cyrilzakka/clinical-trials huggingface dataset:
A Study to Evaluate the Efficacy and Safety of Golcadomide in Combination With Rituximab in Participants With Newly Diagnosed Advanced Stage Follicular Lymphoma

The purpose of this study is to assess the efficacy and safety of golcadomide in combination with rituximab in participants with newly diagnosed advanced stage Follicular Lymphoma (FL).


Eligibility Criteria:
Inclusion Criteria

* Participant has histologically confirmed Grade 1, 2 or 3a follicular lymphoma (FL) or classic FL. Formalin-fixed paraffin embedded (FFPE) archival tissue from 1 year prior to screening is allowed. If more than 1 year has passed, then a fresh biopsy must be obtained to confirm the diagnosis.
* Have no prior systemic treatment for follicular lymphoma. Prior radiation therapy or surgery for previously diagnosed stage I disease is acceptable.
* Stage II to IV disease.
* Deemed to need treatment by treating investigator. Reasons for treatment can include, but are not limited to, the following:.

  i) Bulky disease defined as:.

A. A nodal or extra nodal (except spleen) mass \> 7cm in its greater diameter or, involvement of at least 3 nodal or extra nodal sites (each with a diameter greater than \>3 cm).

ii) Presence of at least one of the following B symptoms:.

A. Fever (\>38°C) of unclear etiology.

B. Night sweats.

C. Weight loss greater than 10% within the prior 6 months.

iii) Splenomegaly with inferior margin below the umbilical line.

iv) Any one of the following cytopenia due to lymphoma:.

A. Platelets \<100,000 cells/mm3 (100 x 109/L).

B. Absolute neutrophil count (ANC) \< 1,000 cells/mm3 (1.0 x 109/L).

C. Hemoglobin \< 10g/dL (6.25 mmol/L).

v) Pleural or peritoneal serous effusion (irrespective of cell content).

vi) Any compressive syndrome (for example, but not restricted to ureteral, orbital, gastrointestinal).

Exclusion Criteria

* Clinical evidence of transformed lymphoma by investigator assessment.
* Follicular Large Cell as per WHO 5th classification or Grade 3b follicular lymphoma as per WHO 4th classification.
* Participant has any significant medical condition, active infection, laboratory abnormality, or psychiatric illness that would prevent the participation in the study.
* Other protocol-defined Inclusion/Exclusion criteria apply.
Gamma Knife Radiosurgery for Treatment of Essential Tremor

The purpose of this study is to examine effects (good and bad) of gamma knife radiosurgery for essential tremor. The gamma knife places a small lesion in the brain to suppress tremors.

This research is being done because although multiple studies evaluating gamma knife for essential tremor show good results, few studies evaluating patients prospectively have been done. Prior studies have looked at patient outcomes following treatment - also known as retrospective studies. In this study, data collection will initiate before treatment, to obtain consistent baseline evaluations from all study participants undergoing the gamma knife treatment and at specific intervals following treatment.

Eligibility Criteria:
Inclusion Criteria:

* Men and women age 18 years or older
* Diagnosis of essential tremor as confirmed from clinical history and examination by a neurologist or neurosurgeon
* Tremor following prior first line therapy with either propranolol or primidone
* Must be able to undergo MRI of brain and CT of head for treatment planning
* Postural or intention tremor severity score of greater than or equal to 2 in one hand/arm as measured by the CRST rating scale

Exclusion Criteria:

* Prior ipsilateral stereotactic radiosurgical ablation of the thalamus, ipsilateral deep brain stimulation, radiofrequency ablation of a ipsilateral thalamic target, or ultrasound ablation of an ipsilateral thalamic target
* Prior whole brain radiation therapy
* Pregnancy
Transoral Endoscopic Thyroidectomy by Vestibular Approach (TOETVA)

Prospective study carried out with ICESP (instituto do Câncer do Estado de São Paulo) patients with thyroid disease with surgical indication

Prospective study carried out with ICESP patients with thyroid disease with surgical indication, according to the aforementioned inclusion criteria, totaling 60 cases, which will be randomized into two groups:

* Conventional Thyroidectomy (30 patients)
* Transoral Endoscopic Thyroidectomy By Vestibular Approach (30 patients)

Eligibility Criteria:
Inclusion Criteria:

* history of hypertrophic scarring and/or motivation to avoid cervical scarring,
* maximum diameter of the thyroid \< 10 cm and of the dominant nodule \< 6 cm,
* estimated thyroid volume \< 45 ml
* benign lesion (multinodular goiter, cyst),
* indeterminate nodule (Bethesda III or IV),
* suspicious nodule for well-differentiated thyroid carcinoma (Bethesda V and VI) \< 2 cm

Exclusion Criteria:

* history of previous surgery or irradiation in the head and neck region and superior mediastinum
* evidence of clinical hyperthyroidism
* preoperative recurrent nerve palsy
* lymph node metastasis
* extra-thyroid extension
* plunging goiter
* oral abscess
Acu-TENS for Pain Relief During Colonoscopy

Background:

Colonoscopy is often regarded as a painful and unpleasant procedure. Transcutaneous Electric Nerve Stimulation on Acupoints (Acu-TENS) is a non-invasive modality that has been used successfully to treat pain of various origins, but few good-quality studies have evaluated its role in treating pain and anxiety during colonoscopy.

Objective:

To investigate the efficacy of Acu-TENS in reducing procedure-related pain and the consumption of sedatives/analgesics during colonoscopy.

Design:

Prospective, randomized, placebo-controlled study.

Subjects:

One hundred and twenty eight consecutive patients undergoing first-time elective day-case colonoscopy without previous experience of acupuncture/Acu-TENS will be recruited.

Interventions:

Patients will be randomized to receive either 45 minutes of Acu-TENS or placebo-TENS before colonoscopy. The acupoints relevant to the treatment of abdominal pain and distension, including Zusanli, Hegu, Neiguan, Tianshu, and Dachangshu will be used. For the placebo-TENS group, a non-conductive plastic film will be placed between the acupoint and the electrode so that no current will be transmitted. Acu-TENS and placebo-TENS will be continued throughout colonoscopy. A mixture of Propofol and Alfentanil, delivered by a patient-controlled syringe pump, will be used for sedation/analgesia in both groups.

Outcome measures:

Primary outcome: doses of patient-controlled sedation/analgesia consumed. Secondary outcomes: pain and satisfaction scores according to a visual analog scale, cecal intubation rate/time, and episodes of hypotension/desaturation.


Eligibility Criteria:
Inclusion Criteria:

* Consecutive patients (aged between 18 and 60 years) undergoing first-time elective day-case colonoscopy
* Patients with American Society of Anesthesiologists (ASA) grading I-II
* Informed consent available

Exclusion Criteria:

* Patients with previous experience of acupuncture or Acu-TENS
* Patients with previous history of colorectal surgery
* Patients who are diagnosed with irritable bowel syndrome according to Rome III criteria
* Patients with chronic pain syndrome
* Patients with psychiatric disorder
* Patients with poor cognitive function
* Patients with renal impairment
* Patients with obstructive sleep apnea syndrome
* Patients with cardiac arrhythmias
* Patients with cardiac pacemaker
* Patients who are pregnant
* Patients who are allergic to the Acu-TENS electrodes or Propofol/Alfentanil
The Effect of OrthoPulse Photobiomodulation on the Rate of Tooth Movement During Alignment With Fixed Appliances

The aim of this study is to determine efficacy of OrthoPulse photobiomodulation on the rate of tooth movement during alignment for Subjects receiving fixed appliance orthodontic treatment.


Eligibility Criteria:
Inclusion Criteria:

* Presence of permanent dentition
* Eligible and scheduled for full-mouth, fixed-appliance orthodontic treatment
* Moderate to severe crowding (LII ≥ 3 mm), with no labio-lingually displaced teeth
* Class I or Class II malocclusion by ½ cusp or less
* Non-extraction in both arches
* Age 11-60
* Good oral hygiene
* Non-smoker; non-use of chewing tobacco

Exclusion Criteria:

* Subject is currently enrolled in another clinical study
* Subject decided on Invisalign rather than braces
* Periodontally involved teeth
* Use of bisphosphonates (osteoporosis drugs) during the study
* Subject plans to relocate over the treatment period
* Spaces between anterior teeth
* Subject has dental implants or an implanted prosthesis
* Sponsor employees, the Investigator and staff, as well as their immediate family members
Study of Symptoms Linked to Covid-19 in Residents and Professionals in EHPAD, Associated With a Dual Diagnostic Approach by PCR and Serology: a Cohort in Île-de-France.

The main purpose is to study the prevalence of Covid-19 in EHPAD. The primary endpoint will be the combination of PCR results and symptomatology, making it possible to define positive cases in EHPAD, in residents and professionals in contact with them. The prevalence obtained can be compared with the results of serology if these are performed.

This study is taking place in several nursing homes in Ile-de-France, which will be recruited at the end of the diagnostic campaign.

At the initiative of the ARS Ile-de-France, residents and professionals of selected EHPADs will be subjected to systematic screening by RT-PCR for Covid-19, then by serology after the first screening, regardless of whether either the result

Samples, by nasopharyngeal swab for RT-PCR, by capillary blood sampling or venipuncture according to the technique for serology, will be carried out according to the doctrines issued by the ARS Ile de France and the variations proposed by the appropriate departmental directorates in depending on local resources. The results will be brought to the attention of EHPADs to adapt the care of residents and positive professionals.

Data will be collected daily from collection for the first test (RT-PCR), or retrospectively if the collection took place before the study.

Regarding the approach for collecting serologies:

* All subjects included with a negative PCR will be offered the serological test, in accordance with the recommendations in force or the medical decisions of the establishments.
* The qualitative results of the serologies of the subjects included in the study (residents and professionals) will be collected according to the same circuit as those of the RT-PCRs.
* Only the symptoms of residents with a positive serology will be collected, from the date of the sample and for a period of 14 days.
* The symptoms of professionals with a positive serology can be collected, from the date of the sample and for a period of 14 days without mandatory character.
* Both techniques (ELISA or TROD) are accepted and the serology values will not be collected.

Eligibility Criteria:
Inclusion Criteria:

1. / Residents of nursing homes in Île-de-France in which systematic Covid-19 screening tests were carried out and agreeing to participate in the study.
2. / Professionals in nursing homes in Île-de-France in which systematic screening tests for Covid-19 were carried out and agreeing to participate in the study: nursing assistants, nurses, coordinating doctors, hotel and service agents hygiene, etc.

Exclusion Criteria:

1. / Expression of opposition to the collection of symptoms by professionals, residents or their legal representatives.
2. / Subjects who have not had a diagnostic test by RT-PCR.
The Western Norway Mental Health Interface Study on Referral Letters

The main object to this trial is to study the function of referral letters as a mean to coordinate the care process for adult people when referred from Primary Care to Specialised Mental Health Care. The study will explore if and to what degree the quality of these referral letters can be improved, and the potential improvement's impact on defined patient-, professional and organisational related outcomes. According to Medical Research Council guidelines for evaluating complex interventions, a stepwise design with the use of both qualitative and quantitative methods will be used to conduct a controlled intervention study.

The study is based on a stepwise progression including four steps. Within step one group interview with four mixed groups of health professionals (both Primary and Specialised Care), patient representatives and managers will be conducted. The groups will give input on firstly, what information they think is important to include in the referral letters, and secondly, what impact they think improved referral letters can have for the organisation and care within Specialised Mental Health Care. Within step two a validated check-list to assess the quality of referral letters will be developed. Within step three outcome measures will be developed and tested. Both step two and three will make use of the results from step one in addition to existing literature and testing. Step four is the intervention study where measures from the former steps will be used.

Eligibility Criteria:
Inclusion Criteria:

* Referral letters send from a GP to Public Specialised Mental Health Care
* Referrals for elective assessment or treatment

Exclusion Criteria:

* Referral letters send from other health personnel
* Referrals for acute care (within 24 hours)
Effect of Three Weight-adjusted Vasopressors for Elective Cesarean Delivery

This study compared the effects of prophylactic infusion of metaraminol, phenylephrine and norepinephrine adjusted according to body weight on fetal acid-base balance and maternal hemodynamics.

At present, the ED90 of metaraminol, phenylephrine, and norepinephrine in the prevention of cesarean section hypotension has been explored. We compare the effects of three drugs on the fetus and mothers at the concentration of ED90 to provide advice on the use of vasoactive drugs for obstetrics anesthesia .

Eligibility Criteria:
Inclusion Criteria:

1. Singleton pregnancy at term scheduled to be delivered via elective cesarean delivery;
2. height 150-180 cm;
3. American Society of Anesthesiologists (ASA) physical status II-III;
4. body mass index (BMI) \<35 kg/m2.

Exclusion Criteria:

1. transverse presentation, fetal macrosomia;
2. uterine abnormalities (eg, large fibroids, bicornuate uterus);
3. polyhydramnios;
4. ruptured membranes, oligohydramnios;
5. intrauterine growth restriction;
6. gestational or nongestational hypertension, diabetes, or eclampsia;
7. hypertensive disorders or any condition associated with autonomic neuropathy (such as diabetes mellitus for \>10 years) or renal failure;
8. contraindications for combined spinal-epidural anesthesia;
9. participants who declined to sign informed consent forms.
Aromatase Inhibitor Growth Study: Letrozole vs. Anastrozole

The purpose of the study is to determine if there are differences in the final height or hormone profile of short pubertal boys placed on different forms of aromatase inhibitor now routinely used to increase stature: Anastrozole and Letrozole. It also should determine if there are differences in the side effect profiles of the two drugs to be used.


Eligibility Criteria:
Inclusion Criteria:

* Current height less than 5th percentile AND/OR
* Predicted adult height (based on bone age) more than 10 cm below target height (mid parental height)
* Evidence of puberty: physical signs and serum luteinizing hormone \> 0.3 IU/L and testosterone \> 15 ng/dl

Exclusion Criteria:

* Bone age reading more than 14.0 years
* Follicle stimulating hormone \> 20 IU/L
Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of AZD1386 in Patients With Osteoarthritis (OA) of the Knee

The primary aim of this study is to investigate if AZD1386 is efficacious as an analgesic in patients with osteoarthritis of the knee and at what dose. This will be done by comparing the effect of AZD1386 to placebo ("inactive substance") on pain.


Eligibility Criteria:
Inclusion Criteria:

* Patients with OA of the knee
* Male or non pregnant females 40 and 80 years old

Exclusion Criteria:

* A current diagnosis of another form of arthritis, in addition to OA
* History, and/or presence of somatic disease, which may interfere with the objectives
Comparison of Endothelial Dysfunction (BMS vs SES) in the Same Patient With Multiple Coronary Artery Lesions

This is a prospective, randomised study to compare the endothelial dysfunction of BMS vs SES, both implanted in the same patient with multiple de novo coronary artery lesions undergoing elective PCI. The primary end point will be the evaluation of endothelial dysfunction at 6 months follow-up by measuring the change in vessel diameter in 5 points of the stent and peri-stent site after infusion of acetylcholine.

This prospective, randomised study compares the endothelial dysfunction of BMS vs SES, both implanted in the same patient with multiple de novo coronary artery lesions undergoing elective PCI. From february 2009 to may 2009 we aim to enroll 20 patients with at least two de novo significant angiographic stenoses in different coronary segments who will have similar diameter and length. The primary end point will be the evaluation of endothelial dysfunction at 6 months follow-up by measuring the change in vessel diameter in 5 points of the stent and peri-stent site after infusion of acetylcholine.

Eligibility Criteria:
Inclusion Criteria:

* stable angina pectoris
* at least two significant angiographic stenoses in different native coronary vessels or in the same vessel but two different ramifications with similar diameter
* non-surgical patients

Exclusion Criteria:

* acute coronary syndromes
* myocardial infarction within 3 months from event
* clinical or angiographic coronary vasospasm
* coronary angiographic findings of a fresh thrombus in the initial angiography (filling defect proximal to or involving the stenosis)
* coronary anatomy unsuitable for for intracoronary acetylcholine testing (left main coronary artery disease \>30%, surgical three vessel disease or other anatomical considerations that make it unsafe to perform intracoronary studies)
* progression of lesions or development of de novo lesions in nontarget lesions or vessels on follow-up angiography
* patients with a vessel diameter \< 2,50 mm and length lesions \<10 and \>30 mm.
* patients with vessel diameter difference (SES vs BMS) \>0,5mm and length difference of the stenosis \>50%
* lesions treated with balloon injury \<10 mm or \>50 mm in length
* severe left ventricular (LV) systolic dysfunction
* bifurcation/ostial
* presence of an unhealed dissection identified by intravascular ultrasound (IVUS) performed at the end of the study.
* angiographic restenosis in follow-up angiography
* patients with severe risk factors for endothelial dysfunction: severe renal failure, life expectancy less than 1 year, uncontrolled diabetes, uncontrolled hypertension (systolic blood pressure \>180mmHg), currently smoking, uncontrolled hypercholesterolemia (total cholesterol \>240mg/dl)
* any contraindication/nontolerance to the use of aspirin, heparin and/or clopidogrel
* lack of consent to participate
Study on Smoking Cessation and Cost Outcomes in the Duke Smoking Cessation Program

The purpose of this study is to conduct an observational assessment of natural outcomes within the Duke Smoking Cessation Program (DSCP), "Quit at Duke." This assessment will include information regarding abstinence rates, changes in patient emotional state following treatment, and costs of operations. Primarily, this study will assess the financial sustainability and the cost-effectiveness of the program.

The purpose of this study is to conduct an observational assessment of natural outcomes within the DSCP, "Quit at Duke." This is an observational study (n=3000) on patients being treated at the DSCP. No interventions are conducted, and data analyzed is collected in the course of clinical care at clinic visits to the Duke Smoking Cessation Program (DSCP). Phone calls are also conducted to determine response to medications and abstinence status up to 12 months following a quit attempt. Outcomes of variables including: demographic variables, evaluation responses, feasibility data, and abstinence rates will be analyzed using general regression models using an ANOVA-based design. Because no intervention is being conducted, there are no safety concerns related to the study.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Being treated at the Duke Smoking Cessation Program
* Fluent in written and spoken English.

Exclusion Criteria: N/A
Evaluation of Implantable Tibial Neuromodulation (TITAN 1) Feasibility Study

This is a prospective, multicenter, feasibility study to characterize the procedure for the implantable TNM device in subjects with overactive bladder.

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:
Primary Inclusion Criteria:

1. Subjects 18 years of age or older
2. Have a diagnosis for at least 6 months of OAB
3. No OAB pharmacotherapy for 2 weeks prior to the baseline voiding diary
4. Willing and able to accurately complete study diaries, questionnaires, attend visits, operate the system and comply with the study protocol
5. Willing and able to provide signed and dated informed consent

Primary Exclusion Criteria:

1. Have neurological conditions such as multiple sclerosis, clinically significant peripheral neuropathy or spinal cord injury
2. Severe uncontrolled diabetes
3. History of urinary retention within the previous 6 months
4. Current symptomatic urinary tract infection
5. Have primary stress incontinence or mixed incontinence where the stress component overrides the urge component
6. Current urinary tract mechanical obstruction
7. Have knowledge of planned magnetic resonance imaging (MRIs) or diathermy
8. History of a prior implantable tibial neuromodulation system
9. Skin lesions or compromised skin integrity at the implant site
10. Anatomical defects, clinically significant edema or previous surgeries which precludes use of the device
11. Previous pelvic floor surgery in the last 6 months
12. Women who are pregnant or planning to become pregnant
13. Characteristics indicating a poor understanding of the study or characteristics that indicate the subject may have poor compliance with the study protocol requirements.
14. Any subject who is considered to be part of a vulnerable patient population.
15. Concurrent participation in another clinical study that may add additional safety risks and/or confound study results.\*\* \*\*Subjects in concurrent studies can only be enrolled with permission from Medtronic.

Contact Medtronic's study manager to determine if the subject can be enrolled in both studies.
Patient Journey With Advanced Lung Cancer Positive for ALK Fusion in Brazil

Observational, retrospective cohort study that will include patients diagnosed with NSCLC and ALK rearrangement between January 2015 and December 2020.


Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years;
* Newly diagnosed advanced stage IIIB-IV NSCLC (AJCC 8th edition) or locally advance/distant relapse in the period of January 2015 to December 2020.
* NSCLC with pathological confirmation of ALK rearrangement by immunohistochemistry, fluorescent in situ hybridization (FISH) or next generation sequencing (NGS);
* ECOG 0-4;
* Patients with CNS metastases are also considered eligible, regardless of the initial treatment instituted.

Exclusion Criteria:

- Incomplete medical chart in terms of date of diagnosis, ALK test results and outcomes