cyrilzakka/clinical-trials huggingface dataset:
The Therapeutic Effects of Topical Cannabidiol (CBD) Products for Atopic Dermatitis

The goal of this observational study is to learn about the potential therapeutic effects of topical CBD products produced by Phoilex Ltd., specifically the Releaf Gel, in those diagnosed with atopic dermatitis. Patients will be routinely assessed via questionnaire, and physical measurements will be taken with respect to the affected area studied in order to judge clinical efficacy.

The main question\[s\] it aims to answer are:

* Did you experience an immediate increase in skin hydration?
* Did you experience a soothing or comforting feeling on your irritated skin area? Please explain where your affected area is located, and also include at what time point this occurred. Example: Affected Area: Palm, Time Point: 1-hour post-application
* Upon the affected area being in the healing phase, was your skin itch/scratch free for 4/6/10/12 hours (please circle)?
* Did you experience immediate relief from your skin inflammation?
* Did the study cream absorb quickly into your skin, without any greasy feeling?
* Has your skin flare disappeared in 2 week(s)?
* Has your skin condition appearance improved? (Yes/No)

Participants will apply Phoilex Releaf Gel (a cream) to their affected areas of atopic dermatitis. The questions listed above shall be discussed and observations recorded at the 0 week, 1 week, 2 week, and 4 week time points. Additional monitoring questions may be asked of the participants to ensure the safety of the product. A chart will be provided to the participants to track Phoilex Releaf Gel usage (how many pumps, and time of day) throughout duration of the study.

We hypothesize that Releaf gel will be suitable to ameliorate the common signs and symptoms of atopic dermatitis as well as improve patient quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Specifically, patients would be recruited based on the following inclusion criteria must be over 18 years old and must be diagnosed with moderate-to-severe eczema.

Exclusion Criteria:

* Exclusion criteria would include not currently using any steroids or biologics, not currently using any other topical products, not pregnant, not breast feeding, nor have any allergies to any ingredients listed within the formula of the Releaf gel. A negative pregnancy test will need to be confirmed prior to patient receiving Phoilex Releaf Gel. Lastly, participants who have been diagnosed with anxiety or depression with a classification of greater than mild anxiety or mild depression will be excluded. As such, screening for possible candidates for the clinical trial will include questions and a brief assessment on participants mental health by study doctor/physician.
Adjusting the Load Carried by the Soldier According to Body Composition Measurements and Aerobic Capacity

In order to reduce the physiological and biomechanical loads that the soldiers are exposed to, the investigators want to examine new approaches for distributing the carried loads according to measurements that are specific for each soldier (body composition and aerobic capacity). A functional index (LCI=load carriage index) will provide the commander a tool for better decisions in distributing the same total load among the same number of soldiers, according to each soldier's ability.

50 healthy, male and female combat soldiers will be recruited. Anthropometry and maximal aerobic capacity will be measured for each participant: Physiological evaluation: the participants will perform physical stress on a treadmill with changing slope and speed, once carrying 40% of their body weight (as the current instructions) and a second time with weight that is calculated by the examined body composition and aerobic capacity based index (LCI). The physiological response will be assessed based on heart rate, lactic acid in the blood and oxygen consumption.

Biomechanical evaluation: the biomechanical response will be measured in the biomechanical lab: pressure on the shoulder and waist from the load and straps, walk analysis and stress scatter in the foot.

By this experiment the investigators want to examine if the new index, the LCI, is physiologically and biomechanically better than the current load distribution instructions.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18-25 years.
* Healthy soldiers volunteers.
* Without heart, cardiovascular, metabolic or respiratory illnesses.
* Without known medical illness or medication use that might endanger the participants.

Exclusion Criteria:

* existence of any of undesired conditions detailed in the inclusion criteria.
* the physician decision.
Artificial Intelligence-augmented Perioperative Clinical Decision Support

The study investigates a novel anaesthesiological clinical decision support (CDS) application, that integrates risk evaluation tools and updated clinical guidelines guided by artificial intelligence in the setting of preoperative anaesthesiological assessment. It will be compared to the current standard preoperative assessment workflow with participants being actual patients. 480 participants will be randomly assigned to either the CDS group (preoperative assessment using the CDS application) or the Control group (standard preoperative assessment workflow).


Eligibility Criteria:
Inclusion Criteria:

* ASA (American Society of Anaesthesiologists)-Class III and IV
* non-cardiac surgery

Exclusion Criteria:

* none
Endobiliary Radiofrequency Ablation for Malignant Biliary Obstruction Due to Perihilar Cholangiocarcinoma

A multicentre, parallel group, open label, randomized controlled trial comparing endobiliary RFA prior to metal stent placement with stent placement only in patients with inoperable perihilar cholangiocarcinoma.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older.
* Capable of providing written and oral informed consent.
* Histological or cytological proof of perihilar CCA (adenocarcinoma).
* Perihilar biliary obstruction with an indication for drainage with uSEMS.\*
* Advanced (no candidate for surgical resection) due to metastases, vascular or lymph node (N2) involvement on imaging or during staging laparoscopy according to multidisciplinary team (MDT).

  * Only patients with pCCA are eligible however in case of reasonable doubt between intrahepatic CCA with a perihilar biliary obstruction or massforming pCCA, patients can be included.

Exclusion Criteria:

* Patients who potentially qualify for curative resection of pCCA.
* pCCA eligible for liver transplantation.
* Life-expectancy less than 3 months.
* ERCP and PTC technically not feasible.
* Uncontrolled coagulopathy (PTT \>1,5x prolonged or thrombocytes below 40\*10E9/L).
* Ongoing cholangitis or liver abscess. Patients are required to be off antibiotic treatment for cholangitis and/or liver abscess at least 7 days.
* Any condition that is unstable or that could jeopardize the safety of the subject and their compliance in the study.
* Patients who are pregnant or breastfeeding.
Evaluation of the Compatibility of Different Eye Lid Retractors to the Direct Selective Laser Trabeculoplasty (DSLT) Procedure

Direct Selective Laser Trabeculoplasty (DSLT) is an emerging therapeutic technology to treat glaucoma. DSLT was previously tested in 2 clinical trials and demonstrated promising safety and efficacy results in reducing the patient's intra ocular pressure.

Experience gained in the previous clinical studies indicates that a full exposure of the limbal area may be a challenge in patients with narrow palpebral fissures, narrow or floppy eyelids, and patients with deep-set eyes.

The DSLT procedure is carried out in the doctor's office while the patient sits in front of the DSLT device (termed the "Eagle" device) for couple of minutes.

In this procedure, 120 laser applications are performed around the full circumference of the ocular limbus, after the system automatically recognizes the limbal target area. It is therefore essential that a full exposure of 3600 limbal area will be achieved, and this is done by placing an eye lid retractor (speculum) in the treated eye at the beginning of the procedure.

The purpose of this study is to evaluate the compatibility of different types of lid retractors. The lid retractors will be tested in adult volunteers visiting the study eye clinic for any reason.

Eligibility Criteria:
Inclusion Criteria.

* Adult volunteers (age ≥18 years old) of both sexes visiting the study eye clinic for any reason.
* Willing and able to participate in the study and to comply with the study procedures.
* Participant capable of giving informed consent.

Exclusion Criteria:

* Prior incisional ocular surgery or ocular trauma in the tested eye.
* Women who are pregnant.
* Any medical condition that interferes with the subject's ability to sit steady in front of the Eagle device.
* Known allergy to local anaesthesia eye drops.
Bioequivalence Study of Ropinirole Hydrochloride ER Tablets 2 mg Under Fasting Condition

This is an open label, randomised, balanced, two-treatment, two-period, two-sequence, crossover, oral bioequivalence study.

The objective of this study was to determine the single-dose oral bioequivalence of Ropinirole Hydrochloride Extended Release Tablets 2 mg of Dr. Reddy's Laboratories Limited, India with REQUIP® XL (Ropinirole) 2 mg ER Tablets of Glaxosmithkline, USA, in normal, healthy, adult, human subjects under fasting condition.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy human subjects aged between 18 and 45 years (including both).
2. Subjects with a BMI between 18.5 - 24.9 Kg/m2 (including both) but body weight not less than 45 Kgs.
3. Subjects with normal health as determined by personal medical history, clinical examination, and laboratory examinations including serological tests.
4. Subjects having normal 12-lead electrocardiogram (ECG).
5. Subjects having normal chest X-Ray (PIA view).
6. Subjects able to communicate effectively.
7. Subjects willing to give written informed consent and adhere to all the requirements of this protocol.
8. Female subjects who are postmenopausal or surgically sterile.
9. Female subjects practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as condoms, foams, jellies, diaphragm,intrauterine device (IUD) or abstinence.

Exclusion Criteria:

1. Subjects having contraindications or hypersensitivity to ropinirole or domperidone or related group of drugs.
2. History or presence of any medical condition or disease according to the opinion of the physician.
3. History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder.
4. History or presence of significant alcoholism or drug abuse in the past one year.
5. History or presence of significant smoking (more than 10 cigarettes or bidis/day or consumption of tobacco products).
6. Difficulty with donating blood.
7. Difficulty in swallowing solids like tablets or capsules.
8. Systolic blood pressure less than 110mm Hg or more than 140 mm Hg.
9. Diastolic blood pressure less than 70 mm Hg or more than 90 mm Hg.
10. Pulse rate less than 50 beats/minute or more than 100 beats/minute.
11. Use of any prescribed medication during last two weeks or OTC medicinal products during the last one week preceding the first dosing.
12. Major illness during 3 months before screening.
13. Participation in a drug research study within past 3 months.
14. Donation of blood in the past 3 months before screening.
15. Female subjects demonstrating a positive pregnancy screen.
16. Female subjects who are currently breast-feeding.
17. Female subjects with child bearing potential using prohibited contraceptive method (Oral, Injectable or Implantable hormonal agents).
A Phase I Study of HS-10386 in Participants With Advanced Solid Tumors

The purpose of this study is to evaluate the safety and tolerability, pharmacokinetics, and preliminary anti-tumor activity of HS-10386 in participants with advanced solid tumors who have failed prior treatments.

This is a phase I open label, multicenter clinical study to evaluate the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of HS-10386 in subjects with advanced solid tumors.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female, 18-75 years old.
2. Histologically or cytologically documented, incurable or metastatic solid tumors for which standard treatment either does not exist or has proven ineffective or unavailable or intolerable.
3. At least one measurable lesion per RECIST v1.1.
4. Willingness to provide fresh or archival tumor biopsy sample.
5. An Eastern Cooperative Oncology Group (ECOG) performance status equal to 0-1 with no deterioration over the previous 2 weeks and a minimum life expectancy of 12 weeks.
6. Willingness to use adequate contraceptive measures throughout the study.
7. Ability to comprehend and willingness to sign a written ICF for the study.

Exclusion Criteria:

1. Treatment with any of the following:

   1. Previous or current treatment with systemic immunotherapy.
   2. Treatment with anticancer medications or investigational drugs within protocol-defined intervals prior to the first scheduled dose of HS-10386.
2. Any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 except for alopecia.
3. Known additional malignancy.
4. History or risk of autoimmune disease.
5. Known primary CNS malignancy or symptomatic CNS metastases. Patients with asymptomatic CNS metastases may be enrolled after consultation.
6. Inadequate bone marrow reserve or organ function.
7. Clinically significant cardiac disease.
8. Any evidence of severe or uncontrolled systemic diseases
9. Severe infections within 4 weeks prior to the first scheduled dose or symptoms of infection within 2 weeks prior to prior to the first scheduled dose.
10. History of organ transplantation or any medical condition requiring the use of systemic immunosuppressive medications.
11. Active HBV or HCV infection that requires treatment.
12. Known history of HIV.
13. Women who are breastfeeding or have a positive urine or serum pregnancy test at the Screening Visit.
14. Administration of a live, attenuated vaccine within 4 weeks prior to the first scheduled dose or anticipation that such a live attenuated vaccine will be required during the study.
15. History of severe anaphylaxis or allergic to any of the components of HS-10386.
16. Any disease or condition that, in the opinion of the investigator, would compromise the safety of the patient or interfere with study assessments.
Genetic Mapping of Atherogenic Lipoprotein Phenotypes

To map the major gene influencing low-density lipoprotein subclass phenotypes, denoted atherogenic lipoprotein (ALP) phenotypes, with a long term goal of cloning the ALP gene and understanding its role in genetic susceptibility to atherosclerosis.

BACKGROUND:

ALP phenotype B (ALP-B), characterized by a predominance of small, dense LDL particles as determined by gradient gel electrophoresis, has been associated with increased risk of myocardial infarction and a constellation of atherogenic lipid and apolipoprotein (apo) changes. Based on complex segregation analysis, ALP-B appeared to be influenced by a single major genetic locus with a dominant mode of inheritance and a common allele frequency. This project was designed to identify a new gene involved in susceptibility to coronary heart disease.

DESIGN NARRATIVE:

The investigators identified, collected and constructed a repository of immortalized cell lines and lipid and apo measurements from members of families informative for ALP. They tested genes implicated in lipoprotein metabolism as possible candidate ALP genes and used highly informative DNA probes to search the genome for linkage to the ALP gene. They also refined the model for the inheritance of ALP phenotypes and tested for genetic-environmental interactions. Forty informative families were recruited for the repository. The families were identified through two sources of probands: former participants in a cholesterol-lowering diet study and patients seen at the lipid clinics at the University of Washington. Each participating family member completed a medical history questionnaire and provided a blood sample for ALP phenotype determination, for DNA studies, and for lipid and apo measurements. Linkage studies and LOD score analyses began with a candidate gene approach, and continued by using DNA probes that revealed restriction fragment length polymorphisms (RFLPs) to search the genome for linkage to the ALP gene. When a linkage was found, ALP genotype information was used to refine the statistical model describing the inheritance of ALP phenotypes, and to evaluate genetic-environmental interactions involving lipid and apo levels and environmental and behavioral factors.

Eligibility Criteria:
No eligibility criteria
Optimising Screening of Intermediate to High-risk Asymptomatic Sportsmen With Exercise Electrocardiogram

The importance of exercise electrocardiogram (ECG) is still controversial in the prevention of cardiac events among sportsmen. The aim of this study was to assess the relevance of exercise electrocardiogram (ECG) as a significant prognostic marker for cardiovascular events when any cardiovascular disease (CVD) risk factors are present.

The SEEPRED (Sport, Exercise ECG, prediction) prospective cohort study included leisure time sportsmen over 35 years old who performed exercise electrocardiogram (ECG) screening in the Sports Medicine Unit of the University Hospital of Saint-Etienne from September 2011 to April 2016. Personal, familial history and physical examination were systematically performed before maximal exercise electrocardiogram (ECG). Cardiovascular events and changes in physical activity were searched after exercise electrocardiogram (ECG).

Eligibility Criteria:
Inclusion criteria:

* Patients referred as asymptomatic by their general practitioner for an exercise electrocardiogram (ECG) screening test carried out as a standard procedure for resuming physical activity
* Patients referred as a systematic pre-participation screening to be declared an athlete.

Exclusion criteria:

* Patients with coronary artery disease (CAD) and
* Patients with uninterpretable ST segment due to bundle branch block
Effects of Combining Eccentric and Aquatic Based Exercise on Muscle Function

The study will compare the effects of eccentric resistance training versus eccentric training combined with aquatic plyometric training on muscle function outcomes.

This study will use a parallel, randomized group design. Two groups will be randomly formed with one group comprising an eccentric only resistance training condition (experimental control) and the other comprising an eccentric combined with aquatic-based plyometrics condition (experimental). All subjects, regardless of group, will train on a multiple-joint eccentric machine one time per week for 7 weeks. The combined group will also perform an aquatic-based exercise session one time (on a separate day from the eccentric training) per week. Muscle function will be assessed via a battery of tests including jumps, sprints, and isometric and eccentric maximal strength.

Eligibility Criteria:
Inclusion Criteria:

* 18 - 30 years

Exclusion Criteria:

* Currently doing resistance exercise \> 3 times per month or aerobic exercise at or more than 30 min, 5 days per week.
* Any lower limb injuries or surgery within a year of the study
* If any of the subject's are too tall for the Eccentron machine (\>76 inches tall)
* If any of the subject's eccentric strength is measured to be greater than 725 pounds during the first test of eccentric strength.
Neoadjuvant Therapy in Cervical Cancer

In the comprehensive dataset of clinical diagnoses and treatments for cervical cancer in China, 49.8% of patients with stage IB3 and IIA2 receive surgical intervention following neoadjuvant chemotherapy. This indicates a pressing need to optimize neoadjuvant chemotherapy regimens for locally advanced cervical cancer. While paclitaxel combined with cisplatin is the conventional approach, 9.8% to 30.6% of patients demonstrate suboptimal responses, with a pathological complete response rate of approximately 10%.

Currently, the efficacy of antibody-drug conjugates in neoadjuvant chemotherapy for cervical cancer remains unexplored. This study seeks to address this gap by evaluating the combination of Disitamab Vedotin and Cisplatin in patients with stage IB3 and IIA2 cervical cancer with positive HER2 expression.The study will assess the impact of this regimen on pathological complete response rates, surgical complications, surgical resection rates, and overall survival.

Primary research objectives:

To evaluate the effect of Disitamab Vedotin combined with cisplatin on pathological response rate (pCR) of locally advanced cervical cancer.

Secondary research objectives:

1. To evaluate the safety of Disitamab Vedotin combined with cisplatin;
2. To evaluate the effects of Disitamab Vedotin combined with cisplatin on surgical complications, surgical clearance rate and postoperative adjuvant treatment ratio;
3. To evaluate the effects of Disitamab Vedotin combined with cisplatin on objective tumor response rate (ORR), disease control rate (DCR) and survival;

Exploratory research objectives:

To explore the changes of tumor tissue protein expression, immune factors and HER-2 receptor expression before and after the use of ADC drugs, as well as biomarkers that can effectively predict the therapeutic effect.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of cervical squamous cell carcinoma
* HER-2 positive

Exclusion Criteria:

* Cervical adenocarcinoma
Basic Sensations Coming From the Bladder

A major complication in studies to identify the nature of bladder sensations is language. It is difficult, if not near impossible, for the lay person, with no knowledge of physiology, anatomy or pathology, to put into simple terms a description of basic visceral sensations. Therefore, before the investigators can speculate about the detailed mechanisms generating sensation the investigators must overcome this language and communication difficulty. This will be addressed in the present study.

There are important reasons why the investigators must identify the mechanisms generating the different sensations as the bladder fills. One of them is that these are basic physiological mechanisms which need to be better understood.


Eligibility Criteria:
Inclusion Criteria:

Healthy volunteers

* Healthy students from The University of Maastricht well versed in Dutch.

Patients

* Patients with OAB diagnosed by their urologist using the criteria of more than 8 micturitions on three consecutive days. Before the start of any anticholinergic or other therapy. Patients on anticholinergic therapy will be asked to stop this therapy for at least 10 days before they enter the first session.
* Well versed in Dutch.

Exclusion Criteria:

Healthy volunteers

* Use of any medication (except oral contraceptives)
* Surgical history of the abdomen
* Urinary complaints (e.g. frequency, urgency)
* Urinary tract infection

Patients:

* Congestive heart disease or history of heart failure
* Presence of urinary tract infection. These patients will be treated by antibiotics.