cyrilzakka/clinical-trials huggingface dataset:
Treatment of Early Knee Osteoarthritis With Autologous Adipose-derived Mesenchymal Stem Cells

The purpose of this study is to explore the efficacy and safety of autologous adipose mesenchymal stem cells in the treatment of early knee arthritis. Investigator believes that autologous adipose mesenchymal stem cells can relieve pain, improve knee function, promote knee cartilage regeneration and improve life satisfaction of patients.

Investigators extracted abdominal fat from eight patients, extracted autologous adipose mesenchymal stem cells and injected them into the knee joint of the patients. The data were followed up regularly after operation and compared with those before operation.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18-65 years, male and female, patient can tolerate surgery;
* Clinical diagnosis of early stage degenerative arthritis by Radiographic Criteria and physical examination;
* Obviously extra-articular malformation;
* Course of disease ≥ six months;
* No medication for knee osteoarthritis in the past three months
* Evaluated has not at the risk of cancer;
* Subjects who understand and sign the consent form for this study.

Exclusion Criteria:

* Acute joint injury;
* Patients with severe primary diseases, such as cardiovascular,cerebrovascular, liver, kidney and hematopoietic system, and psychosis;
* Cancer patients;
* Women who are pregnant or breast feeding,or allergic constitution patient;
* Positive serology for HIV-1 or HIV-2, Hepatitis B (HBsAg, Anti-Hepatitis C virus -Ab), Hepatitis C (Anti-hepatitis C virus -Ab) and syphilis;
* Receive other open surgery related to knee operation within 6 months;
* Participation in another clinical trial;
* Failing to comply with the inclusion criteria, unwilling to comply with the research approach, or incomplete data affecting the curative effect or safety judgment.
Phase I/II Trial of Redox Regulation in Patients With Relapsed or Refractory CD20+ NHL

Monoclonal antibodies such as rituximab and yttrium Y 90 ibritumomab tiuxetan can locate cancer cells and either kill them or deliver radioactive cancer-killing substances to them without harming normal cells. Motexafin gadolinium may increase the effectiveness of yttrium Y 90 ibritumomab tiuxetan by making the cancer cells more sensitive to the drug.

This phase I/II trial is studying the side effects and best dose of motexafin gadolinium when administered with rituximab and yttrium Y 90 ibritumomab tiuxetan and to see how well they work in treating patients with stage II, stage III, or stage IV relapsed or refractory non-Hodgkin's lymphoma.

This is a phase I, dose-escalation study of motexafin gadolinium followed by a phase II study. Patients are stratified according to extent of lymphomatous involvement (≤ 5% vs \> 5 but ≤ 24% of cellular elements).

Cohorts of 3-6 patients in each stratum receive escalating doses of motexafin gadolinium until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity (DLT) OR the dose preceding that at which 2 of 3 or 3 of 6 patients experience DLT.

* Once the MTD is determined, additional patients are treated at that dose level as in phase I.

Patients are followed weekly for 3 months and then monthly for 5 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed diagnosis of one of the following:

  * Low-grade or follicular B-cell non-Hodgkin's lymphoma (NHL)

    * The following histologies are eligible:

      * Small lymphocytic lymphoma
      * Lymphoplasmacytoid lymphoma
      * Follicular center grades 1, 2, or 3 lymphoma
      * Extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue type
      * Nodal marginal zone B-cell lymphoma
    * Relapsed or refractory after 2 prior treatment regimens or 1 anthracycline regimen
  * Diffuse large B-cell NHL or mantle cell lymphoma in first or second relapse
  * Transformed NHL, defined as low-grade NHL transformed to diffuse large B-cell lymphoma, with no more than 1 relapse since transformation

Age 18 and over Recovered from prior immunotherapy Life expectancy At least 3 months Recovered from prior chemotherapy

* More than 4 weeks since prior major surgery and recovered
* More than 4 weeks since prior anticancer therapy recovered from prior radiotherapy

Exclusion criteria:

No major bleeding within the past 4 weeks No uncontrolled hypertension No stroke within the past 4 weeks

* No active infection
* No other active nonmalignant disease
* No known G6PD deficiency
* No history of porphyria
* No other condition that would preclude study participation
* No human anti-mouse antibodies
* No known history of HIV
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No prior radioimmunoconjugate therapy
* No prior exposure to murine antibodies other than rituximab
* More than 4 weeks since prior rituximab
* No history of failed stem cell collection
Dry Eye Assessment and Management Study

The objective of the DREAM study is to evaluate the effectiveness and safety of supplementation with omega-3 fatty acids in relieving the symptoms of moderate to severe dry eye disease.

The study is designed to:

* Test the hypothesis that omega-3 supplementation is an effective treatment for Dry Eye Disease (DED) in Primary Clinical Trial.
* Better understand DED by describing and evaluating a comprehensive set of features of DED and treatment over 12 months of observation in a well-characterized group of patients.
* Determine the effects of extended use and discontinuation of omega-3 through the Extension trial.

Eligibility Criteria:
Inclusion Criteria:

* Greater than or equal to 2 of the following 4 signs in the same eye at screening and baseline visits (Same signs must be present at Screening and Baseline visits): Conjunctival staining present greater than or equal to 1 (out of possible score of 6 per eye), Corneal fluorescein staining present greater than or equal to 4 (out of a possible score of 15 per eye), Tear film break up time (TBUT) less than or equal to 7 seconds, Schirmer's test greater than or equal to 1 to less than or equal to 7 mm in 5 minutes.
* Ocular Surface Disease Index (OSDI) score: 25-80 at screening, 21-80 at baseline.
* Symptoms of DED for greater than or equal to 6 months.
* Use of or desire to use artificial tears at least 2 times per day in preceding 2 weeks.
* Ability to swallow large, soft gelcaps

Exclusion Criteria:

* Allergic to ingredients in supplements or placebo
* Contact lens wear
* Pregnant, nursing, or lactating
* Current ocular infection, inflammation, or acute allergic conjunctivitis
* History of: ocular herpetic keratitis, ocular surgery in past 6 months, LASIK surgery, use of glaucoma medicine or surgery for glaucoma, liver disease, atrial fibrillation, hemophilia or bleeding tendencies
* Currently on anticoagulation therapy
* Eyelid abnormalities or extensive ocular scarring
* Use of EPA/DHA supplements in excess of 1200 mg per dayi
* Current use, insufficient washout period, or intent to change specific treatments for dry eye disease
Different Application Rates of Crisaborole Ointment 2% in Adults With Mild to Moderate Atopic Dermatitis

This study is being conducted to evaluate the efficacy and safety of 3 different application rates of topically applied Crisaborole ointment 2% over vehicle in adults with mild to moderate atopic dermatitis (AD). In each subject four application areas will be identified. Each subject will receive 4 treatments: the 3 different application rates of the active treatment and the vehicle. The areas will be randomly assigned to treatment with topical Crisaborole ointment 2% and vehicle, once daily, for 2 weeks, without occlusion.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of active atopic dermatitis (AD) with at least 6 month history prior to screening and that has been clinically stable for 1 month.
* Has four application areas of 3 cm in diameter with a TSS of ≥5 and TAA of moderate at Day 1. The application areas must not be located on the face, scalp, axillae, groin, genitals, hands, and feet. The application areas should be ≥1 cm apart.

Exclusion Criteria:

* Subject is a female who is breastfeeding, pregnant, or who is planning to become pregnant during the study.
* Subject has clinically infected AD.
* Subject has a Fitzpatrick's Skin Phototype ≥5.
* Subject is known to have immune deficiency or is immunocompromised.
* Subject has a history of cancer or lymphoproliferative disease within 5 years prior to Day 1. Subjects with successfully treated nonmetastatic cutaneous squamous cell or basal cell carcinoma and/or successfully treated localized carcinoma in situ of the cervix are not to be excluded.
* Subject had a major surgery within 8 weeks prior to Day 1 or has a major surgery planned during the study.
* Subject has any clinically significant medical condition that would, in the opinion of the investigator, put the subject at undue risk or interfere with interpretation of study results.
* Subject has a known history of chronic infectious disease (eg, hepatitis B, hepatitis C, or infection with human immunodeficiency virus).
* Subject with a known lack of efficacy to crisaborole.
* Subject has a known or suspected allergy to crisaborole, including any non-medicinal ingredient, or component of the container.
* Subject has a known history of clinically significant drug or alcohol abuse in the last year prior to Day 1.
A Study to Evaluate Pregnancy Outcomes in Females Treated With Oral Elagolix Tablets and Capsules

Orilissa is a drug approved for the management of moderate to severe pain associated with endometriosis. Oriahnn is approved for heavy menstrual bleeding due to uterine fibroids. Elagolix-containing products should not be taken by women who are pregnant or suspected to be pregnant but pregnancies are expected as the medicine does not completely stop ovulation and women may inadvertently continue taking Elagolix-containing products until their pregnancy is confirmed.

This study will assess pregnancy outcomes (maternal, fetal, and infant) of participants with and without exposure to Elagolix-containing products for their endometriosis or other conditions based on approved indications and prescribing patterns of Elagolix. Around 584 participants will be enrolled (292 participants exposed to Elagolix and 292 without exposure) in the United States.

Participants will not receive Elagolix-containing products as part of this study but will be followed for maternal and fetal outcomes up to 1 year after delivery.

There may be a higher burden for participants in this study compared to standard of care. Participants will be asked to provide additional information by questionnaire during each trimester of pregnancy, and at 0-6 weeks, 26 weeks, and 1 year after delivery. Contact Bloom Pregnancy Call Center at 1-833-782-7241 or bloompregnancyregistry@iqvia.com or visit https://www.bloompregnancyregistry.com/.


Eligibility Criteria:
Inclusion Criteria:

Participants exposed to Elagolix:

* Currently pregnant.
* Documentation that the participant was exposed to elagolix-containing product from 14 days after last menstrual period (LMP) or at any time during pregnancy.
* Consents to participate in the study. If the participant is a minor, consent will be obtained according to local regulations.

Internal Comparator:

* Currently pregnant with endometriosis, uterine fibroids, or other conditions based on approved indications and prescribing patterns of elagolix-containing product.
* Documentation that the participant was not exposed to elagolix-containing product from 14 days after LMP or any time during pregnancy.
* Consents to participate in the study. If the participant is a minor, consent will be obtained according to local regulations.

Exclusion Criteria:

-None.
Open-Label Extension Study Of Safety And Tolerability Of Pregabalin In Pediatric Patients With Partial-Onset Seizures

The study will evaluate the long-term safety and tolerability of pregabalin in pediatric patients, age 1 month through 16 years, with partial onset seizures.


Eligibility Criteria:
Inclusion Criteria:

* Partial onset seizures, incompletely controlled on 1-3 medications
* At least 1 seizure per 28 days, on average
* Completion of study A0081074

Exclusion Criteria:

* Primary generalized seizures
* Progressive CNS pathology
* Failure to tolerate pregabalin in study A0081074
Developing a Tool to Support Shared Decision Making Post-Concussion Between Adolescents, Parents and Clinicians

Investigators will conduct a pilot efficacy test of a decision aid about contact sport participation post-concussion.

The clinical trial portion of this study will enroll 40 adolescents and their parent/caregiver who are seen in the Sports Medicine clinic with a diagnosis of concussion. 20 will receive usual care, and 20 will receive a decision aid to facilitate the decision making process about sport participation post-concussion. Adolescents and their parent/caregiver will complete separate surveys at a minimum of three timepoints: before their initial clinic visit, after each clinic visit (up until a decision regarding sports participation post-concussion is made), and three months after their first clinic visit. The study team will also conduct surveys with clinicians about their experiences with implementation.

Eligibility Criteria:
Participants in the clinical trial component of this study will be adolescents, parents, and healthcare providers:

Adolescent Inclusion Criteria:

* Age 11-17
* Sustained at least 1 concussion and is scheduled for a concussion injury visit

Parent Inclusion Criteria:

* Age 18 or older
* Parent of a child between the age of 11 and 17 (inclusive) who has sustained at least 1 concussion and is scheduled for a concussion injury visit

Healthcare Provider Inclusion Criteria:

* Age 18 or older
* Seattle Children's affiliated healthcare provider who provides patient care to youth with concussion
Validation of the French Version of the Stapesplasty Outcome Test 25 (SPOT-25)

Inclusion (J0):

* Audiometry (as part of the treatment, only for cases)
* Clinical evaluation (within the framework of care, only for cases)
* Passage of the French version of the SPOT-25 questionnaire

Visit 1 (D0 + 3 ± 1 week): only for cases Second examination of the French version of the SPOT-25 questionnaire (re-test) either by telephone and e-mail, or during a consultation or hospitalization, if this occurs within a compatible time frame.

Visit 2 (3-6 months postoperatively): only for operated patients Third examination of the French version of the SPOT-25 questionnaire either by telephone and e-mail, or during a consultation or hospitalization, if this occurs within a compatible time frame.

Inclusion (J0):

* Audiometry (as part of the treatment, only for cases)
* Clinical evaluation (within the framework of care, only for cases)
* Passage of the French version of the SPOT-25 questionnaire

Visit 1 (D0 + 3 ± 1 week): only for cases Second examination of the French version of the SPOT-25 questionnaire (re-test) either by telephone and e-mail, or during a consultation or hospitalization, if this occurs within a compatible time frame.

Visit 2 (3-6 months postoperatively): only for operated patients Third examination of the French version of the SPOT-25 questionnaire either by telephone and e-mail, or during a consultation or hospitalization, if this occurs within a compatible time frame.

Eligibility Criteria:
Inclusion Criteria:

* Patient aged\> 18 years
* Diagnosis of otosclerosis with indication for primary stapes surgery by the combination of the arguments:

  * Clinical: normal eardrum and audiometry revealing conductive or mixed hearing loss with audiometric Rinne of\> 15 dB and absence of stapedial reflex.
  * Radiological: otosclerotic foci on preoperative CT scan
* Non-opposition to participating in the study
* Good understanding of French
* Affiliate or beneficiary of a health insurance plan

Inclusion criteria for witnesses:

* Person aged\> 18 years
* Absence of known otological pathology
* Without otological surgical history
* Non-opposition to participating in the study
* Good understanding of French

Exclusion Criteria:

* Comorbidity that may interfere with the interpretation of results
* History of stapes surgery
* Person benefiting from a legal protection measure
A Phase 2a Study Evaluating the Safety and Efficacy of ABT-981 in Patients With Erosive Hand Osteoarthritis

This is a multicenter, randomized, double-blind, placebo-controlled study to compare the safety and efficacy of ABT-981 to placebo in subjects with erosive hand osteoarthritis.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female between the ages of 35 to 80.
2. Must fulfill 1990 American College of Rheumatology (ACR) hand osteoarthritis (OA) criteria
3. Must have radiographic evidence of erosive hand OA
4. Have one or more clinical signs and symptoms of active inflammation in at least three hand joints
5. Subject Assessment of Hand Pain Intensity in at least one hand is ≥ 6.

Exclusion Criteria:

1. Previous exposure to any anti-interleukin-1 treatment, to corticosteroids within 1 month prior to Screening, to intra-articular hyaluronic acid injection into hand joint(s) within 6 months prior to Screening, to any immunosuppressive biologic therapy within 1 month or 5 half-lives (whichever is longer) prior to the first dose of study drug, OR current use of immunosuppressive oral medications within 3 months or 5 half-lives (whichever is longer) prior to the first dose of study drug.
2. Absolute neutrophil count \< 2,000 per mm3
3. Diagnosis of one or more of the following:

   * Fibromyalgia,
   * Inflammatory arthritis such as rheumatoid arthritis, peripheral seronegative spondyloarthropathy,
   * Psoriatic arthritis, psoriasis,
   * Microcrystalline (including gout and pseudo gout) arthritis affecting the hands,
   * Any OA of the hands due to an infectious origin or acute traumatic episode, secondary OA or OA linked to cartilage and bone dysplasia,
   * Other chronic painful syndromes that could interfere with assessment of pain at the hand(s).
4. Any uncontrolled medical illness or an unstable treatment or therapy.
5. Any reason that prohibits a subject to undergo an MRI.
Comparison of Open and Closed Aspiration in Newborns

Endotracheal aspiration is a necessary procedure performed by nurses in neonatal intensive care units to increase oxygenation and remove secretions from the airways. It is one of the painful procedures that most frequently causes stress in intubated newborns.

The aim of this study is to examine the effect of open and closed system suction, which is one of the invasive procedures frequently applied in neonatal intensive care, on the baby's pain and vital signs. There is a need for innovative, evidence-based practices to be implemented by nurses in clinics to minimize complications related to endotracheal suction.

Eligibility Criteria:
Inclusion Criteria:

* Newborns monitored with mechanical ventilation
* Newborn who need suctioning,
* Newborn who did not undergo painful procedures one hour before aspiration.
* Hemodynamically stable newborn;

Exclusion Criteria:

* Newborn with any facial/skull deformities
* Newborn with chromosomal/genetic abnormalities
The Acute Cardiovascular Effects of Marathon Running Using Magnetic Resonance Imaging

Using blood testing and cardiac magnetic resonance imaging (MRI), the investigators aim to determine if there are necrotic areas of myocardium in participants who complete a marathon. In addition, the investigators aim to describe the acute and chronic structural abnormalities that occur as a result of endurance training. The study hypothesis is that myocardial necrosis is present in runners completing a marathon competition.

MARATHON-MI is a prospective, observational study of twenty-five (25) participants with plans of completing the Detroit Free Press Marathon in Detroit, Michigan on October 19, 2008. All participants will undergo a rigorous pre-marathon screening process which will include: 1) blood testing, 2) complete cardiopulmonary exercise testing, 3) ECG testing, 4) Holter monitoring, 5) cardiac MRI. Blood work will be check after the marathon immediately after and one day after the event. Cardiac MRI will be repeated within 12 hours of finishing the marathon. Using the information derived from the blood work and radiological testing, we will attempt to determine if there is an association between marathon running and myocardial necrosis.

Eligibility Criteria:
Inclusion Criteria:

* Detroit Free Press Marathon participant on October 19, 2008,
* Age \> 18 years old,
* Ability to provide informed consent.

Exclusion Criteria:

* Known coronary or structural heart disease
* Pregnancy,
* Extreme claustrophobia,
* Metal implants,
* Renal dysfunction.
To Test Bioequivalence Between Two Formulations of Paracetamol/Phenylephrine

This study is designed to assess bioequivalence between two paracetamol/ phenylephrine combination products.

The study will be a single dose, randomized, two-way crossover study in 40 healthy subjects, with equal numbers of males and females. Drop-outs will not be replaced. The two doses of medication given in the study (a single dose in each of the two study periods) will be separated by a washout period of at least 7 days. In each study period, sixteen blood samples for pharmacokinetic analysis will be taken over 24 hours. Blood samples will be centrifuged and concentrations of paracetamol and phenylephrine in plasma will be measured using a validated chromatographic assay. Pharmacokinetic parameters will be calculated from plasma concentration data. The rate and extent of absorption of the formulations will be compared.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female
* Caucasians
* Aged between 18 and 50 years
* BMI ≤ 30 kg/m2
* Clinically normal medical history
* Physical normal examination
* Normal laboratory test results

Exclusion Criteria:

* Pregnancy, lactation or intended pregnancy
* Hypersensitivity to or intolerant of the study medications
* Donation or loss of blood within 90 days preceding the first dose of study medication
Photon/Proton Radiation Therapy for Cancers of the Nasal Cavity and/or Paranasal Sinuses

The purpose of this study is to collect information from a questionnaire and medical records to see what effects proton radiation has on cancer and collect and analyze morbidity outcomes: incidence of Xerostomia (dry mouth) and tumor control.

The study is non interventional outcomes protocol designed to collect information from a questionnaire and medical records to see what effects proton radiation has on cancer and collect and analyze morbidity outcomes: incidence of Xerostomia (dry mouth) and tumor control.

Eligibility Criteria:
Inclusion Criteria:

* Cancer of nasal cavity and/or paranasal sinuses.
* Will receive treatment with proton radiation.

Exclusion Criteria:

* Evidence of distant metastasis.
* Previous radiation for head and neck cancer.