cyrilzakka/clinical-trials huggingface dataset:
A Study to Evaluate the Effect of IV Doses of Rivipansel on Subjects With Renal Impairment and in Healthy Subjects

The purpose of this study is to determine the effect of renal impairment on rivipansel.


Eligibility Criteria:
Inclusion Criteria:

* Female subjects of non-childbearing potential or male subjects
* Body Mass Index (BMI) of 17.5 to 40.0 kg/m2
* Stable renal function

Exclusion Criteria:

* A positive urine drug screen for illicit drugs
* Treatment with an investigational drug within 30 days of the dose of study medication
* Pregnant females, breastfeeding female subjects and male subjects with partners currently pregnant
* Use of herbal supplements in the 28 days prior to the dose of study medication
* Blood donation (excluding plasma donation) of approximately 1 pint or more within 56 days prior to study medication
* Requiring dialysis
Qigong for Post Acute Sequelae of COVID-19 Infection

The purpose of this study is to conduct a pilot feasibility study of external qigong on health-related quality of life in individuals with prolonged symptoms following COVID-19 infection.

The purpose of this study is to determine whether external qigong, a traditional Chinese medicine healing practice, improves quality of life and symptoms for individuals with prolonged symptoms following a COVID-19 infection (sometimes called "long COVID"). The study involves completing questionnaires and participating in 6 weekly in person small group qigong sessions with an experienced qigong practitioner.

Participants will be randomized to participate in either an immediate or waitlist control group that will receive the qigong sessions starting 8 weeks later. Participants will complete 3 sets of questionnaires, each about 8 weeks apart and an interview about their experiences with qigong after completing the 6 sessions.

Eligibility Criteria:
Inclusion Criteria:

1. English-speaking adults age 18 or greater
2. History of a COVID-19 infection with lingering symptoms lasting longer than 12 weeks
3. Willing and able to access the internet to complete questionnaires
4. Willing and able to travel to the qigong sessions to participate in person in Sacramento, CA.

Exclusion Criteria:

1. Lung scarring secondary to COVID-19 infection as evidenced by signs of parenchymal lung damage on imaging or FVC \< 80% (any patient with post COVID-related shortness of breath must have PFTs to be considered for enrollment).
2. Dementia
3. Any other condition that makes it difficult for the individual to complete questionnaires or attend the qigong sessions.
Effect of Quadriceps Muscle on Physical Outcome Measures in Women With Rheumatoid Arthritis

Studies have reported that individuals with Rheumatoid Arthritis have a smaller muscle cross-sectional area, pennation angle and muscle thickness than healthy controls. Sarcopenia may decrease physical performance and quality of life in individuals with RA. Therefore, morphologic changes in the quadriceps femoris muscle due to sarcopenia may help us to gain insight into physical function and quality of life. This study aims to evaluate the predictive capacity of morphologic characteristics of the quadriceps femoris muscle for disease activity, physical performance, and quality of life in women with Rheumatoid Arthritis.

Studies have reported that individuals with Rheumatoid Arthritis have a smaller muscle cross-sectional area, pennation angle and muscle thickness than healthy controls. Sarcopenia may decrease physical performance and quality of life in individuals with RA. Therefore, morphologic changes in the quadriceps femoris muscle due to sarcopenia may help us to gain insight into physical function and quality of life. This study aims to evaluate the predictive capacity of morphologic characteristics of the quadriceps femoris muscle for disease activity, physical performance, and quality of life in women with Rheumatoid Arthritis.

Within the scope of the study, the morphological characteristics of the quadriceps muscle of the participants will be evaluated by a Physical Medicine and Rehabilitation specialist physician via ultrasound. After appropriate visualization, the image will be captured and saved in JPEG format, and will be exported to the ImageJ program for further analysis and evaluations will be performed by an anatomist. Assessments of quality of life and physical performance will be made by a physiotherapist involved in the study.

Eligibility Criteria:
Inclusion Criteria:

* 18-60 years old
* Female participants with a confirmed diagnosis of RA for at least 3 years according to the 2010 American College of Rheumatology (ACR) criteria
* Presence of sarcopenia

Exclusion Criteria:

* Presence of fractures, burns or lesions in the area to be measured
* Presence of any neuromuscular, cardiovascular or metabolic disease,
* Individuals with knee endoprosthesis,
* Inability to walk
Effect of Serum Vitamin D on MARPE Treatment Response

A total of 30 patients are planned to be included in the study during the first half of 2025, who will apply to the clinic. In our clinical routine, approximately 30% of RME patients are treated using the MARPE method. The patients will be randomly assigned to two different groups. The first group will be referred to the Pediatric Endocrinology outpatient clinic at NEU Faculty of Medicine for vitamin D level measurements at the beginning of the treatment. The second group will proceed with treatment as usual, without vitamin D measurement. At the end of the treatment, vitamin D levels of all patients in both groups will be measured.

This randomized clinical trial aims to evaluate the potential impact of serum vitamin D levels on the outcomes of Miniscrew-Assisted Rapid Palatal Expansion (MARPE) treatment in young adults aged 15-18 years. A total of 30 patients presenting with maxillary transverse deficiency will be recruited during the first half of 2025. Patients will be randomly allocated to two groups. The intervention group will undergo vitamin D level assessment at the beginning of treatment and receive supplementation if found deficient, while the control group will proceed without initial vitamin D evaluation.

Serum 25-hydroxyvitamin D \[25(OH)D\] levels will be measured at T1 and T2 timepoints. Intraoral scans will be performed using an Itero device to assess changes in intercanine and intermolar widths, and the data will be analyzed using the ORTHOCAD software. Pain levels will be recorded by the patients using a Visual Analog Scale (VAS) on specified days during the expansion phase. This study intends to determine whether baseline vitamin D status and subsequent supplementation can improve the biological response and clinical efficiency of MARPE treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with Class I malocclusion
* Presence of maxillary transverse deficiency
* Adolescents aged between 15 and 18 years
* No systemic diseases, cleft lip/palate, or speech disorders
* No history of prior orthodontic treatment
* Willingness to undergo serum vitamin D testing
* Voluntary participation in the study with signed informed consent
* Good oral hygiene status

Exclusion Criteria:

* Patients with systemic diseases
* Patients who smoke
* Patients with poor oral hygiene
* Patients with cooperation or compliance issues
* Patients with intellectual disabilities
* Patients with unmonitored or insufficient pre-treatment vitamin D levels, including:
* Those who had insufficient vitamin D levels before treatment, were started on supplementation by the endocrinology department, but still had insufficient levels at the T2 measurement
* Those who were not tested before treatment but were found to have sufficient vitamin D levels only at T2
Mass Balance and Pharmacokinetics of [14C]-CRN00808 in Healthy Volunteers

A phase 1 healthy volunteer study to assess the mass balance, elimination, and metabolic profile of CRN00808. The study will be conducted in 2 parts: Part A, to characterize the absorption, distribution, metabolism, excretion, and mass balance of orally administered radio-labeled CRN00808; Part B, to determine the absolute bioavailability of CRN00808 administered using CRN00808 and radio-labeled CRN00808 as intravenous and oral forms.


Eligibility Criteria:
Inclusion Criteria:

1. Male subjects 19 to 55 years of age
2. BMI 18 to 30 kg/m2

Exclusion Criteria:

1. Any uncontrolled or active major systemic disease including, but not limited to: acromegaly (with or without pituitary surgery or radiation therapy), cardiac, pulmonary, gastrointestinal, metabolic, urogenital, neurological, immunological, psychiatric, or neoplastic disorder with metastatic potential
2. History or presence of malignancy within the past 5 years. Subjects who have been successfully treated (for 3 months or longer) with no recurrence of basal or squamous cell carcinoma of the skin or carcinoma in-situ of the cervix may be enrolled.
3. Use of any investigational drug within the past 60 days or 5 half-lives, whichever is longer
4. Have a medically significant abnormality observed during screening or the admission physical examination or in any other baseline measurements
5. Use of any prior medication without approval of the investigator within 14 days prior to admission
6. Tested positive at screening for HIV, hepatitis B surface antigen (HBsAg) or hepatitis C antibody (HCV-Ab) or has a history of a positive result
7. History of alcohol or substance abuse in the past 6 months
8. Any condition that in the opinion of the investigator would jeopardize the subject's appropriate participation in this Phase 1 study
Clinical Trial of Deferasirox Combination Treatment With Deferiprone In Thalassaemia Patients

Background: Three iron chelators now available on the market differ in toxicity and organ specificity; evidence on standardized chelation protocol remains inconclusive, but patients with transfusion-dependent beta-thalassemia treated with DFO infusion show significant differences in the limitations of daily activities, physical activity, and quality of life when treated with oral chelator. With licensing of DFP in America, it is reasonable to combine DFP with DFX. Patients find two oral chelators more acceptable than one oral and one injectable. This pilot study rates use of DFP for improving iron excretion profile of deferasirox.

Methods: The investigators enrolled 13 beta-thalassemia patients in China Medical University Children's Hospital in May 2009-October 2011. Five refused to take part in pharmacokinetics; they only participated in iron excretion study. Seven with irregular bowel function were unable to collect feces in the screening period as baseline data. Subjects were randomly assigned and rotated to undergo all treatments (with informed consent): (A) single oral dose of DFX 30 mg/kg once daily, (B) single oral dose of DFP 40 mg/kg twice a day, (C) oral doses of DFX and DFP administered sequentially (DFX 30 mg/kg/d, deferiprone 40 mg/kg/d and deferiprone 40 mg/kg/d at 7-hour intervals). Three-day drug dosage was followed by four-day washout. Collections of urine and stool proceeded 24 hours per day, each analyzed separately. Through a venous catheter, serial blood samples (1 mL/each sampling) were collected in glass tubes containing heparin as anticoagulant at Time 0 (pre-dosing) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 6, 7, 8, 10, 12 and 24 hours after dose; plasma concentrations of DFP and DFX were measured.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* serum ferritin greater than 2000 ng/mL,
* serum creatinine within normal range for a measuring laboratory
* platelet count exceeding 140000/mm3
* body weight at least 40 Kg
* None had a history of clinical significant of gastrointestinal, hepatic, renal, endocrine, oncologic, infectious, pulmonary or cardiovascular disease

Exclusion Criteria:

* HIV positive, history of immunologic hypersensitivity to any medication
* women pregnant or breast feeding
* drug or alcohol abuse
* patients showed abnormal or irregular bowel function (defined as more than three bowel movements a day or less than one bowel movement every other day)
* receiving warfarin, digoxin, or anti-arrhythmic or antiseizure medication.
A Non-significant Risk Clinical Study to Assess Perfusion Changes With Application of a TUS for Patients With PAD

The objective of the clinical trial is to gather evidence on the safety, performance and clinical efficacy Vibrato Sleeve TUS in people with peripheral artery disease (PAD).

Subjects will be randomized to a test or control group and will receive an active or sham Vibrato Sleeve respectively.

Those randomized to the control arm will undergo therapy sessions with a sham Vibrato Sleeve device and two months of follow-up. Upon completion of the 2-month follow-up visit, subjects will be informed of their randomization assignment. Subjects in the sham arm will be allowed to crossover to a treatment regimen that uses an active Vibrato Sleeve device and will follow the same visit schedule as the active test group.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥22.
2. Diagnosis of infrapopliteal PAD.
3. Rutherford class 4 or 5 as determined by the investigator.
4. Toe Brachial Index (TBI) ≤ 0.6 OR Toe Blood Pressure ≤ 50 mmHg.

Exclusion Criteria:

1. Prior stenting in posterior tibial, anterior tibial or peroneal artery.
2. Re-vascularization procedure within 25 days prior to enrollment in the study. (Note: Patients who had re-vascularization procedure earlier than 25 days prior to enrollment are eligible for enrollment if they meet other criteria).
3. Ulcers, cellulitis, or skin breakdown in treatment areas (posterior calf).
4. History or diagnosis of severe chronic venous insufficiency or mixed arterio-venous disease.
5. Acute limb ischemia within 30 days prior to treatment.
6. History or diagnosis of deep venous thrombosis below the knee in treatment leg.
7. Uncontrolled diabetes defined as HbA1c greater than 10%.
8. Ongoing hyperbaric oxygen treatment (HBOT)
9. Any conditions that, in the opinion of the investigator, may render the patient unable to complete the study or lead to difficulties for patient compliance with study requirements, or could confound study data.

9. Patient's enrollment in another investigational study that has not completed the required primary endpoint follow-up period (Note: Patients involved in a long-term surveillance phase of another study are eligible for enrollment in this study).
Correlation of 6-Minute Walk Test and Neuromuscular Parameters in the Elderly

The six-minute walk test had been used to assessment the cardiopulmonary parameter in patients with lung and heart disease. And it has good reliability and validity. It has been used extensively in research into the aerobic capacity in patients of peripheral vascular disease, neural system disease, and even the muscular-skeletal system disease, such as osteoarthritis, total hip or knee arthroplasty. There were studies investigate the predictors based on cardiopulmonary factors, neuromuscular and skeletal factors of the six-minute walk distance. But the last is the neuromuscular and skeletal factors.

The purpose of this study is to investigate the correlations between the six-minute walk distance and neuromuscular parameters: muscle function (including muscle endurance, muscle strength and muscle power), knee proprioception, and standing balance. For that it could be more useful for evaluation and treatment patients in clinic.

The study was planed to select 100 subjects, they are older than 65 years old with independent walking and without any diagnosis or symptoms about cardiopulmonary or neural disease. The evaluation are including knee proprioception (closed chain, active-active test), six-minute walk test, one leg standing balance test (open and close eyes for 30 seconds), quadriceps muscle strength at velocities of 600/s,1200/s and 1800/s, quadriceps muscle power at 1800/s, and quadriceps muscle endurance.

To investigate the correlations between the six-minute walk distance and characteristics of subjects, the correlations between six-minute walk distance and neuromuscular parameters, including quadriceps muscle function (strength, endurance and power), knee proprioception, and one leg standing balance. And to analyze what's the most contribution to the six-minute walk distance.


Eligibility Criteria:
Inclusion Criteria:

* older than 65 years old
* independent walking

Exclusion Criteria:

* diagnosis or symptoms about cardiopulmonary or neural disease
* depression
MSB0011359C (M7824) in Participants With Metastatic or Locally Advanced Solid Tumors

The main purpose of this study was to assess the safety and tolerability of MSB0011359C. Study consists of dose-escalation part and an expansion part in participants with metastatic or locally advanced solid tumors, for which no standard effective therapy exists or a standard therapy had failed.


Eligibility Criteria:
Inclusion Criteria:

* Able and willing to give written informed consent and had signed the appropriate written informed consent form (ICF), prior to performance of any trial activities
* Eligible male and female participants aged greater than or equal to (\>=)20 years
* Histologically or cytologically proven metastatic or locally advanced solid tumors, for which no effective standard therapy exists or standard therapy had failed
* Eastern Cooperative Oncology Group performance status (ECOG) performance status of 0 to 1 at trial entry
* Life expectancy \>=12 weeks as judged by the Investigator.
* Adequate hematological function defined by white blood cell (WBC) count \>=3\*10\^9/Liter with absolute neutrophil count (ANC) \>=1.5\*10\^9/Liter, lymphocyte count \>=0.5\* 10\^9/Liter, platelet count \>=75\*10\^9/Liter, and Hemoglobin (Hgb) \>= 9 grams per deciliter (g/dL) (in absence of blood transfusion)
* Adequate hepatic function defined by a total bilirubin level \<=1.5 × Upper limit of normal (ULN), an AST level \<= 2.5 × ULN, and an ALT level \<= 2.5 × ULN
* Adequate renal function defined by an estimated creatinine clearance \>50 milliliter per minute (mL/min) according to the Cockcroft-Gault formula or by measure of creatinine clearance from 24 hour urine collection

Other protocol-defined exclusion criteria could apply.

Exclusion Criteria:

* Concurrent treatment with non-permitted drugs and other interventions
* Anticancer treatment within 28 days before the start of trial treatment, for example cyto reductive therapy, radiotherapy (with the exception of palliative bone directed radiotherapy), immune therapy, or cytokine therapy
* Major surgery within 28 days before the start of trial treatment (excluding prior diagnostic biopsy)
* Systemic therapy with immunosuppressive agents within 7 days before the start of trial treatment; or use of any investigational drug within 28 days before the start of trial treatment
* Previous malignant disease other than the target malignancy to be investigated in this trial with the exception of cervical carcinoma in situ and superficial or non invasive bladder cancer (treated with curative intent) within the last 5 years or basal cell or squamous cell carcinoma in situ within the last 3 years
* Rapidly progressive disease which, in the opinion of the Investigator, may predispose to inability to tolerate treatment or trial procedures
* Active or history of central nervous system metastases, except as in the melanoma-specific Central nervous system (CNS) criteria listed above
* Receipt of any organ transplantation, including allogeneic stem-cell transplantation, but with the exception of transplants that do not require immunosuppression (eg, corneal transplant, hair transplant)
First Trimester Prediction of Preeclampsia and Fetal Growth Restriction

To evaluate the feasibility of screening for preeclampsia and fetal growth restriction between 11-13+6 weeks' gestation utilizing the combination of uterine artery doppler, maternal blood pressure, maternal characteristics, placental volume, and maternal serum factors, including PAPPA-A, PLGF, AFP and free Beta HCG. This is a non interventional study.

Preeclampsia (PE) is a condition which affects approximately 2% of all pregnancies and can be a major cause of maternal and perinatal morbidity/mortality (2). The suspected underlying mechanism of PE is thought to be impaired trophoblastic invasion of the maternal spiral arteries leading to impaired placental perfusion, placental ischemia and subsequent development of endothelial dysfunction (3). There is evidence that PE, which is commonly associated with fetal growth restriction, can be predicted effectively at 11-13 weeks gestational age by combined screening algorithms combining uterine artery pulsatility index (PI), maternal mean arterial pressure (MAP) and maternal serum concentrations of placental products including but not limited to plasma protein A (PAPP-A), and placental growth factor (PLGF) (4-6).

Aim of Study/Hypothesis:

The aim of this study is to develop an algorithm based on the combination of maternal factors, uterine artery pulsatility index, mean arterial pressure, placental volume and serum biomarkers to estimate patient specific risks for the development of Preeclampsia in a US population.

Eligibility Criteria:
Inclusion Criteria:

All patients during their first trimester visit

Exclusion Criteria:

Fetal anomalies Pregnancies ending in termination, miscarriage or fetal death prior to 22 weeks and cases with no pregnancy follow up.
Forced-dose Titration of SPD489 in Adults With Binge Eating Disorder

To evaluate the efficacy of SPD489 compared to placebo in the treatment of moderate to severe binge eating disorder as measured by the number of binge days per week


Eligibility Criteria:
Inclusion

* Subject meets the following Diagnostic and Statistical Manual of Mental Disorders Fourth Edition - Text Revision (DSM-IV-TR) criteria for a diagnosis of binge eating disorder (BED).
* Binge eating disorder is of at least moderate severity in which subjects report at least 3 binge eating days per week.
* Subject has a body mass index (BMI) of \>24 and \<46.

Exclusion

* Subject has concurrent symptoms of bulimia nervosa or anorexia nervosa.
* Subject is considered a suicide risk or risk to harm others.