cyrilzakka/clinical-trials huggingface dataset:
Use Of Three Commercial Preparations Of Injectable Hyaluronic Acid In Hands Rejuvenation

Assessment of efficacy of hyaluronic acid - Emervel® Volume Lidocaine combined or not with Emervel® Touch and Emervel® Deep Lidocaine combined or not with Emervel® Touch in female patients with loss of fatty tissue in hands.

This is a single center, phase IV, randomized, investigator-blind study of three different hyaluronic dermal filler injections for volume enhancing in the dorsum of the hands. As an investigator-blind study, only the investigators are unaware of which dermal fillers were injected in the dorsum of each hand.

Eligibility Criteria:
Inclusion Criteria:

* Subjects agreeing to take part of all procedures of the study (including pre-test, filler injection, photographs, etc.), after being fully informed on the objectives and nature of the investigations;
* Written Informed Consent;
* Treatment-naive patients for fillers in hands;
* Subjects of both genders over 18 years;
* Fitzpatrick skin phototypes I to VI;
* Subjects presenting a similar loss of fatty tissue on both hands, at least of 2 according the Validated Hand Grading Scale2;
* Medical history and physical examination which, based on the investigator's opinion, do not prevent the patient from taking part in the study and use the product under investigation;
* Female subjects of childbearing age should present a negative urine pregnancy test and should be using an effective contraceptive method;
* Availability of the subject throughout the duration of the study (208 days);
* Subjects with sufficient schooling and awareness to enable them to cooperate to the degree required by this protocol.

Exclusion Criteria:

* Pregnant women or women intending to become pregnant in the next 18 months;
* Subjects with known hypersensitivity to any hyaluronic acid products;
* Subjects with history of adverse effects, such as sensitivity to the components of the formula, or any other adverse effect, which in the investigator's opinion should prevent the patient from participating in the study;
* Subjects participating in other clinical trials;
* Any prior surgery or side effects at the hands area, or any prior cosmetic procedures, including permanent fillers, that may interfere with the results;
* Subjects with active inflammation or infection in the area to be treated;
* Subjects with a history of medical treatment non-adherence or showing unwillingness to adhere to the study protocol;
* Subjects presenting diseases such as coagulation disorders or under the use of anticoagulants, or any condition that, in the opinion of the investigator, can compromise the evaluation of the study.
A Study of Daratumumab in Japanese Participants With Relapsed or Refractory Multiple Myeloma

The purpose of this study is to evaluate the tolerability and safety of Daratumumab in Japanese participants with relapsed (the return of a medical problem) or refractory (not responding to treatment) multiple myeloma (cancer of plasma cells in bone marrow, characterized by the presence of abnormal proteins in the blood).

This is a Phase 1, open-label (all participants and study personnel will know the identity of the study treatments) and multicenter (study conducted at multiple sites) study in Japanese participants. The study will include a Screening Phase, a Treatment Phase, and a Follow-up Phase. The Treatment Phase consists of 2 parts: intense dosing regimen and less intense dosing regimen. Follow-up phase will be until 8 weeks after last dose administration/death/lost to follow up/consent withdrawal for study participation or study end, whichever occurs first. The primary endpoints will be Dose Limiting Toxicity (DLTs) and overall Adverse Events (AEs) profiling. Participants' safety will be monitored throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* Participants proven to have symptomatic (having symptoms) multiple myeloma according the International Myeloma Working Group (IMWG) diagnostic criteria
* Participant must have measurable disease defined by either or both the following measurements: a) Serum M-protein greater than or equal to (\>=) 1 gram per deciliter (g/dL) (\>=10 gram per liter \[g/L\]) (except for serum immunoglobulin A \[IgA\] M-protein \>= 0.5 g/dL); b) Urine M-protein \>=200 milligram per 24 hour (mg/24 h); in case immunoglobulin D \[IgD\] or immunoglobulin E \[IgE\] M-protein, quantification should be performed
* Participant must have relapsed or refractory multiple myeloma after receiving at least 2 previous therapies, and without further established treatment options
* Participant must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2
* Participant must have life expectancy greater than (\>) 3 months

Exclusion Criteria:

* Participant has received daratumumab or other anti-cluster of differentiation 38 (anti-CD38) therapies previously
* Participant has received anti-myeloma treatment within 2 weeks before administration of the study drug
* Participant has previously received an allogenic stem cell transplant; or participant has received autologous stem cell transplantation (ASCT) within 12 weeks before administration of the study drug
* Participant has a history of malignancy (other than multiple myeloma) within 5 years before administration of the study drug
* Participant is exhibiting clinical signs of meningeal involvement of multiple myeloma
A Pilot Study to Assess Effects of Self-Administered Nitrous Oxide (SANO) on Urodynamic Study (UDS) Parameters

A urodynamic study (UDS) is a common procedure done to learn more about the cause of urinary symptoms. For some patients, UDS can be associated with anxiety or discomfort. Nitrous oxide (or laughing-gas) is a well-known sedative which is frequently used in dental offices and for pediatric procedures to reduce anxiety and pain. This study is being done to see if giving low-dose (25-50%) nitrous oxide at the time of UDS affects the measurements taken during the procedure, such as how much volume your bladder can hold, and pressures during urination. If the measurements are the same with and without self-administered nitrous oxide (SANO), it could be suggested that nitrous oxide may be a useful way of reducing patient anxiety and pain during UDS.

The urodynamic study (UDS) procedure will consist of catheter placement and two "runs". Before the start of the procedure, a study staff member will assist the participant with putting on a plastic gas mask. SANO and oxygen will be given through this mask. The dose will be adjusted based on the participant's comfort level but they will not be able to request more gas than allowed. SANO will be administered during catheter placement at the start of the UDS. During the two runs, the participant will either receive SANO (run 1) then oxygen (run 2), or oxygen (run 1) then SANO (run 2).

Before the day of the UDS, participants will be asked questions related to demographics and medical history to determine study eligibility and experience of the treatment. During the UDS, participants will be asked to describe their anxiety and pain levels. Afterwards, they will be asked to complete a 15-20 minute structured interview with a study staff member to learn more about patient experience during UDS.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled for urodynamic study
* Aged 21 to 85 years
* Suitable for inflation of nitrous oxide/oxygen with willingness to undergo two urodynamic study runs during the procedure
* Access to an email and computer

Exclusion Criteria:

* Perioral facial hair impeding good mask seal
* Learning disabilities and/or inability to cognitively complete survey questions
* Has any of the following medical conditions:

  1. Inner ear, bariatric or eye surgery within the last 2 weeks,
  2. Current emphysematous blebs,
  3. Severe B-12 deficiency,
  4. Bleomycin chemotherapy within the past year,
  5. Heart attack within the past year,
  6. Stroke within the past year,
  7. Class III or higher heart failure
Taiwan Health Promotion Intervention Study for Elders

Objectives: 1-year multidomain health promotion on prevention of physical and cognitive decline for community-living older people.

Design:

Methods: Randomized controlled trial

Setting:

Five cities(Taipei, Taichung, Kaohsiung, Kinmen, I-Lan) in Taiwan Participants: age 65 or older community-dwelling prefrail or frail adults Intervention: 1-year multidomain health promotion (physical, cognitive, nutritional intervention)

Measurements:

Primary outcome includes frailty status and cognitive performance. Secondary outcomes include depressive symptoms, nutrition assessment, and functional capacity; All the variables were measured at 0, 6, 12 months. The effect of intervention was investigated by intention-to-treat analysis.

Eligibility criteria includes: community-dwelling older people aged 65 or older, and those with confirmed diagnosis of dementia or dependent on activities of daily living were excluded.

Primary outcome includes frailty status measured by CHS frailty score. general and sub-domain cognitive performance measured by Montreal Cognitive Assessment (MoCA). Secondary outcomes include depressive symptoms, nutrition assessment, and functional capacity; which were evaluated by 5-item Geriatric Depression scale(GDS-5), Mini-nutrition Assessment(MNA), and instrumental activities of daily living (IADL) individually.

Eligibility Criteria:
Inclusion Criteria:

* Prefrail or frail community-dwelling people

Exclusion Criteria:

* Institutionalized or ADL dependent
* Diagnosed dementia
* Limited life expectancy
Glucosamine and Chondroitin Effects

A common starting dose of glucosamine and chondroitin will reduce inflammation as reflected by a reduction in serum C-reactive protein.

Use of glucosamine and chondroitin have been associated with reduced cancer and overall mortality. The aim of this study is to determine whether a common starting dose of glucosamine and chondroitin (1500 mg/d + 1200 mg/d, respectively) reduces systemic inflammation as reflected by a reduction in high sensitivity C-reactive protein.

Eligibility Criteria:
Inclusion Criteria:

* Healthy
* Overweight (body mass index kg/m2 (BMI) between 25 and 32.5)
* Non-smoking men and women
* Aged 20-55y

Exclusion Criteria:

* Chronic medical illness, history of gastrointestinal, hepatic, or renal disorders, or inflammatory conditions (including autoimmune and inflammatory diseases)
* Pregnancy or lactation
* Currently on a weight-loss diet
* BMI (body mass index) \< 25 or \> 30
* Alcohol intake of greater than 2 drinks/day
* Current use of prescription or over-the-counter medications, (Excluding oral contraceptives and hormone-secreting IUDs), including use of aspirin or NSAIDs more than 2 days per week
* Abnormal renal, liver or metabolic test
* Inability to swallow pills
* Known allergy to shellfish
* Not willing to take pills made from shellfish or animal sources
* Intention to relocate out of study area within next 4 months
5E Program for Preventing Venous Thromboembolism in Patients With Spinal Cord Disorders

The goal of this quasi-experimental study is to examine the effects of a venous thromboembolism prevention program, or "5E" program, on the rates of venous thromboembolism in patients with spinal cord disorders. The main questions it aims to answer are:

* Will participants receiving the 5E program have lower rates of venous thromboembolism compared to those receiving the usual care?
* Will participants receiving the 5E program have lower scores of venous thromboembolism signs and symptoms compared to those receiving the usual care?
* Will the average thigh and calf circumferences of participants before and after receiving the 5E program be different?

Participants in the intervention group will receive the 5E program, including

* Education: health education regarding venous thromboembolism prevention
* Elevation: leg elevation of 10-20 degrees
* Exercise: ankle exercises
* Enough fluid: adequate fluid uptake
* Early application of intermittent pneumatic compression (IPC): IPC use within 48 hours after admission


Eligibility Criteria:
Inclusion Criteria:

* Caprini scores of 5-8 and \>8
* Able to communicate in the Thai language
* Willing to participate in this study

Exclusion Criteria:

* Alteration of consciousness
* Experiencing complications, including neurogenic shock and autonomic dysreflexia
* Being pregnant
* Having fluid restriction
Effects of Osteopathic Treatment With Cognitive Training on Low Back Pain

The objective of this study is to verify whether the combined approach (osteopathic manipulative treatment -OMT- and cognitive training -CT) is more effective in the long term than the individual approaches (OMT or CT) in patients with chronic lumbar pain, evaluating the Numeric Rating Scale (NRS) and the Rolland-Morris Disability Questionnaire (RMDQ) questionnaire


Eligibility Criteria:
Inclusion Criteria:

* aged between 30 and 65 y
* diagnosis of aspecific chronic low back pain
* minimum of 3 on the NRS score

Exclusion Criteria:

* Neuropathic pain or chronic widespread pain
* Low back spinal surgery in the last three years
* Low back spinal surgery to osteoporosis and/or traumatic fractures
* Rheumatic disease
* Pregnancy or having a baby in the last 12 months
* Painful disease in evidence through RX, MRI or CT in the last 6 months (listesis, moderate arthrosis, severe, algodystrophy etc.).
* The subjects have not to be treated with physical or manual therapies or psychotherapy in the last 6 months
Revascularization After Transcatheter Aortic Valve Implantation (REVIVAL)

Evaluate incidence, clinical indications, and feasibility of PCI performed after TAVI.

The increasing operator experience combined with an improved performance of devices have led to extend current transcatheter aortic valve implantation (TAVI) indications to patients at low or intermediate risk. The safety of TAVI in this population was initially tested in small observational studies and recently reported in the randomized PARTNER 2 and Surgical Replacement and Transcatheter Aortic Valve Implantation Trial (SURTAVI) trials, which demonstrated non- inferiority of TAVI in low or intermediate risk patients as compared to surgery with respect to the primary endpoint of death or disabling stroke. In view of the changes in the TAVI population, including younger patients with longer survival, the number of patients that may require coronary revascularization after TAVI is expected to increase over the time. Of note, challenges in performing percutaneous coronary interventions (PCI) in patients previously treated with TAVI have been reported in small series.

Against this background, the purpose of this retrospective multicenter study is to evaluate incidence, clinical indications, and feasibility of PCI performed after TAVI.

Objectives

1. Evaluate the incidence of PCI after TAVI
2. Evaluate the clinical indications for PCI after TAVI
3. Evaluate the technical feasibility of PCI in patients with prior TAVI
4. Evaluate in-hospital and long-term clinical outcomes in patients undergoing PCI after TAVI

Eligibility Criteria:
Inclusion Criteria:

* Any patient undergoing PCI after TAVI, irrespective of clinical indications and irrespective of whether planned or not at the time of TAVI

Exclusion Criteria:

* none
Full Dose Tenecteplase (TNK-tPA) Together With Heparin Sodium, Full Dose Tenecteplase With Enoxaparin, Half Dose Tenecteplase Together With Abciximab and Heparin Sodium in Patients With Acute Myocardial Infarction (AMI)

The objective of ASSENT 3 was to evaluate the safety and efficacy of full dose tenecteplase with heparin sodium (group A), full dose tenecteplase combined with enoxaparin (group B) and half dose tenecteplase combined with abciximab and heparin sodium (group C).


Eligibility Criteria:
Inclusion Criteria:

* Onset of symptoms of AMI within six hours prior to randomisation
* A twelve-lead electrocardiogram with one of the following: ST-segment elevation ≥ 0.1 millivolt (mV) in two or more limb leads, or ≥ 0.2 mV in two or more contiguous precordial leads indicative of AMI, or left bundle-branch block
* Age ≥ 18
* Informed consent received

Exclusion Criteria:

* Hypertension defined as blood pressure \> 180/110 mm Hg (systolic BP \>180 mm Hg and/or diastolic BP \>110 mm Hg) on repeated measurements during current admission prior to randomization
* Use of abciximab (ReoPro ®) or other glycoprotein-IIb/IIIa antagonists within the preceding 7 days
* Major surgery, biopsy of a parenchymal organ, or significant trauma within 2 months
* Any minor head trauma and any other trauma occurring after onset of the current myocardial infarction
* Any known history of stroke or transient ischemic attack or dementia
* Any known structural damage of the central nervous system
* Prolonged cardiopulmonary resuscitation (\>10 minutes) in the previous two weeks
* Current oral anticoagulation
* Standard unfractionated heparin (heparin sodium) \>5000 IU or a subcutaneous dose within 6 hours of randomization of a therapeutic dose of any low molecular weight heparin
* Known thrombocytopenia (prior platelet count below 100000 cells/μl (100 x10\*\*9/l))
* Known renal insufficiency (prior S-creatinine \>2.5 mg% (\>220 μmol/l) for men and \>2.0 mg% (\>175 μmol/l)) for women
* Pregnancy or lactation, parturition within the previous 30 days. Women of childbearing potential must have a negative pregnancy test, or use a medically accepted method of birth control
* Treatment with an investigational drug under another study protocol in the past 7 days
* Previous enrollment in this study
* Known sensitivity to TNK-tPA, tPA, abciximab, heparin or low molecular weight heparin
* Any other condition that the investigator feels would place the patient at increased risk if the investigational therapy is initiated
* Inability to follow protocol and comply with follow-up requirements
A Study of Neutrexin Plus Leucovorin in the Treatment of Pneumocystis Carinii Pneumonia (PCP)

To evaluate the safety and efficacy of trimetrexate glucuronate with leucovorin protection in patients with Pneumocystis carinii pneumonia (PCP) who are refractory to or have demonstrated severe or life-threatening toxicities to standard therapies (e.g., TMP/SMX or parenteral pentamidine).

Patients receive intravenous infusions of trimetrexate glucuronate and leucovorin for 21 days. Leucovorin is continued for 3 additional days after discontinuation of trimetrexate glucuronate. Patients are followed for 1 month.

Eligibility Criteria:
Inclusion Criteria

Concurrent Medication:

Allowed:

* Myelosuppressive or nephrotoxic agents at the discretion of the treating physician.

Patients must have:

* Pneumocystis carinii pneumonia (PCP) confirmed within 15 days prior to study entry.
* Serious intolerance and/or resistance to standard therapies (such as trimethoprim/sulfamethoxazole and parenteral pentamidine) during the course of therapy for the current episode of PCP, or a documented history of such intolerance during a prior episode.
* Consent of parent or guardian if less than 18 years of age.

NOTE:

* Pregnant women may enroll after the physician and patient have discussed the potential benefit versus risk.

Exclusion Criteria

Patients with the following prior conditions are excluded:

History of Type I hypersensitivity (i.e., urticaria, angioedema, or anaphylaxis), exfoliative dermatitis, or other life-threatening reactions due to trimetrexate glucuronate.
Effects of Added D-fagomine on Glycaemic Responses to Sucrose

The purpose of this study is to determine whether D-fagomine affects glycaemic responses to sucrose (commercial white sugar)and quantify the response

This is a two treatment randomized double-blind crossover study, with each test product replicated twice.

Randomization: Subjects will be randomized to a Williams Latin square design balanced for treatment order.

Washout: 2 days or more (may return on day 3)

Run-in: High carbohydrate diet guidance (\>150 g/d) 1 day before treatment, recommend same sized dinner the previous night (no food record collection required)

Drop-outs: Subjects who have dropped out before visit 2 will be replaced by another subject randomized in their place (the new subject will complete all treatments)

Subjects will report after an overnight (12 hour) fast for baseline sample collection, and will consume the test product in a fasted state.

Eligibility Criteria:
Inclusion Criteria:

* Male or female (not less than 40% Male)
* Aged 18 - 55 years
* Have a body mass index between 18.5 to 29.99 kg/m2
* Healthy, non-diabetic, no gastric bypass surgery
* Have a fasting plasma glucose (finger-stick) \<100 mg/dl (\<5.5 mmol/L)
* Willing and able to provide written informed consent

Exclusion Criteria:

* Smokers
* Allergic to dairy or soy
Effects of Lifestyle-modification Induced Weight Loss on Sexual and Urinary Function, and Quality of Life in Obese Men

This study aims to evaluate the extent to which weight loss of 5-10% from baseline, induced by exercise and diet, improves metabolic and inflammatory profile, endothelial function, erectile function, sexual desire, lower urinary tract symptoms (LUTS), and quality of life in obese men.

This study aims to evaluate the extent to which weight loss of 5-10% from baseline, induced by exercise and diet, improves metabolic and inflammatory profile, endothelial function, erectile function, sexual desire, lower urinary tract symptoms (LUTS), and quality of life in obese men.Men aged 30-65 years, with body mass index (BMI) ≥ 27.5 kg/m2, will be recruited from referrals to the Sports Medicine Centre in Changi General Hospital. The study will be conducted at the Sports Medicine Centre by trained medical investigators, dieticians and sports trainers.At baseline, 12 and 24 weeks, fasting glucose and lipids, insulin, testosterone, sex-hormone binding globulin, serum C-reactive protein and interleukin-6 are measured, endothelial function is measured by the non-invasive EndoPAT method, and validated questionnaires administered to assess changes in erectile function, sexual desire, LUTS and quality of life

Eligibility Criteria:
Inclusion Criteria:

* Male, aged 30-65 years
* Body Mass Index (BMI) \>/= 27.5 kg/m2
* Waist circumference (WC) \>/= 90 cm

Exclusion Criteria:

* pituitary disease or cranial radiotherapy
* previous or current androgen replacement or deprivation therapy
* current treatment for sexual problems or LUTS
* glomerular filtration rate \< 60 ml/min
* liver disease
* alcohol intake exceeding 500 g/week in the previous 12 months
* use of opiates, glucocorticoids, recreational drugs or phosphodiesterase inhibitors
Conservative Treatment of Mallet Finger Injury

Comparing outcomes of individuals treated with Kinesiotape and oval 8 versus quick cast for a conservatively managed mallet finger injury. Outcomes include DIP joint extension lag, patient satisfaction and function via the MHQ.


Eligibility Criteria:
Inclusion Criteria:

* determined by a physician to require conservative treatment for a mallet finger injury, at least 18 years of age

Exclusion Criteria:

* previous injury to the involved digit impacting ROM