cyrilzakka/clinical-trials huggingface dataset:
Vitamin Deficiency in Immigrants, a Treatment Study

The purpose of this study is to determine the efficacy of different doses of vitamin D in persons, immigrated to Sweden from Middle East or Africa, with decreased S vitamin D.

The participants in the study have taken part in a previous screening study. They are now asked to participate in this treatment study. At a screening visit blood samples for vitamin D3 and PTH are collected. Data regarding previous fractures, life style, exposure for sun, clothes, diet, smoking and physical activities are collected. The Vitamin D value predict the treatment dose.

Eligibility Criteria:
Inclusion Criteria:

* Serum- vitamin D below 75 nmol/L
* Men and female
* 25-65 years of age
* Born in Middle East or Africa, living in Umeå district

Exclusion Criteria:

* Hypersensitive to Cholecalciferol, cocos oil, palm kernel or rubber
* Serum D3 equal to or above75 nmol/L
* Hypercalcemia
* Renal insufficiency
* History of Kidney Calculi
* Nephrocalcinosis
* History of sarcoidosis and other Granulomatous Diseases
* Known malignancy
* Ongoing treatment with phenytoin, barbiturates, rifampicin, isoniazid
* Ongoing treatment with cardiac glycosides
* Ongoing treatment with thiazides
* Ongoing treatment with Etalpha, Rocaltrol, ergocalciferol, Dygratal
* Ongoing treatment with drugs involving fat absorption; Orlistat Colestyramin
* Oral treatment with glucocorticoids
* Ongoing treatment with Aluminum Compounds drugs
* Ongoing treatment with Omega -3, vitamin D and/or calcium
* Immobilisation
* Other medial reason not to participate according to the investigator
* Pregnancy (women with S-D3 below 25 nmol/)
* Breastfeeding
Evaluation of Muscle Ischemia in Arterial Claudication (Tsingtao)

The goal is to compare the results observed in patients that had both an exercise oximetry and a thallium scintigraphy for lower limb claudication

On our routine pratice, patients suffering claudication (specifically atypical claudication or claudication of doubful vascular origin) have exercise oximetry to prove the vascular origin of pain. If still doubtful (inconsistency of pain and oximetry results) patients are referred for thallium scintigraphy. Our goal is to compare the results issued from these two test

Eligibility Criteria:
Inclusion Criteria:

* Claudication suspected of arterial origin

Exclusion Criteria:

* missing endopoint value
Estimation of the Effect of Multiple Dose Ritlecitinib (PF-06651600) on the Pharmacokinetics of a Single Dose of Caffeine in Healthy Participants

This will be a Phase 1, 2 period, fixed sequence, multiple-dose, open-label study of the effect of ritlecitinib on caffeine PK in healthy participants. Approximately 12 healthy male and/or female participants will be enrolled in the study.


Eligibility Criteria:
Inclusion Criteria:

-Male and female participants must be 18 to 55 years of age, inclusive, at the time of signing the ICD.

-BMI of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lb). -

* Male and female participants who are healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and 12-lead ECG.
* Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.

Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, dermatological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
* History of febrile illness within 5 days prior to the first dose of investigational product.
* History of any lymphoproliferative disorder such as EBV related lymphoproliferative disorder, history of lymphoma, history of leukemia, or signs or symptoms suggestive of current lymphatic or lymphoid disease.
* Known presence or a 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.
* Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
* Participants who, according to the information provided on Drugs.com, would be at increased safety risk if dosed with caffeine.
* History of hypersensitivity to caffeine.
I-125 Versus Pd-103 for Low Risk Prostate Cancer

Objective: To test the hypothesis that the shorter half-life of Pd-103 versus I-125, will increase the rate of tumor eradication.

Research design A total of 600 patients with AJC clinical stage T1c-T2a prostatic carcinoma (Gleason grade 2 to 6, PSA 4 to 10 ng/ml) will be randomized to implantation with I-125 (160 Gy) versus Pd-103 (115 Gy).

Objective: To test the hypothesis that the shorter half-life of Pd-103 versus I-125, will increase the rate of tumor eradication.

Research design A total of 600 patients with AJC clinical stage T1c-T2a prostatic carcinoma (Gleason grade 2 to 6, PSA 4 to 10 ng/ml) will be randomized to implantation with I-125 (160 Gy) versus Pd-103 (115 Gy).

Methodology: Patients will be randomized by the method of random permuted blocks.

Cancer status will be monitored by serial serum PSA at 6, 12, 18 and 24 months and yearly thereafter. Treatment-related morbidity will be monitored by personal interview, using standard American Urologic Association and Radiation Therapy Oncology Group criteria at 1, 3, 6, 12 and 24 months. Patients with serum PSA above 1.0 ng/ml two years after treatment will be considered to have residual or recurrent cancer and to have failed therapy.

Eligibility Criteria:
Inclusion Criteria:

* Males age 40-80
* PSA 4-10
* Gleason score 5-6

Exclusion Criteria:

* Lymph node positive
Evaluation of the Prevalence of Pelvic Static Disorders in Women With Localized Breast Cancer

In this study, investigator propose to assess the prevalence of pelvic static disorders in women undergoing adjuvant hormone therapy for localized breast cancer and to assess the overall quality of life in these patients

Breast cancer is the most common cancer in women. Its incidence increases with 58,459 new cases in France in 2018, however its mortality decreases with a survival rate of 87% at 5 years.

Therapeutic options are surgery, radiotherapy, chemotherapy and hormone therapy. Hormone therapy is one of the major treatments for hormone-sensitive tumors with a prescription made in around 70% of breast cancer cases. These different hormone therapies cause a hormonal imbalance with in particular an important anti-estrogenic action. Hormonal deprivation and menopause can be responsible for the occurrence of pelvic statics disorder.\[5-9\] Pelvic static disorder (PTS) is a common problem for women, which can occur at any age.

These disorders include urinary incontinence, stress or urgency, anal incontinence, genital prolapse.

Hypothesis's investigator is that hormone therapy may be responsible for PTS. In this study, investigator propose to assess the prevalence of pelvic static disorders in women undergoing adjuvant hormone therapy for localized breast cancer and to assess the overall quality of life in these patients.

Eligibility Criteria:
Inclusion Criteria:

* Women with Age ≥ 50 years
* Menopaused
* Patient followed for carcinoma in situ or infiltrating the breast with or without hormone therapy
* Patient who was treated by surgery after June 2015, whether or not followed by radiotherapy or chemotherapy.
* Patient who agreed, after receiving information, to participate to the study.

Exclusion Criteria:

* Metastatic breast cancer
* Patient with a history of pelvic static surgery
* Patient with a history of pelvic irradiation
* Patient unable or unwilling to complete the questionnaires
* Patient with a history of urinary incontinence treatment
* Patient not affiliated to the French social security system
* Subject under tutelage, curatorship or safeguard of justice,
* Patient in an emergency situation,
* Patient whose regular monitoring is impossible for psychological, family, social or geographical reasons,
* Pregnant and / or breastfeeding woman.
A Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Ziresovir in Healthy Subjects

This is a randomized, double-blind, placebo-controlled, dose escalation study to evaluate the safety, tolerability, and pharmacokinetics (PK) of ziresovir following a single ascending oral dose administration in healthy adult subjects under fasted conditions.

Up to 3 dose cohorts are planned. The ziresovir dose level of each cohort is determined based on the collective clinical and nonclinical data of ziresovir.

The proposed dose levels of Cohorts 1, 2 and 3 are 300 mg and up to 600 mg and up to 900 mg, respectively.

A total of up to 24 subjects will be randomized with 18 subjects to receive active drug and 6 subjects to receive placebo in a double-blind fashion. Eight subjects will be randomized in each dose cohort, with 6 subjects to receive active drug and 2 subjects o receive placebo.

Eligibility Criteria:
Inclusion Criteria:

1. Capable of giving written informed consent and complying with study procedures;
2. Between the ages of 18 and 55 years, inclusive;
3. Body mass index (BMI) of 18.0 to 32.0 kg/m2 inclusive and body weight not less than 50 kg;
4. Female subjects must have a negative pregnancy test result at screening;
5. Considered healthy by the Investigator, based on subject's reported medical history, full physical examination, 12-lead ECG, and vital signs;
6. Willing and being able to adhere to study restrictions and to be confined at the Clinical Research Unit.

Exclusion Criteria:

1. Clinically significant reported history of gastrointestinal, cardiovascular, musculoskeletal, endocrine, hematologic, psychiatric, renal, hepatic, bronchopulmonary, neurologic, immunologic, lipid metabolism disorders, or drug hypersensitivity as determined by the Investigator;
2. Poor venous access;
3. Taken an investigational drug or participated in a clinical trial evaluating an investigational drug or device within 30 days (or 5 half-lives) prior to the study drug dose, whichever is longer;
4. Taken any prescription medications within 14 days or 5 half-lives (whichever is longer) of the study drug dose;
5. Major surgery or hospitalization within 6 months prior to screening that in the Investigator's opinion would put the subject or study conduct at risk, or have any scheduled surgery or hospitalization during the study period;
6. Any condition or finding that in the Investigator's opinion would put the subject or study conduct at risk if the subject were to participate in the study.
Fetal ST Segment and T Wave Analysis in Labor

The purpose of this research is to test a new instrument, called a fetal STAN monitor, that may be used during labor to monitor the electrical activity of the baby's heart. This new instrument is designed to help the doctor determine how well the baby is doing during labor. It will be used along with the existing electronic fetal monitor used to measure the baby's heart rate and the mother's contractions during birth. The specific purpose of this research study is to see if this new instrument (fetal STAN monitor) will have an impact on newborn health.

A Randomized Trial of Fetal ECG ST Segment and T Wave Analysis as an Adjunct to Electronic Fetal Heart Rate Monitoring (STAN):

Fetal ECG analysis of the ST segment (STAN) is now FDA-approved and clinically available in the United States as an adjunct for the interpretation of electronic fetal heart rate patterns. There have been a number of randomized controlled trials as well as observational studies in Europe documenting utility of this modality in terms of reducing fetal acidosis at birth, and decreasing the need for operative vaginal delivery. However, despite these endorsements, there remain concerns with the application of the technology to the United States. None of the randomized trials were performed in the United States where patient case-mix and obstetrical practice, such as the use of fetal scalp pH, differ from Europe, which may affect the impact of this technology on perinatal outcomes. Moreover, the results of the European studies are not uniformly positive.

This protocol describes a randomized controlled trial of the STAN technology as an adjunct to electronic fetal heart rate monitoring versus fetal heart rate monitoring alone.

Eligibility Criteria:
Inclusion Criteria:

* Singleton, cephalic pregnancy
* Gestational age at least 36 weeks, 1 day
* Cervical dilation of at least 2 cm and no more than 7 cm
* Ruptured membranes

Exclusion Criteria:

* Multifetal gestation
* Planned cesarean delivery
* Need for immediate delivery
* Absent variability or sinusoidal pattern at any time, or a Category II fetal heart rate pattern with absent variability in the last 20 minutes before randomization
* Inability to obtain or maintain an adequate signal within 3 trials of electrode placements
* Occurrence of any ST event during attempt to obtain adequate signal
* Patient pushing in the first stage of labor
* Known major fetal anomaly or fetal demise
* Previous uterine surgery
* Placenta previa on admission
* Maternal fever greater than or equal to 38 C or 100.4 F
* Active HSV infection
* Known HIV or hepatitis infection
* Other maternal and fetal contraindications for using the STAN monitor
* Enrollment in another labor study
* Participation in this trial in a previous pregnancy
* No certified or authorized provider available
Supportive Care Intervention-Pancreas

This is a pilot, randomized controlled trial of an embedded collaborative model of supportive care designed to improve quality of life and decrease use of unwanted healthcare services at the end of life for patients with advanced pancreatic cancer. We will enroll 30 patients who are receiving treatment at the Hillman Cancer Center for recently diagnosed, locally advanced or metastatic pancreatic adenocarcinoma, as well as their accompanying caregivers and providers. Patients will be randomized to receive either the supportive care intervention or usual care. The purpose of this study is to refine an embedded collaborative model of supportive care and to develop protocols for recruitment, randomization, and longitudinal data collection.


Eligibility Criteria:
Inclusion Criteria:

* Patients:

  * Adults (≥ 18 years old)
  * Pathologically-confirmed locally advanced or metastatic pancreatic adenocarcinoma diagnosed within the past 8 weeks
  * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 (asymptomatic), 1 (symptomatic but fully ambulatory), or 2 (symptomatic and in bed \<50% of the day)
  * Planning to receive continued care from an oncologist at the Hillman Cancer Center
  * Accompanied by a caregiver (family member or friend) at the first visit
* Caregivers:

  * Adults (\>= 18 years old)
  * Family member or friend of an eligible patient

Exclusion Criteria:

* Patients:

  * Unable to read and respond to questions in English
  * Not planning to receive continued care from an oncologist at the Hillman Cancer Center
  * Pancreatic neuroendocrine cancer
* Caregivers:

  * Unable to read and respond to questions in English
Study of Safety and Pharmacokinetics of MK-8242 in Participants With Advanced Solid Tumors (P07650)

This study is being done to evaluate the safety and pharmacokinetic profile of MK-8242 and its active metabolite (M16) in participants with advanced solid tumors. In Part 1 of the study, the study drug dose will be escalated to determine the maximum tolerated dose (MTD). In Part 2 of the study, the MTD will be confirmed and the recommended Phase 2 dose (RPTD) established; the effect of MK-8242 on liposarcoma and other tumor types will also be evaluated.

Participants are considered to have completed the study after Cycle 12. Amendment 4 (14 April 2015) was done to allow participants on active treatment at the time the study was closed to enrollment to continue study treatment beyond Cycle 12 if deriving clinical benefit, at the Investigator's discretion.

Eligibility Criteria:
Inclusion criteria:

* Histologically confirmed advanced solid tumor for which there are no effective standard therapy options
* Willing to provide tumor tissue for p53 wild type gene analysis
* Eastern Cooperative Oncology Group (ECOG) performance status of ≤1
* Adequate organ function
* Female participants and male participants and their partners who are of childbearing potential must agree to abstain from sexual intercourse or to use an acceptable method of contraception during the study and for 90 days following the last dose of study drug
* At least one measurable lesion
* In Part 2, participants with liposarcoma must have a confirmed well-differentiated or de-differentiated histology

Exclusion criteria:

* Known treated or untreated leptomeningeal metastases, or metastatic central nervous system disease
* History of recent myocardial infarction (within the past year); or with unstable or uncontrolled angina, New York Heart Association (NYHA) Class III or IV congestive heart failure, uncontrolled hypertension, clinically significant cardiac dysrhythmia or clinically significant electrocardiogram (ECG) abnormality
* Uncontrolled active infection on optimal systemic treatment
* Clinically significant hepatitis or hepatitis C antibody positive, hepatitis B surface antigen positive, or human immunodeficiency virus (HIV) seropositive
* Persistent, unresolved common terminology criteria for adverse events (CTCAE v4.0) ≥Grade 2 drug-related toxicity associated with previous treatment except for alopecia
* Radiation therapy or other loco-regional therapy within 2 weeks prior to study
* Use of moderate and strong cytochrome P450 inhibitors or inducers within 1 week prior to study
* Chemotherapy or any investigational drug(s) within 4 weeks prior to study
* Known hypersensitivity to MK-8242 or its components
* Nursing, pregnant, or intention to become pregnant during the study
* Initiating bisphosphonate therapy or adjusting the bisphosphonate dose or regimen within 30 days of Cycle 1 Day 1
DUCATS Trial: Dynamic Ultrasound to Enhance Understanding of Carpal Tunnel Syndrome

The purpose of this study is to learn if researchers can identify through ultrasound images and clinical assessment which subjects with carpel tunnel syndrome will do better following standard of care non-surgical or surgical treatment.


Eligibility Criteria:
The following criteria must be answered yes to be enrolled:

1. Does the patient have a clinical symptoms of Carpal Tunnel Syndrome (CTS)?
2. Is the patient an adult between the ages of 21 and 80?
3. Has the patient had symptoms of numbness or tingling for at least 4 weeks in at least two digits on one hand that include thumb, index, long or radial border of ring finger?
4. Does the patient have a clinical diagnosis of carpal tunnel syndrome?
5. Has the patient had and electrodiagnostic study (EDS) or EMG? (Does not need to be positive\>)
6. Is the patient able to understand and complete the study questionnaires and medical assessments in English?
7. Is the patient clinically indicated for treatment with either a steroid injection or surgery as treatment for their CTS?

EXCLUSION CRITERIA The following questions if answered yes will exclude the patient from participation in the study.

1. Has the patient had previous carpal tunnel release (CTR) or other volar wrist surgery on the hand?
2. Does the patient have a known tumor, mass or deformity of the study hand or wrist?
3. Does the patient have a previous history of steroid injection into the carpal tunnel (injection group only)?
4. Does the patient have any of the following diagnoses or conditions:

   1. cervical radiculopathy
   2. rheumatoid arthritis or other inflammatory arthritis, including gout
   3. osteoarthritis in the wrist
   4. renal failure
   5. morbid obesity (body mass index \>40)
   6. sarcoidosis
   7. peripheral nerve disease
   8. Diabetes
   9. thyroid disease or other metabolic disorder
   10. pregnancy
   11. amyloidosis
   12. major trauma (fractures or complete ligamentous tears) to the study hand or wrist?
5. Is the patient a prisoner, institutionalized individual or someone who could be considered a vulnerable person, such as an individual with dementia?
ORCA - Oracea® for Rosacea: A Community-based Assessment

The objective of this study is to assess the effectiveness, safety, subject satisfaction and quality of life with Oracea® when used as monotherapy or as add-on therapy to existing topical regimens for the treatment of rosacea.


Eligibility Criteria:
Inclusion Criteria:

* Males and females aged 18 and older
* Subjects with diagnosis of rosacea (IGA of 2 to 4)

Exclusion Criteria:

* Subjects who used a topical or systemic acne treatment within 4 months of the baseline visit (retinoids and isotretinoin)
* Subjects who used a topical or systemic antibiotic within 4 weeks of the baseline visit
* Subjects who had laser or IPL (intense pulsed light) treatments within 3 months of the baseline visit and/or who plan to have these treatments during the study
* Subjects who have a known hypersensitivity to tetracyclines or ingredients of the add on medications
* Subjects who have stomach or GI problems, kidney disease or have an active systemic fungal infection or a vaginal yeast infection are excluded
Everolimus in Combination With Exemestane in the Treatment of Postmenopausal Women With Estrogen Receptor Positive Locally Advanced or Metastatic Breast Cancer Who Are Refractory to Letrozole or Anastrozole

There are no treatments specifically approved after recurrence or progression on a non steroidal aromatase inhibitors (NSAI). In light of the need for new treatment options for postmenopausal women after failure of prior NSAI therapy, the purpose of this Phase III study is to compare efficacy and safety of a treatment with exemestane + everolimus to exemestane + placebo in postmenopausal women with estrogen receptor positive locally advanced or metastatic breast cancer refractory to NSAI.


Eligibility Criteria:
Inclusion Criteria:

* Adult women (≥ 18 years of age) with metastatic or locally advanced breast cancer not amenable to curative treatment by surgery or radiotherapy.
* Histological or cytological confirmation of estrogen-receptor positive (ER+) breast cancer
* Postmenopausal women.
* Disease refractory to non steroidal aromatase inhibitors (NSAI),
* Radiological or clinical evidence of recurrence or progression on or after the last systemic therapy prior to randomization.
* Patients must have at least one lesion that can be accurately measured or bone lesions in the absence of measurable disease as defined above.

Exclusion Criteria:

* HER2-overexpressing patients
* Patients with only non-measurable lesions other than bone metastasis (e.g. pleural effusion, ascites etc.).
* Patients who received more than one chemotherapy line for Advanced Breast Cancer.
* Previous treatment with exemestane or mTOR inhibitors.
* Known hypersensitivity to mTOR inhibitors, e.g. sirolimus (rapamycin).
* Radiotherapy within four weeks prior to randomization
* Currently receiving hormone replacement therapy,

Other protocol-defined inclusion/exclusion criteria may apply
Safety and Efficacy Study of Bimatoprost in Ethnically Japanese Patients With Open-Angle Glaucoma or Ocular Hypertension

This study evaluates the safety and efficacy of once-daily bimatoprost 0.03% and 0.01% ophthalmic solutions compared with once-daily administered bimatoprost vehicle ophthalmic solution for 2 weeks in ethnically Japanese patients with open-angle glaucoma or ocular hypertension


Eligibility Criteria:
Inclusion Criteria:

* Ethnically Japanese patients with glaucoma or ocular hypertension in each eye who require IOP-lowering therapy in both eyes

Exclusion Criteria:

* Uncontrolled systemic disease
* Use of bimatoprost or an ocular prostaglandin (eg, latanoprost, travoprost) within 6 weeks prior to baseline (Day 0)