cyrilzakka/clinical-trials huggingface dataset:
Effect of High Power Pain Threshold Ultrasound on Postnatal Sacroiliac Joint Pain

This study will be conducted to investigate the effect of high-power pain threshold ultrasound on postnatal sacroiliac joint pain.

Sacroiliac joint pain (SIJ) in the pregnant and postpartum females is susceptible to dysfunction due to multiple biomechanical changes that happen over the course of gestation. This includes an increased angle of lordosis, weight gain, and structural trauma due to the physiologic process of childbirth, biomechanical changes, along with hormonal fluctuations through each trimester, particularly with increased levels of estrogen and relaxin, have been found to decrease the stability of the joint leading to sustained postpartum back pain that may necessitate surgical intervention if conservative treatment fails.

PGP can result in significant physical disability and has important psychosocial implications, including extended leave from work during pregnancy and postnatal, poorer quality of life (as a result of being unable to carry out normal roles, affecting their ability to care for their children and the new baby) and predisposition to chronic pain.

There are side effects to using medical treatment for PGP, such as bruising, bleeding, stomach upset (including bleeding in the stomach), peptic (stomach) ulcers, blurred vision, constipation, dry mouth, fatigue, headaches, insomnia, mood changes, nausea, urination problems, and weight gain. So, using other treatment methods, such as ultrasound therapy to treat PGP is beneficial.

Ultrasound therapy is a non-invasive treatment in which sound waves penetrate soft tissues, increasing blood flow; this can help relieve pain, improve circulation, and promote tissue healing. As such, ultrasound therapy is often used to treat injuries, muscle spasms, and chronic issues like neck or back pain.

No previous study has investigated the effect of high-power pain ultrasound on sacroiliac pain in postpartum women. So, this study aims to investigate the effect of high-power ultrasound on postnatal sacroiliac joint pain.

Eligibility Criteria:
Inclusion Criteria:

* Postpartum women diagnosed with sacroiliac joint pain and referred by an orthopedist.
* Their ages will range from 20 to 30 years old.
* Their body mass index (BMI) will range from 25 to 29.9 kg/m2.
* All of them should have symptoms for at least two weeks postnatal

Exclusion Criteria:

* Kidney diseases like stones or renal failure
* History of ischemic heart diseases or Myocardial infarction
* Severe vitamin D3 deficiency
* Severe liver diseases or hepatitis
* Psychological distress
Hyperpolarized Xenon-129 MRI: a New Multi-dimensional Biomarker to Determine Pulmonary Physiologic Responses to COPD Therapeutics

Hyper polarized xenon-129 MRI (HXe MRI) is a unique imaging test which can detect how air is flowing in and out of lungs and how oxygen can move from inhaled air into the blood. Chronic Obstructive Pulmonary Disease (COPD) is a disease in which patients develop narrowing of airways, thus, having difficulties breathing air in and out their lungs and also damaging the lung tissues which patients need to move oxygen from the air into blood.

In this study, two drugs which are already approved by FDA (Anoro and Arnuity) will be administered to patients who are already known to have COPD. While patients are being treated with these two drugs (one drug at a time over a month), lung health by using usual testing methods (CT scan of the lung, pulmonary function test, and blood test) will be assessed in addition to HXe MRI.

The goal of this study is to prove that the HXe MRI is an excellent imaging test to show the state of lung health among COPD patients and also to obtain new informations on how lung health changes with drugs that are already approved by US FDA. This work is anticipated to help develop HXe MRI as a new clinical test which can guide how to treat patients with COPD and if new therapies can improve lung health of patients with COPD.


Eligibility Criteria:
Inclusion Criteria:

* post bronchodilator PFT spirometry FEV1/FVC \< 70% predicted
* History of diagnosis of COPD
* History of alpha 1 anti-trypsin deficiency

Exclusion Criteria:

* previous diagnosis of asthma, interstitial lung disease, pulmonary vascular disease, inability to complete MRI or any of the assessment testings.
Analysis of Patient Understanding of Radiation Therapy Among Patients With Breast Cancer

The purpose of this study is to conduct a descriptive feasibility study of assessing how patients retain and understand information regarding radiation therapy obtained from an initial consult visit. This study will also pilot the use of visual aids and assess their utility to patients during a consult. The study will provide a baseline to conduct larger studies that will later incorporate additional patient education tools to assess changes in patient understanding of information received in radiation oncology patient consultations.


Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years or older with non-invasive or invasive breast cancer receiving consultation at the breast radiation oncology clinic for radiotherapy recommendations

Exclusion Criteria:

* Patients under 18 years old or receiving palliative care
ASSIST Tool and Surgical Randomized Controlled Trial Applicability

Background: The ASSIST tool is a graphical tool to represent and evaluate the applicability of a surgery trial to improve the translation of research to practice.

Objective: To evaluate the impact of the ASSIST tool on the interpretation of the applicability of randomized controlled trials (RCTs) in the field of digestive cancer surgery.

Design: This study is a randomized controlled trial with two parallel arms. Participants: Surgeons who contribute to the assessment of manuscripts as experts (peer-reviewer) for international scientific journals of surgery (Annals of Surgery, Archives of Surgery, Gastrointestinal Surgery World Journal of International Journal of Surgical Oncology).

Intervention: Surgeons will be randomized into 2 groups. A group that will evaluate a case vignette (synopsis) of a randomized trial in surgery, and the other group that will evaluate the same case vignette with the representation of the external validity of the trial with ASSIST tool.

Outcome measures: Participants will indicate on a numeric scale range from 1 to 10 if they feel able to judge the applicability of the trial for 1) patients, 2) centers, 3) surgeons and 4) intervention.

Sample Size: 28 case vignettes with randomized trials and their ASSIST tool have been developed and evaluated. The inclusion of 130 participants (65 per arm) is required.

The study will be conducted in 2 steps:

In a first step, investigators will develop cases vignettes of published RCTs evaluating surgical interventions in the field of digestive cancer with its representations of external validity according to ASSIST.

In a second step, investigators will invite a panel of peer reviewers to appraise the external validity (applicability) of selected RCTs without and with the graphical tool (ASSIST), on a security web site.

Eligibility Criteria:
Inclusion Criteria:

* surgeons
* who contribute to the assessment of manuscripts as experts (peer-reviewer) for international scientific journals of surgery (Annals of Surgery, Archives of Surgery, Gastrointestinal Surgery World Journal of International Journal of Surgical Oncology)

Exclusion Criteria:

* No one
Clinical Variability in Marfan Syndrome

Marfan syndrome is an autosomal dominant connective tissue disorder caused by mutations in the fibrillin-1 gene (FBN1). Penetrance of FBN1 mutations is complete but intra and inter familial clinical expressivity is extremely variable. The underlying mechanisms for variability are not understood. An interesting mechanism is that the expression level of the wild type and/or mutated allele may play a role in the determination of variability.

Principal objective: To evaluate in Marfan patients, if FBN1 expression level (non-mutated or mutated allele) modulates the clinical expression of the disease.

Judgment criteria : Correlation allelic expression level-phenotype Perspectives : To search the predictive factors of severity in order to ameliorate precocity of taking care.

Marfan syndrome is an autosomal dominant connective tissue disorder caused by mutations in the fibrillin-1 gene (FBN1). Penetrance of FBN1 mutations is complete but intra and inter familial clinical expressivity is extremely variable. The underlying mechanisms for variability are not understood. An interesting mechanism is that the expression level of the wild type and/or mutated allele may play a role in the determination of variability.

Principal objective : To evaluate in Marfan patients, if FBN1 expression level (non-mutated or mutated allele) modulates the clinical expression of the disease in individuals from families with clinical variability (intrafamilial) and in independant probands (interfamilial).

Judgment criteria : Correlation allelic expression level-phenotype Method : In Marfan patients with a FBN1 nul allele, FBN1 RNA will be extracted from a fibroblast culture. Allelic FBN1 expression level will be performed by quantitative RT-PCR and then compared with clinical evaluation.

Number of subjects : 160 subjects, 45 Marfan patients in 15 independent families, 5 patients with the same mutation, 30 with a private mutation leading to a nul allele and 80 non Marfan subjects.

Perspectives : To search the predictive factors of severity in order to ameliorate precocity of taking care.

Eligibility Criteria:
Inclusion Criteria:

* Man or woman \> 18 years old
* With a mutation in FBN1 gene
* Has signed an informed consent form

Exclusion Criteria:

-No affiliated to a Healthcare System.
The Effects of Resistance Exercises in Glycemic Control of Women With Gestational Diabetes

The object of this study is to evaluate patients with a diagnosis of GD who are included in a program of RE carried out with rubber tubes, comparing the frequency of women who will use insulin in the group who will participate in the program with the group that won't do the exercises, and to verify the impact of the program on the adequacy of capillary glycemic control of the pregnant women.


Eligibility Criteria:
Inclusion Criteria:

* Gestational diabetes diagnosis
* Sedentary
* Nonsmokers
* Age between 18 and 45 years old
* Pre-pregnancy BMI less than 35, without limiting physical factor for conducting exercises
* With single pregnancy without fetal malformation:gestational age between 24 and 34 weeks, which have no other condition that contraindicate the conduct of exercises, with no risk factors for preterm delivery and who consent to participate in the study

Exclusion Criteria:

* Patients who develop further clinical or obstetric complications that contraindicate the conducting exercises during pregnancy
* Patients who start any form of physical activity after being randomized to the control group
* Patients who start another form of physical activity than the resistance exercises after being randomized to the intervention group
* Patients who were to use another product than insulin as a form of glycemic control
* Patients to abandon the study
CD19 Targeted Universal Chimeric Antigen Receptor T Cells Injection for CD19+ Refractory/Relapsed B-cell Malignancies

It is a single-arm, open-label clinical study to assess the safety and efficacy of the Anti-CD19 Universal CAR-T Cells injection for patients with CD19+ refractory/relapsed B cell acute lymphoblastic leukemia and B cell non-Hodgkin lymphoma.

The study consists of the following periods: screening, lymphodepletion, CAR-T cell infusion, safety follow up, and long term follow-up.

Eligibility Criteria:
Key Inclusion Criteria:

1. Eastern Cooperative Oncology Group Performance Status of 0 or 1；
2. Expected survival time ≥12 weeks;
3. Adequate hematological, renal and liver function;
4. Subjects understand and voluntarily sign the informed consent form.

Key Exclusion Criteria:

1. Positive for any of the following etiological tests: HIV, HBV, HCV, TPPA ;
2. Cyclophosphamide or fludarabine is contraindicated for subjects ;
3. Active central nervous system (CNS) involvement by malignancy；
4. Active infection.
Nutritional Cognitive Behavioral Therapy Feasibility Study in NAFLD and NASH

This single arm interventional cohort study is designed to explore the feasibility of using BT-NCBT-00x to improve liver fat, inflammation, and stiffness in patients diagnosed with NAFLD or NASH over a 3 month intervention.

The treatment, BT-NCBT-00x, consists of a software as a medical device developed by the study Sponsor, Better Therapeutics. It delivers treatment to participants with cardiometabolic disease, using behavioral therapy that targets individual behaviors related to improving dietary quality and physical activity. The study evaluates the use of this behavioral therapy and its effect on clinical measures such as percent liver fat as measured by MRI-PDFF, and Fibroscan Controlled Attenuation Parameter score, liver stiffness as measured by Fibroscan Vibration Controlled Transient Elastography in kPA, body weight and ALT. Participants in this feasibility study will have access to the treatment for 3- months.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of NAFLD or NASH
* At least 2 doses of the COVID-19 Vaccine, per self report
* Possession of a smartphone capable of running the Bt_NCBT-00x application
* BMI \>/= 30 at the screening visit
* Fibroscan CAP \>300 dB/m collected at screening visit
* Completion of baseline MRI-PDFF
* Understand written and spoken english

Exclusion Criteria:

* Inability to read and understand english
* unstable or life-threatening medical illness
* weight loss of greater than 10lbs within the last 90 days
* pregnant or planning to become pregnant women
* concurrent enrollment in any other interventional clinical trial
* presumed or confirmed COVID-19 diagnosis within 30 days prior to study enrollment
* change in medication regimen of hormonal contraceptives, anti-hyperglycemic medications, mental or emotional disorder medications, corticosteroids, thyroid hormones, Tamoxifen or Methotrexate within 90 days
MK-5475-013 INSIGNIA-PH-COPD: A Study of the Efficacy and Safety of MK-5475 (an Inhaled sGC Stimulator) in Adults With PH-COPD

Researchers are looking for ways to treat pulmonary hypertension (PH) caused by chronic obstructive pulmonary disease (COPD). The goal of the study is to learn if people who take MK-5475 can walk farther in 6 minutes at Week 24 compared to people who take placebo.


Eligibility Criteria:
The key inclusion and exclusion criteria include but are not limited to the following:

Inclusion Criteria:

* Has Group 3.1 pulmonary hypertension chronic obstructive pulmonary disease (PH-COPD) as defined by the Clinical Classification of Pulmonary Hypertension.
* Has a right heart catheterization (RHC) at screening or historical RHC within 12 months before screening that meets hemodynamic criteria.
* Has a physician diagnosis of obstructive lung disease on pulmonary function testing (PFT) performed at screening.
* Has a WHO Functional Class assessment of Class II to IV.
* If on supplemental oxygen, the regimen must be stable.
* Has stable and optimized chronic, baseline COPD-specific therapy.
* If on PDE5 inhibitor, has stable concomitant use (initiated at least 3 months prior to randomization and no change in drug or dosage for at least 3 months prior to randomization) and changes to PDE5 inhibitor dosing is not anticipated during the 24 week Base Period.
* If on antihypertensives and/or a diuretic regimen has stable concomitant use.
* If on anticoagulants has stable concomitant use.
* Is of any sex/gender from 40 to 85 years of age inclusive.
* Female is not pregnant or breastfeeding, and is not of childbearing potential or uses acceptable contraceptive method or abstains from sexual intercourse, or has a negative highly sensitive pregnancy test within 24 hours before the first dose of study intervention, or whose history and sexual activity has been reviewed by the investigator.

Exclusion criteria:

* Has Group 1 pulmonary arterial hypertension (PAH), Groups 2, 4 or 5 pulmonary hypertension (PH).
* Has non-COPD related Group 3 PH.
* Has evidence of untreated more than mild obstructive sleep apnea.
* Has significant left heart disease.
* Expects to receive a lung and/or heart transplant from screening through the end of the 24 week Base Period.
* Has evidence of a resting oxygen saturation (SpO2) \< 88%.
* Has experienced a moderate or severe COPD exacerbation within 2 months before randomization.
* Has experienced right heart failure within 2 months before randomization.
* Has uncontrolled tachyarrhythmia.
* Has acute coronary syndrome, undergone coronary artery bypass graft, or percutaneous coronary intervention within 2 months before randomization.
* Has evidence of significant chronic renal insufficiency.
* Has evidence of chronic liver disease, portal hypertension, cirrhosis, or hepatic abnormalities.
* Initiated a pulmonary rehabilitation program within 2 months before randomization.
* Has impairments that limit the ability to perform 6MWT.
* Has history of cancer.
* Is a user of illicit drugs or has a recent history of drug/alcohol abuse or dependence.
* Has used PAH-specific therapies within 2 months of randomization.
Effects of Constraints Induced Movement Therapy Versus Mirror Therapy in Children With Hemiplegic Cerebral Palsy

The aim of this study is to find Effects of constraints induced movement therapy (CIMT) versus mirror therapy (MT) on hand dexterity and grip strength in children with hemiplegic cerebral palsy.

Although quite number of research has been done on effects of CIMT and mirror therapy but most of the studies included stroke population. There was no literature on comparative effect of both CIMT and Mirror therapy in children with hemiplegic cerebral palsy. This study will be covering specifically cerebral palsy children to have better treatment techniques to be introduced in therapeutic programs of hemiplegic cerebral palsy children.

Eligibility Criteria:
Inclusion Criteria:

* Children of age range 9-14 year
* Children with diagnosed hemiplegic cerebral palsy
* Children who can perform active extension of affected wrist and more than
* two fingers at an angle of more than 10 degrees
* Active abduction of affected thumb at an angle of 10 degrees
* Children who can respond to simple communication-

Exclusion Criteria:

* Children with uncontrolled seizures
* Botulinum toxin injections or orthopedic surgery in the upper or lower
* extremities within the previous 12 months or planned within the study period
* Children with depression who were unable to cooperate in treatment
* Children who are unable to perform active task training
Adult ALL Treatment at Diagnosis

The present study has been designed to give participating centers the possibility of better understanding the diagnostic and prognostic factors of ALL patients.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of acute lymphoblastic leukemia (ALL)
* Negative myeloperoxidase stain
* Phenotype T (ALL-T) and B(ALL-B)

Exclusion Criteria:

* Creatinine \> 2.5mg/dL after adequate hydratation
* LVEF \<50%
* Presence of documented infections not responding to antibiotic and/or antifungal therapy
* Presence of concomitant malignant diseases
* Absence of any psychological condition that does not allow to intake high doses of cortisone
* Patients who have received any antineoplastic chemiotherapy for more than 5 days
* Patients who have received any steroids for more than 10 days
Treatment of Cancer-associated Anorexia Using Megestrol Acetate Concentrated Suspension

To compare the effect of megestrol acetate concentrated suspension and placebo on caloric intake in patients with cancer-associated anorexia.


Eligibility Criteria:
Inclusion Criteria:

* Cancer of multiple types in stage II, III, or IV and not a candidate for chemotherapy; but may have been receiving radiation therapy
* Fair, poor, or very poor appetite
* Cancer-associated anorexia/cachexia (documented weight loss of 2% over the prior week, or at least 5% within past 30 days, or at least 7.5% over prior 3 months, or at least 10% over prior 6 months)
* Weight loss perceived to be associated with diminished appetite
* Eastern Cooperative Oncology Group Performance score of 0, 1, or 2
* Life expectancy greater than 3 months
* Alert and mentally competent to complete study assessments
* Women of child-bearing potential required to use an adequate and reliable method of contraception. Post-menopausal women have to have been so for at least 1 year
* Screening laboratory values must not be clinically significant (some exceptions per protocol)

Exclusion Criteria:

* Brain, or head and neck tumors that may interfere with food consumption
* AIDS-related wasting
* Radiation therapy to head and neck, abdomen, or pelvis within past 6 weeks, or for whom radiation therapy is anticipated during the study such that the result may interfere with food consumption
* Presence of conditions that interfere with oral intake or ability to swallow
* Absence of normally functioning gut
* Known mechanical obstruction of the alimentary or biliary tract, or malabsorption syndrome
* Intractable or frequent vomiting
* Clinically significant diarrhea
* History of thromboembolic events, or on long-term anticoagulation for thromboembolism
* Uncontrolled diabetes mellitus, or symptomatic hypoadrenalism
* Poorly controlled hypertension or congestive heart failure
* Pregnant/lactating females, or planning on becoming pregnant
* Use of appetite stimulants within past 30 days
* Use of parenteral nutrition or tube feedings within past 1 week
* Chronic use of steroids within past 3 months (intermittent short-term use allowed)
* Current use of illicit substances
* Allergy, hypersensitivity, or other contraindication to megestrol acetate
Depressive State After Sleeve Gastrectomy

Obesity is an epidemic disease that continues to increase causing morbidity and mortality to those who suffer. Obese patients suffer, frequently, from a depressive state, anger, and emotional disturbances. It cannot be recognized and depression causes obesity affecting eating habits or obesity causes depression based on physical, social and occupational limitations. Many times we see that obese patients are discriminated in every sense of daily life increasing their depressive state. The best treatment for obesity is bariatric surgery that causes a sufficient weight loss to correct sleep apnea, diabetes, hypertension, and many other co-morbidity. The study is based on elucidating the effect of sleeve gastrectomy in obese patients suffering from depression

The patients were classified as suffering from a depressive state before the bariatric surgery and followed until 3 years after surgery, the data was collected by personal interview or telephone survey.

Eligibility Criteria:
Inclusion Criteria: 18 years and older No any type of complication after surgery No difficult to drink, eat or take medicaments

Exclusion Criteria:

Any surgical complication Previous gastrointestinal surgery schizofrenia