cyrilzakka/clinical-trials huggingface dataset:
Effect of Andecaliximab on FEV1 in Adults With Cystic Fibrosis

The primary objective of this study is to evaluate the effect of andecaliximab (GS-5745) on pre-bronchodilator forced expiratory volume in 1 second (FEV1) % predicted in adults with cystic fibrosis (CF) after 8 weeks of treatment.

There will be 2 parts to this study. In Part 1, andecaliximab 600 mg or placebo will be administered for 8 weeks. In Part 2, andecaliximab 300 mg, 150 mg, or placebo will be administered for 8 weeks. Part 2 will be initiated after completion of Part 1.


Eligibility Criteria:
Key Inclusion Criteria:

* Confirmed diagnosis of CF as determined by the 2008 Cystic Fibrosis Foundation Consensus Report criteria
* Must have a body weight of \> 40 kg (88.2 lb) at study screening
* Pre-bronchodilator FEV1 ≥ 40% and ≤ 80% of predicted at screening
* Two pre-bronchodilator spirometry measures during screening and baseline must meet the following 2 criteria:

  * The relative difference of FEV1(L), calculated as the absolute value of \[(first FEV1 - second FEV1) / first FEV1\] x 100 should be \< 12% AND
  * The absolute difference in FEV1 should be \< 200 ml
* Negative Sputum Investigation/History of any Mycobacterium spp. or Burkholderia spp. per specified protocol-defined time periods
* Clinically stable with no evidence of significant respiratory symptoms that would require administration of IV antibiotics, oxygen supplementation, or hospitalization within 30 days of baseline.
* On stable CF chronic medical regimen for at least 30 days prior to baseline and expected to remain stable through the completion of the study. This includes but is not limited to: chronic azithromycin use, inhaled bronchodilators, inhaled corticosteroids, inhaled dornase alpha, inhaled hypertonic saline, inhaled mannitol, ivacaftor, and/or ivacaftor/lumacaftor.

Key Exclusion Criteria:

* Concurrent use of oral antibiotics (excluding chronic azithromycin use) or IV antibiotics within 30 days of baseline. Prophylactic and chronic doxycycline use is prohibited during the study.
* Hospitalization for a respiratory event within 30 days of baseline
* Current use of systemic immunosuppressive drugs including oral corticosteroids within 30 days of Baseline
* Current requirement for daily continuous oxygen supplementation or requirement (medically necessary) of more than 2 L/minute at night (subject would not meet this exclusion criterion if supplemental oxygen is used for comfort only)
* History of solid organ (including lung) or hematologic transplant, or currently on a transplant waiting list

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Study of Fetal Movements Using Multichannel Ultrasound Pulsed Doppler in Normal and Pathologic Pregnancy

To enable an investigation of fetal movements, the researchers have developed a multichannel ultrasound pulsed Doppler called ACTIFOETUS. This new fetal monitor includes three transducers of four sensors which are placed on three different zones of the mother's abdomen. One of the transducers is aimed at the fetal heart, another at the lower limbs and one transducer at the thorax and the fetal upper limbs to detect heart and body movements. The signals are analysed and processed by software which computes a number of parameters describing the movements.

Ninety pregnant women from 28 weeks gestation will be monitored over a 40 minute period every month or every 2 weeks in case of pathological pregnancy. The final purpose will be to develop a system of home monitoring as an indicator of fetal well-being.

The main objective of the study is to detect quantitative and qualitative disorders of fetal movements from 28 weeks of amenorrhea on a fetus presenting in fetal distress.

The fetal rhythm will be recorded during 24 hours and a correlation between maternal and fetal movements will be studied.

Specific measures:

* The fetal heart rate
* The number and extent of fetal movements

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Pregnancy with singleton
* Woman from 28 weeks of amenorrhea

Exclusion Criteria:

* Fetal malformation
Real-World Evaluation of the Effect of Jublia on Nail Polish

A recent publication using cadaver nails suggests that Jublia application has a negative effect on nail polish texture.

It is believed that investigating the affect of Jublia is an important question with regards to how it affects how various nail polished and top coats will be used.

Eligibility Criteria:
Inclusion Criteria:

* Exhibit distal lateral subungual onychomycosis (DLSO)
* Has the informed consent been signed and patient's questions answered.
* Age ≥ 18
* Patient willing and able to participate for the full duration of the study
* No onychomycosis
* Greater than 4 weeks from prior major surgery for any indication
* Willing to abstain from:
* The application of other topical medications or cosmetic products to the toenail
* Professional pedicures for the duration of the study.
* Females of childbearing potential must:
* Have been using adequate contraception (abstinence, IUD, birth control pills or spermicidal gel with diaphragm or condom) since their last menses
* Agree to continue using adequate means of contraception (abstinence, IUD, birth control pills or spermicidal gel with diaphragm or condom) for the duration of study participation
* Females are not considered to be of childbearing potential if they are at least 1 year postmenopausal or have had a tubal ligation, bilateral oophorectomy or hysterectomy.

Exclusion Criteria:

* Active onychomycosis of the toenails or fingernails
* Any of the following in the 4 weeks (or as indicated) prior to randomization:
* Major surgery for any indication
* Any personal history of:
* Invasive cancer diagnosed or treated within the past 5 years. Participants who have been in remission for 5 years or more and have not required treatment in the past 5 years may be eligible if the principal investigator believes there is little to no risk of recurrence.
* Concurrent use of the following medications or treatments
* Other topical antifungals for any concomitant infection
* Females who are pregnant or lactating. Should a woman become pregnant or suspect she is pregnant while she is participating in this study she should notify the study physician immediately.
* Uncontrolled concurrent illness including ongoing or active infection, psychiatric illness or social situations that would limit compliance with study requirements or other underlying serious medical condition which, in the investigator's opinion, might preclude study participation.
A Single Centre Study to Assess the Long-term Performance of the Pinnacle™ Cup With a Ceramic-on-ceramic Bearing in Primary Total Hip Replacement

The purpose of this study is to monitor the performance of the Pinnacle™ Cup with a ceramic-on-ceramic bearing combination in the treatment of patients with hip joint disease requiring a total hip replacement. Patients who enter the study will be evaluated at regular intervals following hip surgery using patient, clinical and x-ray assessments.


Eligibility Criteria:
Inclusion Criteria:

i) Male or female subjects, aged between 18 and 70 years inclusive.

ii) Subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom consent has been obtained.

iii) Subjects who, in the opinion of the Investigator, are able to understand this investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups.

iv) Subjects undergoing primary total hip replacement who are suitable for cementless acetabular components.

Exclusion Criteria:

i) Subjects who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this study.

ii) Subjects undergoing revision hip replacement.

iii) Women who are pregnant.

iv) Subjects who are known drug or alcohol abusers or with psychological disorders that could effect follow-up care or treatment outcomes.

v) Subjects who have participated in a clinical study with an investigational product in the last 12 months.

vi) Subjects who are currently involved in any injury litigation claims.

vii) Subjects undergoing a simultaneous bilateral hip operation.

viii) Subjects undergoing the second stage of a staged bilateral for whom the contralateral hip is part of this clinical investigation.

ix) Subjects undergoing the second stage of a staged bilateral for whom the contralateral hip was implanted less than six months previously or is not performing satisfactorily
Dynamic Stretching Versus Plyometric Push up Training on Upper Body Performance in Cricketers

A comparison of dynamic stretching and plyometric pushup training on upper body performance tests of cricketers was performed.

A Randomised control trial was performed for six weeks in which a sample size of 22 was taken participants were divided into two groups in which one group performed warm-up and dynamic stretching and the other group performed warm-up plyometric pushup.

Eligibility Criteria:
Inclusion Criteria:

* Active cricket players ( who are currently laying cricket on the field)
* National-level cricket players having experience of 3 to 6 months
* Age 18 to 25 years
* Male cricketers

Exclusion Criteria:

* History of recent fracture of cervicothoracic region
* Disc prolapse stage 3
* Any other comorbid condition
Diagnosis and Treatment Strategy of Recurrent Spontaneous Abortion Associated With Thrombophilla

In this clinical cohort study, the investigators observe the efficacy of low molecular weight heparin in the treatment of thrombophilia with recurrent pregnancy loss with a prospective randomized controlled trial.


Eligibility Criteria:
Inclusion Criteria:

* Woman who had their Second miscarriage before 12(th) week of gestation.The patient who is diagnosed as thrombophilia with recurrent pregnancy loss. Signed consent form.

Exclusion Criteria:

1. having experiencedsevere allergies, trauma history and/or operation history within 3 months
2. with a history of mental illness and/or family history of mental illness
3. limb disabled
4. taking medicine within one month
5. suffering major events or having mood swings
6. with a history of recurrent pregnancy loss
7. having internal and surgical disease(after having variety of physical examination such as electrocardiogram/hepatic and renal function/blood routine and urine rotine)
8. Chromosome aberrations in anyone of the couple.
9. patients who have drug contraindications
Clinical Pilates' Impact on Fitness, Symptoms & Kinesiophobia in PMS

Premenstrual syndrome (PMS) is characterized by a series of somatic and psychological symptoms of varying severity that occur during the luteal phase of the menstrual cycle, affecting approximately 30% of women and resolving with menstruation. These symptoms impact daily activities, interpersonal relationships, social engagements, work efficiency, and educational productivity. PMS manifests with physical symptoms such as breast swelling and tenderness, fatigue, headaches, and weight gain, as well as psychological and emotional symptoms such as mood disorders, irritability, and stress. Symptoms typically subside with the onset of menstruation. There is no single accepted treatment for PMS. Due to conflicting findings in studies, various treatment methods are used, including lifestyle modifications, education, stress management techniques (such as massage, reflexology, and yoga), exercise, or medical support. Regular exercise is known to improve overall well-being. It prevents the decrease in endorphin secretion during the luteal phase of the menstrual cycle and has a positive impact on PMS symptoms, particularly mood disorders, fluid retention, and breast tenderness. Pilates-based exercise training is an approach that enhances muscle stability through effective, controlled movements while strengthening muscle groups associated with pain. Clinical Pilates-based exercise training is considered a preferable method for PMS management, as it is believed to improve functional capacity, pain management, mood disorders, endurance, flexibility, symptom severity, and fear of movement in individuals with PMS. Due to the limited number of studies in the literature on PMS, our study aims to investigate the effects of a clinical Pilates-based exercise program on functional fitness parameters, symptom severity, and kinesiophobia.


Eligibility Criteria:
Inclusion Criteria:

* Having Premenstrual Syndrome (PMS)
* Being able to read and understand Turkish
* Willingness to participate in the study

Exclusion Criteria:

* Being in menopause or perimenopause
* Being pregnant
* Currently participating in or having engaged in a regular exercise program (other than clinical Pilates) within the past year
* Having comorbid orthopedic, musculoskeletal, psychological, or cardiovascular conditions that may affect test evaluations
Peripheral Nerve Blocks vs Periarticular Local Anesthetic Injection for Total Knee Arthroplasty (TKA)

The purpose of this study is to find a better way to make patients comfortable after their knee surgery. The investigators compared three ways of providing pain relief, either by use of a nerve block at the femoral and sciatic nerve areas, or with actual injections in the surgical joint area with one of two different medicines, either ropivacaine or liposomal bupivacaine (Exparel®). The hypothesis was that the nerve block at the femoral and sciatic nerve areas would result in lower pain scores and opioid consumption than either of the two injections in the surgical joint area.


Eligibility Criteria:
Inclusion Criteria:

1. Adult patients with an American Society of Anesthesiologists (ASA) physiological status I-III
2. Patients presenting for unilateral primary total knee replacement.
3. No focal neurologic deficit of the surgical lower extremity.
4. Cognitively intact with the ability to sign informed consent

Exclusion Criteria:

1. Chronic pain syndromes such as fibromyalgia or complex regional pain syndrome
2. History of long term use of daily opioids (\>1 months) with oral morphine equivalent (OME) \>5mg/day.
3. Body mass index (BMI) \> 40 kg/m2
4. Allergies to medications used in this study such as: fentanyl, hydromorphone, ketorolac, ibuprofen, acetaminophen, local anesthetics, oxycodone, OxyContin, tramadol, ondansetron, droperidol, or dexamethasone, celecoxib
5. Major systemic medical problems such as:

   * Severe renal disorder defined as glomerular filtration rate (GFR) \<50 units/m2
   * Cardiovascular disorders defined as congestive heart failure (CHF) New York Heart Association (NYHA) class III-IV
   * Severe hepatic disorder defined as current or past diagnosis of acute/subacute necrosis liver, acute hepatic failure, chronic liver disease, cirrhosis (primary biliary cirrhosis), fatty liver, chronic hepatitis/toxic hepatitis, liver abscess, hepatic coma, hepatorenal syndrome, other disorders of liver.
6. Impaired cognitive function or inability to understand the study protocol
7. Contraindication to a regional anesthesia technique (e.g., preexisting neuropathy in the operative extremity, coagulopathy \[platelets \< 100,000, International Normalized Ratio (INR) \>1.5\], refusal, etc.).
8. Previous contralateral knee replacement managed with regional or periarticular injection
9. Unable to follow-up at the 3 month interval at Mayo Clinic in Rochester, Minnesota
10. Pregnancy or breast feeding (women of child-bearing potential, must have a negative pregnancy test)
Educating Smokers About Lung Cancer Screening Using Tobacco Quitlines

This implementation study will examine the best ways to refer heavy smokers to information about lung cancer screening.

PRIMARY OBJECTIVE:

I. To increase the number of smokers eligible for lung cancer screening (LCS) who receive high-quality educational materials about LCS through tobacco quitlines.

OUTLINE:

CALL CENTER STAFF: Participants undergo training consisting of a 60-minute educational session.

CALLERS SUBSTUDY: Participants are referred to lung cancer screening educational materials. Participants also complete questionnaires at 1 week and 6 months after referral to educational materials.

Eligibility Criteria:
Inclusion Criteria:

* QUITLINE CALL CENTER STAFF
* Staff member of a quitline
* Aged 18 years and above
* CALLERS (SMOKERS WHO CONTACT THE QUITLINE ABOUT SMOKING CESSATION SERVICES) INCLUSION CRITERIA
* Callers 55-80 years of age
* Current smoker, or former smoker with a cessation history of \< 15 years
* \>= 30 pack-year smoking history
* English-speaking

Exclusion Criteria:

* CALLERS (SMOKERS WHO CONTACT THE QUITLINE ABOUT SMOKING CESSATION SERVICES) EXCLUSION CRITERIA
* History of lung cancer by self-report
Comparison of the Effectiveness of 2 Manual Therapies on Functional Outcome in Sub-acute and Chronic Non-specific Low Back Pain

The purpose of this study is to determine whether a standardised osteopathic manipulative treatment is more effective than a placebo of osteopathic manipulative treatment, in sub-acute and chronic non-specific low back pain on functional recovery at 3 months.

Sub-acute (4-12-week duration) and chronic (more than 3-month duration) non-specific low back pain (LBP) is frequent, disabling and costly. The effectiveness of usual treatments (including pain killers, anti-inflammatory drugs, spinal injections, physiotherapy, spinal traction, transcutaneous electrical nerve stimulation, etc) may be not sufficient, and many patients resort to alternative therapies. Manipulative treatments represent en emerging therapy in this area, although studies assessing their effectiveness are limited and often biased. The purpose of this study is to evaluate the efficacy of two manual therapies on improving functional recovery in sub-acute and chronic non-specific low back pain at 3 months. A standardised osteopathic manipulative treatment is compare to a placebo of osteopathic manipulative treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patient consulting for subacute and chronic non-specific low
* Male or female aged from 18 to 65 years (included)
* Patient can speak and understand French
* Patient giving his informed consent to participate in the study
* Patient affiliated to or beneficiary of social insurance

Exclusion Criteria:

* Specific low-back pain caused by inflammatory, tumoral, infectious disease or a back traumatism in the 3 past months
* History of back surgery and/or vertebral fracture in the previous 6 months
* Presence of a motor impairment related to the reason for consultation
* The patient is a student or a practitioner in manipulative therapies
* Pregnancy
* Inability to understand the process of the study
* The patient is already included in another clinical study
DRIVE Trial (Dialysis Patients' Response to Intravenous [IV] Iron With Elevated Ferritin)

This study explores the safety and efficacy of intravenous iron therapy in anemic hemodialysis patients treated with epoetin alfa, who have higher serum ferritin levels, but low to normal transferrin saturation.


Eligibility Criteria:
Inclusion Criteria:

* Chronic hemodialysis
* Elevated serum ferritin with low to normal transferrin saturation (TSAT)
* Moderate to severe anemia
* Receiving epoetin alfa treatment

Exclusion Criteria:

* Known sensitivity to Ferrlecit®
* Medical conditions that would confound the efficacy evaluation
* Recent blood transfusion
Drug-Drug Interaction (DDI) w/Ketoconazole or Fluconazole

The purpose of the study is to determine if the concomitant administration of either ketoconazole or fluconazole with BMS-708163 will affect the PK of BMS-708163 and to assess safety and tolerability of BMS-708163


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and postmenopausal female subjects 18-55 yrs old inclusive

Exclusion:

* Premenopausal women
Effect of Multiple Doses of Itraconazole on the Pharmacokinetics of a Single-Dose of PF-06651600 in Healthy Participants

This study will estimate the impact of a strong CYP3A4 inhibitor (itraconazole) on the pharmacokinetics of an investigational product (PF-06651600) in healthy adult participants.

This is an open-label, fixed sequence two period study with healthy participants that will receive a single dose of PF-06651600 alone and co-administered with multiple doses of itraconazole at a single center.

Participants will be screened within 28 days of the first dose of the investigational products and if entry criteria are met, the participant will report to the clinic on the day before the Day 1 visit. On Day 1 of Period 1, each participant will receive a 30 mg dose of PF-06651600 and PK samples will be collected for 48 hours. In Period 2, participants will receive itraconazole solution from Day 1-5. On Day 4 of Period 2 the participant will receive 30 mg of PF-06651600 with the itraconazole. PK samples will be collected up to 48 hours after the PF-06651600 dose. Participants will be confined for a total of 9 days in the clinic. The participant will be followed up by phone contact.


Eligibility Criteria:
Inclusion Criteria:

* Willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations and other study procedures.
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg.

Exclusion Criteria:

* Evidence of congestive heart failure or history of congestive heart failure or any of the following: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, cerebrovascular accident including transient ischemic attack or pulmonary embolus.
* Known hypersensitivity to itraconazole or it excipients or to other azole antifungals.
* Infection with Hepatitis B, C or HIV
* Known present or history of malignancy other than a successfully treated or excised non-metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ.