cyrilzakka/clinical-trials huggingface dataset:
Efficacy of Extracorporeal Shockwave Therapy on Ultrasonographic Changes in de Quervain Tenosynovitis

The current study will be conducted to explore the efficacy of ESWT on ultrasonographic changes, pain intensity level, upper limb function and hand grip strength in patients with de Quervain tenosynovitis.

De Quervain tenosynovitis (DQT) is a painful condition involving the tendons of the abductor pollicis longus (APL) and extensor pollicis brevis (EPB). The pathogenesis is generally defined as a stenosing condition of the first dorsal compartment of the wrist, characterized by thickening of the extensor retinaculum of APL and EPB, which can cause tendon gliding difficulties and impingement between the tendons and their fibrous sheaths.

The prevalence rate of DQT in the general population is 0.5% for males and 1.3% for females, with peak prevalence at the age of 40-60 years. Female prevalence is 6 to 10 times higher than that in men. De Quervain tenosynovitis is a repetitive strain injury consider postures where the thumb is held in abduction and extension to be predisposing factors. De Quervain tenosynovitis incidence increased by virtue of modern life conditions such as excessive computer use and increased use of cellular phones.

However, little research has been carried out to determine the therapeutic effects of ESWT in DQT, and up till now, there is a gap in literature that explore ESWT efficacy on ultrasonographic changes of DQT. So This current study will be conducted to explore the efficacy of ESWT on ultrasonographic changes, pain intensity level, upper limb function and hand grip strength in patients with de Quervain tenosynovitis.

Sixty patients from both genders will be involved in this study and will be randomly subdivided into two equal groups in number. First Group (A) (Experimental Group) will receive radial Extracorporeal Shockwave therapy plus Traditional physical therapy program and the second Group (B) (Control Group): This group will receive Traditional physical therapy program.

Eligibility Criteria:
Inclusion Criteria:

1. Age from 18 to 65 years
2. Both genders (males and females).
3. Normal BMI ranges between 18.5:24.9 kg/m2.
4. Patients will be referred from an orthopedist with diagnosis of DQT.
5. Chronic pain more than 2 months.
6. No history of undergoing physiotherapy modalities or corticosterone injection therapies for any reasons during the past month.
7. De Quervain tenosynovitis patients will be diagnosed based on the standard criteria, including pain and tenderness in the lateral wrist and a positive result for the Finkelstein test.

Exclusion Criteria:

1. History of undergoing physiotherapy modalities or corticosterone injection therapies for any reason during the past month.
2. Subjects with other neurological disorders rheumatologic diseases causing wrist pain.
3. Pregnancy.
4. History of fracture or surgery on the hand.
5. Severe trauma, and coagulation disorders.
Characterization of Circulating and Tumor-infiltrating Immune Cells in Malignant Brain Tumors

The goal of this observational study is to characterize the circulating leukocyte profile and the immune T cells distribution within the tumor in patients with malignant brain tumors and to correlate these findings with the oncological outcome.

Participants will be subjected to blood sampling before surgery and for 12 months of follow-up. Additional sampling and analysis will be performed on tumor samples.

High-grade gliomas are the most frequent type of primary brain tumor in adults, and among them, glioblastoma multiforme (GBM) is the most malignant with an associated poor prognosis. Although significant advances have been achieved in GBM biology comprehension, patients' life expectancy is still limited to 18 months.

Brain metastases (BM) are the most frequent neoplasm in the CNS; it is estimated that up to 14% of all newly diagnosed cancers will soon or later metastasize into the brain.

A variety of mechanisms to escape a tumor-specific T cell-mediated immune response have been identified in glioma and other cancer entities.

This project is an observational, prospective, monocentric study on patients candidates for neurosurgical procedures for brain malignant tumors with additional collection of biological material. With the present study, we aim to characterize the phenotype of both circulating- and tumor-infiltrating- immune cells at the diagnosis and their changes during disease progression and after treatment in primary and secondary brain tumors.

Samples will be taken at baseline (before surgery) and at time-points: 3, 6, 9, 12 months

Eligibility Criteria:
Inclusion criteria:

* Adult patients (≥18 years)
* Able to express informed consent
* With primary or secondary malignant brain tumor
* Requiring neurosurgical treatment (radiosurgery, stereotactic biopsy, surgery)

Exclusion Criteria:

* Patients who do not meet inclusion criteria.
A Study of STAR-0215 in Healthy Adult Participants

This is a first-in-human, single-center, randomized, double-blind, placebo-controlled, single ascending dose study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of a single subcutaneous (SC) or intravenous (IV) administration of STAR-0215 in healthy adult participants.


Eligibility Criteria:
Inclusion Criteria:

* Good health as determined by the Investigator based upon a medical evaluation, including medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory measurements. Assessments may be repeated per Investigator discretion.
* Body mass index of 18 to 35 kilograms (kg)/square meter with a weight of at least 60 kg for men and at least 50 kg for women, with a maximum weight of 130 kg for any participant.
* Female participants capable of becoming pregnant must have a negative serum pregnancy test at Screening, not be nursing, and must agree to use an effective method of contraception and abstain from egg donation or fertility treatment.
* Male participants must agree to use an effective method of contraception and abstain from sperm donation.

Exclusion Criteria:

* Prior or ongoing medical condition (for example, gastrointestinal, renal, hepatic, dermatological, neurological or psychiatric, cardiovascular, respiratory, or hematological), medical history, physical examination, vital signs, ECG, or clinical laboratory abnormality that, in the Investigator's opinion, could adversely affect the safety of the participant. Assessments may be repeated once prior to dosing as needed per Investigator discretion.
* Known sensitivity to the ingredients in STAR-0215.
* Regular use of prescription or non-prescription drugs unless Investigator believes the medication(s) will not interfere with the study or compromise participant safety.
* Participation in a recent clinical study involving receipt of an investigational product within 30 days prior to the first dose of study drug or exposure to more than 4 investigational products within 12 months prior to the first dose of study drug.
Uterine Massage After Vaginal Delivery

The participants will be randomized into an oxytocin plus uterine massage group and an oxytocin-only group in the third stage of the labor. Women allocated to the uterine massage group will be provided with trans-abdominal uterine massage starting promptly after delivery of the fetus until delivery of the placenta. The amount of postpartum hemorrhage and placental delivery time will be recorded and compared between the groups.

Women allocated to oxytocin only group will be given 10 units of oxytocin intramuscularly immediately after delivery of the fetus. Women allocated to the oxytocin plus uterine massage group will be will be given 10 units of oxytocin intramuscularly immediately after delivery of the fetus and will be provided with trans-abdominal uterine massage starting promptly after delivery of the fetus until delivery of the placenta. Collection of blood loss will be initiated immediately after delivery of the fetus by putting a drape under the woman's buttocks. Collected blood will be weighed and the amount will be recorded in grams.

Eligibility Criteria:
Inclusion Criteria:

* 18-40 years old women delivering vaginally

Exclusion Criteria:

* women with bleeding disorder
Skin Prep to Reduce Postoperative Shoulder Infection

Propionibacterium acnes is the most common pathogen identified from a surgical site infection in the shoulder. Standard skin preps do not prevent this type of infection. Patients will undergo either a chlorhexidine or benzoyl peroxide prep in days leading up to surgery. Bacterial burden will be determined at the time of surgery.

After surgical posting, patients will be randomized to chlorhexidine or benzoyl peroxide group. The solutions used will be 5% benzoyl peroxide emollient foam and 4% chlorhexidine gluconate skin cleanser. Participants will be instructed to conduct skin wash using the appropriate solution in the shower over the operative shoulder and axilla for three mornings prior to surgery (pre op day -2, pre op day -1, and morning of surgery). Specific instructions will include leaving the solution on the skin for three minutes and avoiding contact with eyes, ears, and mouth. Proper technique will be demonstrated at time of patient recruitment and given as a handout with the wash solution provided. A reminder phone call will occur two days before surgery to remind patients of proper procedure to improve compliance. On the day of surgery, patients be interviewed about pre-operative compliance.

On the day of surgery, two cultures will be taken in three separate sites on both shoulders (anterior, lateral, and posterior) using a detergent scrub technique, the current dermatologic standard for biopsy of the deep sebaceous glands. (3,11) This procedure is typically performed on the skin of awake patients and causes minimal pain and skin irritation. Cultures will be evaluated in our lab. We will also test for hemolysis as a possible indicator of a more virulent strain in the literature.

The research team may take photos of the shoulder skin being swabbed. Photos will not include the facial or defining characteristics. Photos may be taken either in the clinic at time of recruitment or in the operating room when samples are being taken.

Inclusion criteria: all patients undergoing open shoulder surgery or shoulder arthroscopy. Exclusion criteria: anyone with a history of allergic reaction to chlorhexidine or benzoyl peroxide. Anyone with a history of previous shoulder infection, current open skin lesions around the shoulder or the use of current anti-acne medications around the shoulder.

Healthy volunteer portion: Healthy volunteers will respond to the study from fliers on campus. A cotton swab test on both shoulders will be performed prior to any treatment. If a threshold of P. Acnes is met (\>1000 Colony Forming Units (CFUs)) then volunteers will be randomized to the same two groups and retested after three days of unilateral treatment. Finally, volunteers will undergo repeat cotton swab testing one week after 3 day wash was finalized.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18
* Indicated for shoulder surgery

Exclusion Criteria:

* History of previous shoulder infection
* Allergy to Chlorhexidine or benzoyl peroxide
* Current use of anti-acne medicine around the shoulder
* Patient is pregnant or concerned about pregnancy
Non Alcoholic Fatty Liver Disease in Rheumatoid Arthritis

Rheumatoid arthritis is a chronic inflammatory systemic disease. It has a worldwide distribution and can affect all age group. The peak incidence is between fourth and sixth decade. It is more prevalent in women, and it's prevalence in the general population in North America is between 0.2-1.5%. The etiology of RA is unknown, although clusters of the disease in families and high concordance in mono-zydotic twins support genetic predisposition. The prevalence of fatty liver disease in patients with rheumatoid arthritis is currently unknown. We wish to study the link between the two conditions by performing a son graphic imaging of the liver in a cohort of RA patients. If indeed a high prevalence of NAFLD will be found in the RA patients, further support will be landed for the link between inflammation and fatty liver disease. These findings may also have implications regarding the management and follow up of RA patients.

The validity of sonographic imaging for detection of fatty liver diseases is currently accepted: On ultrasonographic, fatty infiltration of the liver produces a diffuse increase in echogenicity as compared with that of the kidneys. Ultrasonography has a sensitivity of 89% and a specificity of 93% in detecting steatosis and sensitivity and specificity of 77% and 89% respectively in detecting increase fibrosis.

In view of all the above data, we expected to find higher prevalence of fatty liver in the patients with higher inflammation markers compare with patients with lower markers.


Eligibility Criteria:
Inclusion Criteria:

* Rheumatoid arthritis

Exclusion Criteria:

* Age below 18
Maternal Weight Gain in Gestational Diabetes Controlled by Metformin Versus Insulin

Insulin has many disadvantages for mothers with GDM including the need to give injections, frequent daily testing for monitoring, and risks of hypoglycemia, increase in appetite, weight gain and high cost. Metformin, an oral biguanide, may be a more logical alternative to insulin for women with GDM who are unable to cope with the increasing insulin resistance of pregnancy.

This study aim to compare maternal weight gain during pregnancy in women with gestational diabetes, treated by insulin versus metformin.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged (19-35) years
* BMI 18-30 kg/m2
* Gestational age \>24 weeks
* Singleton pregnancy
* Gestational diabetes mellitus with failure to achieve adequate glucose control on diet therapy alone (FBG \> 105) OR patients with gestational diabetes who are controlled with either metformin alone or insulin alone.

Exclusion Criteria:

* Pregnant women with preexisting diabetes mellitus
* Women who have contraindication to take metformin e.g.: impaired renal function, hepatic cirrhosis, hepatitis).
* Patients with other medical disorders that could affect perinatal outcome (e.g., hypertension, SLE etc).
* Fetal anomalies identified on ultrasound prior to initiation of therapy.
* Patients who refused to participate
Spatial Analysis of Host-parasite Interactions in Cutaneous Leishmaniasis in Ethiopia

Cutaneous leishmaniasis manifestations range from self-healing localized skin ulcers/nodules to diffusely spread chronic lesions. Knowledge on the host-parasite interactions underpinning the different clinical presentations is scarce, in particular for L. aethiopica infections where disease can be extremely severe. Our aim is to define differences in skin immune responses and parasite virulence in CL patients at single cell/parasite level and how it underpins the different clinical presentations (localised, mucocutaneous and diffuse), by producing the first spatially-resolved 'ecological' map of the lesions.

Specific objectives:

1. To profile the full heterogeneity in skin and lesion immunity (single cell RNAseq), and the cellular microenvironment surrounding infected and non-infected macrophages (digital spatial profiling).
2. To study the genomic diversity of L. aethiopica and identify features associated with the different clinical presentations (whole genome sequencing).
3. To understand how parasites respond to the microenvironmental conditions and define parasite survival niches (digital spatial profiling).
4. Study metabolic determinants of skin immunity (e.g. lipid metabolism, bioenergetics, short-chain fatty acids) in the context of key structural features of the skin landscape known to influence local metabolism and immune response (e.g. adipose tissue, follicles, microvasculature) (SpatialOMx).
5. To investigate the association between patient outcomes and the above host/parasite factors at baseline.

Eligibility Criteria:
Inclusion Criteria:

* Willing and able to provide informed consent
* Clinically confirmed CL diagnosis
* Between 12 and 50 years of age

Exclusion Criteria:

* Difficult or too painful sampling zone (see skin biopsy procedure below)
* (Primary) lesion size \< 1 cm
* Already receiving CL treatment or received CL treatment in the last 3 months (excluding traditional medicine)
* Known major comorbidity at time of diagnosis (e.g. VL, HIV, TB, malaria, severe intestinal helminth infection)
* Medical history of VL
* Severely underweight (BMI\<16)
* Known pregnancy
* Use of immunosuppressive medication in the last month
* Known excessive alcohol use (between \>10 intakes/day and \>10 intakes/week)
* History of hypersensitivity to local anaesthetics
* Presence of keloids/hypertrophic scars
Evaluating the Indego Exoskeleton for Persons With Hemiplegia Due to CVA

The purpose of this study is to evaluate the safety and effectiveness of the Indego exoskeleton as a gait training tool for individuals with hemiplegia due to Cerebrovascular Accident (CVA).


Eligibility Criteria:
Inclusion Criteria:

* Height 5'1" to 6'3" (acceptable height may vary by a few inches depending on femur length)
* Weight 250 pounds or less
* History of one sided ischemic or hemorrhagic stroke with resultant hemiparesis
* Manual Muscle Test (MMT) 4/5 in at least upper extremity
* No restrictions on time since stroke (acuity), but all subjects need to be cleared by MD for locomotor training
* No other brain abnormalities or neurological diseases/disorders
* Has not been diagnosed with more than one stroke
* Passive range of motion (PROM) at shoulders, trunk, hips, knees and ankles within functional limits for safe gait
* Skin intact where interfaces with Indego device
* Modified Ashworth Scale (MAS) for spasticity 3 or less in the lower extremities
* Absence of complicating physical or mental conditions as determined by MD that would preclude the individual from safely participating in gait training
* Must be able to follow directions and communicate basic needs, demonstrated by a Mini- Mental State Exam (MMSE) score of 18 or greater

Exclusion Criteria:

* Failure to meet all inclusion criteria
* Pregnancy
* Colostomy bag
* Uncontrolled/untreated hyper- or hypotension
Efficacy of Portion Size Measurement Aids

Portion size measurement aids (PSMAs) are tools that facilitate the estimation of food servings. The objectives of this study are to determine (a) if food portion size estimation accuracy differs when using a two dimensional (2D) PSMA (actual-size photos called Portion Size Cards) compared to a 3D PSMA (Portion Size Kit) and (b) whether differences exist in the short-term usefulness of and satisfaction with these PSMAs in a sample of parents of overweight children and youth. We hypothesize that the group that receives the 3D PSMAs will be more accurate in food portion size estimation and will be more satisfied with the tool compared to the group that receives the 2D PSMAs.

Forty primary caregivers of overweight children and youth attending the Pediatric Centre for Weight and Health (Edmonton, AB) will be recruited. Participants will be randomly assigned to one of the two groups (2D PSMAs versus 3D PSMAs). After a brief explanation of the respective tool, participants will estimate the volumes of pre-measured rubber food portion models on a test plate. Participants will then be given the 2D or 3D PSMAs to take home with them to use in the real-world. After 2-4 weeks, participants will be telephoned by the research team to complete a brief survey to evaluate their usefulness of and satisfaction with the 2D or 3D PSMAs at home.

Eligibility Criteria:
Inclusion Criteria:

* Participants must be primary caregivers of children or youth attending a clinical appointment for weight management (clients must have a BMI greater or equal to the 85th percentile at this clinic)
* Participants must be literate and fluent in English

Exclusion Criteria:

* Any participant who does not meet the above criteria
* Participants must not have had any previous education or resources on food portion sizes at this clinic
Healthy Weight for Teens

POWER is uniquely positioned to evaluate characteristics of multi-component PWM programs that are associated with "favorable" health outcomes for treatment-seeking youth with obesity. The POWER Data Coordinating Center developed ranking reports of the 33 participating sites based on weight status change at 6 months. An in-depth review of program design of 4 "top-performing" sites was conducted. A unique feature identified was offering an individual program orientation session to patient-families prior to the start of the multi-component PWM program. This orientation helped patient-families better understand the program's expectations, and offered an opportunity to evaluate readiness to change, barriers for making lifestyle changes, and mental health problems. This information was used to tailor the intervention to better meet the needs of participating patient-families. When a survey of program characteristics was conducted of the 33 participating sites, this "top-performing site" was the only one to offer such a program orientation session prior to patient-families starting the PWM program. Therefore this program feature was included as part of the "bundle of program enhancements" (BPE) for this proposed pragmatic pilot study.


Eligibility Criteria:
Inclusion Criteria:

* ≥ 12 years of age and \< 18
* Scheduled for a new patient clinic visit at the multi-component PWM program at CCHMC or HDVCH
* Severe obesity (≥ 120% of the 95th percentile for BMI based on age and gender at time of screening visit)
* Able to understand and complete the consent process
* Have access to a smart phone, device, or computer with a web camera
* Have access to the internet

Exclusion Criteria:

* Lacking capacity to provide informed consent
* Non-English speaking
* Participating in any other weight management program or research study related to weight management
* Have a sibling participating in any other weight management program or research study related to weight management
* Taking anti-obesity medication (Phentermine, Orlistat, Qsymia, Naltrxone-Bupropion, Lorcaserin, others at the discretion of the PI)