cyrilzakka/clinical-trials huggingface dataset:
PTC596 in Patients With Advanced Solid Tumors

This is a Phase 1, open-label, first-in-human, safety and pharmacokinetic study of PTC596 in patients with advanced cancer.

This is a Phase 1, open-label, first-in-human, safety and pharmacokinetic (PK) study of PTC596 in patients with advanced cancer. A variation of the traditional 3+3 dose escalation design will be employed.

PTC596 will be administered orally on a twice a week (biw) schedule. Each 4-week period of drug administration will be considered one cycle. The objective of the study will be to determine the recommended Phase 2 dose (RP2D) and to determine preliminary proof of mechanism of action.

Collectively, data from the Good Laboratory Practice (GLP) and non-GLP studies indicate that 40 mg/kg biw is approximately the severely toxic dose in 10% of animals (STD 10). Therefore, the starting dose in this study will be calculated as one-tenth of the human equivalent dose (HED) of 40 mg/kg biw in rats, which is 0.65 mg/kg biw.

In this study, escalating dose levels will be evaluated to determine the RP2D. Three patients will be enrolled at the starting dose level (0.65 mg/kg biw); if 1 of the 3 patients experiences a dose-limiting toxicity (DLT), an additional 3 patients will be enrolled at the same dose level. Thus, 3 to 6 patients will receive the starting dose level of 0.65 mg/kg. Dose escalation will continue until the occurrence of DLT in ≥2/6 patients at a given dose level. Dose escalation will occur in approximately 100% increments until Grade ≥2, first-cycle toxicity is seen in at least 2 patients across all dose levels, after which dose escalation will occur in smaller (50% or 33%) increments.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have histologically or cytologically confirmed solid malignancy that is metastatic or unresectable, for which standard curative measures do not exist, that has progressed on at least one line of standard therapy or for which no standard therapies exists
* Discontinuation of all other therapies (including other investigational drugs, radiotherapy, or chemotherapy) for the treatment of cancer ≥4 weeks (≥6 weeks if nitrosoureas, ≥12 weeks if radiotherapy) before initiation of study treatment
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Life expectancy of at least 3 months
* A measured or estimated creatinine clearance (CrCl) ≥60 mL/min/1.73 m2

Exclusion Criteria:

* Prior bone marrow/hematopoietic stem cell transplantation
* History of solid organ, bone marrow, or progenitor cell transplantation
* History of major surgical procedure within 28 days prior to start of study treatment
* Evidence of ongoing systemic bacterial, fungal, or viral infection. Known human immunodeficiency virus (HIV) infection or acquired-immunodeficiency syndrome (AIDS)-related illness
* Any of the following in the past 6 months: myocardial infarction, unstable angina, coronary/peripheral artery bypass graft, congestive heart failure (New York Heart Association Class III or IV), cerebrovascular accident, transient ischemic attack, other arterial thromboembolic event, or pulmonary embolism
FAECAL MICROBIOTA TRANSPLANTATION IN OBESITY

40 patients meeting the criteria for obesity surgery are enrolled. Fecal microbiota transplantation (FMT) will be administered in gastroscopy 6 months before obesity surgery. 20 of the patients will receive a fecal transplant of a thin donor and 20 will receive placebo - a transplant made of their on feces. Changes in weight, laboratory values, general well being and stool microbiota will be measured up to one year after the surgery; one and a half years after FMT. The hypothesis is that FMT and the change in gut microbiota will help to reduce and maintain lower weight.


Eligibility Criteria:
Inclusion Criteria:

• Candidates for the bariatric surgery

BMI ≥ 40 or BMI ≥35 and at least two obesity-related co-morbidities such as type II diabetes (T2DM), hypertension, sleep apnea and other respiratory disorders, non-alcoholic fatty liver disease, osteoarthritis, lipid abnormalities, gastrointestinal disorders, or heart disease.

* Availability of consecutive fecal samples during one year
* Compliance to attend gastroscopy and FMT
* 18-65 years

Exclusion Criteria:

* Unable to provide informed consent
* Pregnancy
* Type I Diabetes Mellitus
* Severe renal insufficiency, GFR\<30%
* Chronic or recurrent bacterial infection needing antimicrobial treatment
* Large hiatal hernia
The Pathogenesis of OSA in People Living With HIV

The purpose of this study is to help us understand how HIV and/or Anti-Retroviral Therapy (ART) may predispose individuals to Obstructive Sleep Apnea (OSA). The traditional risk factors for OSA are weight and age. However, people living with HIV on ART seem to have OSA even when they are thin and young. The study involves a detailed physiological sleep study and an MRI of the head and neck to understand the underlying cause of OSA in those with and without HIV.

Participants who have sleep apnea and are using positive airway pressure (PAP) with and without HIV will be enrolled if they otherwise meet all the inclusion criteria, and none of the exclusion criteria.

Subjects will undergo two overnight sleep studies (polysomnograms, PSGs) and a MRI scan of the upper airway. The first sleep study will evaluate the severity of sleep disordered breathing and will be identical to a clinical PSG. The second sleep study will measure the physiological traits most important for OSA, such as upper airway anatomy, control of breathing, sleep stability, and upper airway muscle activation. These measurements are performed while subjects sleep using PAP, but the PAP level is adjusted during the night, and the subject's response is measured. The MRI scan will be of the head and neck and will occur during the evening time. Subjects will be encouraged to sleep during this portion of the study, as well.

Eligibility Criteria:
Inclusion Criteria:

* Men and women with physician-diagnosed OSA who have been prescribed CPAP Ages \>= 40 years old
* BMI 20 - 35 kg/m2
* For HIV group: physician diagnosis of HIV and viral suppression

Exclusion Criteria:

* Not compliant with CPAP (by Medicare criteria, e.g. ≥4 hours per night on 70% of nights during a consecutive 30-day period via direct download or visual inspection of usage data).
* Use of medication that affects the traits, e.g. narcotics or sedative-hypnotics
* Any cardiovascular, pulmonary or renal disease other than well controlled hypertension or asthma.
* Pregnancy
* Currently smoking
* Any respiratory disorder other than OSA or well controlled asthma
* contraindication to MRI
Randomized Trial of Iron Supplementation to Prevent Anemia in Very-low-birth-weight Infants

The purpose of this study is to determine if iron supplementation in addition to routine iron intake decreases the risk of developing anemia in preterm infants.

Objective was to determine if iron supplementation of 2 mg/kg per day, in addition to routine iron-fortified formula or mother's milk, increased the hematocrit (Hct) at 36 weeks' postmenstrual age (PMA).

All infants have a decline in hemoglobin(Hgb) after birth because of increasing PaO2 and Hgb saturation after birth. In very low birth weight (VLBW) infants (birth weight ,1500 g), the nadir at 1 to 3 months after birth is lower than in term infants because of (1) greater phlebotomy losses for blood tests, (2) shortened red blood cell survival, and (3)rapid growth.

VLBW infants may be at increased risk of developing iron deficiency anemia because of (1) low iron stores at birth, (2) rapid depletion of iron stores owing to phlebotomy losses, and (3) inability to regulate iron absorption by the gastrointestinal tract.

Eligibility Criteria:
Inclusion Criteria:

1. birth weight: \< 1500 grams
2. Tolerating iron fortified preterm formula or fortified breast milk at 120cc/kg/day by 8 weeks of age
3. ≤32 weeks adjusted post-menstrual age at the time of enrollment

Exclusion Criteria:

1. cyanotic heart disease
2. bowel resection prior to enrollment
The Effect of Salpingectomy Operation on Ovarian Reserve

This study aimed to evaluate the effect of salpingectomy operation on ovarian reserve. Ovarian reserve was evaluated by measuring anti-mullerian hormone levels from serum samples taken from the patients before the operation and 6 weeks after the operation. Ovarian doppler flow were evaluated by measuring the ovarian artery pulsatility index with transvaginal ultrasonography preoperatively, postoperative days 2 and postoperative weeks 6 . In our study, it was determined that ovarian functions may be negatively affected in the acute period after salpingectomy operation.


Eligibility Criteria:
Inclusion Criteria:

1. Women between the ages of 37-45 with continuing menstrual cycles (37 and 45 included)
2. Patients who will undergo uterine surgery for benign reasons or who will undergo salpingectomy only due to hydrosalpinx, ectopic pregnancy, tubo-ovarian abscess
3. Patients who have not had ovarian surgery before
4. Those without menopause and premature ovarian failure
5. Patients who accept the study

Exclusion Criteria:

1. Age younger than 37 or older than 45
2. Those who want to withdraw from the study
3. Those who do not come for follow-up examination
4. Use of drugs that affect ovarian reserve
5. Any surgical procedure performed on the ovaries during the operation
6. No menstrual bleeding in the last year
7. Patients who received radiotherapy and hormonal therapy within 3 months before surgery
Treatment Study of Vitamin D Deficiency in Adolescents

To compare the efficacy of two high dose vitamin D3 regimens (5,000 IU daily vs. 50,000 IU weekly) used clinically for the treatment of vitamin D deficiency versus a low dose of vitamin D3 used for supplementation (1,000 IU daily) in a clinical sample of predominantly Hispanic and black adolescents with vitamin D deficiency \[25(OH)D level \<20 ng/ml\] by assessing change in 25(OH)D levels before and after 8 weeks of treatment.

To compare the effects of vitamin D repletion \[25(OH)D level \>20 ng/mL\] on selected musculoskeletal, cardiometabolic and immune markers in predominantly Hispanic and black adolescents with vitamin D deficiency \[25(OH)D level \< 20 ng/mL\].

Hypothesis 1: Increase in vitamin D level will be associated with improvement in musculoskeletal, cardiometabolic, and immune markers including blood pressure, waist circumference, musculoskeletal symptoms, asthma severity and hand-grip strength.

Vitamin D is an essential nutrient and pro-hormone that has garnered widespread attention over the past decade for both its known and theorized health benefits. Patients, clinicians and researchers have all been alerted to the increasing prevalence of vitamin D deficiency (defined as level of 25(OH)D \<20 ng/mL) and the significance of the extra-skeletal health effects of vitamin D. Aside from the skeletal impacts of Vitamin D, there has been recent evidence about potential health benefits of vitamin D related to the multiple extra-skeletal roles of this hormone. In fact, vitamin D receptors are found in many organs including brain, heart, skin, small intestine, gonads, prostate and breast as well in almost all nucleated cells including osteoblasts, activated T and B-lymphocytes, and B islet cells. Studies in children and adolescents as well as in adults show associations of vitamin D deficiency with cardiovascular risk factors, musculoskeletal health, asthma, and autoimmune diseases.

While Vitamin D deficiency is quite prevalent, adolescents who are obese or who are darker skinned are consistently shown to have higher rates of vitamin D deficiency than lean and lighter skinned adolescents. Treatment of vitamin D deficiency and maintenance of sufficient levels in adolescents are largely under-studied leaving patients and clinicians without clear evidence-based guidelines to follow.

The goal of this study is to compare the efficacy of different treatment regimens for vitamin D deficiency in our population of predominantly minority adolescents and to examine the effect of correction of vitamin D deficiency on selected extra-skeletal targets of vitamin D action including musculoskeletal, cardiometabolic, and immune function.

Eligibility Criteria:
Inclusion Criteria:

* age 13-20

Exclusion Criteria:

* currently receiving treatment for hypovitaminosis D
* hepatic or renal disease
* metabolic rickets
* inability to complete the questionnaire
Post-Approval Study Protocol for the Simplify Cervical Artificial Disc

This study is intended to demonstrate the 5-year long-term safety and efficacy of the Simplify® Cervical Artificial Disc ("Simplify Disc") in subjects enrolled in the non-randomized Simplify Disc IDE study. This study was conducted under IDE G140154.

This post approval study (PAS) is a continuation of the IDE pivotal study (G140154) as required under P200022. These data include long-term follow-up of subjects enrolled and treated under the IDE study from February 2016 to 2018 out to 60 months post-op. The control group is comprised of a historical ACDF population. Subjects were enrolled (signed consent) into the PAS on a rolling basis at either the 36 month, 48 month or 60 month visit based on their treatment date (under IDE G140154) and the date of PAS protocol approval. Data presented are compared to baseline data collected as part of the IDE study. Therefore, the start date and end dates of the PAS are not inclusive of the full 60 months of reported data.

Eligibility Criteria:
Inclusion Criteria:

- All subjects enrolled in the Simplify Disc IDE study are considered for this long-term follow-up study.

Exclusion Criteria:

* Subjects who were not implanted with the Simplify Disc during the IDE study
* Subjects who had a secondary surgical intervention at the index level during the IDE study
* Subjects who were withdrawn or withdrew consent to participate in the IDE study
* Subjects who do not consent to participate in long-term follow-up post-approval study
Prognostic Value of Endothelial Dysfunction and Coronary Complexity

The investigators test the additional clinical value of the physiological assessment of endothelial function to the morphological assessment of coronary complexity and classical risk score in predicting cardiovascular events.

The investigators enroll consecutive, stable high risk patients for cardiovascular events. The reactive hyperemia peripheral arterial tonometry index (RHI) was measured before coronary angiography and coronary lesions were assessed angiographically by SYNTAX Scoring system. The investigators all subjects and examined the occurrence of cardiovascular events (CV death, non-fatal myocardial infarction and ischemic stroke, unstable angina pectoris, hospitalization for HF, coronary revascularization, or non-fatal aortic and peripheral vascular disease).

Eligibility Criteria:
Inclusion Criteria:

* Stable, high-risk patients with diabetes mellitus, or more than two conventional coronary risk factors, who are referred for coronary angiography because of angina-like chest symptoms.

Exclusion Criteria:

* An ejection fraction \< 50%
* Moderate to severe valvular heart disease
* Cardiomyopathy
* Allergy to latex
* Significant endocrine, hepatic, renal, or inflammatory disease
* cerebrovascular disease
Neuraxial Labor Analgesia and the Incidence of Postpartum Depression

Postpartum depression (PPD) affects approximately 15% of women during the first year after giving birth, and is common across cultures. The etiology of postpartum depression is not totally clear. The severe pain experienced during childbirth was reported to be associated with the development of postpartum depression. The purpose of the present study is to evaluate whether use of neuraxial labor analgesia can reduce the incidence of postpartum depression.

Postpartum depression (PPD) affects approximately 15% of women during the first year after giving birth, and is common across cultures. In postpartum Chinese women, the reported incidence ranged from 6.5% to 29.5%.

The etiology of postpartum depression is not totally clear. Identified risk factors include previous maternal blues, unplanned pregnancy, lack of marital or social support, and previous psychiatric illnesses. Furthermore, the severe pain experienced during childbirth was reported to be associated with the occurrence of postpartum depression.

A recent study of the investigators found that use of epidural analgesia during labor was associated with decreased risk of postpartum depression. However, several limitations existed in that study and further evidence is needed to reconfirm the finding. The purpose of the present study is to reevaluate whether use of neuraxial labor analgesia can reduce the incidence of postpartum depression.

Eligibility Criteria:
Inclusion Criteria:

1. Primiparae between 18 and 34 years of age with term single cephalic pregnancy;
2. Admitted to the delivery room during daytime working hours (from 8 am to 5 pm).
3. Preparing to deliver vaginally.

Exclusion Criteria:

1. History of psychiatric disease (indicate those that are diagnosed before or during pregnancy by psychiatrists);
2. Presence of contraindications to epidural analgesia, which includes: (1) History of infectious disease of the central nervous system (poliomyelitis, cerebrospinal meningitis, encephalitis, etc.); (2) History of spinal or intra-spinal disease (trauma or surgery of spinal column, intra-spinal canal mass, etc.); (3) Systemic infection (sepsis); (4) Skin or soft tissue infection at the site of epidural puncture; (5) Coagulopathy.
3. Other reasons that are considered unsuitable for study participation.
Simeprevir in Combination With Sofosbuvir in Treatment-Naïve or -Experienced Adults With Chronic Genotype 4 Hepatitis C Virus Infection

This study will look at the safety and efficacy of 8 week and 12 week treatment with Sofosbuvir and Simeprevir in treatment-naïve and treatment-experienced patients with chronic hepatitis C genotype 4.

Patients with confirmed absence of cirrhosis will receive 8 weeks of treatment with Sofosbuvir and Simeprevir. Patients with confirmed presence of cirrhosis will receive 12 weeks of treatment with Sofosbuvir and Simeprevir. All patients will followed for 24 weeks post-treatment. Presence or absence of cirrhosis will be evaluated by FibroScan if no historical liver biopsy or FibroScan is available.

Eligibility Criteria:
Inclusion Criteria:

* HCV genotype 4 infection
* HCV RNA \>10,000 IU/mL at screening.

Exclusion Criteria:

* Evidence of clinical hepatic decompensation (history or current evidence of ascites, bleeding varices or hepatic encephalopathy).
* Any liver disease of non-HCV etiology. This includes, but is not limited to, acute hepatitis A, drug- or alcohol-related liver disease, autoimmune hepatitis, hemochromatosis, Wilson's disease, alpha-1 antitrypsin deficiency, non-alcoholic steatohepatitis, primary biliary cirrhosis, or any other non-HCV liver disease considered clinically significant by the investigator.
* Infection/co-infection with HCV non-genotype 4.
* Co-infection with human immunodeficiency virus (HIV) type 1 or type 2 (HIV-1 or HIV-2) (positive HIV-1 or HIV-2 antibodies test at screening).
* Co-infection with hepatitis-B virus (hepatitis-B-surface-antigen \[HBsAg\] positive).
* Presence of significant co-morbidities or conditions that would compromise the subject's safety and could interfere with the subject's participation for the full duration of the study in the opinion of the investigator
* Previously been treated with any direct acting anti-HCV agent (approved or investigational) for chronic HCV infection.
Barre Exercise in Parkinson's

This study asks if a barre exercise program is a feasible and acceptable form of exercise for individuals with Parkinson disease. The study will also evaluate barre's potential effects on motor outcomes, including balance, strength, and functional mobility.

The primary objectives of this study are to: 1) evaluate the feasibility and acceptability of a barre exercise intervention and 2) gather preliminary data regarding the effect of a barre exercise intervention on balance, strength, functional mobility and quality of life in individuals with mild to moderate Parkinson disease (PD). Individuals with PD (N=15) will be recruited to participate in a pilot barre exercise class led by a certified barre instructor. The intervention will include 24, 45-50 minute group classes (twice weekly for 12 weeks, excluding holidays). Pre- and post-intervention data collection will include assessments of balance, lower extremity strength, and functional mobility.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed by a neurologist with idiopathic Parkinson disease
* at least 18 years of age
* a score on the Hoehn \& Yahr (H\&Y) scale between I-III to indicate mild to moderate disease severity
* able to provide informed consent
* able to walk for 10 continuous minutes without assistance from another person
* stable medication regimen for at least one month prior to enrollment

Exclusion Criteria:

* any neurological condition other than PD
* history of orthopedic or other medical conditions that limit the ability to safely participate in the intervention or
* language, visual, or hearing barriers to participation
* evidence of dementia (Montreal Cognitive Assessment \< 24) to ensure understanding of the intervention class instructions
To Evaluate Food Effect on the Pharmacokinetics of Rebamipide in Healthy Volunteers

This is a randomized, open label, single dose, crossover study to evaluate the food effect on the pharmacokinetics after single oral dose of "rebamipide SR 150 mg" in healthy adult volunteers.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects who give consent to voluntary participation by signing the informed consent form
2. Healthy adult males aged ≥19 and ≤45 years at screening
3. Subjects with weight ≥50 kg AND body mass index (BMI) ≥18.0 and ≤27.0

Exclusion Criteria:

1. Subjects with hypersensitivity to the active ingredient of the IP or other anti-ulcer agents or history of clinically significant hypersensitivity
2. Subjects with any past history of gastrointestinal diseases which can affect the absorption of the IP
3. Subjects who have participated in other clinical trial and received any other investigational products within 6 months before the expected date of IP administration
4. Subjects who have taken any inducers or inhibitors of drug metabolism enzyme
5. Subjects who have been on diets that may affect the absorption, distribution, metabolism, and excretion of a drug
6. Subjects who donated whole blood within 2 months or underwent apheresis within 1 month prior to obtaining informed consent or who did not agree to prohibit blood donation
7. Smokers who have smoked \>10 cigarettes per day within the last 6 months
8. Subjects with any positive result on HBsAg, hepatitis C virus (HCV) Ab, HIV Ab, and (venereal disease research laboratory) VDRL tests