cyrilzakka/clinical-trials huggingface dataset:
A Study of Cesium-131 Brachytherapy Following Sub-Lobar Resection for Early Stage Non Small Cell Lung Cancer

For patients diagnosed with early (Stage I) non-small cell lung cancer, a lobe of lung is usually removed at surgery to treat the cancer. For some patients, the removal of a lobe of lung may leave too little lung behind for easy breathing. For some of these patients, it may be possible to perform a smaller-scale surgery ("sub-lobar resection") and place a radioactive implant behind to prevent the cancer from growing back. This study will see how these patients do in terms of controlling their disease treated with a radioactive implant called Cesium-131.


Eligibility Criteria:
Inclusion Criteria:

1. Patients must have suspicious lung nodule for clinical stage I/recurrent non-small cell Lung Cancer
2. Mass Tumor size \< 7 cm
3. Patient must have a CT scan of the chest with upper abdomen within 90 days prior to date of pre-registration.
4. Patient must have ECOG/Zubrod performance status 0,1, or 2.

Exclusion Criteria:

1. Patient has already received high dose radiation to the area
2. Cancerous nodule is very close to the esophagus or spinal cord, thereby increasing the risk of radiation treatment
3. Pregnancy or unwillingness to practice a form of birth control (i.e. abstinence, oral contraceptives, etc.)
Pulsed Radiofrequency Treatment in Lumbar Facet-Related Pain

Facet joint-related pain is one of the leading causes of low back pain. Facet joint-related disorders can have a negative impact on quality of life and daily living activities, in addition to the pain.Conservative treatment methods such as analgesic medications, physical therapy, and manual therapy are used for facet joint-related low back pain, and interventional pain management practices are used in patients who do not respond adequately to these treatments.

Pulse radiofrequency application, which is a recent popular treatment in interventional pain management, is also frequently applied in the treatment of facet-joint related pain. Pulsed radiofrequency intervention can be applied directly intra-articularly or can be applied to the median branch, which is important structure in pain transmission. Although both methods are frequently used in pain management, there is a lack of information in the literature about which is more effective. This study aimed to compare the treatment results of intraarticular pulse radiofrequency application and median branch pulse radiofrequency application in facet joint-related low back pain.


Eligibility Criteria:
Inclusion Criteria:

* Having facet joint-related low back pain at least 3 months
* No response to other conservative treatments (analgesic medications, physical therapy, manuel therapy etc.)
* Patients with a pain severity score of at least 6 according to NRS

Exclusion Criteria:

* History of lumbar region surgery
* Patients with bleeding disorders
* Presence of pregnancy and breastfeeding status
* Presence of the infection related findings and any other systemic disorder
* History of allergic reaction to contrast agent
* Patients who do not have sufficient mental function to fill out the scales during the follow-up periods
Postoperative Nudges to Reduce Opioid Prescribing

This study tests the effectiveness of two email-based behavioral nudges, one based on peer behavior and one based on best practice guidelines, in reducing excessive opioid prescriptions after surgery. It will be conducted in three surgical specialties (general surgery, orthopedic surgery, and obstetric/gynecological surgery) at 19 hospitals within one healthcare system. These specialties will each be randomized to a control group or one of two nudge groups. Each month for one year, surgeons in the nudge groups will receive emails comparing their opioid prescribing either to their peers' prescribing or to prescribing guidelines. Both types of email-based nudges are expected to reduce opioid prescribing after surgery.


Eligibility Criteria:
The nudges that a surgeon in either intervention arm will receive are based on that surgeon's eligible discharge opioid prescriptions in the previous month. Eligible prescriptions meet all of the following criteria:

* the patient is at least 18 years old at the date of surgery
* the patient is discharged to their home
* the surgical procedure has an applicable post-operative opioid prescribing guideline
* the surgical procedure is the only surgical procedure performed during the patient's hospital stay
* the prescription is for an opioid taken orally (tablets, capsules, or liquid solution)

To avoid contamination between the intervention arms, surgeons who operate across multiple surgical specialties (defined as surgeons who performed less than 90% of their total procedures in one specialty between June 2020 and May 2021) will not be eligible.
MOA Study of Ze 339 in Seasonal Allergic Rhinitis

Randomised, double-blind and prospective clinical study to examine the mechanism of action of the Petasites hybridus leaf extract IG-RD-001 (Ze-339, petasol butenoate complex) compared to desloratadine and placebo in patients with seasonal allergic rhinitis of all degrees of severity (provoked by grasses). The treatment arm with desloratadine is an established standard treatment and is intended to ensure the comparative methodology of the study.


Eligibility Criteria:
Inclusion Criteria:

* Allergic rhinitis since at least 2 years
* Age: = \> 18 years
* Consent in accordance with the AMG (=German Drug Law)
* Positive skin test, skin prick test or positive RAST for grasses The skin prick test is positive if the wheal is \>= 3 mm greater than control; a skin test is positive if the wheal is \>= 7 mm greater than control
* Women of childbearing potential have to use a highly effective method of birth control (according CPMP/ICH/286/95 Note 3) during the duration of the study. A highly effective method of birth control is defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner.

Exclusion Criteria:

* Past or current psychological disease or disorder which can impair the study participant's ability to understand the study requirements, t take part in the study or give consent after briefing
* Past or current alcohol or medication dependency or abuse
* Bronchial asthma (FEV \< 80 %)
* Glaucoma, cataract or ocular herpes simplex
* Clinically relevant deviations from normal laboratory parameters (if known)
* Antihistamines with a long-term effect
* Malignant diseases, including in the patient's case history
* Parasites
* Study participants who are taking part in another study or took an investigational product during the last 4 weeks before the start of treatment
* Progressive systemic diseases such as tuberculosis, leukoses, collagenoses, multiple sclerosis, Aids, HIV infection and other autoimmune diseases
* Other types of rhinitis with different causes, acute or chronic sinusitis
* Pregnancy or lactation
* Serious internal diseases, e.g. serious decompensated diseases of the heart, liver, kidneys or diabetes mellitus
* Patients with rarely occurring hereditary problems galactose-intolerance, Lapp-lactase-deficiency or glucose-galactose-malabsorption
* Pre-existing liver damage
* The use of non-steroidal antirheumatic agents (NSAR)
* Hypersensitivity towards one of the ingredients in the investigational product
* Not adhering to the following periods of abstention before the nasal provocation test: 3 days for DNCG, nedocromil, nasal and oral antihistamines, and tricyclic psychotropic drugs, 1 months systemic treatment with glucocorticoids, 14 days for nasal and topical corticosteroids, 1 week for antihistamines, and 1 day for α-adrenergic drugs. The use of ACE inhibitors or ß-blockers
* Previous organ transplants
The Prevalence of Metabolic Syndrome in Patients Suffering From Chronic Pain

Obesity is considered as the epidemic of the century. Central obesity is one of the metabolic syndrome's features. It has been proven that obesity can cause back pain and headaches; thus, there might be a link between chronic pain and the syndrome.

The objective of this study is to assess the prevalence of metabolic syndrome in patients suffering from chronic pain.

All patients will answer a questionnaire, their hip circumference will be measured, and their BMI will be calculated (weight/(height)2 ).

The patients' blood pressure will be measured. The patients will be asked to bring their blood tests (lipids and glucose).

Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 that suffer from chronic pain and are being treated at the pain medicine unit

Exclusion Criteria:

* Pregnant women, patients with abdominal wall defects
Clinical Trial to Evaluate Safety and Efficacy of Cell Therapy in Patients With Cicatricial Conjuntivitis.

A phase IIa, open label, non controlled clinical trial to assess the feasibility and safety of allogeneic adipose-derived mesenchymal stem cells (ASC) in the treatment of cicatricial conjunctivitis associated with Lyell's syndrome, Stevens-Johnson's syndrome and mucous membrane pemphigoid with ocular involvement

A multicentre, nationwide clinical trial will be performed. 20 patients fulfilling eligibility criteria will be included in two different dose level cohorts: the first 10 patients included will receive a single cell application and the remainder 10 will be administered 2 cell applications separated by 15 days.

The investigational drug consists of locally administered, expanded, allogeneic adipose-derived adult mesenchymal stem cells (ASCs), at a dose of 5 million cells per ml (0,5 ml to be infused per quadrant)

Study cronogram: recruitment is estimated to take 8 months, and follow-up period will be 12 months.

Eligibility Criteria:
Inclusion Criteria:

1. Men and women over 18 years of age.
2. Diagnosis of ocular pemphigoid in Foster stages I-IIcIIIb (2) or diagnosis of recurrent chronic or episodic inflammation accompanied by cicatricial conjunctivitis of the mucous membranes with ocular involvement after the acute phase of Stevens-Johnson Syndrome or Lyell Syndrome with insufficient disease control or inaceptable toxicity or impossibility to administer usual care treatments (according to physician or patient criteria)
3. In the case of women of childbearing age, who are willing to use an effective contraceptive method during the period of participation in the study
4. Consent to participate and signature of the informed consent

Exclusion Criteria:

1. Signs of active infection on the ocular surface.
2. History of neoplasms in the last 5 years. except for epithelial basal or squamous cell carcinoma
3. Allergy to local anesthetics
4. Patients who have participated in another clinical trial with medication during the 90 days prior to signing the IC
5. Medical or psychiatric illness of any kind that, in the opinion of the investigator, may be a reason for exclusion from the study.
6. Congenital or acquired immunodeficiencies.
7. Major surgery or serious trauma of the subject in the semester prior to signing the IC.
8. Pregnant or lactating women.
9. Impossibility or refusal to carry out the follow-up required in the study by the patient
Open Label Study to Assess the Efficacy and Safety of AKB-9778 in Subjects With Macular Edema Due to RVO

Phase 2a open-label study to assess the efficacy and safety of subcutaneous 15mg AKB-9778 administered twice daily for 84 days in subjects with macular edema due to RVO.

Subjects will participate in the study for up to 168 days. Up to 20 subjects will be enrolled in the study.

Subjects will self-administer study medication as subcutaneous (SC) injections in the abdomen (preferably) twice per day; the first dose each day should be administered in the morning and the evening dose should be administered within 8 to 16 hours after the morning dose.

Safety assessments will be conducted at each study visit during treatment and AEs will be collected throughout the Treatment period and during the 56-days observation period visits.

Eligibility Criteria:
The following is a abbreviated list of Inclusion Criteria:

* Definite retinal thickening due to RVO involving the central macula based on Investigator's clinical evaluation and demonstrated by sdOCT.
* Mean central subfield thickness of at least 300 µm by sdOCT with presence of intraretinal fluid
* ETDRS BCVA letter score ≤ 76 and ≥ 24.
* Decrease in vision determined to be primarily the result of macular dema due to RVO and not due to other causes.

The following is a abbreviated list of Exclusion Criteria:

* Macular edema is considered to be due to a cause other than RVO
* Any other ocular disease that may cause substantial reduction in visual acuity, including iris neovascularization, retinal detachment, epiretinal membrane, vitreous hemorrhage or fibrosis, ocular inflammation (uveitis), retinal inflammatory, infectious disease, or primary open-angle glaucoma.
* High myopia (-8 diopter or more correction).
* History of idiopathic or autoimmune uveitis.
* History of any ocular surgery within 3 months prior to Day 1.
* History of panretinal scatter photocoagulation (PRP) or focal laser within 3 months prior to Day 1.
* History of prior intravitreal, subtenon, or periocular steroid therapy within 3 months prior to Day 1 (e.g., triamcinolone).
* History of prior treatment with intravitreal anti-VEGF treatment within 16 weeks prior to Day 1.
Efficacy and Safety of Armodafinil as Adjunctive Therapy in Schizophrenic Adults With Cognitive Deficits

The primary objective of this study is to evaluate if adjunctive armodafinil treatment can improve the cognitive deficits in patients with schizophrenia


Eligibility Criteria:
Key Inclusion Criteria:

* The patient has a diagnosis of schizophrenia according to the DSM-IV-TR criteria as determined by the SCID and has been clinically stable in a nonacute phase of their illness for at least 8 weeks prior to the baseline visit.
* The patient has received treatment with olanzapine, oral risperidone, or paliperidone for schizophrenia for at least 6 weeks prior to the screening visit and has been on a stable dose of olanzapine, oral risperidone, or paliperidone for at least 4 weeks prior to the screening visit. The patient is prepared to remain at these stable dosages for the duration of the study.
* The patient is a man or woman 18 through 60 years of age.
* The patient is in good health (except for the diagnosis of schizophrenia) as judged by the investigator on the basis of medical and psychiatric history, medical examination, ECG, serum chemistry, hematology, and urinalysis.
* Women of childbearing potential must use a medically accepted method of contraception and must agree to continue use of this method for the duration of the study and for 30 days after participation in the study.
* The patient must be willing and able to comply with study restrictions, to remain at the clinic for the required duration during the study period, and to return to the clinic for the follow-up evaluation as specified in this protocol.

Key Exclusion Criteria:

* The patient has any Axis I disorder, including schizoaffective disorder and sleep disorders, apart from schizophrenia, and nicotine dependence.
* The patient has tardive dyskinesia or any other clinically significant movement disorder.
* The patient has any clinically significant uncontrolled medical (including illnesses related to the cardiovascular, renal, or hepatic systems) or surgical condition.
* The patient has previously received modafinil or armodafinil, or the patient has a known sensitivity to any ingredients in the study drug tablets.
* The patient is a pregnant or lactating woman. (Any woman becoming pregnant during the study will be withdrawn from the study.)
Motivational Interviewing to Improve Medication Adherence Among Hispanic Adults With Depression

This study will determine the effectiveness of motivational interviewing in improving antidepressant medication adherence among Hispanics.

Depression is a serious mental illness characterized by symptoms that can interfere with a person's ability to work, study, eat, sleep, and enjoy activities that were once pleasurable. Studies have shown that people of Hispanic descent tend to underutilize mental health care services. Additionally, Hispanics have demonstrated lower compliance and completion rates for antidepressant treatment. This may be due to low socioeconomic status, lack of family financial support, and inadequate communication with mental health care providers. Motivational interviewing is a goal-oriented type of therapy that focuses on eliciting behavior change by identifying and mobilizing a person's values. This study will determine the effectiveness of culturally sensitive motivational interviewing in improving antidepressant medication adherence in Hispanics.

Participants in this 6-month, open-label study will be randomly assigned to receive either motivational interviewing in addition to their antidepressant therapy or treatment as usual. All participants will first attend a 45-minute screening visit, which will include questionnaires and an interview about psychiatric symptoms, medication attitudes, and medication adherence behavior. Participants will also receive an electronic medication container that will record how consistently medication is taken. Participants assigned to motivational interviewing will then attend two 1-hour sessions of motivational interviewing over 2 consecutive weeks, followed by a third session 8 weeks later. The group assigned to treatment as usual will not partake in motivational interviewing, but will continue to receive their normal care. All participants will return to the study site for follow-up assessments, which will include measures of antidepressant adherence, at Months 2 and 5.

Eligibility Criteria:
Inclusion Criteria:

* Self-identifies as Hispanic
* DSM-IV diagnosis of any unipolar depressive disorder (i.e., MDD, dysthymia, or depressive disorder not otherwise specified)
* Currently taking antidepressant medication

Exclusion Criteria:

* Clinically significant suicidal ideation
* DSM-IV diagnosis of any substance-related disorder, bipolar disorder, or psychotic disorder/features within 12 months prior to study entry
* Unstable general medical condition
Investigation of the Relationship of Smartphone Use Time With Neck Endurance, Head Posture, Lateral Grip Strength, Hand Grip Strength and Postural Control Parameters in Young Adults

In the planned study, young adults between the ages of 18-35 with different phone usage durations will be evaluated. The aim of the study is to investigate whether the average daily phone usage time has a direct relationship with neck muscle endurance, rough grip strength, lateral grip strength and head posture, and whether there is an indirect relationship with postural control. People who have phones with IOS 12 or Android 9 and above will be invited to the study. By looking at the screen time tracking feature in these versions, the daily phone usage hour for the last week will be calculated and the participants will be divided into two groups as the daily phone usage average of 5, and below and 5 hours. In the planned study, neck endurance will be tested on flexor and extensor muscle groups in accordance with the literature. The lateral flexion and anterior tilt angles will be calculated with two photographs taken from the anterior and lateral sides of the head posture of the person's shoulder, and the hand grip strength will be measured with a Jamar hand dynamometer and the lateral grip strength will be measured with a pinchmeter. Postural control evaluation will be measured by means of center of pressure-CoP parameters measured with TekScan brand pressure platform. The study is planned to be carried out in the Movement Analysis Laboratory of the Faculty of Physical Therapy and Rehabilitation of Dokuz Eylul University. Participants will be selected from healthy adults between the ages of 18-35 who volunteered to participate in the study among the students of the Faculty of Physical Therapy and Rehabilitation, their relatives and the relatives of the researcher. The study is planned to be completed within 6 months following ethical approval.


Eligibility Criteria:
Inclusion Criteria:

* Using a phone with IOS 12 or android 9 and above for at least one week

Exclusion Criteria:

* Presence of orthopedic surgery in the last 6 months
* Those who have a disease or take medication that will prevent neuromuscular system and postural control measurements
* have neck pain
A Provocation Study Using Biogenic Amines to Show the Efficacy of Oral Diamine Oxidase Supplementation

This study aims to define a provocation test for histamine intolerance (aka. biogenic amine intolerance syndrome) and test the capability of an oral enzyme supplementation to ameliorate this condition.

The clinical picture of the so-called histamine intolerance has been described by various authors since the 1990ies. However, the existence of this multifactorial condition is also being contested due to the lack of both a positive definition and unambiguous diagnostics. Various provocation studies using pure histamine or histamine-containing foods support the existence of the disease pattern, however many questions still remain open.

A lack of diamine oxidase (DAO) is considered the etiological cause of the condition. DAO is an enzyme known to degrade a wide array of biogenic amines. The aim of this study is to provoke a response in patients by oral administration of a defined mixture of biogenic amines. By administration of DAO before provocation an attenuation of the symptoms is to be expected.

Eligibility Criteria:
Inclusion Criteria:

* Persons suspected of suffering from BAIS (BAIS Score ≥ 50) according the the questionaire used for histamine intolerance so far

Exclusion Criteria:

* pregnancy
* coronary heart disease
* labile hypertension
* bronchial asthma
* periodical therapy using H1-blockers
* chirurgical intervention with the GI tract within the previous 3 months
* participation in a clinical trial within the previous 4 weeks