and the levels of Bifidobacteria and Lactobacillus in humans.

This study will be a placebo-controlled, double-blind, and parallel 6-month duration study

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 3-18 years with intractable childhood-onset epilepsy.

  * All patients are diagnosed to have drug-resistant epilepsy (refractory epilepsy) according to the ILAE definition.
  * The subject is willing and able to comply with the study requirements

Exclusion Criteria:

* Any metabolic conditions that might increase the risks associated with trial participation or investigational product administration, such as hepatic enzyme elevation greater than twice normal and/or a GFR \< 60 mL/min/1.73 m2 or electrolyte imbalance.

  * Patients who are currently using or used antibiotics therapy in the preceding month
  * Patients who are currently using or used other probiotic products in the preceding two weeks
  * Patients scheduled to undergo GIT surgery or those who underwent GIT surgery
  * Patients with a Known allergy to probiotics.
  * Patients receiving artificial enteral or intravenous nutrition
Lactated Ringer's and PlasmaLyte in Critically Ill Adults

In recent years, there has been a large amount of literature reports that normal saline can increase the incidence of renal injury in critically ill patients compared with balanced salt solution.However, no studies have compared the effects of different types of balanced salt solutions on the incidence of renal injury.


Eligibility Criteria:
Inclusion Criteria:

* All patients admitted to ICU

Exclusion Criteria:

* Patients \<18 year old when admission
* Patients who stay less than 24 hours in ICU
* Patients who do not sufficient data for further analysis
* Readmission patients during the study period
Bayesian Estimation of Diagnostic Performance for Cardiovascular Autonomic Neuropathy

This study aimed to evaluate the reference values for the short-term heart rate variable (HRV), estimate the performance of cardiovascular autonomic neuropathy (CAN) diagnostic tests in the absence of a gold standard, and assess CAN prevalence in our cross-sectional dataset.

The CAN prevalence is rapidly growing in all populations worldwide. No document has been reported about normal reference values for CAN using this test in the Chinese population. This study aimed to evaluate the reference values for the short-term HRV in a large cross-sectional dataset, and to estimate sensitivities and specificities of CAN diagnostic tests using the Bayesian approach, in the absence of a gold standard in another independence dataset. Finally, CAN prevalence was estimated in the investigators' cross-sectional dataset. Firstly, the reference the values for the short-term HRV were calculated in the investigators' previous study (including 371 healthy subjects). This study dataset contained 88 subjects who completed both the short-term HRV test and Ewing's test. Simultaneous inferences about the population prevalence and the performance of each diagnostic test were possible using the Bayesian approach without a gold standard.

Eligibility Criteria:
Inclusion Criteria:

* Survey participants with undiagnosed CAN, aged 30-80 years, were included in this study.

Exclusion Criteria:

* Some subjects were excluded from the study to eliminate potential confounding factors that may have influenced their CA function 11. Briefly, the exclusion criteria were as follows:

  1. history or findings of arrhythmia, and hyperthyroidism or hypothyroidism;
  2. pregnancy or lactation; and/or
  3. serious hepatic or renal dysfunctions.
A Single Group Study to Evaluate the Effects of a Probiotic Supplement on Vaginal Health.

This virtual single-group clinical trial aims to evaluate the effects of the Good Girl Probiotics supplement on vaginal health. Participants will take one capsule of the probiotic supplement daily for eight weeks. They will complete questionnaires at Baseline, after the first dose, and at the end of Weeks 2, 4, 6, and 8 to assess changes in vaginal pH, vaginal health, and urinary tract health.


Eligibility Criteria:
Inclusion Criteria:

* Female at birth.
* Aged 18+.
* Interested in supporting a balanced vaginal pH, vaginal health, and urinary tract health.
* Regularly experience symptoms of an unbalanced vagina, including an atypical smell, discharge, itching, swelling, irritation, pain during sex, and/or burning sensation while urinating.
* Willing to avoid using products or medications that target vaginal or urinary tract health infections.
* Willing to avoid other probiotics.
* Able to follow the study protocol.

Exclusion Criteria:

* Two or more bladder infections in six months or three or more infections in a year.
* Recent surgeries or invasive treatments within the last six months.
* Use of products or medications targeting vaginal or urinary tract health in the last 12 weeks.
* Known allergies to the product ingredients.
* Chronic health conditions impacting participation.
* Pregnant, breastfeeding, or trying to conceive.
* History of substance abuse.
* Current or former smoker within the past six months.
* Participation in another clinical trial.
* Diagnosed vaginal or pelvic conditions.
* Use of vaginal-related birth control (NuvaRing, IUD).
* Changes in hormonal birth control in the last three months.
To Evaluate a Phase Ia/Ib Clinical Study of EG017 in Patients With Advanced Breast Cancer.

To evaluate the safety, tolerability, pharmacokinetics and efficacy of EG017 in androgen receptor-positive, estrogen receptor-positive, and human epidermal growth factor receptor-2-negative patients with advanced breast cancer.

The major aims of the study are to define the safety profile of this new drug, and to determine a recommended.

Eligibility Criteria:
Inclusion Criteria:

1. Female, 18-75 years old;
2. Expected survival ≥ 12 weeks;
3. Subjects with ECOG score of physical state 0\~1;
4. Histologically confirmed recurrent or metastatic advanced breast cancer;

Exclusion Criteria:

1. Those who have had a severe allergic reaction to any drug or its components in this study in the past;
2. Present with primary central nervous system (CNS) malignancies; Subjects with CNS metastasis who have failed local treatment (except asymptomatic BMS, or symptomatic BMS with complete remission of symptoms ≥ 2 weeks after treatment for BMS);
3. Has any disease or syndrome that requires or is likely to require systemic steroid therapy during the study period;
4. Gastrointestinal disorders or gastrointestinal diseases will significantly affect the absorption of test drugs (such as ulcerative disease, uncontrolled vomiting, diarrhea, malabsorption syndrome, biliary drainage status, etc.), or subjects cannot take drugs orally:
Actual Use Trial of Atorvastatin Calcium 10 mg

The purpose of this actual use study is to simulate the over the counter use of atorvastatin calcium 10 mg.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age (19 in Alabama).
* Provide written informed consent.
* Never participated in a study about cholesterol medicines.

Exclusion Criteria:

* Females subjects who are pregnant or breastfeeding.
* Subjects with active liver disease.
* Subjects taking cyclosporine.
* Subjects with a known allergy to atorvastatin calcium.
Ranibizumab "Treat and Extend" in Diabetic Macular Edma

This study is designed to explore a more individualized treatment regime based on achievement of disease stability to define a personal optimal treatment interval with ranibizumab in patients with visual impairment due to diabetic macular edema.


Eligibility Criteria:
Inclusion Criteria:

* Visual impairment due to focal or diffuse macular edema with center involvement
* Diabetes type 1 or 2, HbA1c \< 12.0%
* CRT = or \> 250 μm

Exclusion Criteria:

* Active inflammation or infection
* Uncontrolled glaucoma
* Iris neovascularization, active proliferative retinopathy or vitreomacular traction
* Prior laser photocoagulation according to defined timelines
* History of stroke, uncontrolled hypertension

Other protocol-defined inclusion/exclusion criteria may apply
Clinical Implications of Azole-Resistant Aspergillosis in Hematological Malignancy

In order to determine the efficacy of antifungal therapy in patients with documented azole-resistant invasive Aspergillosis (IA), anonymized clinical information of patients with a hematological malignancy with a culture-positive invasive fungal infection caused by Aspergillus fumigatus are collected in an online registry. Respective fungal isolates are analysed for azole susceptibility and resistance mechanisms. Patients diagnosed with an IA in 2016 and later are included in the study.

For mold-active azoles (e.g. isavuconazole, itraconazole, posaconazole and voriconazole), cross-resistance of Aspergillus spp. is an increasingly recognized problem. The study aims to determine the efficacy of antifungal therapy in patients with documented azole-resistant IA. On the basis of this study, it will be possible to assess the clinical implications of IA caused by azole-resistant versus azole-susceptible Aspergillus spp.

The investigators aim at collecting at least 55 azole-resistant and 130 azole-susceptible cases. Cases diagnosed with an IA by culture from January 1st, 2016 onwards with an underlying hematological malignancy are eligible for inclusion. Culture of azole-resistant cases must be provided for confirmation of the species, sequencing for azole-resistance mutations and determination of MIC using the EUCAST reference method. Isolates obtained from patients with presumed azole-susceptible disease will be analyzed to confirm the wild type phenotype.

Eligible azole-resistant and azole-susceptible IA cases will be documented using the web-based case report form. If there is ≥1 resistant isolate, the patient fulfills the definition of a resistant case. Patient level data will be recorded at the respective study centres in a continuous fashion. Data items to be documented will include: demographic data; type and status of underlying conditions; concurrent immunosuppressive treatment; diagnostic measures (clinical presentation, radiology, microbiology, pathology, organ involvement); medical and surgical treatment (including prior exposure to antifungals); response to treatment (clinical and radiological) at day 14, 42, 84; overall survival at day 14, 42, 84 and at last contact; and cause of death (if applicable).

Eligibility Criteria:
Inclusion Criteria:

* Adult and pediatric patients diagnosed with an IA in 2016 and later
* Patients with a hematological malignancy
* Evidence of invasive Aspergillosis
* Aspergillus fumigatus culture from clinical material of the patient

Exclusion Criteria:

* Colonization only, without proof of invasive infection
* Non-availability of the azole resistant isolate
Acute and Subacute Iliofemoral and/or Caval Deep Vein Thrombosis: Evaluation of Mechanical Thrombectomy Systems

This is a physician-initiated, observational, monocentric, retrospective and prospective Study. The study is intended to assess the feasibility of mechanical thrombectomy of caval and iliofemoral veins according to normal clinical practice in adult patients with symptomatic acute or subacute ileofemoral or caval deep vein thrombosis objectively diagnosed with CT scan imaging.

Subjects with bilateral DVT may be enrolled, so long as the study limb(s) meet inclusion/exclusion criteria, including IVC patency. It is recommended that in a subject with bilateral DVT, central imaging be performed prior to treatment to evaluate the status of the IVC.

All the visits and procedures described will be performed according to the diagnostic and therapeutic assignment required by clinical practice for the patients under study. Therefore, the choice of assigning the patient to the diagnostic and therapeutic procedures deemed most appropriate for each case is completely independent of the study.

Anticoagulation therapy with enoxaparin sodium (1 mg/kg twice a day) shall be initiated at least 48 hours prior to initiation of study treatment. Hemoglobin, INR, and platelet count must be obtained within 24 hours prior to the mechanical thrombectomy procedure in order to confirm eligibility. The access site is determined by the extent of occlusive disease. When treating a single limb at time, access via the popliteal vein is reasonable.

Upon completion of study treatment, the catheter and sheath shall be removed and hemostasis obtained with pressure over the insertion site followed by placement of a pressure dressing. PCB shall remain placed on both legs until hospital discharge. Anticoagulation therapy with weight based enoxaparin sodium shall also be continued through discharge. The following assessments should be performed following the completion of study treatment, according to the normal clinical practice:

* Duplex imaging (within 24 hours of the completion of treatment)
* Laboratory tests (within 24 hours of the completion of treatment)
* Collection of Adverse Events

Eligibility Criteria:
Inclusion Criteria:

All patients admitted in the Unit of Vascular Surgery with proximal DVT (inferior vena cava, and/or iliac vein, and/or common femoral vein, and/or deep femoral vein, and/or femoral vein), according to ESVS guidelines (2022).

Exclusion Criteria:

* Patient treated with thrombolysis drugs within 48 hours prior to the index procedure
* Active bleeding, recent (\<3 months) gastrointestinal (GI) bleeding, active peptic ulcer, severe liver dysfunction, and bleeding diathesis
* Impossibility or refusal to give informed consent
Diagnostic Performance of a Novel Lipoarabinomannan.

The Fujifilm SILVAMP TB LAM (FujiLAM; Fujifilm, Tokyo, Japan) is a novel (not commercialized) urine based point-of-care assay to diagnose TB in HIV-positive patients. A first study using urine frozen samples has reported a higher sensitivity of this test over the currently commercialised Alere Determine TB LAM Ag assay (AlereLAM).

The study aims to assess the performance of a new test called the Fujifilm SILVAMP TB LAM or simply the Fuji-LAM test. The Fuji-LAM test is a test that can be done on urine to look for specific proteins that are produced by the bacteria that causes tuberculosis. This test offers an advantage over the tests that are based on phlegm because most patients can produce urine for testing even when they are very sick. Additionally, this test does not require a complex laboratory set up and it can therefore be used by health workers as they interact with the patient. This study will also look at how the new test compares with an existing test AlereLAM - that is based on similar technology. Initial laboratory-based studies conducted on frozen urine samples show that the new test has better performance than the existing test. This study is different from the first studies because it is being conducted in real life settings rather than in a laboratory.

The study will be conducted at the Homa Bay County Hospital in Kenya. Individuals living with HIV with and without signs and symptoms of TB will be invited to take part. Individuals who agree to participate will be seen by the health workers in the study and will provide samples for testing using the FujiLAM test and other standard tests used to investigate individuals for suspected tuberculosis.

Investigators are also conducting similar studies in other African countries including Uganda, Mozambique and South Africa. This will enable investigators to assess the performance of the test in diverse settings.

Eligibility Criteria:
Inclusion Criteria:

* 15 years of age or older
* HIV-positive Group 1: At least one symptom of TB

Group 2:

* Advanced HIV disease (CD4 count less than 200cell/µl or clinical stage III/IV)
* No signs and symptoms of TB
* Signature of the informed consent

Exclusion Criteria:

* Intake of anti-tuberculosis drugs for more than 5 days in the month prior to the consultation except preventive TB treatment.
* Decline to sign informed consent.