cyrilzakka/clinical-trials huggingface dataset:
Phase III Clinical Study of VC005 Tablets in Adult Patients with Moderate to Severe Atopic Dermatitis

This clinical trial is a multicenter, randomized, double-blind, controlled phase III clinical study


Eligibility Criteria:
Inclusion Criteria:

(1）The patient understands and voluntarily signs the Informed Consent Form (ICF), and has the willingness and ability to complete the regular visits,treatment plans, laboratory tests and other experimental procedures required by the program. (2) Male or female patients aged ≥18 and ≤75 years at the time of signing the ICF. (3) Meet Hanifin-Rajka diagnostic criteria at screening and have atopic dermatitis （AD) symptoms for at least 1 year prior to baseline. (4) At screening and baseline, meets criteria for moderately severe AD based on the investigator's assessment of 3 of the following:Eczema area and severity index (EASI) score ≥12;Psoriasis Area Severity Index (IGA) score ≥3;AD involvement in ≥10% of the Body Surface Area (BSA). (5) Recent (within 1 year prior to screening) topical treatment for AD with inadequate or intolerant clinical response, as determined by the investigator

Exclusion Criteria:

(1) Inability to swallow the test drug or refractory nausea and vomiting, malabsorption, extracorporeal biliary shunt, or the presence of a gastrointestinal disorder (e.g., Crohn's disease, ulcerative colitis, or short bowel syndrome) or other malabsorption condition that interferes with the absorption of the drug; (2) Current or history of lymphoproliferative disorders or presence of signs or symptoms suggestive of possible lymphoproliferative disorders of lymphoid tissue, including lymphadenopathy or splenomegaly; malignancies of any kind, or a history of any malignancy within the 5 years prior to Screening (except for completely resected carcinoma in situ of the cervix or non-metastatic squamous cell or basal cell carcinoma of the skin or papillary carcinoma of the thyroid gland); (3) Patients with prior thromboembolism (including deep vein thrombosis, pulmonary embolism, arterial thrombosis, etc.) or other high-risk groups prone to thromboembolism; (4) Patients with a history of herpes virus infection within the last 1 month or those with recurrent episodes of herpes zoster (≥2), disseminated herpes zoster, disseminated herpes simplex, or those for whom herpes zoster or herpes simplex infections cannot be excluded at this time;
Effects of Intense Exercise on Neural Responses to Food.

The primary aim of this study was to determine the effects of an acute bout of high intensity exercise on the brains response to viewing pictures of food using functional magnetic resonance imaging (fMRI).

It is clear that intense exercise impacts on peripheral appetite regulation, however very little is known about the impact of high-intensity exercise on central appetite regulation. This study aimed to investigate the effects of high-intensity exercise on both central and peripheral responses to images of food. Functional magnetic resonance techniques were used to assess the brains response to images of high and low calorie foods, following a short bout of high-intensity exercise. Appetite hormone concentrations were also measured. It was hypothesized that, due to the known effects of high-intensity exercise on appetite regulatory hormones and subjective appetite ratings, the activation of reward-related brain regions to visual food cues would be modulated following intense physical activity.

Eligibility Criteria:
Inclusion Criteria:

* Healthy, non-smokers, free from cardiovascular disease and metabolic disease, no medication, participated in moderate/vigorous physical activity (\>2 hours per week)

Exclusion Criteria:

* Smokers, history of cardiovascular/metabolic disease, low physical activity levels, inability to participate in fMRI scanning sessions including contraindications to MRI
Velocimetric Study of Temporal Arteries in Patients With Horton Disease Using Scan-Doppler

The use of ultrasonography in detecting giant cell arteritis ( GCA) is emerging. Currently, temporal biopsy is the gold standard to diagnose GCA but studies have shown the interest to use B mode ultrasonography. However, until now, the study of velocities in GCA have not been yet performed.


Eligibility Criteria:
Inclusion Criteria:

* patients with suspicious giant arteritis

Exclusion Criteria:

* patients who have already been treated or diagnosed for giant arteritis
Phase 3 Study Evaluating Safety and Efficacy of OTX-TP in Subjects With OAG or OHT

The objective of the study is to evaluate evaluate the safety and IOP lowering efficacy of OTX-TP, a sustained release travoprost drug product, placed in the canaliculus of the eyelid in the treatment of subjects with open-angle glaucoma or ocular hypertension

This was a prospective, multicenter, randomized, parallel-arm, double masked, placebo vehicle (PV) controlled study conducted to evaluate the safety and IOP-lowering efficacy of OTX-TP, a sustained release drug product placed in the canaliculus of the eyelid in subjects with open-angle glaucoma or ocular hypertension. A total of up to 550 subjects (1100 eyes) with a clinical diagnosis of open-angle glaucoma or ocular hypertension in both eyes received either OTX-TP or PV to evaluate the safety and efficacy of OTX-TP.

Eligibility Criteria:
Inclusion Criteria:

* Documented diagnosis of ocular hypertension with an open angle of Schaffer Grade 3 or greater or open-angle glaucoma without pseudoexfoliation or pigment dispersion or evidence of traumatic angle recession
* IOP is currently controlled as assessed by the Investigator

Exclusion Criteria:

* Punctum size smaller than 0.4 mm or greater than 0.9 mm in either eye as measured using a standard punctum gauge
* A history of an inadequate response or no response to topical prostaglandin
* Known or suspected allergy and/or hypersensitivity to travoprost or any prostaglandin, fluorescein, or to any component of the study products
The Proactive Support of Labor Study

The duration of labor is decisive for maternal and fetal health. Poor progression often results in tired mothers, bad experience, delivery complications and a demand for cesarean section in next pregnancy. Proactive support of labor is a method originally from the Netherlands.

The main idea is to define start of active labor earlier than the traditional "3-4 cm opening of the cervix and regular contractions" to be cervix \< 0.5 cm in length, and 1 cm opening and painful contractions. From this point, it is expected to be a progress of 1cm/hour opening of cervix. If not, progress is supported by amniotomy or stimulation of contractions.

This method is embraced by several clinics with great enthusiasm. However, there are no randomized controlled trials to prove that this method is better than others.


Eligibility Criteria:
Inclusion Criteria:

* spontaneous start of labor
* nulliparous
* term pregnancy
* cephalic presentation

Exclusion Criteria:

* twins
* breech presentation
* given birth earlier
* known uterine anomaly
* insulin treated diabetes
* preeclampsia
* other serious medical conditions in mother or fetus
Chronic Effects of Local Vibration on Neuromuscular Reconditioning After Anterior Cruciate Ligament Reconstruction

These last years, it has been proven that the solicitation of a muscle using vibration may lead to positive effects on the neuromuscular function. Thus, the aim of the current study is to assess if the addition of local vibration training sessions on the quadriceps muscle to the classic readaptation program (i.e. physiotherapist sessions) may allow a better recuperation 2 months after the surgery and the reconstruction of the anterior cruciate ligament.

The aim of the vibration training proposed in the current study is to allow a better recuperation 2 months after the anterior cruciate ligament reconstruction when compared with conventional physiotherapy alone.


Eligibility Criteria:
Inclusion Criteria:

* Undergoing to surgery (i.e. ligamentoplasty) of the anterior cruciate ligament

Exclusion Criteria:

* Taking neuro-active substances which can lead to alteration of the corticospinal excitability
* Contra indications for using magnetic stimulation
* Participating in another study in the same time
ComParative Diagnostic Study Between Multislice Computed Tomography (MSCT) and Stress Echography in Coronarin Patients.

The aim of this study is to define the best prognostic strategy for patients presenting suspected acute CORONARY syndrome, between MSCT and stress echocardiography.

Patients presenting with a suspected acute CORONARY syndrome is based on the interrogation, the realization of an electrocardiogram (ECG) and 2 dosages of the cardiac troponin at some hours of interval. However, the ECG and the troponin are frequently normal and this does not absolutely eliminate the diagnosis. In that case, it is at present recommended to practise an effort ECG or a stress imaging, such as echocardiography. Several studies estimated the diagnostic exactness of stress echography for patients presenting a recent chest pain without modification of the ECG nor a rise of the troponin with a sensibility from 71 to 86% and a specificity from 91 to 98%. Recently, several teams estimated the interest of multislice computed tomography (MSCT) in the same population. The MSCT sensibility reported by 2 teams is promising because was found between 91 and 100%. On the other hand, the specificity was appreciably less good : between 76 and 82%. The negative predictive value to MSCT was excellent : between 97 and 100%.The aim of this work is to compare the diagnostic exactness between stress echography and MSCT for patients presenting with a suspected acute coronary syndrome without modification of the ECG nor rise of the troponin. It is about a prospective monocentric diagnostic study concerning 400 patients. The primary end point is the proportion report of true positives in MSCT with regard to stress echocardiography (the main diagnosis is the coronarography). The secondary end points include the proportion of false positives, the non interpretable or non contributory examination rate and especially the proportion of unwanted events in 6 months for the negative patients in both examinations according to a combined criteria including death, myocardial infraction (MI), percutaneous CORONARY intervention (PCI), coronary artery bypass graft (CABG) or readmission for chest pain with coronarography visualizing a stenosis greater than 50 %.

Eligibility Criteria:
Inclusion Criteria:

* chest pain \< 24 hours
* normal ECG
* normal troponin I

Exclusion Criteria:

* ECG evolution
* troponin I evolution
* hemodynamic instability
* rhythmic instability
* allergy to iodized contrast products
* Creatinin \> 150 micromol/L
* venous capital absence
* auricular fibrillation
A Study of BMS-512148 (Dapagliflozin) in Patients With Type 2 Diabetes and Inadequately Controlled Hypertension on an Angiotensin-Converting Enzyme Inhibitor or Angiotensin Receptor Blocker

The purpose of this study is to learn whether dapagliflozin, after 12 weeks, can improve (decrease) blood pressure in patients with type 2 diabetes with uncontrolled hypertension who are on an angiotensin-converting enzyme inhibitor or an angiotensin receptor blocker. The safety of this treatment will also be studied.


Eligibility Criteria:
Key inclusion criteria

* Participants willing and able to give signed and written informed consent
* Males and females, aged 18 to 89 years, who have type 2 diabetes with inadequate glycemic control (hemoglobin A1c between 7% and 10.5%) and uncontrolled hypertension (seated systolic blood pressure of 140 to 165 mm Hg and seated diastolic blood pressure 85 to 105 mm Hg)
* Mean 24-hour BP\>=130/80 mmHg determined by ABPM
* Stable dose of oral antidiabetic agent (OAD) for at least 6 weeks (12 weeks for thiazolidinedione) or a stable daily dose of insulin as monotherapy or in combination with another OAD, for 8 weeks, and a stable dose of an angiotensin-converting enzyme inhibitor or angiotensin-receptor blocker for at least 4 weeks
* C-peptide level ≥0.8 ng/mL
* Body mass index ≤ 45.0 kg/m\^2

Key exclusion criteria

* Aspartate aminotransferase or alanine aminotransferase level \>3\*upper limit of normal (ULN)
* Serum total bilirubin level \>1.5\*ULN
* Serum creatinine ≥2.0 mg/dL unless subject was on metformin, where exclusionary limits were serum creatinine ≥1.50 mg/dL for men and ≥1.40 mg/dL for women
* Estimated creatinine clearance of \<60 mL/min
* Hemoglobin ≤10.0 g/dL for men and ≤9.0 g/dL for women
* Creatine kinase \>3\*ULN
* Positive for hepatitis B surface antigen
* Positive for antihepatitis C virus antibody
* Abnormal free T4 value
* History of diabetes insipidus
* Symptoms of poorly controlled diabetes that would preclude participation in this trial, including but not limited to, marked polyuria and polydipsia with greater than 10% weight loss during the 3 months prior to enrollment.
* History of diabetic ketoacidosis or hyperosmolar nonketotic coma
* History of malignant and accelerated hypertension
* Known or suspected secondary hypertension
* Any of the following within 6 months of enrollment visit:

  * Myocardial infarction
  * Cardiac surgery or revascularization (coronary artery bypass surgery /percutaneous transluminal coronary angioplasty)
  * Unstable angina
  * Unstable congestive heart disease or New York Heart Association Class III or IV
  * Transient ischemic attack or significant cerebrovascular disease
  * Unstable or previously undiagnosed arrhythmia
Detecting Fluid Accumulation With a Wearable Bioimpedance Sensor

The investigation is a prospective cohort study, where two patient groups will be monitored by a wearable bioimpedance sensor during their scheduled treatment. The overall objective is to assess the bioimpedance sensor's ability to detect local and systemic fluid accumulation.

Sub-investigation A will investigate the ability of the device to detect fluid accumulation in patients with stable chronic kidney disease undergoing regular and planned hemodialysis.

Sub-investigation B will investigate the ability of the device to track hydration status in patients scheduled for an "intensive" dialysis treatment regime, due to severe overhydration.

In Sub-investigation A, patients will be monitored for at least 10 consecutive dialysis sessions, and for a minimum of 3 weeks. Patients will wear two sensors (upper back and lower anterior leg).

In Sub-investigation B, patients will use the device throughout their whole treatment period, and for most patients, this will correspond to 2-6 dialysis treatments over 3 to 10 days. Patients will wear four patches (upper back, lateral thorax, anterior thigh, and lower anterior leg).

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Regular hemodialysis (≥ 2 times weekly) with ultrafiltration volume ≥ 1 liter (Sub-investigation A)
* Scheduled for intensive dialysis treatment due to severe overhydration (Sub-investigation B)

Exclusion Criteria:

* Known allergies or skin sensitivities to electrode hydrogel and/or acrylic adhesives
* Implantable pulse generators such as pacemakers and defibrillators, and/or use of other electrical medical equipment for which an interaction effect with the investigational device cannot be ruled out.
* Patients undergoing MRI
* Breached skin at patch mounting area
* Pregnancy
* Any medical or psychiatric condition, which in the opinion of the investigator precludes participation
A Clinical Study To Understand How Radiolabeled MK-5475 Is Taken Up By The Body, Broken Down And Then Removed From The Body in Healthy Participants (MK-5475-011)

The goal of this study is to understand how radiolabeled MK-5475 administered intravenously (IV) is taken up by the body, broken down and then removed from the body in healthy male participants. The study also aims to understand how much of the compound is broken down and how much leaves the body unchanged.


Eligibility Criteria:
Inclusion Criteria:

* Is in good health.
* Body mass index (BMI) \>18 and ≤32 kg/m2, inclusive.

Exclusion Criteria:

* Has history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases.
* Has significant multiple and/or severe allergies, or has had an anaphylactic reaction or significant intolerability to prescription or nonprescription drugs or food.
* Has had a major surgery and/or donated or lost 1 unit of blood (approximately 500 mL) or blood products within 4 weeks prior to the prestudy (screening).
* Has history of exposure to significant diagnostic or therapeutic radiation or current employment in a job requiring radiation exposure monitoring within 12 months prior to check-in.
* Has participated in more than 3 radiolabeled drug studies in the last 12 months.
Pedobarographic Assessments of Clubfoot Treated Patients

The purpose of this study is to determine the utility of pedobarographs in evaluating clubfoot post-treatment.

Detailed Description: Using Tekscan's HRMat Pressure assessment system or EMED pedobarography system the distribution of force will be measured across the plantar surface of the subject' foot. The Tekscan system is comprised of a 50 cm square pressure sensor connected to a computer interface. The data collection will be made up of two parts:

Part I: Static Profile: The child will be asked to stand on the mat for 6 seconds for five trials. During this time the data collection software will collect force data across the foot 60 times per second. The software will then calculate centre of force as well as changes in pressure during the static trial. The foot will be assessed into the distribution of forces across the hindfoot, midfoot, forefoot, and the big toe. In addition, the centre of gravity will also be determined.

Part II: Dynamic Profile: The dynamic test will involve the child walking across the mat for a total of 5 passes per foot. Measurements of force will again be taken at 60 Hz.

The EMED-x400 sensor is rectangular and its dimensions are 47.5 cm by 32 cm. Measurements of force will be recorded at up to rates of 400 Hz. Foam pieces (included with the EMED platform) are constructed around the platform to establish a levelled and safe runway for the patient to walk along. The EMED platform is connected to a computer interface which operates on the Novel analysis software. The subject will be asked to walk across the mat independently at their ordinary pace. The foot is required to land in the centre of the mat, at a minimum of three trials per foot10. Plantar pressure recording takes 10-20 minutes for each subject.

Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria - all clubfoot patients seen at BC Children's Hospital who have commenced walking and compliant to the study protocol. As the goal of the study is to evaluate the utility of pedobarographs in evaluating clubfoot treatment, we will be following subjects with all presentations of clubfoot (this includes idiopathic clubfoot and clubfoot that is secondary to another global disorder).

Exclusion Criteria:
Timing of Renal Replacement Therapy Initiation in Tumor Lysis Syndrome

The TENDERS study aims to evaluate the impact of the timing of renal replacement therapy (RRT) initiation on outcomes in patients with tumor lysis syndrome (TLS) and associated acute kidney injury (AKI). The study will compare early versus delayed RRT initiation, examining the effect on renal function at 30 days post-treatment.

Tumor lysis syndrome (TLS) is a common and life-threatening complication in patients with hematologic malignancies, characterized by severe metabolic imbalances due to rapid tumor cell destruction. This syndrome frequently leads to acute kidney injury (AKI), requiring renal replacement therapy (RRT) in about 50% of cases. Despite its clinical significance, there is a lack of consensus on the optimal timing of RRT initiation in TLS-related AKI. Studies in other forms of AKI suggest no difference in outcomes between early and delayed RRT initiation, but these results are not directly applicable to TLS patients. This study seeks to fill this gap by analyzing the timing and outcomes of RRT initiation in TLS patients. The retrospective study will collect data from multiple intensive care units (ICUs) across France. Procedure: The study will retrospectively analyze patient data from 2013 to 2023, comparing early vs. delayed RRT initiation. Follow-up: Data on renal function, RRT usage, and mortality will be collected 30 days and one year after ICU admission.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged ≥18 years.
* Hospitalized in the ICU between January 1, 2013, and December 31, 2023.
* Diagnosed with a hematologic malignancy or solid tumor requiring chemotherapy.
* Diagnosed with TLS based on the presence of two or more biochemical criteria (e.g., hyperkalemia, hyperphosphatemia, hyperuricemia, hypocalcemia) within 3 days before or 7 days after chemotherapy initiation.

Exclusion Criteria:

* Patient or family opposition to data collection for research purposes.
* Incomplete medical records that preclude data extraction.
Psychosocial and Physiological Mechanisms in the Effect of Hormonal Contraception on the Female Sexual Desire

75 heterosexual women are asked to use 3 different types of contraception (Nuvaring, low-dose combination pill, minipill), each during 3 months. On a monthly basis, questionnaires are filled out about sexual desire and psychosocial, relational en sexual parameters. Also the sexual desire of the partner is questioned. On a three-monthly basis, blood samples are drawn to determine changes in hormonal parameters (one sample per product period).

75 lesbian women are doing the same trial, but during an extra 3 months period, they are asked to have their natural menstrual cyclus as a control condition. Blood samples during these extra months will be drawn at the third or fourth day after start of the menses.


Eligibility Criteria:
Inclusion Criteria:

* Heterosexual or lesbian women
* Aged between 18 and 45 years
* Stable monogameous relationship
* Normal menstrual cyclus

Exclusion Criteria:

* Polycystic ovarial syndrome
* Normal exclusion criteria for the use of contraception
* Use of medication known to influence sexual desire and/or androgen levels
* Women who wants to become pregnant, are pregnant or breastfeeding
Evaluation of Reactogenicity and Safety of GSK Biologicals' Rotarix™ (Human Rotavirus Vaccine) in Infants

This Post Marketing Surveillance (PMS) will collect reactogenicity and safety data on the use of human rotavirus vaccine in healthy infants aged from 6 weeks (first dose) to not more than 24 weeks (second dose).


Eligibility Criteria:
Inclusion Criteria:

* Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol .
* A male or female at least 6 weeks of age at the time of the first vaccination.
* Written informed consent obtained from the parent or guardian of the subject.

Exclusion Criteria:

* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
* Acute disease at the time of enrolment.
* Any history of uncorrected congenital malformation of the gastrointestinal tract that would predispose for intussusception.
* Any contraindication as stated in the updated and approved Prescribing Information