cyrilzakka/clinical-trials huggingface dataset:
Impaired Wound Healing in Diabetic Foot Ulceration

An observational study to gather information about people who may have certain abnormalities in skin microcirculation and muscle metabolism and to determine whether these abnormalities affect wound healing. The study also examines the association of a specific type of cell with the rate of wound healing.

An observational study which entails: medical history; physical examination; blood tests; MRI; microcirculation tests (two noninvasive tests: 1) a procedure that measures the resting blood flow of the skin and 2) a technique that introduces acetylcholine and sodium nitroprusside in the skin and measures the ability of the skin's vessels to dilate and increase blood flow); and macrocirculation tests (noninvasive ultrasound of arm). This study also involves 2 Visits to the Beth Israel Deaconess Medical Center in Boston, MA. (Joslin-Beth Israel Deaconess Foot Center, Lowry Outpatient Laboratory, MRI Suite).

Eligibility Criteria:
Inclusion Criteria:

* Current diagnosis of Type I or Type II Diabetes Mellitus.
* Ulcer present for minimum 4 weeks
* Have adequate circulation to the foot
* Can return for follow-up visits
* Be able to read and sign the Informed Consent form before enrollment

Exclusion Criteria:

* Active Charcot's foot ulcer on the foot to be studied
* Presence of any serious disease that can affect wound healing including end stage renal failure requiring hemodialysis or renal transplantation, active malignant disease requiring treatment, hepatic, hematologic, neurologic, or immune disease
* Alcohol or drug abuse problems
* Treatment with oral or parenteral corticosteroids, immunosuppressive or cytotoxic agents
* Presence of infectious disease that can preclude EPC measurements (including HIV, Hepatitis B and C)
* Pregnancy
Effects of 8-weeks Strength Training on Strength Program, Power and Agility in Traceurs

The goal of this Randomized controlled trial was to examine effects of 8-weeks strength training program on strength, power and agility in traceurs. The main question it aims to answer is:

• To determine the effects of 8-weeks strength training program in traceurs. Participants were a given consent form and after subjects read and sign the informed consent, they were included in study according to eligibility criteria. 2 groups were included in study, Strength Group with parkour routine training was applied on group A and the control group, group B was provided with parkour routine training. Outcome was measured through different outcome measure tools.

The parkour is a physical activity that contains exceptional technique applications and requires a major number of jumps. The purpose of this study was to examine the effects of 8-week strength training on strength program, power, and agility in traceurs (parkour practitioners). Officially incorporated as a sport in the UK in 2017 but born in France almost 30 years ago. Parkour consists of practitioners finding a route through predominantly urban terrain, mastering various physical and psychological skills to overcome obstacles in the most efficient, effective way possible.

A randomized controlled trial will be performed in which total 16 traceurs will be observed for 8 weeks. The data was collected from Pakistan Parkour \& Free running Academy in Quetta, Balochistan. Participants would be randomly divided into two balanced groups. One group was provided with parkour training sessions, and the other group was provided with both strength and parkour training sessions. The participants, who have done strength training along with the parkour trainings, apply 4 sets of strength training exercises with 10 repetitions determined from ACSM two days a week, with a minimum of 72 hours between these days. The control group was applied only two hours of parkour training for two days a week.

Aim of study was to observe effects of strength training in vertical jump heights at the end of the 8-week strength trainings comparison to the control group and that of the strength training. This study aids in learning of the vertical jump heights by including strength training programs with routine trainings, which is a central parameter for successful performance in traceurs, can enable the coaches and athletes to prepare a better training.

Eligibility Criteria:
Inclusion Criteria:

* Age (16-30years)
* Male traceurs
* Parkour participants had been involved in parkour practice for at least two years (2 times per week for a minimum of 2 hours per day) and did not have any bone, articular or muscular injuries in the previous 6 months.

Exclusion Criteria:

* Participants been involved in strength training before.
* Participants not been involved in parkour practice for minimum 2years.
* Participant who have injuries within previous 6 months.
* Participants who smokes or were taking medication.
Effectiveness of Physical Teraphy in the Treatment of Myogenic Temporomandibular Disorders

The aim of study is evaluate the effectiveness of physical therapy in of the treatment myogenic temporomandibular disorders.

They will enrolled 100 patient which will be divided into two groups. The primary objective is evaluate the effectiveness of physiotherapy on pain (measured with the Visual Analogic Scale - VAS scale).

The second objective is evaluate mandibular motion (by measuring the range of motion - ROM) and investigate the presence of psychosocial factors (using the Anxiety and Depression Scale - HADS questionnaire).

Randomized controlled clinical trial with randomization according to a multi-phase design.

Phase 1 involves the enrollment of patients with DTMs based on diagnostic criteria.

Phase 2 includes the algogenic, kinetic and gnathological evaluation of the enrolled patients.

Phase 3 provides for the adoption of the criterion to one of the 2 treatment groups on the basis of the randomization list.

The 2 therapeutic protocols are:

* gnathological therapy (splint) associated with education and physiotherapy (test group);
* gnathological therapy (splint) associated with education (control group). During the first visit the patient will be enlisted by evaluating the inclusion and exclusion criteria and signed the informed consent, he / she will be assigned a unique identification code.

The code consists of a progressive number followed by the patient's initials (eg 01-F.R.).

Subsequently, the patients will be randomized blinded and assigned to one of the two study groups.

Randomization will be performed using random, computer-generated, centralized numbers placed in sealed opaque envelopes provided by the study coordinator.

Both types of treatment will be performed by a single operator respectively.

Eligibility Criteria:
Inclusion Criteria:

* patients with myogenic temporomandibular disorders assessed with clinical examination as established by the DC / TMD1;
* patients older than 18 years;
* good knowledge of Italian language;
* patients who have signed informed consent

Exclusion Criteria:

* edentulism which makes it impossible to apply gnathological bite;
* patients with psychiatric problems;
* patients included in other experimental protocols;
* patients already undergoing surgical and / or radial therapy of the cervical and facial areas;
* other temporomandibular disorders without a myogenic component;
* treatment of the cervical and TMJ district in the previous 3 months;
* history of drug abuse.
Clinical Performance of Composites in Patients With Amelogenesis Imperfecta

In AI patients, adhesion still remains the first option in order to achieve an early, minimally invasive intervention, and the altered enamel still represents an acceptable substrate for bonding in some AI variants. Many cases have revealed that the direct composite restorations provide satisfactory esthetic and functionality in restoring AI-affected teeth. The objective of this study was to evaluate the clinical performance of composite restorations in posterior teeth in patients afflicted with Amelogenesis Imperfecta using nanohybrid and nanofill composite materials


Eligibility Criteria:
Inclusion Criteria:

* the patient had to require treatment due to carious lesions in one or more surface of molars and premolars,
* AI diagnosis had to be made, which had to be verified clinically, and also confirmed by anamnestic family history, or clinical examination concerning Witkop's classification

Exclusion Criteria:

* patients with developmental enamel defects of other origins such as fluorosis, molar incisor hypomineralization;
* AI was associated with other oral developmental or systemic disorders, and dental abnormalities such as open-bite, deep-bite, and cross-bite;
* patients who were unable to provide their informed consent.
Virtuoso Improving Anatomic Bladder Lesion Excision Trial

A robotic assisted surgery for bladder lesion excision.

This is a single-center, non-randomized study to evaluate the use of the Virtuoso Endoscopy System (VES) to perform safe and effective bladder lesion excisions.

Eligibility Criteria:
Inclusion Criteria:

1. The subject is 22 years or older.
2. The subject is eligible and fit for transurethral bladder lesion removal and/or biopsy and has an appropriate indication to go through this surgery.
3. The subject is willing and able to provide written informed consent and comply with the study protocol.
4. The subject can undergo general anesthesia per anesthesiologist assessment.
5. The subject's aggregate bladder lesion(s) size is smaller than 3 cm.

Exclusion Criteria:

1. The subject has acute untreated urinary tract infection or urosepsis.
2. The subject has a documented nickel allergy or nickel sensitivity.
3. The subject is confirmed to be or suspected to be pregnant.
4. The subject is receiving anticoagulants and is unable or not willing to cease the medication for the investigational procedure.
5. The subject belongs to a vulnerable group (prisoner, etc.)
6. The subject has bladder dome or diverticular lesions that are at an increased risk for perforation of the bladder.
7. The subject's lesion(s) involve a ureteral orifice(s) necessitating additional endoscopic management and stenting.
8. The subject has a urethral abnormality, implant, or previous surgery which would conflict with the procedure.
9. The subject has undergone a transurethral bladder resection procedure in the past 6 months.
10. The subject has a history of radiation treatment within the pelvis.
11. Bladder tumor base maximal dimension is greater than 3 cm.
12. Bladder tumor detected during intravesical therapy.
13. Previous histological diagnosis different than non-muscle invasive bladder cancer.
14. Presence or prior history of upper urinary tract malignancy.
15. Eastern Cooperative Oncology Group performance status greater than or equal to 3.
16. American Society of Anesthesiologists physical status classification of III or above.
17. History of bleeding disorder, coagulation abnormality, or use of anticoagulants.
18. The presence of other active malignancy.
19. Life expectancy \<1 yr.
A Phase-1 Study to Assess the Pharmacokinetics, Safety and Tolerability of AVP-786 in Healthy Volunteers

To assess the multiple-dose pharmacokinetics (PK), safety and tolerability of AVP-786 (deuterated \[d6\] dextromethorphan hydrobromide \[DM\]/quinidine sulfate \[Q\]) in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adult males
* 18 - 45 years of age
* BMI 18 - 30 kg/m2

Exclusion Criteria:

* History or presence of significant disease
* History of substance abuse and/or alcohol abuse with the past 3 years
* Use of tobacco-containing or nicotine-containing products within 6 months
* Use of any prescription or the over-the-counter medications within 14 days
Effect of Changes in Glucose Intake and Sweet Perception on Post Prandial Glycaemia

Sugar-sweetened beverages are the main source of added sugars in most Westernized countries, and for this reason constitute a primary target for sugar reduction by many companies, including Nestlé. Instead of using high-intensity sweeteners which are non-caloric in nature, an alternative would be to reduce sugars without altering sweetness.

In this protocol, the general goal is to investigate the relative contribution of sweet taste perception and sugar intake on post-prandial glucose response. 4 different nutritional products will be tested by 16 healthy subjects in a crossover design.

After enrollment, participants will be asked to come to the investigational site 6 times for:

* two sensory tests dedicated to assess the sensory capacity of the participants from the same sensory test repeated twice, for better consistency.
* 4 testing visits for a 3-h blood kinetics after each product intake. These visits will be scheduled on different days separated by a washout period of at least one week. Outcomes will be glycemia and insulinemia.

Eligibility Criteria:
Inclusion Criteria:

* BMI between 18.5 and 29.9 kg/m2
* Fasting capillary blood glucose level ≤ 7 mmol/L
* Able to understand and sign an informed consent form

Exclusion Criteria:

* Pregnancy on anamnesis
* Lactating mothers
* Individuals undergoing either dietary or exercise mediated weight loss program prescribed by a health care professional
* Medically-treated diabetes mellitus or use of anti-hyperglycemic drugs or insulin
* Family history of type 2 diabetes (parents)
* Any other metabolic disease possibly impacting the postprandial glucose and insulin response (to the opinion of the medical doctor)
* Known ageusia or other tasting trouble
* Chronic intake of medications known to affect glucose tolerance to the opinion of the investigator (steroids, protease inhibitors, antidepressants, anxiolytic, or antipsychotics)
* Presence of disease or intake of drug that affects digestion and absorption of nutrients, to the opinion of the medical doctor
* Major medical/surgical event requiring hospitalisation in the last 3 months
Systems Biology of Gastrointestinal and Related Diseases

This is a longitudinal observational study on patients with gastrointestinal and related disease. The study will be conducted for at least 10 years, following each participant over time, as they either go through relapses and remissions, or progression of their disease.

This is a longitudinal, observational study whose main goal is to identify the human and microbial determinants of gastrointestinal diseases. Molecular and metadata will be collected from a large study population at multiple time points. Machine learning will be applied to all data, and models will be evaluated for development of novel diagnostic and therapeutic tools.

Eligibility Criteria:
Inclusion criteria

* Any patient 18 years old or older that schedules a visit to WAGI clinics or endoscopy center
* Able to use electronic communications
* Able to communicate in English
* Consent to participate in the study

Exclusion Criteria:

* None
Improving Adherence to Medication After Coronary Artery Bypass Surgery (CABG) in Older Adults

Coronary artery bypass grafting (CABG) surgery is often performed in elderly patients, but non-adherence to post-CABG guideline medications is a common and serious clinical concern in this age group. A recent systematic review found that higher medication adherence significantly improved primary and secondary prevention of coronary artery disease outcomes in all the included studies. Another systematic review assessed studies published from 1999-2009 about motivational interviews, such as implementation intention, in relation to cardiovascular health. They found that motivational interview was an effective means of changing behavior, while offering promise in improving cardiovascular health status. The study is aimed to investigate effectiveness of long term volitional intervention in proving medication adherence in the CABG patient.


Eligibility Criteria:
Inclusion Criteria:

* Aged 65 years or older
* Undergoing Elective/subacute multivessel CABG
* Able to give informed consent

Exclusion Criteria:

* Pregnant
* Already using Dosette boxes (or similar) to improve their medication adherence
* Currently enrolled in another clinical trial
* Unable to attend required follow-up visits
* Mini Mental Status Examination (MMSE) less than 20
* Significant dysphasia
* Concomitant surgery
* Myocardial infarction \<48h of surgery
* Known platelet disease
* Allergic to aspirin
* Alcohol or narcotics abuse
* Geographically not available for follow up
* Ongoing bleeding
* Missing written consent
* Emergency surgery
* Severe kidney disease (creatinine clearance \< 30 ml/min)
* Oxygen-dependent chronic obstructive pulmonary disease
* Active hepatitis
* Significant hepatic failure
* Prior peptic ulcer• Platelet count \< 150 E9
* Patient has terminal condition and may not survive until 6-month follow-up
* Patient is a known participant in other RC studies
* The inability to read and write Persian/Farsi
* Participants who are not responsible for their own medication
Donor CHIP and Allogeneic HSCT Outcome

Current data on the impact of donor CHIP on long-term recipient outcome remain largely speculative. Data on the impact of donor CHIP including on allograft function, immunologic dysfunction, graft versus host disease (GVHD), disease relapse and survival across various donor populations are scarce. This is a retrospective-prospective cohort study designed to determine the association between donor gene mutations and outcome following allogeneic HSCT.

This is a single centre prospective and retrospective cohort study. This study involves allo-HSCT recipients and their donors at Queen Mary Hospital, Hong Kong. Information on the presence of gene mutations in donor peripheral blood or bone marrow sample; gene mutations in recipient peripheral blood or bone marrow post-allo-HSCT; and donor and recipient outcome will be collected in either prospective, partial-prospective/retrospective or retrospective manner. The information will be used to determine the association between the presence of clonal haematopoiesis in the donor and recipient outcome following allo-HSCT.

Data will be collected through routine clinical visits and/or reviewing medical records. Data will be collected at the time of peripheral blood stem cells (PBSC) or bone marrow stem cells donation, at the time of allo-HSCT, one month post-allo-HSCT and every 6 months thereafter until death/study termination.

Genetic profile of donors will be collected at the time of PBSC or BM stem cell donation. Genetic profile of recipients will be collected at 1-month, 6-month, 12-month post-HSCT and at time of relapse or occurrence of leukaemia.

Gene mutations and pathogenic gene fusion will be determined in the peripheral blood and/or marrow samples by next-generation sequencing (NGS) using a myeloid-gene panel and nanopore long-read sequencing.

Eligibility Criteria:
Inclusion Criteria:

1. Adult aged 18 year or above
2. Donor and recipient of allo-HSCT
3. In prospective and partial prospective/retrospective case, subjects who have provided a signed written informed consent. In retrospective case, subjects who had provided a previously signed written informed consent on:

   1. voluntary provision of clinical data, and
   2. voluntary provision of archived/remaining specimens for genetic analysis, and
   3. authorizing storage and usage of archived/remaining specimens for any further analysis

Exclusion Criteria:

1. Autologous peripheral blood stem cells or bone marrow stem cell donors for autologous HSCT
A Phase II Trial of CG 8020 and CG 2505 in Patients With Nonresectable or Metastatic Pancreatic Cancer

To evaluate the safety and effectiveness of CG8020 and CG2505.

To evaluate clinical and laboratory safety of CG 8020 and CG 2505 and to evaluate the efficacy of CG 8020 and CG 2505 as measured by clinical benefit response, progression-free survival, survival and CA 19-9 serum marker levels in chemotherapy naive or experienced patients with nonresectable or metastatic adenocarcinoma of the pancreas

Eligibility Criteria:
Inclusion Criteria:

* Histologic or cytologic diagnosis of nonresectable or metastatic pancreatic adenocarcinoma
* Chemotherapy naïve or chemotherapy experienced pancreatic cancer

Exclusion Criteria:

* Prior cancer vaccines or gene therapy
* History of clinically significant autoimmune disease (eg, systemic lupus erythematosus, sarcoidosis, rheumatoid arthritis, glomerulonephritis, or vasculitis)
* History of another malignancy in the past five years, except adequately treated non-melanomatous skin cancer or superficial bladder cancer or carcinoma-in-situ of the cervix, unless approved by the Medical Monitor
Efficacy of BIS Monitoring in Deep Hypnotic State

Determining the efficacy of the BIS monitor in monitoring deep hypnotic states as well as intra- and post-operative outcomes in neurosurgery patients

This study will be conducted with a two-group, double-blind, randomized clinical trial design in elective patients who will undergo neurosurgical procedures under general anesthesia. Patients scheduled for elective neurosurgery who meet the inclusion criteria will be randomized into one of the intervention groups, with or without BIS. Demographic data will be taken from medical records. In both groups, the BIS probe will be inserted before induction, but for the control group, the BIS monitor will be closed, while for the intervention group, anesthesia will be titrated according to the BIS value to maintain the BIS value in the range of 40-60. In the group with an open BIS, the anesthesia protocol is the use of anesthetic gas, and the anesthetic drug will be adjusted to the BIS value range of 40-60 or BIS-guided, while the anesthesia protocol used in a closed BIS is carried out like general anesthesia without using BIS. The BIS value will be recorded minute by minute according to the extraction feature of the BIS machine after surgery. The total use of anesthetic agents, duration of surgery, and intraoperative hemodynamics will be recorded through anesthesia status. The patient will follow the progress until the patient is discharged from the hospital

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 30-60 years with an ASA tolerance of 1-2 who will undergo general anesthesia techniques
* Operation duration \> 3 hours
* The patient agrees to take part in the study.

Exclusion Criteria:

* Continuous intraoperative use of ketamine, magnesium sulfate, dexmedetomidine, lidocaine agents
* Massive bleeding that causes hemodynamic disturbances
* Severe electrolyte disturbances
* Severe liver or kidney function disorders
* The patient was decided not to extubate in the operating room
Blue Light Therapy for Liver Surgery

The investigators hypothesize that subjects undergoing liver resection and who are exposed preoperatively to high illuminance blue spectrum light will exhibit reduced organ injury, specifically liver dysfunction, than subjects exposed to standard ambient white fluorescent light.


Eligibility Criteria:
Inclusion Criteria:

* age greater than 17 years
* undergoing right or left hepatic lobectomy

Exclusion Criteria:

* presence of acute traumatic brain injury
* blindness
* immunosuppression or immunocompromised condition
Comparing the Prognosis of Lactate-directed and Goal-directed Therapy in Hyperthermic Intraperitoneal Chemotherapy.

Hyperthermic intraperitoneal chemotherapy is a major surgery for tumor peritoneal metastasis. For anesthesiologist, the intra-operative fluid control is always a big challenge. We try to compare the prognosis of lactate-directed and goal-directed therapy. We expect to confirm the better prognosis of lactate-directed therapy.


Eligibility Criteria:
Inclusion Criteria:

* Patients receiving hyperthermic intraperitoneal chemotherapy

Exclusion Criteria:

* Unable to set arterial line Severe liver or renal disease Severe heart disease Unconscious patients