cyrilzakka/clinical-trials huggingface dataset:
A Phase 1,Open -Label Study to Assess the Absorption, Metabolism and Excretion of 14C-OPS-2071 Following a Single Oral Dose to Healthy Male Japanese Subjects

To obtain absorption, metabolism and excretion data for parent drug and any metabolites.


Eligibility Criteria:
Inclusion Criteria:

* Healthy males
* Body mass index (BMI) between 18.5 and 25.0 kg/m2, inclusive
* Subjects will have given their written informed consent to participate in the study and to abide by the study restrictions

Exclusion Criteria:

* Subjects who have a significant history of alcoholism or drug/chemical abuse, as determined by the Investigator.
* Subjects who smoke, or who have used nicotine within 3 months prior to screening..
* Subjects who have a significant history of drug allergy, as determined by the Investigator.
* Subjects who have any clinically significant abnormal physical examination finding.
* Subjects who have any clinically significant medical history, as determined by the Investigator.
* Subjects who are exposed to radiation as a result of their occupation.
* Subjects who have had an X ray or CT scan, or who have participated in any trial involving a radiolabelled investigational product or have been exposed to radiolabelled substances within 12 months prior to dose administration.
Study of ISB 2001 in Relapsed/Refractory Multiple Myeloma

This study is a first-in-human, Phase 1, open-label study that will evaluate safety and anti-myeloma activity of ISB 2001 in participants with relapsed/refractory multiple myeloma (R/R MM).

The study will enroll participants with R/R MM that have been treated with immunomodulatory drugs (IMiDs), proteasome inhibitors, and anti-CD38 therapies either in combination or as a single agent and are refractory to, or intolerant of, established therapies known to provide clinical benefit in MM.

The study will be conducted in two parts:

* Part 1: Dose escalation
* Part 2: Dose expansion

Dose escalation will continue until either the maximum tolerated dose (MTD) is defined, the maximum planned dose is reached, or a recommended phase 2 dose (RP2D) is selected. Dose expansion cohorts will be initiated to further confirm safety and optimal biologically active dose. Participants will receive ISB 2001 until disease progression, unacceptable toxicity occurs, any criterion for stopping the study treatment, or participant withdrawal from the study.

Eligibility Criteria:
Inclusion Criteria:

1. Participants with pathologically confirmed MM with measurable M-protein: serum and/or 24 hour urine, serum-free light chains or measurable isolated plasmacytoma
2. Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less
3. Must have adequate hematologic, hepatic, renal, and cardiac functions

Exclusion Criteria:

1. Active malignant central nervous system involvement
2. Uncontrolled infection requiring systemic antibiotic therapy or other serious infection prior to C1D1
3. History of autoimmune disease requiring systemic immunosuppressive therapy
4. Any concurrent or uncontrolled medical, comorbid, psychiatric or social condition that would limit compliance with study procedures, interfere with the study results, substantially increase the risk of AEs, compromise ability to provide written informed consent or, in the opinion of the Investigator, constitute a hazard for participating in this study.
5. Female subjects who are lactating and breastfeeding or have a positive pregnancy test during the screening period or on Day 1 before first dose of ISB 2001.
Sleep Quality in Patients With Rheumatoid Arthritis

This study was designed to investigate the factors affecting sleep quality of Rheumatoid arthritis patients in Turkish population.

Demographic data, duration of disease, routine biochemical tests and currently used medications were recorded. Disease activity was assessed with Disease Activity Score 28 (DAS 28). Visual Analog Scale (VAS) was used to evaluate pain levels. Health Assessment Questionnaire (HAQ) was used to assess activities of daily living. Beck depression inventory (BDI) was used to investigate the signs of depression in patients. Sleep quality was considered to be poor in patients with a Pittsburgh Sleep Quality Index (PSQI) global score of 5 and greater.

Eligibility Criteria:
Inclusion Criteria:

* patients with RA who met the 2010 American College of Rheumatology (ACR) RA classification criteria were included

Exclusion Criteria:

* Patients who had difficulties understanding and responding to questions were excluded from the study.
Paracervical Block for Pain Associated With Laminaria Insertion

To assess if paracervical block is effective at reducing discomfort during placement of intracervical laminaria for pre-operative cervical preparation.

Pre-operative dilation of the cervix with use of osmotic dilators (e.g. laminaria, dilapan-S) is commonly done prior to pregnancy termination to make the procedure safer. This study seeks to assess whether paracervical blocks are effective at reducing pain associated with placement of laminaria. Secondarily, this study will evaluate if paracervical blocks are effective at reducing overall procedural pain and increasing overall patient satisfaction for the intracervical laminaria placement procedure.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women between the ages of 18-49 years
* Desiring surgical termination of pregnancy or surgical management of a fetal demise
* Treatment plan involves cervical preparation with laminaria
* Participant able to provide informed consent in English and willing to participate in the study

Exclusion Criteria:

* Unable to read/speak/understand English
* Contraindications to receiving lidocaine
SBRT as Bridging Therapy for Hepatocellular Carcinoma Patients on Transplant Waitlist

This is a single center, prospective study to assess the efficacy and safety of using stereotactic body radiation therapy (SBRT) as bridging treatment for hepatocellular carcinoma (HCC) patients on transplant waitlist.

The study population includes patients 18 years of age or older with HCC, who are accepted on waiting list for deceased donor liver transplantation (DDLT).

Patient will be assessed in a multidisciplinary committee and they will receive SBRT unless otherwise contraindicated. Patients will undergo SBRT under standard protocol.

Patients with HCC beyond University of California, San Francisco criteria (UCSF) will be removed from waitlist.

Eligibility Criteria:
Inclusion Criteria:

1. Radiological diagnosis of HCC confirmed according to AASLD criteria
2. All patients who are accepted on deceased donor waiting list
3. HCC within UCSF criteria (defined as solitary tumor \<=6.5cm OR up to 3 tumors \<=4.5cm, total sum \<=8cm)

Exclusion Criteria:

1. age \<18 year old;
2. Child's C cirrhosis;
3. Eastern Cooperative Oncology Group (ECOG) score \>2;
4. presence of extrahepatic metastasis;
5. radiological tumor invasion to portal, hepatic vein or its branches;
6. absolute contraindications to RT (e.g. previous RT to liver);
7. positive pregnancy test;
8. unwilling or unable to adhere to study requirements and procedure;
9. any other condition, in the investigator's judgment, that increases the risk of SBRT or prevents safe trial participation.
A Comparative Study of Sibling Oocytes: ICSI vs. the IMSI Sperm Selection Method

The aim of this research is to compare sibling oocytes using two sperm selection methods for choosing the best quality spermatozoa before they are injected into oocytes and the influence of each of these methods on embryo quality and IVF outcome.


Eligibility Criteria:
Inclusion Criteria:

* Males aged 18-60
* Females aged 18-35
* Males defined as Moderate OTA or Isolated Teratozoospermia with less than 4% morphologically normal spermatozoa
* Patients with 0.5- 7% normal sperm according to MSOME analysis
* Females with normal FSH and AMH values
* Females who have retrieved at least 6 oocytes in previous cycles
* Couples who have had at least 2 failed IVF-ICSI cycles

Exclusion Criteria:

* Couples who have been exposed to heavy smoking, drugs and chronic diseases
* Males who have undergone testicular surgery (TESE) or defined as severe OTA
* Females with egg factor infertility
Osteoarthritis Topical Treatment

This is a phase 2a clinical trial performed to evaluate the efficacy of a topical treatment of ibuprofen compared to the use of a placebo topical treatment.

A multi-center, double-blinded, randomized placebo controlled study. Study length: 14 days Dosing twice daily (b.i.d.)


Eligibility Criteria:
Main Inclusion Criteria:

* Male or female patients aged at least 40 years.
* Primary osteoarthritis in a single knee joint, grade II/III based on the Kellgren and Lawrence classification system.
* Radiographic evidence consistent with osteoarthritis carried out within 6 months before screening.
* pain is currently not adequately controlled with a simple analgesic or an NSAID OR would necessitate treatment, but is not yet treated.

Main Exclusion Criteria:

* Concomitant presence of another type of continuous pain that is more severe in intensity in comparison with the osteoarthritis target joint pain
* Osteoarthritis causing significant pain in any joint other than the identified knee, or contralateral knee (≥ 20 mm pain) as confirmed by a separate VAS at visit 1 for any other painful joint concerned.
* Female patients who are pregnant or breast-feeding.
Esophageal Stent Migration With Endoscopic Suture Fixation Compared to Standard Deployment

Esophageal stents are commonly used for benign esophageal pathology, especially strictures or esophageal mucosal defects such as leaks, fistulae, or perforations. The major limiting factor to stent placement is the high migration rate of the stent. Investigators are trying to prospectively evaluate the efficacy of endostitch in preventing stent migration in benign esophageal disease in comparison with standard, fully covered self-expanding metal stents (FCSEMS) placement without fixation.

The use of removable, fully covered self-expanding metal stents (FCSEMS) in the management of benign esophageal pathology has been increasingly applied in recent years. Several studies have shown promising results with its application in esophageal perforation, fistula, or leak, and refractory benign strictures. However, the major limiting factor to successful treatment with FCSEMS in this setting is the substantial migration rates.

Different strategies has been used to secure esophageal stents but to little success. Several tertiary institutions including investigators have adopted the use of endostitch (ES) with the OverStitchTM system (Apollo Endosurgery, Austin, Texas) as the preferred method for stent fixation. Animal ex-vivo studies have confirmed the greater anchoring ability and tensile strength with this method when compared to esophageal stenting alone or with through the endoscope clip fixation while retrospective series have shown promising results with lower rates of stent migration when compared to conventional stent insertion. However, although the use of endostitch stent fixation has been used in several centers in the United-States with strong retrospective data (including investigators data), no prospective randomized controlled trial have confirmed its effectiveness in preventing stent migration.

Eligibility Criteria:
Inclusion Criteria:

1. Adult patients age 18 years and older
2. Patients with esophageal refractory benign strictures (peptic, anastomotic, caustic, radiation, and idiopathic) where a 14 mm luminal diameter cannot be achieved over 2 dilation sessions at 1-3-week intervals.
3. Patients with esophageal leak, perforation, or fistula referred for endoscopic stenting
4. Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

1. Pediatric patients age under 18 years
2. Pregnant or breastfeeding patients
3. Patients with malignant esophageal lesions, primary or metastatic, requiring endoscopic stenting (all females of child bearing age will undergo urine pregnancy testing as per standard1 preprocedural testing)
4. Benign strictures not having had two attempts at endoscopic dilation
5. Uncorrectable coagulopathy defined by partial thromboplastin time (PTT) greater than 50 sec, or international normalized ratio (INR) greater than 1.5
6. Uncorrectable thrombocytopenia with platelet count less than 50, 000
Pivotal Study of Proton Radiotherapy Treatments Using Fixed Beam Chair-Based Delivery System

This study with Chair-Based, Gantry-less Proton System (CBGS) (aka P-CURE Proton Beam Therapy System or Fixed Beam Chair-based Delivery System) is composed of 3 arms, as following:

ARM1: Patients with locally recurrent, previously irradiated thoracic cancer indicated for re- irradiation.

ARM2: Patients with recurrent Head and Neck, Brain and Spinal Cord tumors, indicated for re- irradiation.

ARM3: Patients with unresectable pancreatic cancer.

The primary objectives of the study for all arms are: 1. to describe the efficacy (local control after 3 month) and acute toxicity for patients treated with a fully-integrated CBGS and (2) to compare treatment plans between the fully-integrated CBGS and Photon therapy defined for each patient, based upon OAR sparing for comparable target coverage.


Eligibility Criteria:
Inclusion Criteria:

* Pathologically (histologically or cytologically) proven malignancy
* Treatment planning analysis shows advantage to proton over photon treatments
* both malignancies (such as thoracic tumors) as well as metastatic lesions (such as metastatic breast cancer or colorectal cancer to the lungs) are allowed
* Patient must have CT confirmation of the tumor
* Patients must have a life expectancy of \> 6 months
* Patients must have measurable disease to be treated with proton radiation (minimum tumor dimension at least 10 mm on CT imaging).
* Patients must be a candidate for definitive radiation dose
* There are no limits on prior therapy. Patients are allowed to have prior chemotherapy and surgery. Patients are allowed to have concurrent chemotherapy with radiation treatment. Patients are allowed to have chemotherapy or surgery after radiation treatment

Exclusion Criteria:

1. Severe, active co-morbidity, defined as follows:

   1. Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
   2. Transmural myocardial infarction within the last 6 months
   3. Chronic obstructive pulmonary disease exacerbation or other respiratory illness other than the diagnosed lung cancer requiring hospitalization or precluding study therapy within 30 days before registration
   4. Acquired immune deficiency syndrome (AIDS) based upon current CDC definition (protocol may be significantly immunosuppressive endangering AIDS patients)
2. Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception
3. Patients with life expectancy \< 6 months
4. Patients that participate in another, active clinical trial carried out concurrently with this protocol
Sun Protection Factor Assay (SPF Assay 199/2016)

To evaluate the Sun Protection Factor efficacy on human skin.


Eligibility Criteria:
Inclusion Criteria:

* Fitzpatrick Skin Type l, ll and/or lll for UVB testing. Fitzpatrick Skin Type ll, lll and/or lV for UVA testing.
* Male and female.
* Aged between 18-70 years old.
* Good health as determined from the HRL SHF (Subject History Form).
* Signed and dated Informed Consent Form.
* Signed and dated HIPAA (Health Insurance Portability and Accountability Act) form.
* An unambiguous MED (Minimal Erythema Dose) or MPPD (Minimal Persistent Pigment Darkening Dose)

Exclusion Criteria:

* Subjects on test at any other research laboratory or clinic.
* Known allergy or sensitivity to sunscreens, cosmetics and toiletries, topical drugs and/or ultraviolet light.
* Pre-existing dermatologic conditions which have been diagnoses by a medical professional (e.g. psoriasis, eczema, etc.)which would interfere with this study.
* Pre-existing other medical conditions (e.g. adult asthma, diabetes).
* Treatment with antihistamines or corticosteroids within one week prior to initiation of the test.
* Treatment with antibiotics within two weeks prior to initiation of the test.
* Chronic medication which could affect the results of the study.
* Known pregnant or nursing women.
Safety and Efficacy of SofWave Treatment to Lift Lax Tissue in the Submental and Neck Zones and to Lift the Eyebrow

This is a prospective, open label, multi-center, self-controlled clinical study to demonstrate the safety and efficacy of SofWave treatment to lift lax tissue in the submental and neck zones and to lift the eyebrow.

This is a prospective, open label, multi-center, self-controlled clinical study to demonstrate the safety and efficacy of SofWave treatment to lift lax tissue in the submental and neck zones and to lift the eyebrow.

Up to 112 healthy candidates who are seeking treatment from participating investigators will be enrolled at up to 5 participating study sites. Patients will receive 2 treatments (4-6 weeks ± 2 weeks apart) with the SofWave system and will be followed up to 3 months post the last treatment (FU2).

Eligibility Criteria:
Inclusion Criteria:

1. Healthy female and male subjects between the ages 35-80.
2. Non-Smoker.
3. Fitzpatrick skin type I-VI.
4. Desire to lift lax skin in the neck and submental and/or to lift the brows.
5. Able and willing to comply with all visit, treatment and evaluation schedules and requirements.
6. Able to understand and provide written Informed Consent
7. Women of child-bearing age are required to be using a reliable method of birth control at least 3 months prior to study enrollment.

Exclusion Criteria:

1. Pregnant or planning to become pregnant, having given birth less than 3 months ago, and/or breast feeding.
2. Presence of any active systemic or local infections.
3. Presence of active local skin disease that may alter wound healing.
4. Severe solar elastosis.
5. History of Epileptic seizures.
6. History of severe migraine tendency.
7. History of smoking in past 10 years.
8. History of chronic drug or alcohol abuse.
9. Excessive subcutaneous fat on the cheeks.
10. Significant scarring in the area to be treated.
11. Severe or cystic facial acne, acutance uses during past 6 months.
12. Presence of a metal stent or implant in the facial area.
13. Inability to understand the protocol or to give informed consent.
14. On-going use of psychiatric medication.
15. History of cosmetic treatments in the facial area to be treated, including facial skin-tightening procedure within the past year; injectable filler of any type within the past year; Botox or fillers in the lower face within the past 6 months; ablative or non-ablative resurfacing/rejuvenation laser treatment or light treatment within the past 6 months, dermabrasion or deep facial peels within the past 12 months; facelift, blepharoplasty, or brow lift (including contour threads) within the past 12 months.
16. Taking Isotretinoin or other oral retinoid within the past 6 months; taking psychiatric drugs, anti-platelet or anti-coagulant within the past 2 weeks.
17. As per the investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.

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Nordic Walking as Gait Training for Frail Elderly

The elderly are the fastest growing proportion of the population. Ageism implies a decline of physical functions affecting functional and safe ambulation. Based on the ICF model intervening in walking capacity could have favourable impact on quality of life of frail elders. Over ground walking training is indicated as a possible exercise. However, to achieve positive results on walking capacity, an exercise-dose response is needed. A more intensive way of promoting walking training is to add skiing poles while walking, a technique called Nordic Walking (NW). This study will be the first to compare NW with usual walking training. It aims to estimate for frail elderly the relative efficacy in improving functional walking capacity of two gait training strategies: NW and usual walking training and explore its impact on fear of falling. This study hypothesized that participants receiving Nordic Walking will walk longer, faster and fear less. NW if proven effective will positively impact on the functional capacities and quality of life of frail elders and provide an more intense method of walking training.

This is a single blind, randomized, pilot trial designed to estimate the amount of change between two programs. Subjects will be randomized and stratified by setting into one of two groups, over ground walking training with poles (Nordic Walking) or traditional over ground walking training (without poles). Randomization will be computer generated using randomization scheme from the website Randomization.com at http://www.randomization.com Basic descriptive statistics will be used to characterize the participants and compare the two groups at baseline. Paired t-test will be used to estimate the efficacy of each intervention. Effects size of each interventions and its ratio will be calculated. Group-specific change score will be calculated to explore the impact of prognostic variables (age, gender, number of comorbities, baseline gait speed) on change of an outcome (with or without poles).

Eligibility Criteria:
Inclusion Criteria:

1. 65 years old or more
2. undergoing rehabilitation program or living a residence facility
3. medically stable or in their usually state of health.

Exclusion Criteria:

1. severe cognitive impairments (short mini mental score less than 14/18)47
2. unable to ambulate a minimum of 15 meters with or without aids
3. without mobility restrictions as represented by a gait speed greater than 1.2 m/s
4. moderate to severe limitations of upper extremity represented by a shoulder flexion range of motion (ROM) less than 90 degrees and extension less than 20 degrees; elbow flexion ROM less than 90 degrees; and with a poor grip judged by the ability to release a can of 5 cm diameter
5. pathological or musculoskeletal conditions of the upper extremity
6. individuals unable to attend a minimum of eight weeks of intervention.