cyrilzakka/clinical-trials huggingface dataset:
Study to Investigate the Safety Profile of AZD4721 After Single Doses at Different Dose Levels

Study to investigate the safety profile of AZD4721 after single doses at different dose levels

A study to investigate safety and tolerability of single ascending doses of AZD4721 given to healthy volunteers. Including a bioequivalence part to compare a solution of AZD4721 with a suspension.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy male and/or female Caucasian (neither Black/African American nor Japanese) volunteers aged 18-50 years. ("Healthy" is as determined by medical history and physical examination, clinical laboratory parameters, and ECG )
2. Females must have a negative pregnancy test at screening and on admission to the unit, must not be lactating and must be of nonchildbearing potential
3. Volunteers should have a BMI between 18 and 30 kg/m2 (inclusive) and weigh at least 50 kg and no more than 100 kg (inclusive).

Exclusion Criteria:

1. History of any clinically important disease or disorder which, in the opinion of the Investigator, may either put the volunteer at risk because of participation in the study, or influence the results or the volunteer's ability to participate
2. Current smokers or those who have smoked or used nicotine products within the previous 3 months

2.Clinically significant lower respiratory tract infection not resolved within 4 weeks prior to Visit 1, as determined by the Investigator

4. Other latent or chronic infections (eg, recurrent sinusitis, genital or ocular herpes, urinary tract infection) or at risk of infection (surgery, trauma, or significant infection) in previous 90 days, or history of skin abscesses within the previous
Prednisolone in the Treatment of Withdrawal Headache in Probable Medication Overuse Headache

The purpose of this study is to determine whether prednisolone is more effective than placebo in the first six days after initiation of medication withdrawal therapy for a medication overuse headache. Another purpose is to study whether patients followed by a neurologist 1 year after withdrawal do better than patients followed by a general practitioner.

Data published BoeMG,Mygland A,Salvesen R; Neurology 2007 Jul 3;69(1):26-31

Eligibility Criteria:
Inclusion Criteria:

* Chronic daily headache and medication overuse fulfilling International Headache Society (IHS)-II criteria

Exclusion Criteria:

* Pregnancy
* Age under 18 and over 70 years
* Major mental disorders
Improving Quality of Life Using Patient Reported Outcomes Measures Post-operative Via Text Messaging

This study is investigating a new way to monitor patients who are recovering at home after surgery. This study uses text messages to ask patients to review their own symptoms and then reply with the level of severity of specific symptoms. Based on each patient's specific response to the text message survey, a pre-programmed, automated response will be sent from the study prompting the patient to take specific actions (or no action if no symptoms). Investigators will assess whether this method improves patients' well-being as compared to the current standard of care for patients. Currently, after surgery, patients are provided counseling and written instructions when they leave the hospital on how to care for themselves at home. If the patient has questions or concerns, they contact their care team. The optimal way to help patients assess their own symptoms at home remains unknown. Investigators are also assessing if using the symptom survey reduces readmissions to the hospital.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years of age or greater.
* Planning to undergo a surgical procedure via a laparotomy incision for a suspected or known gynecologic malignancy. There is no restriction on the spectrum of pathology or disease.
* The ability and willingness to send and receive short messaging service (SMS) text messages.
* Able to read and understand English.
* Willing and able to provide informed consent

Exclusion Criteria:

* Persons who are planning to undergo a minimally invasive procedure without laparotomy.
* Persons unable to be contacted by SMS text message or choose to opt-out of the study.
* Patients who do not have access to the internet via a home computer or a smart phone.
Association Between Clinical Effect of Continuous Morphine Administration After Surgery and Pharmacogenetics

Identification of the genetic polymorphisms that could be correlated either with a better clinical response or with a major predisposition of patients to develop tolerance and/or side effects to the treatment with morphine.

Valuation of the rescue doses necessary to maintain NRS\<4 in the first 24 hours post-surgery in the two groups of patients, A e B. Group A: homozygous patients for the more frequent allele of the polymorphism A118G of OPRM1 gene (about 80%); group B: both homozygous and heterozygous patients for the less frequent allele (about 20%).

Eligibility Criteria:
Inclusion criteria:

* Males and females over 18 years, under 75 years, scheduled for postoperative pain control with continuous morphine administration
* HIV negative
* Classification American Society of Anesthesiologists (ASA) I: without systemic disease
* Classification ASA II or III (mild systemic disease or severe systemic disease that limits the activity without invalidity).
* Undergoing abdominal and urologic major surgery (neither urgent nor emergency surgery)
* Signed informed consent

Exclusion criteria:

* Usual assumption of analgesic opioids
* Cognitive alterations nor mental retardation
* Severe hepatic/renal insufficiency (cholinesterase \<3000 mU/ml, total bilirubinaemia \<2 mg/dl and creatininaemia \<1.2 mg/dl)
* Inpatients in intensive therapy, either with sedation and/or mechanic ventilation.
* Allergies to morphine and derivates
Research of SORD-CMT Natural History and Epalrestat Treatment

Charcot-Marie-Tooth disease (CMT) is a group of the most common hereditary peripheral neuropathy with high clinical and genetic heterogeneity. Biallelic pathogenic variants in SORD gene leading to loss of function of SORD protein cause axonal degeneration. Current research suggests that SORD-CMT2 may be the most common subtype of AR-CMT2. The primary purpose of this study is to explore the natural history of SORD-CMT2 patients by detecting the ONLS scale score and serum sorbitol level changes at 6th, 12th, 24th, and 36th months and to evaluate the effectiveness and safety of epalrestat. Patients with strong treatment willingness and voluntary purchase of drugs are included in the epalrestat treatment group, and patients without drug treatment willingness are included in the control group. Patients in the drug treatment group take epalrestat (50 mg) orally three times daily. This study is expected to be carried out simultaneously in 5 hospitals in mainland China. About 30 SORD-CMT2 patients will be enrolled in this study, and the study period will be 36 months.


Eligibility Criteria:
Inclusion Criteria:

* Genetically confirmed SORD-CMT2 patients.
* Male or non-pregnant, non-lactating female patients, aged \> 14 and ≤ 50 years old.
* Rule out secondary peripheral neuropathy (e.g., diabetic peripheral neuropathy)
* Voluntarily participate in clinical trials, sign informed consent, and be able to understand and abide by research procedures.

P.S. Patients who have a strong willingness to treat and voluntarily purchase epalrestat for treatment (50mg, three times a day) are included in the treatment group.

Exclusion Criteria:

* Presence of any other cause of peripheral neuropathy.
* Subjects with other neurological disorders affecting the evaluation of study treatment.
* History of clinically significant unstable medical disease that may cause harm to subjects participating in this study within the past 1 year.
* Patients with major trauma or extremity surgery before enrollment or planned for extremity surgery before completion of follow-up.
* Patients with previous bilateral ankle stabilization surgery.
* Patients who were treated with other related drugs in the 3 months before enrollment.
* Have any history of drug abuse; have a history of alcohol dependence in the past 3 months.
* Subjects who are positive for syphilis antibody and HIV antibody.
* Subjects whose chest X-ray and B-ultrasound show tumors.
* Patients with poor compliance and unable to complete the study follow-up.
* Patients who do not agree to participate in the study.
* Other factors are not suitable for inclusion.
Preventing Excessive Gestational Weight Gain in Obese Women

The purpose of this study is to study the effects of a multicomponent lifestyle intervention that includes partial meal replacements as a means to prevent excessive gestational weight gain in obese women. The primary hypothesis is that the intervention will reduce the rate of gestational weight gain compared with standard care.


Eligibility Criteria:
Inclusion criteria:

* Over 18 years old
* \< 16 weeks gestation
* BMI \>= 25
* Willing to consent

Exclusion Criteria:

* Pregnant with Twins
* Untreated medical or psychological problem
* Inability to be physically active
Study Evaluating the Efficacy and Safety With CD19CAR-T for Relapsed or Refractory Non-Hodgkin Lymphoma

This study is a single-arm, open label, phase I clinical trial to evaluate the safety and feasibility of CD19CAR-T in treatment of relapsed / refractory non-hodgkin lymphoma


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis with Relapsed or refractory Non Hodgkin Lymphoma with CD19 positive
2. Age 18 to 65 years old, both male and female;
3. Is expected to survive more than 12 weeks;
4. Physical condition is good: 0-1 score ECOG score;
5. No obvious abnormal heart, liver, kidney, no large wounds that haven't healed on the body;
6. Into groups to participate in voluntarily, good adherence, can cooperate test observation, childbearing age women must be 7 days before starting treatment expert pregnancy test and the results were negative, and signed a written informed consent form.

Exclusion Criteria:

1. Organ failure, such as heart: Class III and IV; liver: to Child grading of liver function grade C; kidney: kidney failure and uremia stage; lung: symptoms of severe respiratory failure; brain: disorder of consciousness;
2. Existing serious acute infection, uncontrollable, or have fester sex and chronic infection, wound in delay no more;
3. Pregnancy and lactation women;
4. Patients who have participated in other clinical trials or other clinical trials in the past 30 days;
5. The Investigator believe the patients should not participate in this experiment.
Multi-Plane Hallux Valgus Correction With the Phantom® Nail

The goal of this research study is to determine the change in frontal plane rotation of the 1st metatarsal from pre to post arthrodesis of the 1st TMT joint with the Phantom® Intramedullary Nail combined with a supinating reduction technique.

The study hypothesis is that multi-planar correction can be achieved with the Phantom® Intramedullary Nail.

Each subject will undergo a Lapidus Arthrodesis combined with a supinating reduction technique.

The subjects will undergo 3 weight-bearing CBCT scans of their foot and ankle, one pre-arthrodesis, one two weeks post-arthrodesis, and one 12 weeks post-arthrodesis. These scans will be used to determine change in frontal plane rotation of the 1st metatarsal from pre to post arthrodesis of the 1st TMT joint, change in angular/positional alignment of the 1st TMT joint using various measurements (1-2 IMA, Meary's Angle, HVA, MAA, Sesamoid Position, and Sesamoid Frontal Plane Rotation), maintenance of correction of the 1st TMT joint, and union status.

The subjects will also complete three surveys, the Pain and Satisfaction Survey, the AOFAS Hallux MTP-IP Scale, and the FAOS Foot and Ankle Survey, at the Pre-Operative Visit, 2 Week Visit (post-op), 6 Week Visit (post-op), and 12 Week Visit (post-op). Furthermore, the subjects will be asked about their willingness to undergo the procedure again at the 12 Week Visit (post-op). All of these scores will be considered in the secondary objectives.

Aside from the study activities listed above, all procedures, visits, and instructions for the subject are to follow the standard of care.

Eligibility Criteria:
Inclusion Criteria:

* The subject is at least 18 years of age at the time of screening.
* The subject has been diagnosed with hallux valgus.
* The subject has pain associated with hallux valgus.
* The subject agrees to comply with the requirements of the study and complete the study measures.
* The subject is willing and able to provide written informed consent.
* The subject plans to undergo a Lapidus Arthrodesis procedure with a 3-Hole Phantom® Intramedullary Nail.

Exclusion Criteria:

* The subject is pregnant.
* The subject has had previous surgery for hallux valgus on operative side.
* The subject will require a structural graft in the 1st TMT joint.
* The unshod foot in question is greater than 28 cm in length.
* The subject is not expected to complete the study according to the investigation plan.
* The subject has been deemed physiologically or psychologically inadequate by the enrolling physician.
* The subject is a prisoner, unable to understand what participation in the study entails, mentally incompetent, a known abuser of alcohol and/or drugs, or anticipated to be non-compliant.
Customized Headrest or Standard Headrest in Holding Patients Still While Undergoing Radiation Therapy for Head and Neck Cancer

RATIONALE: Using a customized headrest to hold patients in one position may help doctors plan treatment for patients with head and neck cancer. It is not yet known whether a customized headrest is more effective than a standard headrest in holding patients still during radiation therapy.

PURPOSE: This randomized clinical trial is studying a customized headrest to see how well it works compared with a standard headrest in holding patients still while undergoing radiation therapy for head and neck cancer.

OBJECTIVES:

Primary

* To evaluate and compare the treatment set-up accuracy of customized vs standard headrest in immobilizing patients undergoing radiotherapy for head and neck cancer.
* To determine and compare patient comfort with the two immobilization techniques.

Secondary

* To evaluate radiation therapists' satisfaction with the two immobilization techniques.
* To examine and compare the cost effectiveness of the two immobilization techniques.

OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 arms.

* Arm I: Patients are immobilized using the standard thermoplastic four-point fixation mask and the standard headrest system. Patients undergo 3-dimensional conformal radiotherapy as per standard of care.
* Arm II: Patients are immobilized using the standard thermoplastic four-point fixation mask and the customized headrest system. Patients undergo 3-dimensional conformal radiotherapy as per standard of care.

Patients score their comfort using the Visual Analogue Scale during the course of radiotherapy. Radiation therapists complete an evaluation questionnaire for each treatment planning and procedure.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed head and neck malignancy
* Planning to undergo radical 3-dimensional conformal radiotherapy (using the Oncentra MasterPlan treatment planning system) at St Luke's Hospital

PATIENT CHARACTERISTICS:

* No evidence of any other significant clinical disorder or laboratory finding that would make it undesirable for the patient to participate in the study
* Able to comply with the study, in the opinion of the researcher and/or medical team

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Total Knee Replacement With Tourniquet or Aquamantys

The purpose of this study is to compare quadriceps muscle strength, pain, opioid consumption and patient function during the first three months after short-stay total knee replacement between patients treated with short-duration tourniquet knee replacement with the Aquamantys® bipolar sealer versus those treated with the standard of care (tourniquet used throughout the case and no Aquamantys®).

By doing this study, investigators hope to learn if short duration tourniquet knee replacement with the Aquamantys® bipolar sealer is more effective than standard of care (tourniquet used throughout the case and no Aquamantys®). The purpose of this study is to compare quadriceps muscle strength, pain, opioid consumption and patient function during the first three months after short-stay total knee replacement between patients treated with short-duration tourniquet knee replacement with the Aquamantys® bipolar sealer versus those treated with the standard of care (tourniquet used throughout the case and no Aquamantys®).


Eligibility Criteria:
Inclusion Criteria:

* primary total knee arthroplasty

Exclusion Criteria:

* repeat knee replacement (revision arthroplasty)
* bilateral knee replacements on the same day
* partial knee replacements
* health or social limitations that do not allow for the participant to be discharged to home on the same day or day after surgery.
A Study to Evaluate Efficacy and Safety of Subcutaneous Abatacept With Steroid Treatment Compared to Steroid Treatment Alone in Adults With Giant Cell Arteritis (GCA)

To investigate the safety and efficacy of abatacept with steroid treatment in comparison to steroid treatment alone in up to a 28 week taper of steroid treatment to sustain remission of Giant Cell Arteritis in adults.


Eligibility Criteria:
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* New headache (new onset or new type of localized pain in the head)
* Elevated ESR (≥ 50 mm/h by the Westergren method) or CRP ≥ 1 mg/dL
* Temporal artery abnormality (i.e. temporal artery tenderness to palpation or decreased pulsation, unrelated to arteriosclerosis of cervical arteries)
* Temporal artery biopsy showing vasculitis characterized by a predominance of mononuclear cell infiltration or granulomatous inflammation, usually with multinucleated giant cells
* Large vessel biopsy showing vasculitis characterized by a predominance of mononuclear cell infiltration or granulomatous inflammation, usually with multinucleated giant cells or characteristic changes of large vessel stenosis or aneurysm secondary to GCA as seen by arteriography (Magnetic Resonance Imaging/ Magnetic Resonance Angiography), ultrasound (eg, halo sign on color duplex sonography), or CT scan
* Patients must be treated with prednisone or prednisolone of 20-60 mg/day (prednisone equivalent) and be on a dose between 20-60 mg/day for at least 2 weeks prior to enrollment into the study

Exclusion Criteria:

* Rheumatic disease other than GCA such as Takayasu's Arteritis, granulomatosis with polyangiitis (Wegener's), rheumatoid arthritis, systemic lupus erythematosus
* Patients with unilateral blindness (partial or complete) or who have unstable or recurrent visual symptoms attributable to GCA within 4 weeks of randomization
* Patients with a history of dissection of aorta
* Patients with a history of myocardial infarction, stroke or transient ischemic attack attributable to GCA within the 3 months of screening
* Patients who have been treated with intravenous ("pulse") doses of glucocorticoids defined as methylprednisolone \> 1000 mg/day if given within 6 weeks of randomization
* Patients who will require oral or IV glucocorticoid treatment during the trial for conditions other than GCA
* Patients at risk of tuberculosis

Other protocol defined inclusion/exclusion criteria could apply
Efects of Noninvasive Mechanical Ventilation and Conventional Mechanical Ventilation in Patients With Severe Comunity Pneumonia

The purpose of this study is to determine whether the noninvasive ventilation is more effective in the treatment of severe comunity acquired pneumonia in comparison with the conventional mechanical ventilation with orotracheal intubation.


Eligibility Criteria:
Inclusion Criteria:

The criteria for the diagnosis of SCAP included:

* Blood systolic pressure lower than 90 mmHg or blood diastolic pressure lower than 60 mmHg
* RR higher than 30 breaths per minute
* PaO2/FiO2 lower than 250 while breathing through a Venturi mask with a 50% inspired oxygen fraction (FiO2)
* Bilateral or multiple lobar infiltrations evidenced by thorax X-ray, and
* Use of vasopressor drugs

Exclusion Criteria:

Exclusion criteria included:

* COPD
* Asthma
* Acute cardiogenic pulmonary edema
* Severe haemodynamic instability (arterial systolic pressure lower than 70 mmHg) or requirements of vasoactive drugs
* Glasgow score equal to or lower than 9 or requiring OTI for airway protection or for recent pulmonary resucitation
* Antecedents of respiratory failure resulting from neuromuscular pathology
* Failure of two or more organs
* Facial deformities; and
* Recent facial, aesophagic and gastric surgeries
Effect of Acupuncture and Pain Medication on Radicular Pain Using QST

In this aim, we propose to conduct a double blinded, placebo-controlled, and randomized clinical trial to compare the clinical effectiveness of radicular pain relief by either acupuncture therapy or a course of pain medication (e.g., Gabapentin) using Quantitative Sensory Testing (QST).


Eligibility Criteria:
Inclusion Criteria:

1. Subject will be between ages 18 to 75 years. Both male and female subjects will be recruited.
2. Subject should have had cervical or lumbar radicular pain for at least two months. This requirement is to avoid the uncertainty of an unstable pain condition and to minimize the study variation.
3. Subject has a pain score of 4 or above (visual analog scale, VAS: 0 - 10 from no pain to worst pain).
4. Cervical or lumbar radicular pain will include, but is not limited to, such clinical conditions as disk herniation, spinal stenosis, and post-laminectomy syndrome.

Exclusion Criteria:

1. Subject has detectable sensory deficits at the site of QST. Sensory deficits refer to such conditions resulting from neurological diseases or medical conditions causing peripheral polyneuropathy and sensory changes, which include but are not limited to diabetic neuropathy, alcoholic neuropathy, AIDS neuropathy, severe thyroid disease, and severe liver or kidney disorders.
2. Subject has scar tissue, infection, or acute injury at the site of QST.
3. Subject is pregnant.
4. Subject tests positive for illicit drugs.
5. Subject has a pacemaker.
6. Subject is currently taking gabapentin.
Study Comparing the Pharmacokinetics of FTD as a Component of TAS-102 With FTD Alone

The purpose of this study is to compare the pharmacokinetics of trifluorothymidine (FTD) as a component of TAS-102 with FTD alone.

This is a Phase 1, open-label, randomized, parallel, 2-group study evaluating the PK of FTD as a TAS-102 component compared with FTD alone in patients with advanced solid tumors (excluding breast cancer). Patients will be randomized to receive a single dose of TAS-102 or FTD during the PK contribution phase and will receive continuing cycles of TAS-102 during the extension phase.

Eligibility Criteria:
Inclusion Criteria:

1. Has provided written informed consent
2. Has advanced solid tumors (excluding breast cancer) for which no standard therapy exists
3. ECOG performance status of 0 or 1
4. Is able to take medications orally
5. Has adequate organ function (bone marrow, kidney and liver)
6. Women of childbearing potential must have a negative pregnancy test and must agree to adequate birth control if conception is possible. Males must agree to adequate birth control.

Exclusion Criteria:

1. Has had certain other recent treatment e.g. anticancer therapy, received investigational agent, within the specified time frames prior to study drug administration
2. Certain serious illnesses or medical condition(s)
3. Has had either partial or total gastrectomy
4. Has unresolved toxicity of greater than or equal to CTCAE Grade 2 attributed to any prior therapies
5. Known sensitivity to TAS-102 or its components
6. Is a pregnant or lactating female
7. Refuses to use an adequate means of contraception (including male patients)