cyrilzakka/clinical-trials huggingface dataset:
Safety and Tolerability Study of MEDI0382 in Japanese Preobese or Obese Subjects With Type 2 Diabetes

This is a Phase 2a study designed to assess the safety and tolerability of MEDI0382 titrated up to a dose level of 100, 200 or 300 µg from 50 µg vs Placebo across 48 days in Japanese subjects.

The study D5674C00001 can be conducted with a reasonable expectation of safety and tolerability in Japanese T2DM patients. The design of this study has taken into account the known benefits and risks of GLP-1 receptor agonists and glucagon receptor agonists as well as the translatable effects observed in nonclinical studies of MEDI0382.

This is a randomized, parallel-group, placebo-controlled, double-blind, multicenter Phase Ⅱa study to evaluate the safety, efficacy, and pharmacokinetics of MEDI0382 in Japanese preobese and obese subjects with type 2 diabetes who have inadequate glycemic control with diet and exercise. Subject fulfilling all of the inclusion criteria and none of the exclusion criteria will be randomised in a 1:1:1:1 ratio to four treatment arms. This is a Phase IIa study designed to evaluate the dose range for MEDI0382 to explore the safety profile, as well as blood glucose control and weight loss effects of MEDI0382 in Japanese patients with T2DM. The design of this study has taken into account the known benefits and risks of GLP-1 receptor agonists and glucagon receptor agonists as well as the translatable effects observed in nonclinical studies of MEDI0382, such that benefit-risk balance for the Japanese preobese and obese patients with T2DM in this study is considered favourable. A treatment period of 48 days is required to properly evaluate the dose range and safety and tolerability in three different doses. Inclusion of placebo in the study allows appropriate basis of AEs, glycaemic control, and weight loss. Benefits related to participation in this trial include close follow-up of a subject's diabetes and treatment with anti-diabetes agents. Although one of possible treatments is placebo, appropriate rescue therapy for worsening glycaemic control will be implemented if required.

Eligibility Criteria:
Inclusion Criteria:

* Individuals whose HbA1c range of 7.0% to 10.5% (inclusive) at screening.
* Individuals who are diagnosed with T2DM
* Individuals whose current condition at enrolment (Visit 1) is drug naïve
* BMI within the range of 24 - 40 kg/m2 (inclusive) at screening

Exclusion Criteria:

* Subjects with any of the following results at screening:
* Aspartate transaminase (AST) ≥ 2.5 × upper limit of normal (ULN)
* Alanine transaminase (ALT) ≥ 2.5 × ULN
* Total bilirubin (TBL) ≥ 2 × ULN
* Impaired renal function defined as estimated glomerular filtration rate (eGFR) ≤ 60 mL/minute/1.73 m2 at screening
* Participation in another clinical study with an investigational product administered in the last 30 days or 5 half-lives of the drug (whichever is longer) at the time of screening
Extended Follow Up of Young Women in Costa Rica Who Received Vaccine for Human Papillomavirus Types 16 and 18 and Unvaccinated Controls

This research trial studies extended follow up of young women in Costa Rica who received vaccine for human papillomavirus types 16 and 18 and unvaccinated controls. Collecting information from young women in Costa Rica who have received vaccine for human papillomavirus types 16 and 18 and a new group of unvaccinated controls enrolled for the follow-up period, may help doctors learn more about the risks and benefits of prophylactic human papillomavirus vaccine.

PRIMARY OBJECTIVES:

I. To evaluate the 10-year global impact of human papillomavirus (HPV)-16/18 vaccination of young adult women.

II. To evaluate determinants of the immune response to HPV and the vaccine, and markers of long-term protection.

III. To evaluate the natural history of HPV and cervical disease in vaccinated and unvaccinated populations.

OUTLINE:

Participants undergo long term follow-up comprising risk factor questionnaire, pelvic examination for all sexually experienced women, and specimen collection at years 6, 8, and 10.

Eligibility Criteria:
Inclusion Criteria:

* Women who participated in the Costa Rica Vaccine Trial (CVT) and lived in the Guanacaste province and a few areas of Puntarenas closest to Guanacaste will be eligible for the long-term follow up LTFU study
* Women who received the HPV-16/18 vaccine at the start of CVT will be invited for up to 6 years of additional follow-up, and women who were originally in the control arm of CVT and were offered the HPV-16/18 vaccine at crossover will be invited for an additional 2 years of follow-up
* A subset of the control arm women who are in the crossover immunogenicity subcohort will be followed the full 6 years
* Some women who received HPV vaccination and were not invited into the LTFU protocol (stopped attending their screening visits during CVT, discontinued their study participation during CVT or lived outside the study area) will be invited to participate in the LTFU protocol, particularly those who received an incomplete vaccination schedule
* UNVACCINATED CONTROL GROUP:
* Born in or between July 1978 and November 1987
* Residents of Guanacaste Province and a few areas of Puntarenas closest to Guanacaste at some point during 2005
* Able to speak/understand Spanish
* Apparently mentally competent
* Written informed consent obtained prior to enrollment

Exclusion Criteria:

* History of cervical cancer
* History of hysterectomy
* Any important medical condition or other criteria that the investigator considers that precludes enrollment
* Vaccination with Gardasil or Cervarix will be an exclusionary criterion, but few women are expected to have received these vaccines at the time of enrollment; use of these vaccines after enrollment is not a criterion for study interruption but we plan to collect information on vaccination history so that the few women who report having been vaccinated with one of the HPV vaccines after enrollment can be evaluated separately at analysis
A Prospective Study of Apatinib Plus Concurrent Neoadjuvant Chemoradiotherapy in Patients With Esophageal Squamous Cell Carcinoma

The purpose of this study is to assess the efficacy and safety of apatinib plus concurrent neoadjuvant chemoradiotherapy in patients with esophageal squamous cell carcinoma.


Eligibility Criteria:
Inclusion Criteria:

1. Age:18 to 70 years old (man or female);
2. Pathologically diagnosed with esophageal squamous cell carcinoma;
3. Patients with Stage for Ⅱ-Ⅲ(T2-4N0/+M0) (According to transesophageal ultrasonography;
4. Patients with measurable lesions(According to the criteria in RECIST1.1);
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
6. Life expectancy greater than or equal to 3 months;
7. Major organ function has to meet the following certeria:

(1) For results of blood routine test

1. HB≥80g/L;
2. ANC≥1.5×109/L;
3. PLT≥90×109/L; (2) For results of blood biochemical test

a) ALT and AST≤2.5×ULN; b) TBIL\<1.5×ULN; c) Serum creatinine ≤1.5×ULN; 8. Doctors believe that treatment can bring benefits to patients; 9. Participants were willing to join in this study, and written informed consent, good adherence, cooperate with the follow-up.

Exclusion Criteria:

1. Have received prior treatment with chemotherapy or radiotherapy；
2. Have high blood pressure and antihypertensive drug treatment can not control;
3. Patients with severe cardiovascular disease ;
4. Accompanied by esophageal perforation and esophagotracheal fistula;
5. Patients with active bleeding or bleeding tendency;
6. Pregnant or lactating women;
7. The researchers think inappropriate.
Real-Time Optical Biopsy in Improving Lung Cancer Diagnosis in Patients Undergoing Lung Biopsy

This pilot early phase I trial studies how well real-time optical biopsy works in improving lung cancer diagnosis in patients undergoing lung biopsy. Real-time optical biopsy using confocal microscopy may improve the ability of physicians to diagnose lung cancer and accurately differentiate cancerous and benign lesions found during computed tomography screening.

PRIMARY OBJECTIVES:

I. Show that it is possible to distinguish lung cancer from benign lesions in ex vivo tissue samples using optical microscopy.

II. Test a proof-of-concept endoscopic instrument for imaging through a biopsy needle under computed tomography (CT) guidance on ex vivo tissue samples.

OUTLINE:

Patients undergo extraction of up to 3 additional lung biopsies from target lesions that are at least 2-3 cm in diameter using the 19 gauge SuperCore biopsy needle or the 20 gauge Rotax needle. The extracted tissue is imaged via confocal fluorescence microscopy using a variety of fluorescent contrast agents, such as, fluorescein sodium, methylene blue, or indocyanine green and then undergo hematoxylin and eosin processing.

Eligibility Criteria:
Inclusion Criteria:

* Participants will be drawn from the pool of patients who have suspicious lesions identified on CT and who are already scheduled for a lung biopsy procedure with Dr. Woodhead or one of his colleagues
* Patients will be asked to consent to 2 to 3 extra biopsy samples to be used for this research project

Exclusion Criteria:

- Excluded from this study will be minors below age 18, prisoners, pregnant women, patients with a contraindication for additional lung biopsies, and patients who cannot give informed consent (language barrier, cognitive impairment, etc.)
A Single Dose Study of Tamiflu in Volunteers in Dialysis And in Volunteers With Reduced Creatinine Clearance

This open-label, prospective, single dose study will evaluate the pharmacokinetics and safety of Tamiflu (oseltamivir) in volunteers on dialysis and in volunteers with a creatinine clearance from 10 to 30 mL/min. Volunteers will receive a single oral dose of Tamiflu.


Eligibility Criteria:
Inclusion Criteria:

General

* Adult volunteers, aged 19 to 90 years
* Medically stable with no hospitalization for a significant disease in the 3 months before study start

Volunteers on dialysis

* A documented and well-established dialysis therapy

Volunteers with reduced creatinine clearance

* Creatinine clearance from 10 to 30 mL/min
* Stable renal function

Exclusion Criteria:

* Clinically significant and unstable disease (e.g., cardiac, hepatic, pulmonary)
* Medical history of concurrent medical condition that would compromise participation in the study
* Hypotensive episodes or symptoms of fainting, dizziness or lightheadedness in the 4 weeks before screening
* Uncontrolled hypotension or hypertension
* Infection with hepatitis B, hepatitis C or human immunodeficiency virus
Research Study Investigating How Well NDec Works in People With Sickle Cell Disease

This study examines how well a new, potential medicine called NDec works and is tolerated in people with sickle cell disease. NDec is a combination of two medicines (decitabine-tetrahydrouridine). Both medicines are new for the treatment of sickle cell disease. Participants who are not taking Hydroxyurea (HU) will get NDec, NDec and placebo, or placebo. Participants who are on HU treatment before joining the study will get NDec, NDec and placebo, or continue on HU. Which treatment participants get is decided by chance. Participants getting NDec and/or Placebo will get capsules to take twice weekly. The study will last for about a year.


Eligibility Criteria:
Inclusion Criteria:

* Age above or equal to 18 years at the time of signing informed consent
* Confirmed diagnosis of SCD (including HbSS, HbSC, HbSβ0 thalassaemia and HbSβ+ thalassaemia or other Sickle Cell disease variants)
* 2-10 episodes of documented vaso-occlusive crisis (VOCs) within the last 12 months prior to the screening visit
* Haemoglobin greater than or equal to 5.0 g/dL and below or equal to 10.5 g/dL at visit 1
* Absolute reticulocyte count above upper limit of the normal (ULN) at visit 1
* Body weight 40 to 125 kg (inclusive).

Exclusion Criteria:

* Patient is on chronic transfusion therapy as defined by receiving scheduled (pre-planned) series of blood transfusion (simple or exchange) for prophylactic purposes, or the patient is likely to begin chronic transfusion therapy during the course of the trial, or has received RBC or whole blood transfusion for any reason within 28 days of visit 1
* Receipt of erythropoietin or other haematopoietic growth factor treatment within 28 days of signing ICF, or planned treatment with these agents during the trial
* Receipt of voxelotor, crizanlizumab or L-glutamine treatment within 12 weeks of signing the informed consent form, or planned treatment with such agents during the trial
* Platelet count greater than 800 x 10\^9/L at visit 1
* Absolute neutrophil count below or equal to 1.5 x 10\^9/L at visit 1
* Any condition/concurrent chronic disease involving the stomach or small intestine which may affect drug absorption, as per investigator's judgement
* Female who is

  * pregnant, breast-feeding or intends to become pregnant within 6 months after the final trial product administration
  * child-bearing potential and not using highly effective methods of contraception and whose male partner is not using effective contraception, at screening and until 6 months after the last dose of trial product
* Male with female partner of childbearing potential who does not agree to use condom and whose female partner of childbearing potential is not using a highly effective contraceptive measure from trial start to:

  * Six (6) months after the last dose of trial product for patients on NDec/Placebo
  * Six (6) months after the last dose of trial product for patients outside US and CA randomised to HU
  * Twelve (12) months after the last dose of trial product for patients randomised to HU in US and CA
Telerehabilitation in Multiple Sclerosis

Patients with multiple sclerosis will be randomized into two groups. One group will receive live telerehabilitation sessions 3 times a week over a course of three months. The other group will receive video instructions for aerobic and strengthening exercises. Patients fatigue, sleep quality and quality of life will be measured.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of multiple scleroisis

Exclusion Criteria:

* Any musculoskeletal condition preventing patients to actively participate in exercise sessions
Study of the Efficacy, Safety, and Tolerability of Serlopitant for Pruritus (Itch) in Atopic Dermatitis

Study of the Efficacy, Safety, and Tolerability of Serlopitant for Pruritus (Itch) in Atopic Dermatitis

This is a double-blind, randomized, placebo-controlled study. Approximately 450 subjects will be randomized in a 1:1:1 ratio to receive daily oral doses of serlopitant 1 mg, 5 mg, or placebo for 6 weeks. During the screening period, subjects will be provided with an electronic device for recording electronic diary (eDiary) assessments throughout the study. This eDiary will be used to capture efficacy endpoint data and treatment information. At the Baseline visit, eligible subjects will be randomized, and study drug dispensed beginning with a loading dose of 3 tablets to be taken at bedtime that same day. Starting on Study Day 2, subjects will take one tablet per day at bedtime. Treatment will continue for 6 weeks. The primary efficacy endpoint will be assessed during Week 6. After completion of the 6-week treatment period, all subjects will enter a 4-week follow-up period.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, age 13 years or older
* Pruritus prior to and during the initial screening period
* Diagnosis of atopic dermatitis
* Judged to be in good health in the investigator's opinion

Exclusion Criteria:

* Prior treatment with study drug or similar drug
* Pruritus due to another reason besides atopic dermatitis
* Presence of any medical condition or disability that could interfere with study
* History of hypersensitivity to serlopitant or any of its components
* Currently pregnant or male partner of pregnant female
* Females of childbearing potential who are unable or unwilling to use adequate contraception or who are breast feeding
Treatment of Class II Malocclusion Combined With Low-level Laser

This experimental study will evaluate the effect of combined treatment with low-level laser and functional appliances (twin-block) on the correction of Class II malocclusion, compared with the control group treated with functional appliances (twin-block) only.

The study sample will consist of 40 patients with Class II malocclusion. The sample will be allocated randomly into two groups: a control group and an experimental group.

Functional appliance (twin-block) will be applied for all patients. Low-level laser will be applied for the experimental group only. The skeleto-dental changes occurring after functional treatment will be assessed using cephalometric radiographs; pre- and post- treatment changes for each group will be evaluated individually.

Class II malocclusion is considered as the most common malocclusion between patients.

Recently low-level laser enters the world of dentistry, some studies assessed the effect of low-level laser on the growth of mandibles and condyles in animals and showed that there is a good effect of laser on the mandible growth.

This study will evaluate the effect of low-level laser on the growth of the mandible and the duration of functional treatment.

Twin-block will be applied in two groups: The control group will receive the twin-block only, and the experimental group will receive the twin-block combined with low-level laser therapy on the TMG region.

Cephalometric radiographs will be gotten before and after functional treatment to evaluate the dento-skeletal changes.

Eligibility Criteria:
Inclusion Criteria:

* Skeletal Class II malocclusion because of mandibular retrognathia
* ANB \> 4
* Overjet \> 5
* SNB \< 78

Exclusion Criteria:

* Poor oral hygiene
* Previous orthodontic treatment.
* Patients with syndromes, clefts, or craniofacial abnormalities.
* Reason of contraindication of functional treatment
RAHM Foundation Retrospective Study of Various Diseases

This is a retrospective data collection on treatment of various disorders. This registry will include a variety of different products, implants, technologies and procedures. The registry will also collect any adverse events/complications that occur during or following treatment of these conditions. The data may be utilized to develop strategic treatment pathways and/or benchmarking that will improve patient care. Ultimately, the goal of the registry is to enhance the understanding of healthcare and the treatment in these disease states.

The purpose is to collect data on patients with a variety of disorders. This includes point of care (primary care, internal medicine, pain management providers, etc.) as well as a variety of specialty providers including neurosurgeons, orthopedic surgeons, oncologists, and dermatologists. The retrospective data collection will consist of a core set of data if available. The registry will attempt to collect data prior to surgery/treatment/procedures, during surgery, and various time points following surgery/treatment/procedures. The data will include, but is not limited to demographic data, past medical history, previous treatments, time off of work, type of surgery performed, products/implants/procedures/technology used during surgery, treatments/procedures/technology used for non-surgical conditions, anesthesia used during surgery, complications/adverse events following surgery and or treatment, outcome tools, imaging results, pain assessment, pain medication utilization, length of hospital stay, unplanned hospital admissions, revision surgery, adjacent level disease, genetic testing, urinary drug testing, other diagnostic or assessment testing, patient return to work and patient return to normal activity. The data collected will vary depending on disease state and treatment. This registry will also allow for comparisons on different treatments, procedures, etc. with a goal of developing the best pathways for a variety of different disease states.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who meet eligibility criteria across 1 of the 6 therapeutic areas

Exclusion Criteria:

* Subjects who do not meet eligibility criteria for any of the 6 therapeutic areas
Enhancement of Circadian Rhythms in ICU Patients Through Light Intervention

The investigators will examine the effects of dynamic light therapy on circadian rhythms in intensive care unit (ICU) patients. In a randomized controlled trial (RCT), they will investigate the effects of a specific light algorithm on rhythms of serum melatonin, clock gene expression, the proteome, and metabolome, compared to standard hospital lighting, supported by the data science algorithms to improve vital-based algorithms with light interventions.


Eligibility Criteria:
Inclusion Criteria:

* Patient capable of giving consent or additionally existing legal caregiver or authorized/spouse representative in case of non-consenting patients in the intensive care unit
* Male and female patients with age ≥ 18 years
* Expected intensive care unit stay ≥ 2 days

Exclusion Criteria:

* Participation in other clinical studies during the study period and ten days before
* Previous ICU treatment during the current hospital stay
* Patients with psychiatric diseases
* Patients with a history of stroke and known severe residual cognitive deficits
* Patients with a history of cardiopulmonary arrest or pulseless electric activity with cardiopulmonary resuscitation followed by therapeutic hypothermia during entire hospital stay
* Analphabetism
* Anacusis or Hypoacusis with hearing aid device,
* Amaurosis
* Accommodation in an institution due to an official or judicial order
* History of sleep-related breathing disorders
* History or suspicion of hypoxic brain damage
* History or suspicion of elevated intracranial pressure in the last 7 days before study inclusion
* Patients with an open chest after cardiac surgery
* Patient has a power of attorney or patient's provision, where he/she refuses participation in any clinical trial
* The informed consent of the patient or the subject's legally acceptable representative can't be obtained in time
* History of photoallergic reactions or history of visually triggered seizures
* Severe eye diseases (e.g. retinopathy, glaucoma) or high sensitivity to bright light
* Patients with liver cirrhosis
* Patients with a probability of survival \<24h
* Optic neuritis within the last 3 months
* Travel across two time zones within 3 months prior to study screening
* Women who are pregnant, have a positive pregnancy test, are breastfeeding or plan to become pregnant during the course of this clinical trial