cyrilzakka/clinical-trials huggingface dataset:
Comparative Effects of Stabilization Exercises and Muscle Energy Techniques in Sacroiliac Joint Pain

Sacroiliac joint is in pelvis. It links the iliac bone (pelvic) bone to the sacrum. This joint pain is due to hyper mobility or instability of the joint, it may also cause by damage to joint between the spine and hip. This pain is typically felt in the lower back, or hip and may radiate to groin area. The aim of this study will be to compare the effects of stabilization exercises and muscle energy techniques on pain and disability in patients with sacroiliac joint pain.

A randomized clinical trial will be conducted at Ibn- e- Siena hospital and research institute Multan and in Bakhtawar Amin hospital Multan through convenience sampling technique on 30 patients which will be allocated through simple random sampling through sealed opaque enveloped into group A and group B. After giving common treatment of hot pack and transcutaneous electrical stimulation and assessing pre-treatment patient's condition Group A will be treated with stabilization exercises in which iliopsoas, gluteal and hamstring muscles will be stabilized. Total twelve sessions will be given as three sets three times per week for four weeks. Group B will be treated with muscle energy technique, this is active form of manual therapy in which patient will exert force against physiotherapist force through autogenic inhibition and reciprocal inhibition. (20% patient force against that applied by the physiotherapist and hold contractions for 10 seconds over 5 to 12 repetitions, 3 times per week for 4 weeks). Post-treatment assessment will be done after one month. Outcome measure will be conducted through pain and disability questionnaire after 6 weeks. Data will be analyzed using SPSS software version 21. After assessing normality of data by Shapiro -Wilk test, it will be decided either parametric or non-parametric test will be used within a group or between two groups. Stabilization exercises and muscle energy techniques will be applied for comparing their effectiveness in patients with sacroiliac joint pain.

Eligibility Criteria:
Inclusion Criteria:

* Both men and women age between 30-50 with positive Laslett's criteria. The Cluster of Laslett is a group of four test used for sacroiliac joint pain, the four tests are:

  1. Sacroiliac Distraction (Gapping) Test
  2. Thigh Thrust Test
  3. Sacroiliac Compression (Squish) Test
  4. Sacral Thrust test
* If a patient has three or more positive pain provocation tests, and then there is a 59% chance that the patient will have Sacroiliac joint pain.

Exclusion Criteria:

* Trochanteric bursitis
* Pelvic bone fracture
* Pelvic implants
* Pregnancy
* Lumbosacral disc herniation
* Sacroiliac joint inflammation
* Inflammatory bowel disease
* Malignancy
Effects of Legume Consumption on Adiponectin and Inflammatory Markers Among Adults

The aim of this randomized cross-over study was to determine the effects of legume consumption on adiponectin and inflammatory factors among first degree relatives of diabetic patients


Eligibility Criteria:
Inclusion Criteria:

* age more than 30 years
* no history of chronic diseases
* no use of blood glucose lowering drugs

Exclusion Criteria:

* do not use recommended amounts of legumes
* incidence of chronic diseases during the study
* to start use of blood glucose lowering drugs
Investigation of the Clinical Efficacy of Low-dose Ionizing Radiation in the Treatment of Osteoarthritis

IMMO-LDRT02 is a prospective, placebo-controlled, double-blind, randomized trial to investigate the clinical efficacy of low dose radiation therapy (LDRT) in the treatment of arthrosis. Newly diagnosed or already existing arthroses of the fingers, wrists, shoulders, knees, ankles and feet will be enclosed. Finally, the evidence of clinical benefit from LDRT (6 x 0.5 Gy) will be compared to the placebo group (6 x 0 Gy), by determination via a visual analog scale and identification of immunological changes.

The prevalence of chronic degenerative and inflammatory disorders, such as osteoarthritis, is constantly rising. As not all patients do respond adequately to the standard therapies, alternative treatment options such as low dose radiation therapy (LDRT) has gained further importance. LDRT is known to induce a long-lasting pain reduction, while having few side effects. Nonetheless, the detailed biological and immunological modes of action remain mostly elusive. In addition, there is a lack in placebo controlled randomised controlled trials (RCTs) proofing the pain-relieving effects of LDRT. So, the prospective, placebo-controlled, double-blind, randomized IMMO-LDRT02 trial to investigate the clinical efficacy of LDRT in the treatment of arthrosis should close this gap. Newly diagnosed or already existing arthroses of the fingers, wrists, shoulders, knees, ankles and feet will be enclosed. Finally, the evidence of clinical benefit from LDRT (6 x 0.5 Gy) will be compared to the placebo group (6 x 0 Gy), by determination via a visual analog scale (VAS) and identification of immunological changes, which contribute to the success of therapy and are specifically found in the test group (IMMO-LDRT01 trial; ClinicalTrials.gov Identifier: NCT02653079).

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed osteoarthritis according to ACR criteria (exclusion of other other arthritides and chronic rheumatoid arthritis via laboratory tests):

  * Finger and wrist osteoarthritis
  * Elbow arthrosis
  * Shoulder arthrosis
  * Knee arthrosis
  * Ankle and foot joint arthrosis
* First time application of low-dose radiotherapy (LDRT) of the affected joint.
* Willingness to cooperate and accessibility of the patients (geographical proximity) for treatment and Follow-up care

Exclusion Criteria:

* Patients with tumor diseases
* People capable of childbearing or procreation who do not take consistent contraceptive measures during therapy
* Persistent drug, medication or alcohol abuse
* Patients for whom, in the physician's judgment, participation is not justifiable with regard to their well-being due to temporary withdrawal of standard medication.
* Patients in whom the diagnosis of osteoarthritis of the affected joint cannot be made without doubt. To establish the diagnosis, the guidelines of the American College of Rheumatology (ACR) are followed.
* Earlier radiation therapy for treatment of cancer
Real-World Evidence of Effectiveness and Safety of Tirabrutinib in Patients with Relapsed or Refractory Primary Central Nervous System Lymphoma in Taiwan: a Nationwide Study

The goal of this observational study is to describe the real-world effectiveness and safety of tirabrutinib among relapsed or refractory PCNSL patients in Taiwan.


Eligibility Criteria:
Inclusion Criteria:

1. Patient is ≥ 18 years of age.
2. r/r PCNSL patient, who has newly started NHI public reimbursement tirabrutinib from 01 June 2024 to 30 June 2025.
3. Have provided voluntary written consent, directly from the subject, or through his/her legal representative for a patient who has died or lacks the capacity to give informed consent

Note: The NHI reimbursement criteria are listed below for reference purposes only. Subject enrollment depends on whether reimbursement has been received.

1. Histopathologically confirmed large B-cell PCNSL.
2. Patients with relapsed or refractory PCNSL previously treated at least 2 cycles of HD-MTX.
3. Exclude HIV infection
4. Exclude Burkitt lymphoma
5. Exclude patients using chemotherapy or monoclonal antibodies at the initiation of tirabrutinib treatment.
Usability Study for SOBERLINK System

The Soberlink Cellular device, in its original packaging, along with the QuickStart guide will be provided to the end user in a simulated home use environment or by Rx in clinic. The patient labeling will be in the format intended for distribution.

Ten (10) Rx subjects will be provided instruction for use in clinic for the Soberlink Cellular device while an additional ten (10) Rx subjects will be provided instruction for use in clinic for the Soberlink Cellular device and Sober Sky web portal. An additional ten (10) simulated home use subjects will be provided instruction for use for the Soberlink Cellular device while an additional ten (10) simulated home use subjects will be provided instruction for use in clinic for the Soberlink Cellular device and Sober Sky web portal. All subjects will be provided with a post-test questionnaire on how to operate the device.

The post-test questionnaire will collect information regarding device use. The device's use will be compared with identified risks to determine if the percentage of failures is within the study protocol success criteria. Additionally, measurable usability criteria for specific, critical steps will be evaluated.

Forty (40) subjects identified as potential end users of the device will be recruited to the study and screened according to the study inclusion and exclusion criteria. Subjects will be asked to sign informed consent. The Soberlink Cellular device, in its original packaging, along with the QuickStart guide will be provided to the patient in a simulated home-use environment and Rx clinical setting. The patient labeling will be in the format intended for distribution.

Ten (10) Rx subjects will be provided instruction for use in clinic for the Soberlink Cellular device while an additional ten (10) Rx subjects will be provided instruction for use in clinic for the Soberlink Cellular device and Sober Sky web portal. An additional ten (10) simulated home use subjects will be provided instruction for use for the Soberlink Cellular device while an additional ten (10) simulated home use subjects will be provided instruction for use in clinic for the Soberlink Cellular device and Sober Sky web portal. All subjects will be provided with a post-test questionnaire on how to operate the device.

The post-test questionnaire will collect information regarding device use. The device's use will be compared with identified risks to determine if the percentage of failures is within the study protocol success criteria. Additionally, measurable usability criteria for specific, critical steps will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Male and female participants between the ages of 18-99 years old in a clinical setting under the care of a healthcare provider.
* Male and female participants between the ages of 18-99 years old in an over-the-counter setting (home use setting).

Exclusion Criteria:

* Participants with lung disease unable to exhale for 4 seconds.
In Vivo Study of Interactions Between the Endocannabinoid System and the Corticotropic Axis in Man

Working hypothesis: the interactions between the endogenous endocannabinoïds (ECS) - and cortisol, the end product of the Hypothalamo-Pituitary-Adrenal (HPA) axis may play a role in the pathophysiology of Cushing's syndrome.

The investigators speculate that:

* acute or chronic variations in plasma cortisol may induce changes in the activity of the ECS
* that there is a circadian rhythm of the ECS driven by the rythm of plasma cortisol

The study aim to identify the relationship between the ECS and the HPA axis in humans with a main objective to assess if Cushing's syndrome induces changes in the ECS activity.

For this purpose:

1. the investigors will compare plasma levels of ECS between obese controls and patients with Cushing's syndrome
2. the investigors will compare plasma levels of ECS in patients with Cushing's syndrome before and immediately after curative surgery
3. the investigors will compare plasma levels of ECS in patients with hypoadrenalism before and after the intake of substitutive doses of hydrocortisone
4. the investigors will evaluate the plasma levels of ECS during a short synacthen test in healthy subjects.

Eligibility Criteria:
Inclusion Criteria:

For all patients groups:

* Age ≥ 18,
* Social security.

" Hypercortisolism " group:

* 18 \< BMI \< 40 kg/m2,
* Cushing's syndrome in front of :
* impaired 1 mg dexamethasone test (08:00 A.M. cortisol \> 50 nmol/L)
* qualitative and quantitative disrupted circadian rhythm of cortisol with increased plasma concentrations
* free urinary cortisol upper normal range (90 µg/24H),
* Hypercortisolism that can be treated with surgery (adrenal adenoma treated with adrenalectomy or Cushing disease treated with pituitary surgery).

" Obese " group:

* Obese patients: 30 \< BMI \< 40 kg/m2,
* Normal HPA axis function:
* 08:00 A.M. cortisol \> 250 nmol/L and peak above 550 nmol/L after 1 mg SST,
* Normal 24H free urinary cortisol and dexamethasone test. " Control " group:
* Lean or overweight patients (18 \< BMI \< 30 kg/m2),
* Non cortisol secreting pituitary or adrenal tumor,
* Patient in whom a biological evaluation of the HPA axis is recommended.

" Hydrocortisone " group:

* Lean or overweight patients (18 \< BMI \< 30 kg/m2),
* Primary or secondary adrenal insufficiency,
* With a need for hydrocortisone supplementation.

Exclusion Criteria:

* Patients with eating disorders, major depressive disorders or psychiatric disorders other than Cushing's syndrome,
* Cannabis consumption, alcoholism or drug addiction,
* Active smoking,
* cortisone treatment other than hydrocortisone,
* Pregnancy or feeding,
* Surgery for obesity,
* Incapability,
* Pathology that is life-threatening in the short term,
* Any situation that interfere with study or is risked for patient.
Fetal Neurobehavioral Development in Methadone Maintained Pregnancies

The purpose of this study is to examine differences in fetal neurobehavior at peak (2 hours after oral dose) vs. trough (2 hours before oral dose) maternal plasma methadone levels.

This study will examine differences in fetal neurobehavior at peak (2 hours after oral dose) vs. trough (2 hours before oral dose) plasma methadone levels. Anecdotal clinical observations suggest that fetal activity is increased at trough methadone levels and decreased at peak methadone levels, yet the investigators do not understand how in utero methadone exposure affects fetal neurobehavioral state development.

Eligibility Criteria:
Actively enrolled pregnant patients in CAP SA treatment.

Inclusion Criteria:

* Maternal age 18-40 years
* Single intrauterine fetus
* Estimated gestational age of 32 weeks
* DSMIV criteria for opioid dependence according to e-module of the SCID
* Daily methadone maintenance at a stable dose for greater than a week

Exclusion Criteria:

* Concurrent DSMIV axis I diagnosis that would preclude informed consent procedures (i.e., schizophrenia, major depression) or confound study outcomes (e.g., Alcohol Dependence)
* Presence of a serious medical or psychiatric illness requiring chronic medication or other intervention (i.e., HIV infection) that may confound data interpretation
* Evidence of preterm labor
* Evidence of prescription drug use (e.g., antidepressants, tranquilizers)
* Presence of major congenital fetal malformation
* Recent use (last month) of other illicit drugs (e.g., cocaine, marijuana) based on self report or positive on-Trak urine drug toxicology at time of actograph sessions
* Split methadone dosing schedule
Study of Lenalidomide to Evaluate Safety and Effectiveness in Patients With Diffuse Large B-Cell Lymphoma (DLBCL)

The purpose of this study is to compare lenalidomide to a control drug and see which one delays Diffuse Large B-Cell Lymphoma (DLBCL) disease progression longer.

This research study is for patients who have been diagnosed with Diffuse Large B-cell Lymphoma (DLBCL) that did not respond to (refractory) or that has come back after chemotherapy treatment (relapsed). Lymphoma is a cancer of a type of blood cell called lymphocytes. DLBCL is just one type of lymphoma. Within DLBCL there are two different subtypes called Germinal Center B-cell (GCB) and non-GCB which can be determined by cell surface marker tests or by gene expression tests. Scientists can look at cells and genes in the laboratory and see that the two kinds are different, but they don't know yet what the difference means. To patients and doctors these two kinds seem the same. Right now doctors don't usually do tests to find out which kind a patient has because the treatment is the same for both.

This study will have two stages, 1 and 2. The main purpose of Stage 1 is to separate patients by subtype and then test whether patients taking lenalidomide or any one of four other drugs have a better response. It is possible that lenalidomide will work better than one of the other drugs in zero, one, or both subtypes. Stage 2 will further test only the subtype(s) from Stage 1 that showed a good response to lenalidomide. The main purpose of Stage 2 is to test how long patients are disease free on lenalidomide compared to one of the four other drugs.

On 29 January 2013 the enrolment goal for the Stage 1 portion of the study was met and enrollment was stopped. The final analysis for Stage 1 was performed as of the 04 Jul 2013 data cutoff date. According to the Stage 1 results as assessed by the independent response adjudication committee (IRAC), neither subtype met the pre specified requirement to be further studied in Stage 2. Additionally, a suitable assay for the selection of participants for the Stage 2 study was not available. Therefore, on 6 January 2014, Celgene decided to not open Stage 2.

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven Diffuse Large B-Cell Lymphoma (DLBCL).
* Relapsed or refractory to combination chemotherapy for DLBCL that contains rituximab and an anthracycline, and one additional combination chemotherapy or stem cell transplant.
* Measurable DLBCL disease by computed tomograph (CT) / magnetic resonance imagining (MRI).
* Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2.

Exclusion Criteria:

* Diagnosis of lymphoma histologies other than DLBCL.
* History of malignancies, other than DLBCL, unless the patient has been disease free for 3 years or more.
* Eligible for autologous stem cell transplant.
* Known seropositive for, or history of, active human immunodeficiency virus (HIV) hepatitis B virus (HBV), hepatitis C virus (HCV)
* Neuropathy grade 4.
A Comparison Of The Pharmacokinetics Of PF-04191834 Following Single Dose Administration Of A Dispersion Formulation And A Suspension Formulation In Healthy Volunteers

This study investigates the safety, tolerability and pharmacokinetics of PF-04191834 when respectively given orally as a single dispersion dose and a single dose of a suspension. The suspension is the test formulation and the dispersion is the formulation with which the novel preparation will be compared.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female subjects of non-childbearing potential between the ages of 18 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG or clinical laboratory tests.
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg(110 lbs).

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
* Clinical evidence of existing hepatic disease or a medical history of such a condition in the last year. Subjects with AST or ALT \>ULN. Subjects with total bilirubin \>ULN (except those with a documented history of Gilbert's Syndrome). Subjects with AST/ALT/total bilirubin \>ULN and \<1.5X ULN may be retested once.
* Treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) preceding the first dose of study medication;
* Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day;
* Females of childbearing potential.
* Subjects with positive responses (score 1) for suicidality on the Sheehan Suicidality Tracking Scale (S-STS) (specifically items 1a, 1b, 3, 4, 5, 6, 7, or 9).
Cardiovascular and Endothelial Markers During OGTT Before and at Six and Twelve Months Post-treatment in Women With PCOS

The aim of the present study is to investigate a) the presence of subclinical markers of vascular, myocardial and endothelial function in women with PCOS b) the acute alterations in these markers during the oral glucose tolerance test (OGTT) c) the impact of potential treatment interventions in these markers.

All the woman who will recruited in the study will undergo OGTT. At 0, 60, and 120 min of glucose load the investigators will measure: a) glucose and insulin, b) pulse wave velocity (PWV) c) augmentation index (Aix) and d) perfused boundary region of sublingual microvessels (high PBR values represent reduced glycocalyx thickness). At 0 and 120 min of glucose load, the investigators will assess: a) coronary flow reserve (CFR) using Doppler echocardiography, b) LV longitudinal strain (LS) of subendocardial, mid-myocardial and subepicardial layers and global LS (GLS) c) peak twisting (pTw), untwisting velocity (pUtwVel) by speckle tracking echocardiography d) flow mediated dilation (FMD) of the brachial artery, e) Carotid intima-media thickness. Matsuda index, insulin sensitivity index (ISI) and HOMA index will be also measured. The levels of Testosterone (Τesto), Sex hormone binding globulin (SHBG), dehydroepiandrosterone sulfate (DHEA-s), Prolactin (PRL), 17-hydroxyprogesterone (17-OH-PRG) ,Androstenedione (Δ4) and Metalloproteinase 9 will be also assessed. After six months of treatment intervention, the patient will undergo the previously described measurements. Primary Endpoints include the change in GLS, PWV, and PBR during OGTT and six months after treatment intervention. Secondary Endpoints include the change in CFR and FMD during OGTT and six months after treatment intervention.

Eligibility Criteria:
Inclusion Criteria:

1. Age \> 16 years old
2. Diagonis of PCOS according to Rotterdam criteria: presence of two of the three of the following:

   * Clinical or biochemical hyperandrogenism
   * Anovulation or oligo-ovulation
   * Polycystic ovarian morphology (PCOM)
3. Absence of treatment for PCOS the last six months
4. Patients who have the ability to understand and sign the consent form.

Exclusion Criteria:

1. Disorders with clinical presentation similar to PCOS: thyroid disease, hyperprolactinemia, and non-classic congenital adrenal hyperplasia (primarily 21-hydroxylase deficiency by serum 17-hydroxyprogesterone \[17-OHP\]), Cushing syndrome, acromegaly
2. Treatment with contraceptive or metformin
3. Type 2 diabetes mellitus
4. Treatment for diabetes
5. Pregnancy
6. Lactation
7. Malignancy