cyrilzakka/clinical-trials huggingface dataset:
A Study of LP-128 Capsules in Healthy Subjects

A Randomized, Double-blind, Placebo-controlled Study to Evaluate Safety, Tolerability and Pharmacokinetics of LP-128 Capsules After Single- and Multiple-Dose in Healthy Subjects

This trial includes single dose and multiple dose phases. The single-dose phase included six dose cohorts. Based on the safety and pharmacokinetic results of single-dose study, approximately 2 doses will be selected to conduct multiple-dose study. The primary study objectives are to evaluate the safety, tolerability, and pharmacokinetic characteristics of LP-128 capsules in healthy subjects after single and multiple dosing.

Eligibility Criteria:
Inclusion Criteria:

* Subjects have no history of serious digestive system, central nervous system, cardiovascular system, kidney, respiratory system, metabolism and endocrine, skeletal and muscular system, blood system disease and cancer
* Subjects (including partners) are willing to take effective contraception measures during study and within 3 months after last dose
* Male and female healthy subjects aged 18 to 55 years old
* Male subjects weigh ≥ 50 kg, and female subjects weigh ≥ 45 kg
* Subjects able to understand and comply with study requirements
* Willing to sign the informed consent and fully understand the content, process and possible adverse reactions of the trial

Exclusion Criteria:

* Abnormal vital signs, physical examination or laboratory tests with clinical significance
* Abnormal ECG, chest X-ray, abdominal ultrasound or echocardiography with clinical significance
* Positive screening for viral hepatitis, HIV and syphilis
* Subjects who have taken any drugs or health care products within 14 or 28 days before administration the study drug; or subjects who have consumed tea or alcohol-containing food product within 24hrs before administration the study drug
* Subjects who have a history of dysphagia or condition may affect drug absorption, distribution, metabolism and excretion
* Female subjects are breastfeeding or pregnant
* Subjects who have a history of drug/alcohol/tobacco abuse
* Subjects who have had a blood donation or massive blood loss within three months before screening; or had major surgery within six months before screening
* Subjects who have participated in other clinical trial within three months before screening
* Subjects have special dietary requirements or cannot tolerate a standard meal
* Subjects who are not suitable for this trial based on the assessment of investigator
A Clinical Trial of Pronation Versus Supination Maneuvers for the Reduction of the Pulled Elbow

Nursemaid elbow or pulled elbow is a condition commonly seen in the emergency department. It is the sudden pull of the radial head (a bone in the elbow) in toddlers. Usually occur when a parent tries to pull the child by the arm and a "clic" or "clunk" is felt with immediate pain and unwilling to move the arm. It is not a dangerous condition although it is distressing for kids and their parents/caretakers.

The usual therapy consists of one of two maneuvers: supination maneuver or pronation maneuver. They both are safe to perform but none of them have been statistically superior over the other. More studies are needed to confirm or discard the tendency of the studies to favor the pronation maneuver.

The investigators intend to perform a randomized trial evaluating which of these techniques is better than the other in terms of returning the mobility of the affected arm and decreasing pain.

Eligibility Criteria:
Inclusion Criteria:

* Pulled elbow suspected in any child presenting one of the following:

  1. History of an adult or bigger person that had pulled the child's elbow non-intentionally
  2. Presence of intense pain at the arrival at the emergency department and unwilling to move the arm.

Exclusion Criteria:

* Any suspect of injury that could be intentional (child abuse)
* Any suspicion child of suffering a possible fracture (the mechanism of the injury was not from pulling the child's arm, the arm presents obvious deformity, ecchymoses, edema, etc.)
* The mechanism was from multiple trauma
* Any chronic disease affecting the adequate bone mineralization (vitamin D deficiency, osteogenesis, etc.)
Chronic Myeloid Leukemia (CML) Real-Life Database

Establish the largest possible real-life cohort collecting long-term follow-up of a maximum number of CML patients in order to carry out observational studies: epidemiological, identification of subgroups according to their response to treatment, evaluation of new molecules in real life, therapeutic discontinuations, impact of the evolution of recommendations, etc.

Observational study collecting real-life clinico-biological data from patients with CML. Data are collected prospectively and retrospectively, from diagnosis and throughout the long-term follow-up of CML (follow up continues after treatment stopped).

Eligibility Criteria:
Inclusion Criteria:

* Patient diagnosed for chronic myelocytic leukemia

Exclusion Criteria:

* CML allograft without TKI treatment
* Refusal or inability to sign the consent
Prospective Treatment Efficacy in IPF Using Genotype for Nac Selection (PRECISIONS) Trial

The purpose of this study is to compare the effect of n-acetylcysteine (NAC) plus standard care with matched placebo plus standard of care in patients diagnosed with idiopathic pulmonary fibrosis (IPF) who have the TOLLIP rs3750920 TT genotype. The study will compare the time to a composite endpoint of relative decline in lung function \[10% relative decline in forced vital capacity (FVC), first respiratory hospitalization, lung transplantation, or all-cause mortality\]

The secondary objectives will be to examine the effect of NAC on the components of the primary composite endpoint, the rates of clinical events, change in physiology, change in health status, and change in respiratory symptoms.

This is a multi-center, randomized, double-blind, placebo-controlled trial of NAC or placebo in about 200 participants with IPF with a TOLLIP rs3750920 TT genotype.

Eligible participants will be randomized in a 1:1 fashion to NAC or placebo, stratified by stable concomitant IPF therapy use (i.e., pirfenidone or nintedanib administered for at least 6 weeks prior to screening) versus no pirfenidone or nintedanib use. Participants will receive 600 mg NAC orally or matched placebo to take three times daily for 24 months.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 40 years of age
* Diagnosed with IPF according to 2018 ATS/ERS/JRS/ALAT, confirmed by enrolling investigator
* Signed informed consent
* If taking pirfenidone or nintedanib, must be on stable dose for at least 6 weeks prior to enrollment visit
* Confirmed rs3570920 TT TOLLIP genotype

Exclusion Criteria:

* Pregnancy or planning to become pregnant
* Women of childbearing potential not willing to remain abstinent (refrain from heterosexual intercourse) or use two adequate methods of contraception, including at least one method with a failure rate of \<1% per year during study participation
* Significant medical, surgical or psychiatric illness that in the opinion of the investigator would affect subject safety, including liver and renal failure
* Receipt of an investigational drug or biological agent within the previous 4 weeks of the screening visit or 5 times the half-life, if longer
* Supplemental or prescribed NAC therapy within 60 days of enrollment
* Listed for lung transplantation at the time of screening
* History of lung cancer
* Inability to perform spirometry
* Forced vital capacity (FVC) less than 45% predicted, using the global lung function index (GLI) equation at Visit 1
* Active respiratory infection requiring treatment with antibiotics within 4 weeks of Visit 1
A Study of LY2623091 in Participants With High Blood Pressure

The main purpose of this study is to evaluate the safety and effectiveness of the study drug known as LY2623091 in participants with high blood pressure.


Eligibility Criteria:
Inclusion Criteria:

* Have a history of hypertension.
* If participants are naïve to treatment of hypertension, or have not been treated with any antihypertensive medications within the 30 days immediately prior to screening:

  * Have seated systolic (SBP) of ≥140 and \<170 millimeters of mercury (mmHg) at screening and at the end of the lead-in period.
* If participants are currently being treated for hypertension:

  * Are taking a stable dose of 1 or 2 antihypertensive medications for at least the previous 30 days. A combination antihypertensive medication from 2 classes is considered as 2 antihypertensive medications.
  * Are willing to discontinue the antihypertensive medications during the study.
  * Have seated SBP of ≥140 and \<170 mmHg at the end of the lead-in period.
* Have a body mass index (BMI) ≥18.5 and \<40 kilograms/m\^2.

Exclusion Criteria:

* Have a history of severe hypertension (defined as SBP ≥180 mmHg and/or diastolic (DBP) ≥120 mmHg), secondary hypertension, symptomatic postural hypotension, or hospitalization due to hypertension.
* Have SBP ≥180 mmHg and/or DBP ≥110 mmHg at screening, lead-in period, or randomization.
* Have a history of hospitalization due to hyperkalemia, or history of drug discontinuation due to elevated serum potassium levels.
* Have a serum potassium ≤3.5 or \>5.0 millimoles per liter (mmol/L).
* Have an estimated glomerular filtration rate (eGFR) \<50 milliliters/minute/1.73 m\^2.
ADOlescent DysmenoRrhea Endometriosis Assessment Magnetic Resonance Imaging (Adodream)

To date, no MRI study has been published describing the prevalence of endometriosis in adolescent girls, not even in those with significant dysmenorrhea and therefore more particularly at risk. Likewise, there are no precise data on the type of superficial or early-onset deep endometriosis that appears in adolescence. The collection of these data would allow an earlier diagnosis, because it is better documented, of endometriosis. The lesions would then be treated earlier, avoiding their development and the problems of infertility related to this pathology. The aim of this sudy is to assess the prevalence of endometriosis and its phenotypic representation in the study population consulting for dysmenorrhea with suspected endometriosis.


Eligibility Criteria:
Inclusion Criteria:

* Patient aged between 12 and 20 years old.
* After menarche.
* Requiring pelvic MRI for exploration of dysmenorrhea (after or not ultrasound), in the case of patients with suspected endometriosis, or for any other reason (cyst, tumor, non-obstructive urogenital malformations), in the case of patients without symptoms clinic associated with endometriosis.
* Patient affiliated or beneficiary of a social security scheme.
* Patient and her legal representative, if applicable, having been informed and not opposing this research.

Exclusion Criteria:

* Patient whose pelvic MRI is performed as part of an exploration of obstructive uterine malformations.
* Patient claustrophobic, making it impossible to perform an MRI.
* Contraindication to MRI: pacemaker, ferromagnetic object incompatible with MRI.
* Pregnant, breastfeeding or parturient woman.
* Protected patient: Major under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision; Hospitalized without consent.
Placental Cord Drainage Versus no Placental Drainage in the Management of Third Stage of Labour

The aim of this work is to compare the effectiveness of placental cord drainage with no drainage in reducing the duration and blood loss in 3rd stage of labour.


Eligibility Criteria:
Inclusion Criteria:

* Full term Uncomplicated singleton pregnancy Pregnancy with vertex presentation Patients expected to have spontaneous vaginal delivery

Exclusion Criteria:

* Over distended uterus(hydramnios.large fetus) Previous history of postpartum haemorrhage Known coagulation disorder Haemoglobin less than 8 g/dl Ante partum haemorrhage Multiple pregnancies Instrumental delivery
A Study of the SMART Stent in the Treatment SFA Disease.

The main objective of this study is to assess the safety and performance of the sirolimus coated Cordis SMART™ nitinol self expandable stent device and its delivery system in the treatment of obstructive superficial femoral artery (SFA) disease in reducing percent in-stent mean lumen diameter stenosis in de novo or restenotic native lesions as compared to the uncoated SMART™ stent.

This is a multi-center, prospective, randomized, double blind, two-arm feasibility study evaluating the safety and performance of the sirolimus coated Cordis SMART™ nitinol self-expanding stent and delivery system as compared to the uncoated SMART™ stent and delivery system. It is anticipated that a total of 90 patients will be entered into the study. Patients will be randomized on a 1:1 basis of coated to uncoated stents.

Ninety (90) patients with de novo or restenotic native SFA lesions will be randomized to the Sirolimus Coated SMART™ nitinol self-expanding stent or to the uncoated (bare) SMART™ stent.

Patients will be followed for 24 months post-procedure, with all patients having duplex ultrasound and clinical assessments at discharge, 1, 6, 9, 18 and 24 months, angiography at 6 six months and plain X-ray at 18 months. This study will be conducted at nine investigational sites. (Protocol was amended where 56 additional patients were recruited and followed for up to 5 years.)

Eligibility Criteria:
Inclusion Criteria:

1. One superficial femoral artery presenting \> 70% stenosis(es) or total occlusion
2. Symptomatic leg ischemia by Rutherford Classification (category 1, 2, 3 or 4)

Exclusion Criteria:

1. Tissue loss due to ischemic disease (Rutherford category 5 or 6).
2. Tandem lesion requiring non overlapping stents;
Ritonavir-Boosted GS-9137 vs. Ritonavir-Boosted Protease Inhibitor(s) in Combination With Background ART.

The purpose of this study is to evaluate the non-inferiority of ritonavir-boosted GS-9137 relative to a ritonavir-boosted Comparator Protease Inhibitor when used as part of combination antiretroviral regimens in subjects who have failed, or are failing, protease inhibitor therapy.


Eligibility Criteria:
Inclusion Criteria:

* HIV RNA greater than or equal to 1000 c/mL.
* Failed/Failing protease inhibitor based antiretroviral therapy.
* Stable antiretroviral therapy for greater than or equal to 30 days prior to screening.
* Negative Serum Pregnancy Test.
* GFR by Cockcroft Gault greater than or equal to 80 mL/min.
* AST \& ALT less than or equal to 2.5x ULN.
* Total Bilirubin less than or equal to 1.5 mg/dL.
* Albumin greater than 3.5 mg/dL.
* Prothrombin Time INR 1.0-1.4
* Platelets greater than or equal to 50,000.
* Hemoglobin greater than or equal to 8.0 mg/dL.
* Absolute Neutrophil Count greater than or equal to 1000.

Exclusion Criteria:

* New AIDS defining condition within 30 days of baseline.
* Prior treatment with HIV-1 integrase inhibitor (except patients from 183-101).
* Ascites or encephalopathy.
* Breast Feeding.
* Cancer Diagnosis (besides Kaposi Sarcoma or Basal Cell Carcinoma).
An Innovative Virtually Supervised Exercise for Dialysis Patients

Among patients with diabetes 35% suffer from chronic renal disease and may require dialysis or kidney replacement over time. Furthermore, in diabetics with end stage renal disease (ESRD) that require dialysis, the risk of foot complications and amputation is even more common, expensive, and devastating. Interestingly, even though incidence of foot ulcers in patients with dialysis has been reported to be same as with patients with history of foot ulcers; dialysis patients have significantly higher rate of foot amputation.

The goal of this research is to incorporate an innovative virtually supervised non-weight bearing exercise in patients undergoing dialysis to reduce risk of fall and foot ulceration by enhancing lower extremity blood flow, joint perception and joint mobility.

Diabetic patients on hemodialysis at Hamad Medical Company will be recruited and will be randomized to either intervention (IG) or control (CG) group and followed for 6 months. The intervention group will take part in a 4-week non-weight bearing exercise program twice per week at the hemodialysis clinic under the supervision of a qualified research staff member. This intervention includes interactive game-based exercises including repetitive ankle and foot movements. Wearable sensors will provide real-time visual/auditory feedback from foot and ankle position and allowed perception of motor-errors during each motor-action. The control group will be instructed to complete a supervised foot and ankle exercise without using sensor technology. Changes in balance, gait, and physical activity, incidence of foot problems will be compared pre- and post-intervention. In addition, the incident of falls, foot ulcers, and limb amputation up to 6 months post intervention will be documented. Investigators hypothesize that patients receiving sensor-based exercises will benefit more compared to group receiving conventional non-technology training in terms of improving functional performance and reducing incidence of foot problems, falls, and limb amputation.


Eligibility Criteria:
Inclusion Criteria:

* Adults of 50 years or older, who are undergoing hemodialysis process
* Patients in diabetes
* Ability to provide consent

Exclusion Criteria:

* Non-ambulatory patients (unable to walk independently a distance of 20m with or without existence)
* Active foot ulcer
* Major foot amputation
* Charcot neuroarthropathy
* Major hearing/vision impaired
* Any patient with changes in psychotropic or sleep medications in the last 6 weeks
* Patients concurrently participating in another exercise training
* Patients with any clinically significant medical or psychiatric condition, or laboratory abnormality
Maintenance ZD1839 (IRESSA®) Following Completion of Front Line, Platinum-Based, Double Chemotherapy in Subjects With Advanced or Metastatic Non-Small Cell Lung Cancer

In this Phase IIIb, randomized, double-blind, maintenance study, 300 subjects with advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) (Stage IIIB {T4-pleural effusion} and IV) who have SD or objective tumor response immediately following the completion of 4-6 cycles of front line, platinum-based, doublet chemotherapy will be randomized in a double-blind manner to receive either ZD1839 or placebo.


Eligibility Criteria:
Inclusion Criteria:

* Must sign Informed Consent
* Females and males aged 18 years and over.
* Confirmed stage IIIB (T4-pleural effusion) and IV NSCLC.
* Either complete response, partial response, or stable disease following at least 4 cycles (3 in the setting of intolerable toxicity) but no more than 6 cycles of definitive front line, platinum-based, doublet chemotherapy.
* No prior EGFR therapy
* No newly diagnosed intracerebral metastases while receiving or after completing chemotherapy
* At least 3 weeks (21 days) but no more than 4 weeks (28 days) since last dose of chemotherapy
* Must be completely healed from previous major oncologic surgery
* Life expectancy of ≥ 8 weeks.

Exclusion Criteria:

* Known severe hypersensitivity to ZD1839 or any of the excipients of these products.
* Any evidence of clinically active interstitial lung disease (subjects with chronic, stable, radiographic changes who are asymptomatic need not be excluded).
* Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ.
* Any unresolved chronic toxicity greater than common toxicity criteria (CTC) grade 2 from previous anticancer therapy excluding peripheral neuropathy or alopecia.
* Evidence of any significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study.
* Pregnancy or breast feeding (women of child bearing potential). Women of childbearing potential must practice acceptable methods of birth control to prevent pregnancy.
* Treatment with a non-approved or investigational drug within 30 days before Day 1 of study treatment.
* Signs of neurological symptoms consistent with new onset spinal cord compression or CNS metastases.
* Treatment with any systemic anticancer therapies other than the prescribed protocol chemotherapy regimen (refer to Inclusion criterion -). Exception: Palliative radiotherapy for symptom relief of lesions present at diagnosis will be allowed; however, this radiotherapy must occur prior to completion of pre-study doublet chemotherapy.
* Males must also be willing to practice acceptable methods of birth control while taking the drug to prevent pregnancy of a partner.
mHealth Insulin Titration and Management (iSage)

The purpose of this study is to determine the benefits of using the iSage app for basal insulin titration and support. By doing this study the investigators hope to learn whether the app improves the participant's ability to follow his/her healthcare provider's instructions to adjust his/her insulin doses.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed Type 2 Diabetes, based on the World Health Organization (WHO) criteria, treated with basal insulin
* HbA1c 8-11% inclusive
* Glomerular filtration rate (GFR) \> 60 ml/min
* Has an Android or iOS based compatible smartphone (iOS 9.0 or above, Android 4.4 or above)
* Willing to perform at least 1 fasting finger stick glucose measurements every morning
* English speaking

Exclusion Criteria:

* Diagnosis of hypoglycemic unawareness
* Diagnosis of hyperglycemic hyperosmolar non-ketotic coma (HONK) or diabetic ketoacidosis (DKA) within 6 months of enrollment
* Recent (within the last 6 months)/current use of non-topical steroids
* Insulin requirements in excess of 1 U/kg per day
* Use of pioglitazone or another thiazolidinedione (TZD)
* In the opinion of the provider, HgbA1c goals should be adjusted above 7% due to infirmity, unstable cardiovascular disease, etc.
Nipple Sparing Mastectomy - Cosmetic Outcomes

The purpose of this study is to observe the cosmetic outcomes, patient satisfaction, and complications after skin sparing mastectomy with preservation of the nipple areolar complex.

The outcomes will be observed in patients with both known cancer diagnosis and in those with indications for prophylactic mastectomy. The cosmetic appearance and complications will be followed through several post operative visits throughout the duration of the study. This study is conducted in conjunction with the plastic and reconstructive surgeons who will be performing the breast reconstruction procedures. Patient satisfaction will be measured via survey format. In addition, local recurrence rates will be compared to patients undergoing traditional mastectomy.

Eligibility Criteria:
Inclusion Criteria:

* Patients requiring mastectomy for cancer and/or prophylaxis
* Age greater than or equal to 18 at time of surgery
* BMI less than or equal to 35
* If mastectomy is indicated for removal of breast cancer, tumor is clinically T1 or T2

Exclusion Criteria:

* Currently smoking
* Prior radiation to the affected breast
* Systemic lupus erythematosus
* Central tumor location and/or tumor within 2 cm of NAC
* Paget's disease of the nipple
* Clinical evidence of tumor involvement in the nipple
* Clinical evidence of axillary nodal tumor involvement
* Lymphovascular invasion of the tumor on core biopsy