cyrilzakka/clinical-trials huggingface dataset:
Effects of 12-Week Clinical Pilates Exercises on Mechanical Low Back Pain

Objective: This study evaluates the effect of 12-week clinical pilates exercises on young adults with mechanical low back pain.

Design: This is a randomized controlled trial. Setting: This study was conducted in a university's physiotherapy and exercise practice laboratory.

Cases: A total of 63 mechanical low back pain volunteers were included. Interventions: Participants were randomly assigned to the intervention group consisting of clinical Pilates exercises for 12 weeks (n = 31) or the control group not receiving any treatment (n = 32).

Objective: This study evaluates the effect of 12-week clinical pilates exercises on young adults with mechanical low back pain.

Design: This is a randomized controlled trial. Setting: This study was conducted in a university's physiotherapy and exercise practice laboratory.

Cases: A total of 63 mechanical low back pain volunteers were included. The diagnosis of mechanical low back pain was made by a physical medicine and rehabilitation physician. Exercises are performed by an experienced physiotherapist with Clinical Pilates certification.

Interventions: Participants were randomly assigned to the intervention group consisting of clinical Pilates exercises for 12 weeks (n = 31) or the control group not receiving any treatment (n = 32).

Leading measures: Dysfunction was evaluated with the Oswestry Dysfunction Index. The Oswestry Disability Index (ODI)7,9 is the most commonly used outcome-measure questionnaire for low back pain in a hospital setting. Low bak pain was evaluated with the Visual Analog Scale (VAS). VAS is a tool used to help a person rate the intensity of certain sensations and feelings, such as pain. The visual analog scale for pain is a straight line with one end meaning no pain and the other end meaning the worst pain imaginable. And flexibility was evaluated with the sit and reach test test. The sit and reach test is a common measure of flexibility, and specifically measures the flexibility of the lower back and hamstring muscles. Measurements were performed at baseline and the end of the 12th week of the study.

Eligibility Criteria:
Inclusion Criteria:

* 18 to 30 years of age; who had suffered from low back pain for at least three months; who had not used medication for low back pain in the last three months; who did not have a surgical history due to spinal problems; who did not have radiculopathy or other injuries such as fractures, stenosis or tumors in the spine; who had not received any treatment related to low back within the last six months; who had not previously continued pilates exercise; and who had sufficient physical autonomy to participate in the physical activities required by the study.

Exclusion Criteria:

* Volunteers who did not meet the inclusion criteria were excluded.
Antiplaque, Antigingivitis and Anti-inflammatory Effects of Myrrh Mouthwash

Myrrh-based mouthwash has the potential to be a suitable alternative to the gold standard chlorhexidine mouthwash for dental plaque and gingivitis reduction. To date, however, little research has been carried out to determine its true clinical significance on periodontal health. The purpose of this study is to evaluate and compare the efficacy of 1% myrrh mouthwash with commercially available 0.2% chlorhexidine mouthwash in terms of plaque and gingivitis reduction and inflammatory mediator (interleukin-1β) inhibition.

This will be a single-center, triple-blinded, randomized, three-arm parallel, controlled trial in periodontally healthy adult volunteers (no clinical attachment loss and bleeding on probing \< 10%). We will include all eligible patients seeking dental treatment at the center after gaining a written informed consent. After the initial dental screening and a session of professional teeth cleaning procedures, participants will be instructed to refrain from regular oral hygiene practices for 2 weeks to develop experimental gingivitis. Participants will then be randomly allocated to one of the three treatment groups \[1:1:1\] using a simple randomization method (i.e. computer-generated random numbers). They will be instructed to continue refrain from regular oral hygiene practices and use 10 ml of the assigned mouthwash twice daily for 1 minute. Treatment effect will be evaluated by comparing the baseline (day 0) and post-intervention (day 14) values of all clinical parameters (modified gingival index, plaque index, proinflammatory interleukin-1β biomarker, and Gingival Bleeding Index).

Eligibility Criteria:
Inclusion Criteria:

* good periodontal health;
* dentition of ≥20 teeth and a minimum of 5 teeth per quadrant;
* the absence of any systemic illness;
* no history of oral prophylaxis in the past 6 months;
* no relevant medical history that might compromise normal oral hygiene practice.

Exclusion Criteria:

* pocket depth \>3 mm
* severe misalignment of teeth;
* the presence of orthodontic appliances;
* intake of antibiotic and/or anti-inflammatory medications within the past 6 months;
* use of tobacco;
* inability of comply with the study's appointment schedule;
* pregnant or breast-feeding mothers.
Cerebrum and Cardiac Protection With Allopurinol in Neonates With Critical Congenital Heart Disease Requiring Cardiac Surgery With Cardiopulmonary Bypass

Neurodevelopmental impairment due to delayed brain development and brain injury is a fundamental problem in children with critical congenital heart disease (CCHD). Significant longterm motor-, cognitive-, and behavioral problems are the result of early postnatally and perioperatively induced brain injury. Allopurinol, a xanthine oxidase inhibitor, prevents the formation of toxic free oxygen radicals, thereby limiting hypoxia-reperfusion damage. Both animal and neonatal studies suggest that administration of allopurinol reduces hypoxic-ischemic brain injury, is cardioprotective, and safe. This study aims to evaluate the efficacy and safety of allopurinol administered early postnatally and perioperatively in children with a CCHD requiring cardiac surgery with cardiopulmonary bypass.


Eligibility Criteria:
Inclusion Criteria:

* Neonates with a prenatally or postnatally confirmed diagnosis of CCHD requiring (anticipated) cardiac surgery with CPB within the first 4 weeks of life.
* Informed consent provided by both parents.

Exclusion Criteria:

* Inability to enroll the patient before the start of delivery in case of prenatal diagnosis, or 24 hours before surgery in case of postnatal diagnosis.
* Doubt whether the aortic arch anomaly before birth requires cardiac surgery with CPB in the neonatal period.
* Gestational age below 36 weeks and/or birth weight less than 2000 gram.
* Surgery not requiring cardiopulmonary bypass.
* Decision for "comfort care only".
Early Administration of Norepinephrine in Sepsis

The management of septic states includes, in addition to the specific treatment (antimicrobials and eradication of the source), a restoration of the hemodynamic disorders and assistance of the failing organs. In general, the restoration of hemodynamic disorders begins first with volume expansion, followed by the use of Noepinephrine (NE) when the target mean arterial pressure (MAP) is not reached after optimizing the intravascular volume. Recently, several studies have supported the interest of early NE on MAP, cardiac output and mortality. It is therefore tempting to restrict fluid administration even in the initial phase of hemodynamic management of severe sepsis by starting NE earlier.

Sepsis is characterized by systemic inflammation induced by a severe infection resulting in an inappropriate host response against that infection. On the microcirculatory scale, vasoplegia with capillary leakage is distinguished. Management of sepsis includes, in addition to specific treatment which includes antimicrobials and eradication of the source, restoration of hemodynamic disorders and assistance to failing organs. In general, the restoration of hemodynamic disorders begins first with volume expansion, followed by the use of vasopressors (mainly norepinephrine: NE as first-line therapy) when the mean arterial pressure target (MAP: reflecting the perfusion pressure organs) is not reached after optimizing the intravascular volume.

Recently, several studies have supported the benefit of administering NE at the start of resuscitation of sepsis. Indeed, its administration at an earlier phase than usually recommended improved MAP and cardiac output with a favorable effect on mortality. At a median interval of 1.3 hours from ICU admission and exclusive administration of NE, MAP was adequately restored within a relatively short time (30 min) and was associated with a better survival rate than that predicted by the severity scores of similar patients from other series reported in the literature. In the recent Thai "CENSER" trial, shock was controlled in 76% of patients in the early NE group versus 48% (p\<0.001). On the other hand, the administration of a large quantity of fluids inevitably increases the risk of fluid overload, which is a frequent complication in septic patients. In front of all these arguments, it is therefore tempting to restrict fluid administration even to the initial phase of the hemodynamic management of sepsis by starting NE earlier.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older.
* The patient or his/her legal representative has given informed consent in writing.
* Diagnosis of sepsis according to the definitions updated by the consensus of sepsis 3.
* Mean arterial pressure \< 65 mmHg

Exclusion Criteria:

* Diagnosis of septic shock prior to randomization (where NA requirements exceed those of the trial protocol)
* Pregnancy,
* Need for immediate surgery,
* Neoplasia at an advanced stage
* Circumstances where water restriction is the rule:
* Acute pulmonary edema
* Acute coronary syndrome,
A Study of TLN-254 in Participants with Relapsed or Refractory T-cell Lymphoma

The primary purpose of this study is to evaluate the anti-tumor activity of TLN-254 monotherapy in participants with relapsed or refractory T-cell lymphoma.


Eligibility Criteria:
Inclusion Criteria:

Age:

1. At least 18 years of age at the time of signing the informed consent form (ICF).

   Type of Participant and Disease Characteristics:
2. Cohort 1: Peripheral T-cell lymphoma (PTCL) that has relapsed after, or not responded to at least one prior systemic treatment regimen. Participants with Anaplastic large cell lymphoma (ALCL) should have received prior brentuximab vedotin treatment.

   * Nodal T-follicular helper (TFH) cell lymphoma angioimmunoblastic; Follicular helper T-cell lymphoma, angioimmunoblastic type (angioimmunoblastic T-cell lymphoma).
   * Nodal TFH cell lymphoma, follicular type; Follicular helper T-cell lymphoma, follicular type.
   * Nodal TFH cell lymphoma, not otherwise specified (NOS); Follicular helper T-cell lymphoma, NOS.
   * PTCL, NOS.
   * Anaplastic large-cell lymphoma, Alkaline phosphatase (ALK) positive.
   * Anaplastic large-cell lymphoma, ALK negative.

   Cohort 2: Relapsed/refractory CTCL which has relapsed after, or not responded to at least two prior systemic treatments.
   * Sezary syndrome
   * Mycosis fungoides
3. Participant must have measurable disease at study entry.
4. Freshly biopsied or archival tissue available.

   Diagnostic Assessments:
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
6. Adequate organ function.

   Contraception:
7. Participants must accept and follow the pregnancy prevention plan.

Exclusion Criteria:

Medical Conditions:

1. Participants must not have prior systemic anti-cancer treatment less than or equal to (≤) 5 half-lives or 4 weeks, allogeneic SCT≤90 days or autologous SCT ≤60 days prior to study intervention initiation.
2. Participants must not have any condition, including significant acute or chronic medical illness, active or uncontrolled infection, or the presence of laboratory abnormalities, that places participants at unacceptable risk if participating in this study.
3. Current or past history of central nervous system (CNS) involvement.

Other Exclusions:

* Pregnant or lactating women.
* Unable to swallow tablets.
Cognitive Impairments in Psychotic Disorders

Patients with Psychotic disorders (Schizophrenia, Bipolar disorder and Schizoaffective disorder) often suffer from significant cognitive impairments, however how these develop and change over time before and after the first psychotic break is unclear. While there are data by several groups, showing that many future patients have significant cognitive impairments years before the onset of psychosis, many future patients seem to be doing well before the manifestation of psychosis, and decline steeply in functioning after their first psychotic episode. Hence the timing of the onset of cognitive impairment in patients with psychotic disorders requires further exploration. The current study will investigate the timing of cognitive impairment by using IQ tests before and after the first psychotic break

In this study the investigators aim to use the DAPAR tests (A cognitive assessment which all 17 year old Jewish adolescents in Israel undergo to participate in mandatory military service), which measures intelligence, and is equivalent to the IQ test. The subjects will be persons who had their first psychotic break, at least one year following the DAPAR tests. As part of the study, the participants will re-take the DAPAR tests, after the onset of the psychotic illness.

Eligibility Criteria:
Inclusion Criteria - Study Group:

* Patients between the ages 27-18 who had first psychotic break in the last ten years, and more than a year from the date of the DAPAR tests.
* Diagnoses of schizophrenia, Bipolar disorder or Schizoaffective disorder according to DSM-5 criteria.
* Previous DAPAR tests at the age of 17.

Inclusion Criteria - Control group:

* Participants between the ages of 27-18.
* No history of psychotic break.
* Previous DAPAR tests at the age of 17.

Exclusion Criteria - Both groups:

* Participants who did not perform the full battery of the DAPAR tests.
* Participants who have been appointed a guardian.

Exclusion Criteria - Control group:

- Participants who have a first-degree relative who suffers from a psychotic disorder.
Efficacy of a New Nanoemulsion Artificial Tear Targeting Dry Eye Disease

This is a prospective cohort study to compare subjective changes in symptoms using the Ocular Surface Disease Index (OSDI) questionnaire, following the recommended dosage of the new nanoemulsion eye drops (Systane Complete)in mild to moderate dry eye patients, and to investigate objective ocular surface changes using modern clinical instruments during the study period.

This study, lasting for 3 months in total, is to investigate the changes in both subjective reports (OSDI score) and objective measurements (Non-invasive Tear Break Time (NITBUT) and other clinical signs such as corneal staining) after the use of this nanoemulsion eye drops (Systane Complete). Subjects are required to use the eyedrop qid for 3 months, and come back for follow-up at 2-week and 3-month visits. Other secondary measurements such as Meibography and lipid layer thickness, will also be investigated.

Eligibility Criteria:
Inclusion Criteria:

1. Age 20-50 years old
2. Best corrected distance visual acuity ≥ 6/9
3. Mild to moderate OSDI score 13-32
4. Any one of the objective test positive (NITBUT/Corneal fluorescein staining/Tear osmolarity)

Exclusion Criteria:

1. Any active ocular infections
2. Inflammations or anomalies in the eyelid
3. Uncontrolled, newly diagnosed systemic diseases or with modified long-term medications within 6 months that are known to affect tear profile.
4. Pregnancy and breastfeeding
5. Contact lens wearers are required to stop contact lenses wear for at least 1 week before the evaluation.
6. Subjects who are using artificial tears or other eyedrops will be excluded.
7. Subjects who are taking systemic drugs that may cause dry eye, e.g., Antidepressants/antipsychotics, Systemic corticosteroids.
Prolonged Adjuvant Temozolomide vs "Stop & Go" in Glioblastoma Patients

This study will test the hypothesis that prolonged adjuvant Temozolomide (TMZ) may delay relapses in patients with glioblastoma compared to the standard care consisting in observation with brain MRI every 3 months and rechallenging with TMZ at relapse (Stop and Go arm).


Eligibility Criteria:
Inclusion Criteria:

1. Patients with histologically confirmed diagnosis of GBM
2. Availability of pre-treatment GBM tissue to determine the activation status of MGMT gene is not mandatory but strongly recommended
3. Patients must have received radiation and TMZ for 6 weeks followed by 6 months of TMZ. Randomization should be performed within the 6 weeks after the last chemotherapy.
4. A brain MRI with or without a PET-Scan-methionine must be performed before enrolment.
5. Age ≥ 18 years
6. Karnofsky Performance status ≥ 60
7. Normal haematological functions: ANC ≥ 1.5 x 109cells/l, platelets ≥ 100 x 109 cells/l
8. Normal liver function: total bilirubin \< 1.5 x ULN, alkaline phosphatase and transaminases (ASAT/ALAT) \< 2.5 times the upper limit of the normal range
9. Serum creatinine \< 1.5 x ULN
10. Clinically normal cardiac function without history of ischemic heart disease in the past 12 months. Absence of cardiac insufficiency NYHA grade III and IV, instable angina, arrhythmia
11. No previous or current malignancy (except treated basal or squamous cell skin carcinoma, cervix cancer or in situ carcinoma of the breast).
12. All patients (male and female) with reproductive potential must use effective contraception. Females must have a negative serum pregnancy test at entry to study.
13. Signed informed consent from the patient or legal representative must be obtained.

Exclusion Criteria:

All non inclusion criteria
Evaluation of Treatment Efficacy by Circulating Tumor Cell Phenotype Surveillance in Breast Cancer Patients

The phenotype of circulating tumor cells (CTCs) is supposed to be significant indicator that is correlated the prognosis of breast cancer patients who have completed neoadjuvant chemotherapy, primary tumor surgery with/without adjuvant chemotherapy. The aim of this observational study is to assess the efficacy of CTCs surveillance in predicting the prognosis of breast cancer patients.

The aim of this observational study is to assess the efficacy of CTCs surveillance in predicting the treatment response of neoadjuvant chemotherapy, surgery and adjuvant chemotherapy. This study also aims to evaluate the efficacy of CTCs surveillance in predicting invasive-disease free survival (iDFS), overall survival (OS) and metastasis. Additionally, this study evaluate the expression of PDL1 and FOXC3 on CTCs.

Eligibility Criteria:
Inclusion Criteria

* The age is more than 18 years old;
* Pathology confirmed malignant breast tumor;
* No clinical diagnosis of other malignancies, unstable complications or uncontrolled infection;
* Life expectancy is greater than 6 month;
* The main organ function is normal;
* The subjects volunteered to participate in this study, signed informed consent, followed up with good compliance.

Exclusion Criteria

* Patients who had suffered from other malignant tumors;
* With uncontrolled bacterial, viral or fungal infections;
* With physical or mental disorders
* Without or limited civil capacity;
* Infected with human immunodeficiency virus (HIV)；
* Circumstances in which the investigator considers it inappropriate to participate in this study.
A Single-center Prospective Interventional Study on FPG500 in Non-metastatic Prostate Cancer Patients

The search for clinically actionable alterations within the non-metastatic prostate cancer setting has been an overlooked issue so far. Genomic alterations predicting tumor progression or representative of micrometastatic spread could be crucial to prompt the correct treatment strategy, sequencing and possible intensification in the high-risk and locally advanced settings. Similarly, the definition of the genomic landscape in low-risk patients progressing to more aggressive disease could be of importance to prompt an immediate active treatment to those patients otherwise eligible to active surveillance.

A CGP program has been launched by the Fondazione Policlinico Universitario Agostino Gemelli IRCCS (FPG), a leading Italian research hospital (ID: FPG500, ethical approval number 3837) and it convers 10 cancer types. This program offers genomic testing of over 500 genes through an efficient in-house process. To now, a CGP from FPG 500 has been applied to cholangiocarcinoma, endometrial cancer, non-small cell lung cancer.

Investigators propose a prospective interventional single center study whose aim is to implement a comprehensive genome profiling (CGP) through this next generation sequencing (NGS) program for non-metastatic PCa and to define actionable mutations that correlate with tumor progression. The actionability relies on the opportunity to intensify treatment in non metastatic cases at risk of progression or to identify distant spread before it becomes biochemically and/or radiographically evident for high risk non metastatic cancers.

From previous research, a genomic profiling may reveal distinct mutations or gene expression patterns linked to metastasis, biochemical recurrence, and PSA persistence. Some of these genomics alterations may be associated with poorer outcomes in high-risk and locally advanced patients. Conversely, patients under active surveillance might exhibit a more stable genomic profile, with fewer mutations representative of aggressive disease. Expected outcomes will include the development of accurate prognostic tools, allowing for better-tailored treatment plans and early intervention strategies to manage disease progression.


Eligibility Criteria:
Inclusion Criteria:

* histologically proven diagnosis of low-risk, or high-risk or locally advanced prostate cancer
* high-risk and locally advanced prostate cancer undergoing surgery
* low-risk prostate cancer undergoing active surveillance or surgery

Exclusion Criteria:

* previous or concomitant malignancies
* patients already undergoing androgen suppression or other medical treatments for prostate cancer