cyrilzakka/clinical-trials huggingface dataset:
A Phase Ia/Ib Study of CS1001 in Subjects With Advanced Solid Tumors

This is a phase Ia/Ib, open-label, multiple-dose, dose-escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics and anti-tumor activity of CS1001 in subjects with advanced solid tumors.


Eligibility Criteria:
Inclusion Criteria:

1. With advanced-stage or metastatic tumor (unresectable) and experienced progression since last anti-tumor treatment; standard therapy is not available or rejected.
2. ECOG performance status of 0 or 1.
3. Subjects must have at least one measurable lesion.
4. Patients with life expectancy ≥ 3 months.
5. Subject must have adequate organ function.
6. Fertile men and women of childbearing potential must agree to use an effective method of birth control from providing signed consent and for six months after last study drug administration.

Exclusion Criteria:

1. Known brain metastasis or other CNS metastasis that is either symptomatic or untreated.
2. Subjects with active autoimmune diseases or history of autoimmune diseases should be excluded.
3. Patients who have received immune checkpoint proteins/antibody/medicine (including PD-1, PD-L1, etc) for treatment.
4. Known history of HIV infection.
5. Hepatitis B surface antigen (HBsAg) and Hepatitis B core antibody (HBcAb) positive or Hepatitis C virus (HCV) antibody positive.
6. Patients who have serious hypersensitive reaction to monoclonal antibodies, and have history of uncontrolled allergic asthma.
7. Known history of alcoholism or drugs abuse.

For more information regarding trial participation, please contact at cstonera@cstonepharma.com
Study of Oral Ubrogepant to Assess Adverse Events and Change in Disease Activity in Adult Participants With Menstrual Migraine

A migraine is a moderate to severe headache typically on one side of the head. A migraine attack is a headache that may be accompanied by throbbing, nausea, vomiting, sensitivity to light and sound, or other symptoms. Menstrual migraine (MM) is defined as migraine attacks that occur within the perimenstrual period (PMP) in at least 2 out of 3 menstrual cycles. The PMP is from 2 days before the onset of menstrual bleeding to 2 days after. This study will assess how safe and effective ubrogepant is in treating menstrual migraine. Adverse Events and change in disease activity will be assessed.

Ubrogepant is an investigational drug being developed for short-term prevention of menstrual migraine. Participants will be randomly assigned to one of the 2 groups to receive either ubrogepant or placebo. Around 450 adult female participants with menstrual migraine will be enrolled in approximately 100 sites in the United States and Puerto Rico.

Participants will receive oral ubrogepant tablets once daily for 7 consecutive days starting 3 days prior to estimated onset of menses per cycle for 3 PMPs during double-blind period (16 weeks). Eligible participants may continue to receive oral ubrogepant tablets once daily for 7 consecutive days per cycle starting 3 days prior to estimated onset of menses during open-label extension period (52 weeks).

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will collect data daily in electronic diaries and attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* At least a 1-year history of migraine with or without aura.
* Have experienced migraine attacks in at least 2 of 3 perimenstrual periods (PMPs) during the screening period.
* Collection of daily eDiary data for 3 perimenstrual periods during the up to 16-week screening period to confirm a menstrual migraine (MM) diagnosis.
* Have regular menstrual cycles of between 21-35 days in length.
* Less than 15 headache days per month.
* At least 70% compliance completing screening period and at least 3 out of 5 days of ediary data in each of 3 screening PMP.

Exclusion Criteria:

* History of migraine with brainstem aura, hemiplegic migraine, or retinal migraine.
* Clinically significant history of cardiovascular or cerebrovascular disease per the investigator's opinion.
* Clinically significant abnormalities in the physical examination as determined by the investigator.
* Clinically significant hematologic, endocrine, pulmonary, renal, hepatic, gastrointestinal, gynecological, or neurologic disease per the investigator's opinion.
* Acute headache medication overuse.
Endothelial Function and Progenitor Cells in Acute Ischemic Stroke

The purpose of this study is to determine whether levels of circulating endothelial progenitor cells (cEPC) are increased in the acute phase of ischemic stroke.

Endothelial dysfunction is a key component of atherosclerosis which contributes to the development of cardio- and cerebrovascular diseases. However, endothelial dysfunction (ED) is not established as a risk factor for ischemic stroke.

As a novelty the proposed trial investigates the following variety of indirect markers of endothelial function in acute ischemic stroke:

circulating endothelial progenitor cells (EPC), endothelial microparticles (EMP), ENDOPAT (RH- PAT ratio) in two regards:

1. time after ischemic events (\< 48h, Days 4-5, day 7 or at discharge)
2. etiological stroke subtypes

It is not known whether these parameters are changed after acute cerebral ischemia and could possibly serve as specific target for treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patients with first ever ischemic stroke
* TIA, or transient symptoms with infarction (TSI)
* Age \> or = 18 years old within 24 hours after onset
* Written informed consent to participate
* No evidence for dysphagia

Exclusion Criteria:

* Malignant hematopoietic disease (e.g. leukemia), severe systemic infections, severe immunological disease, renal or hepatic failure
* Pancreatitis, cholecystolithiasis, intestinal malabsorption
* Lactose intolerance
* Increased risk of aspiration
* Pregnancy
* Life expectancy less than 12 months
* Inability to give written informed consent
* Psychosis
* Alcohol dependency
* Abuse of illegal drugs
Behavioral Parenting Skills as a Novel Target for Improving Pediatric Medication Adherence: Study 3

The current study will assess the acceptability and feasibility of the CareMeds intervention with a larger sample (N = 100) across multiple sites in Buffalo, NY, and Atlanta, GA.

This is a pilot randomized controlled trial of the CareMeds program to assess feasibility and obtain preliminary efficacy data among families of young children (ages 3-9) with ALL. The objective of this aim is to implement our study procedures and study conditions (CareMeds vs. usual care control). We hypothesize that pilot findings will support the feasibility of the intervention and suggest important improvements in our behavioral secondary outcomes (i.e., behavioral parenting skills, medication adherence

Eligibility Criteria:
Inclusion Criteria:

* Parent of a child who is diagnosed and being treated for any type of acute lymphoblastic leukemia (ALL) at a study site.
* Parent has primary medication responsibility.
* Pediatric patient aged 3-9 years
* Child on therapy that includes home-based oral anti-cancer medication taken at home, such as 6-MP.
* Parent has verbal English or Spanish fluency.
* Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure

Exclusion Criteria:

* Parent of a child who is not diagnosed nor being treated for any type of acute lymphoblastic leukemia (ALL) at a study site.
* Parent does not have primary medication responsibility.
* Pediatric patient aged 3-9 years
* Pediatric patient is not on therapy that includes oral anti-cancer medication (e.g., 6-MP).
* Parent does not have verbal English or Spanish fluency.
* Parent is unwilling or unable to follow protocol requirements
Pregabalin (Lyrica) for the Treatment of Restless Legs Syndrome

This study will evaluate the safety and efficacy of Pregabalin (Lyrica) in treating patients with Restless Legs Syndrome (RLS) in a double-blind, placebo-controlled trial.


Eligibility Criteria:
Inclusion Criteria:

1. Outpatients with RLS diagnosed by a movement disorder specialist/ Sleep specialist .
2. Patients must report some degree of pain which occurs on a regular basis.
3. Age 18 years to 80 years.
4. Women of child-bearing potential must use a reliable method of contraception and must provide a negative pregnancy test at entry into the study.
5. Stable doses of all medications for 30 days prior to study entry and for the duration of the study.
6. Willing and able to provide informed consent.
7. Willing to comply with protocol. -

Exclusion Criteria:

1. Any illness that in the investigator's opinion preclude participation in this study.
2. Pregnancy or lactation.
3. Concurrent participation in another clinical study.
4. Current treatment with a dopamine agonist (unless stopped at least 2 weeks prior to baseline).
5. Dementia or other psychiatric illness that prevents the patient from giving informed consent (Mini Mental Status Exam score less than 24).
6. Legal incapacity or limited legal capacity.
7. Presence of severe renal disease BUN 50% greater than normal, Patients must have evidence from their PCP or Urologists of normal PSA and urodynamic tests within the last 12 month. Normal BUN levels should be within a range of 5 to 20 mg/ d L and creatinine between .7 and 1.4 mg/ d L. Labs will be requested from PCP.
8. Presence of major hepatic impairment (Cirrhosis, Viral Hepatitis, Nonalcoholic Steatohepatitis, Wilson's disease, or Hemochromatosis). LFT must show non-clinically significant results (Albumin range 3.0-6.0; Alkaline phosphatase range 40-150; ALT range 0-55; AST range 5-34).
9. Presence of severe daytime sleepiness.
10. Present complaints of somnolence, dizziness, blurred vision, bleeding tendencies, cardiac abnormalities.
11. Patients taking dopamine agonists for any condition other than RLS. -
Comparison of Acetaminophen With Codeine and Ibuprofen for Children With Injuries

We compared the pain relief of acetaminophen with codeine versus ibuprofen for children ages 5-18 years who came to the Pediatric Emergency Department with injuries to their arms or legs.

We conducted a randomized, double-blinded equivalence trial. Pediatric Emergency Department patients 5-18 years of age with acute extremity pain received acetaminophen-codeine (1 mg/kg as codeine) or ibuprofen (10 mg/kg). They provided Color Analog Scale pain scores at baseline and at 20, 40, and 60 minutes after medication administration. The primary outcome measured was the difference in changes in pain score at 40 minutes, compared against a previously described minimal clinically significant change in pain score of 2 cm. Additional outcomes included need for rescue medication and adverse effects.

Eligibility Criteria:
Inclusion Criteria:

* 5 to 18 years of age
* Spoke English as a primary language
* Complained of an extremity injury with tenderness to palpation from the clavicle or femoral neck to the distal phalanges
* Scored 5 or greater on a 10-point ordinal or Varni-Ryan pain scale administered at triage

Exclusion Criteria:

* Allergy or prior adverse reaction to acetaminophen, codeine or ibuprofen;
* Administration of any analgesic within 6 hours of presentation;
* Significant deformity or vascular insufficiency of the extremity requiring immediate treatment as determined by the treating physician;
* Inability to use the study pain instrument;
* Any laceration near the suspected injury;
* Chronic hepatic or renal disease;
* Pregnancy in the third trimester;
* Concurrent use of contraindicated medications such as monoamine oxidase inhibitors; or
* Use of central nervous system depressants such as ethanol, benzodiazepines, barbiturates, antidepressants, or recreational drugs
Hemin to Prevent Post-ERCP (Endoscopic Retrograde Cholangiopancreatography) Acute Pancreatitis

ERCP (endoscopic retrograde cholangiopancreatography) has been largely demonstrated to be effective in multiple bilio-pancreatic indications. However, one of the feared complication of this technique is acute pancreatitis, which happens in 5 to 25% of cases. Some patient groups have been demonstrated to present a higher risk linked to individual factors or to the procedure. Some interventions (endoscopic or pharmacologic) have been evaluated to reduce the incidence of this complication but each has his own inconvenient. Recently, the activation of heme oxygenase (HO) by intraperitoneal administration of hemin has been demonstrated to be effective in prevention and treatment of acute pancreatitis mice models. This protective effect has been associated to intrapancreatic HO-1 positive macrophage recruitment activated by hemin. The investigators thus propose to conduct a prospective randomized double blind controlled trial to demonstrate a protective effect of hemin administration against post-ERCP acute pancreatitis in high risk patients.

Patients for who a pancreatic stent placement is indicated will be excluded from the study.

The aims of this study are: 1) to study in a pathophysiologic point of view the activation of HO-1 by hemin in human and its protective effect in post-ERCP acute pancreatitis incidence. 2) to use the human situation of post-ERCP acute pancreatitis as early pancreatitis model to study the administration of hemin as treatment of acute pancreatitis in general.

Eligibility Criteria:
Inclusion Criteria: one or more factors of \>10% post-ERCP acute pancreatitis risk:

* former episode of acute pancreatitis
* former episode of post-ERCP acute pancreatitis
* normal bilirubin level
* main pancreatic duct injection
* endoscopic biliary sphincteroplasty (balloon dilation of biliary sphincter)
* precut papillotomy
* pancreatic sphincterotomy

Exclusion Criteria:

* patient for whom a pancreatic stent is inserted (Sphincter of Oddi dysfunction, ampullectomy)
* ongoing acute pancreatitis
* chronic pancreatitis (Cremer classification \>=2)
* age \< 18 y/o
* pregnancy
* hemin allergy
* severe renal failure (MDRD\<30ml/min/1.73m2)
Study to Evaluate the Safety and Efficacy of VIRAZOLE® in Hospitalized Adult Participants With Respiratory Distress Due to COVID-19

This study is a Phase 1, open label, non-randomized, two-arm interventional clinical trial to evaluate the safety and efficacy of Virazole® in hospitalized adult patients who have tested positive for COVID-19 and, as a result, have significant respiratory distress (PaO2/FiO2 ratio \<300 mmHg).


Eligibility Criteria:
Inclusion Criteria:

1. Male or non-pregnant female ≥ 18 years of age.
2. Willing and able to provide written informed consent (or provided by a proxy).
3. Currently hospitalized with laboratory confirmed COVID-19 novel coronavirus infection.
4. PaO2/FiO2 ratio \<300 mmHg.
5. Illness of any duration, and at least one of the following:

   * Radiographic infiltrates by imaging (chest x-ray, CT scan, etc.), OR
   * Clinical assessment (evidence of rales/crackles on exam) AND SpO2 ≤94% on room air, OR
   * Requiring mechanical ventilation and/or supplemental oxygen.
6. Once released from the hospital, women of childbearing potential (WOCBP) and all men must agree to use at contraception methods for 9 months.

Exclusion Criteria:

1. Pregnant or breast feeding.
2. Respiratory distress for reasons other than COVID-19 infection (e.g., congestive heart failure (CHF), bacterial pneumonia, etc.).
3. Presence of secondary bacterial pneumonia.
4. Presence of significant pulmonary fibrosis.
5. Hypotension (need for hemodynamic pressors to maintain blood pressure).
6. Greater than 7 days on mechanical ventilation.
7. Anemia defined as hemoglobin or RBC \<75% of the institutional lower limit of normal for race, age and gender.
8. History of COPD or bronchospasm prior to COVID-19 infection.
9. History of hypersensitivity to ribavirin.
10. Any condition that could cause noncompliance with treatment or may otherwise contraindicate the subject's participation in the study
11. Subject is currently participating in any drug or device clinical investigation.
12. Subject has received an investigational agent or approved drug that, in the Investigator's judgement, may have a chemical or pharmacological interaction with Virazole if administered within 5 half-lives or 30 days of the Baseline Visit.
Comparison Between a Telerehabilitation Program for Urinary Incontinence Versus a Conventional Face-to-face Program

Urinary incontinence (UI) is defined as any involuntary loss of urine. It affects a significant percentage of the population, mainly female, with a prevalence of 21.4% in Portuguese women, having a negative impact on quality of life and sexual function.

About half presents with stress UI (SUI), followed by mixed UI (MUI), with isolated urgency UI being less common.

Pelvic floor rehabilitiation is a first line treatment for SUI and MUI, however, it is not yet defined which is the best treatment program or the ideal strategies to improve adherence to it.

Telerehabilitation assumed a leading role in the covid pandemic phase, although there are few studies on pelvic floor rehabilitation for UI, none in Portugal to date.

The authors aim to evaluate the effectiveness of a hybrid program of pelvic floor rehabilitation in female patients with SUI and MUI with a predominance of SUI, including consultation and face-to-face sessions complemented with telerehabilitation.

Randomized longitudinal study including consecutively admitted patients on pelvic floor rehabilitation consultation of the Physical Medicine and Rehabilitation Department of Centro Hospitalar São João for conservative treatment of UI.

Patients who meet the inclusion criteria and do not meet any of the exclusion criteria will be randomized one to one between the intervention group and the control group.

The intervention group includes a hybrid program of face-to-face sessions followed by sessions of video, while the control group develops the entire program in face-to-face sessions.

The effectiveness of the program will be assessed by the results in the UI-related quality of life (primary outcome); UI severity, patient's overall perception of improvement, sexual function, depression/anxiety symptoms and satisfaction and adherence to treatment (secondary outcomes).

Eligibility Criteria:
Inclusion Criteria:

* Female patients aged between 18 and 65 years with SUI or MUI with a predominance of SUI with at least 1 urinary incontinence episode per week in the last month
* Pelvic floor muscle strength greater than or equal to 2 (modified Oxford scale)
* Capable of understanding and executing the therapeutic program and expressing agreement to participate in the study after free and informed consent

Exclusion Criteria:

* Patients with urgency urinary incontinence or MUI with a predominance of urgency
* Pregnant women
* Submitted to conservative or surgical treatment of UI in the last 12 months
* Active urinary tract infection
* Macroscopic hematuria
* Neurogenic dysfunction of the lower urinary tract
* Cognitive deficit
* Osteoarticular, neurological or psychiatric pathologies that prevent the realization of the therapeutic program
* Active pelvic neoplasia
* Pelvic organ prolapse grade greater than or equal to 2
* Impossibility of access or illiteracy to technological means (phone or computer)
* Unavailable to attend the face-to-face program due to accessibility, schedule, economic reasons or fear of the pandemic context
Effect of Hand-Washing Training in Covid-19

This study was conducted in order to inform, the women with chronic disease in rural areas, about hand-washing and nutrition, and to evaluate the efficiency of the training program. A randomized-controlled trial was performed based on CONSORT checklist. 90 women in total were included in the study, 45 for each group. The women in the intervention group were given, by the researcher, the training on the importance of hand-washing and appropriate food choices. The training given to the women in rural areas created significant benefit for them to have the appropriate food choices and hand-washing behaviours.


Eligibility Criteria:
Inclusion Criteria:

* Be women, agreeing to participate.

Exclusion Criteria:

* Be man, unable to communicate.
Rotator Cuff Reconstruction With Xenologous Dermis-patch Augmentation and ACP® - Injection

The purpose of this study is to show that an augmentation with the DX Reinforcement Matrix from Arthrex is possible with the arthroscopic technique.

The shoulder joint, specially the rotator cuff, is one of the most complicated joints of the human body. If the tendon has to be fixed at the bone during surgery, the weak point in obtaining a successful surgery is the fixation of the tendon at the bone insertion site. Tendon belongs to the bradytrophic tissue conditional on the reduced blood flow, deep mitosis rate and lowered healing potential.

The patients in this study have 60 years or more. The tissue of these patients isn't as good as in young patients. The patch will be used to improve the strength of the tendon at the insertion site and the ingrowth process of the new tissue at this area. Additionally the investigators can boost the healing process with a selective use of PRP (PRP = platelet rich plasma). In this process, the healing site is delivered with an elevated concentration of thrombocytes and also growth factors which are constituent parts of them.

Eligibility Criteria:
Inclusion Criteria:

* Arthroscopic rotator cuff reconstructions of degenerative or traumatic full thickness rotatorcuff tears (supraspinatus should be affected)performed by Dr. Flury
* Age: 60 years or more
* Suture bridge technique
* Women: No longer of childbearing age (at menopause and last menstrual period more than 12 months, prevented surgically Ovaries and/or uterus removed surgically)
* Signed consent form

Exclusion Criteria:

* Partial reconstruction of the rotator cuff (PASTA)
* Open reconstruction
* Tendon transfer (latissimus dorsi or pectoralis major)
* Revision surgery
* Omarthrosis (Level ≥ 2 Samilson \& Prieto)
* Systemic arthritis
* Rheumatoid arthritis
* Diabetes (insulin treated)
* Requiring surgery in reconstruction of the subscapularis tendon
* Progressive fat inclusion (fatty infiltration of the rotator cuff musculature goutallier level IV
* Acute or chronic infection
* Pathological bone metabolism
* Insufficient perfusion in the affected arm
* Neuromuscular disease in the affected arm
* Non compliance of the patient
* Disorders which handicap or inhibit the patient to follow the orders of the clinical testers