cyrilzakka/clinical-trials huggingface dataset:
Acetato de Caspofungin (Cancidas®) in the Treatment of Fungal Infection

We wanted to determine the efficacy and the safety of caspofungin acetate (CANCIDAS®) in the treatment of invader fungal infection (IFI) specifically, Invasive Candidiasis (CI) in adults patients without neutropenia and Invasive Aspergillosis (AI) in adults patients who are refractory to or intolerant of other therapies (i.e., amphotericin B, lipid formulations of amphotericin B, and/or itraconazole).

Study post-marketing (observational). It is multicenter and prospective. No masking is used, without control group neither is randomized

Eligibility Criteria:
Inclusion Criteria:

* Female and male with 18 years old at least.
* Diagnosis of AI or CI. It will be based in Clinical History, signs and symptoms that the patient takes, discovery of studies of radiology and results of cultivation and/or studies of anatomopathology positives for Candida spp. or Aspergillus spp.
* Patients with AI, must be refractory to or intolerant of other therapies antifungal used in the hospital.
* Patients with CI, must be or not refractory to or intolerant of other therapies antifungal used in the hospital.

Exclusion Criteria:

* Patients with diagnosis uncertain based in one or more of next criterions: Cultivation positive for Candida in an only localization (urine, spittle, end/current of catheter; osteomyelitis or endocarditis by Candida without treatment appropriated surgical; infection by Candida of prosthetic material without retired of the same; positive blood cultive for Candida in appearance of vascular prosthesis; allergic lung Aspergillosis; and aspergilloma or aspergillosis eye without treatment appropriated surgical).
* Allergic / hypersensitivity to caspofungin.
* Insufficiency several liver (rate of Chile-Pugh \>9).
* Prediction of survival \<5 days.
* Pregnant or breast feeding.
* Previous Participation of patient in this study.
* Presence of other disease or any condition that it can mix up the interpretation of results or create risks.
* Previous Participation of patient in other clinical study that it involve the administration of a drug in investigation in the 14 days previous to your inclusion in the study or during the administration of caspofungin. We can include patients took with antineoplastic drugs in research whenever at lefts a Investigator Coordinator authorizes it before
enFlow IV Fluid and Blood Warming System

This study is part of a post-market clinical follow-up (PMCF). The purpose of this study is to verify in a routine clinical environment with a number of caregivers and subjects that the enFlow performs as intended when used as an element of maintaining acceptable core temperatures.

Eligible subjects from the study will be recruited from patients with scheduled surgeries. After being informed about the study and potential risks, patients given informed consent will undergo scheduled surgery with the use of enFlow IV Fluid and Blood Warming System. The following temperature measurements will be collected during surgery:

* Baseline temperature measurement (0-15 minutes prior to induction)
* Induction temperature measurements (15 minutes, 30 minutes, 60 minutes, 90 minute post-induction)
* Continued temperature measurements (every 30 minutes, plus end of surgery)
* OR ambient temperature at induction and end of surgery.

Temperature will be measured and collected post-surgery upon arrival to the PACU and 30 minutes post-arrival.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Patients requiring surgery expected to last at least 1 hour.
* Expectation of the perioperative need for at least one liter of infused fluids warmed during infusion
* Informed Consent

Exclusion Criteria:

* Recent history of fever (\>38 C, within 24 hours of surgery)
* Active infection
* Pregnant women
* Terminal illness (\<30 days)
* Intended use of cardiopulmonary bypass
* Clinical intention for perioperative cooling and hypothermia
* unavailability of esophageal measurement during surgery
* Attending physician does not believe participation of the patient is in their best interest.
Clinical Investigation of Infections Due to Leishmanial Parasites

Mechanisms of host immune response to intracellular protozoa will be investigated in patients with naturally acquired infection employing a variety of in-vitro techniques. Both non-specific and antigen-specific humoral and cellular immune responses will be assessed. Parasites will be isolated from patients, cultivated in-vitro, and characterized. Responses to chemotherapy will be assessed parasitologically, immunologically and clinically.

The main purpose of this protocol is to permit us to see patients who are referred to us for diagnosis and treatment of known or suspected leishmaniasis (from the Peace Corps, Smithsonian Institution, tourists, etc.). In the process of working up these patients, we sometimes encounter parasite isolates that are useful for research. We also can perform tests of cell-mediated immune function to evaluate how patients are responding to therapy. In addition, the protocol permits us to observe therapeutic responses to other drugs besides pentavalent antimony, if necessary.

Eligibility Criteria:
Must be between the ages of 1 and 65 years.
Observational Study to Determine the Efficacy and Safety of Potenfill for Temporary Penile Enhancement

This is an observational study to determine the efficacy and safety of Potenfill for temporary penile enhancement.

The pivotal study of Potenfill has already been completed and this observational study determines the long-term efficacy and safety for up to 24 months in subjects who have been participated and treated in the pivotal study.


Eligibility Criteria:
Inclusion Criteria:

* Males over 19 and under 65 who have participated in the previous clinical investigation (pivotal) and were treated with the investigational medical device and completed all the anticipated visits.

Exclusion Criteria:

* Subjects who have received any procedures or surgeries (penile enhancement procedure, HA filler, collagen, etc.) in the penile area from the time after the participation of the previous clinical investigation (pivotal) and before the screening for this clinical investigation.
* Subjects deemed as ineligible to participate by the investigator
A Pharmacoeconomic Study Comparing the Use of Mycophenolate Mofetil or Cyclophosphamide as Induction Therapy in Lupus Nephritis Patients in Egypt

The aim of this study is to conduct a pharmacoeconomic analysis to compare the use of Mycophenolate Mofetil or i.v. Cyclophosphamide as induction therapy from a third party payer perspective in LN patients in the Egyptian context


Eligibility Criteria:
Inclusion Criteria:

- LN patients between 18 and 65 years of age who were followed up in the Department of Rheumatology and Rehabilitation were included during the study period. All patients fulfilled at least 4 of the 11 American College of Rheumatology (ACR) revised criteria for the classification of SLE 21. Patients were included if they had active lupus nephritis LN(LN) that was confirmed by Class III, or Class IV, or Class V renal biopsy and which was performed within six months of enrolment. Furthermore, laboratory tests must show active nephritis demonstrated by a clinically significant high level of proteinuria, which might indicate a recent decline in renal function 22. Patients with class III or V LN must have either proteinuria (≥ 2 gm/day) or serum creatinine \> 1.3 mg/dl. Patients with class IV must have either proteinuria ≥ 1 gm/day or serum creatinine \> 1.3 mg/dl 23. Newly diagnosed patients who were given either IV CYC or oral MMF as induction therapy or patients who needed to be induced when flared up were included in the study.

All patients signed a written informed consent form. For those below the age of 21, written informed consent was obtained from the parents.

Exclusion Criteria:

* Patients were excluded from the study if they had a history of known allergy to study drugs, received previous kidney transplantation, or were on continuous dialysis for more than two weeks before the study. Patients with combinations of membranous and proliferative glomerulonephritis (i.e., class III + V or class IV + V) renal biopsies were not included. Other reasons for exclusion were pregnancy and lactation, pancreatitis, current infection episode requiring IV antibiotics, severe viral infection, history of cancer, or overlapping autoimmune condition.
Comparison of Dynamic Distraction Systems in Proximal Interphalangeal Joint Fractures

Fractures of the proximal interphalangeal joints continue to pose significant management challenges. Thus the aim of our study is to compare two dynamic finger joint distractors (Litos® and Ligamentotaxor®) in respect to the radiological standard follow-up examination and functional assessments.


Eligibility Criteria:
Inclusion Criteria:

* proximal interphalangeal fracture treated with external dynamic fixator
* Operative care \<21 days from trauma
* Age between 18 and 90 years.
* Male and female

Exclusion Criteria:

- additional fractures or disabilities of the hand
Efficacy and Safety of MK0928 for Insomnia in Adults (0928-003)(COMPLETED)

The purpose of this trial is to study the safety and effectiveness of MK0928 for adults with insomnia.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of insomnia
Bone Microstructure in Nasal Salmon Calcitonin Treated Postmenopausal Women

Calcitonin has been used for many years for treating osteoporosis in postmenopausal women. Recent data from the 2 years placebo-controlled QUEST study have shown a preservation of microarchitecture as measured by high resolution MRI in postmenopausal women with prevalent vertebral fractures at baseline.This pilot study should provide additional new insights in the mode of action of nasal calcitonin, on structural changes as measured by high resolution peripheral CT, and on the comparison between weight bearing and non weight bearing bones in postmenopausal women.


Eligibility Criteria:
Inclusion Criteria:

* Women between age 45-70
* Natural or surgical menopause ≥ 1 year
* T-Score between 0.0 and -2.49 (spine or proximal femur - total or femoral neck measured by DXA)

Exclusion Criteria:

* Osteoporosis (T-score ≤ -2.5 in spine or proximal femur - total or femoral neck, measured by DXA)
* Severe vertebral fracture, as identified by screening DXA assessment
* Any history of metabolic disease, which could affect bone metabolism: hyperparathyroidism, osteogenesis imperfecta, Paget's disease, osteomalacia
* Thyroid disease (if receiving thyroid hormone replacement, the patients must be euthyroid, and on a stable dose of thyroid hormone)
* Impaired renal function (estimated GFR\<30 ml/min)
* History of previous or active malignancy of any organ system, treated or not treated within the past 5 years.
* History of corticosteroids treatments during 6 months or more, daily dosage \>5 mg .
* BMI \< 18 or \>30.
* Treatments with estrogens, SERMs, tibolone, calcitonin, strontium ranelate, teriparatide or PTH, oral or iv bisphosphonates in the previous year.
Effects of Self-administered Acupressure in Psychiatric Patients With Constipation

This study is to evaluate the effects of self-administered acupressure therapy for psychiatric in-patients with constipation

Two main research questions include:

1. What are the effects of the standardized self-administered acupressure program on reducing those adult psychiatric patients' symptoms of constipation?
2. What are the psychiatric patients' (participants') perceived benefits and limitations of self-administered acupressure on management of their constipation?

In this study, the participants who met the study criteria and completed the baseline measurement would be randomly assigned into either the self-administered acupressure program, or a sham control group who receive a placebo, non-acupoint pressure. The null hypotheses of this study are:

1. There is no significant difference between the acupressure and sham group immediately and/or two weeks after the completion of intervention on patients' symptom severity of constipation; and
2. There is no significant difference between the acupressure and sham group on patients' perceived quality of life at immediately and two weeks after treatment completion.

Main outcomes of this study include the Constipation Assessment Scale (CAS), Patient Assessment Constipation Quality of Life Questionnaire (PAC-QoL), and the socio-demographic and clinical data collected by a trained assessor who was blind to the intervention assignment of the participants. These data would be measured at recruitment (baseline) and immediately (Post-test 1) and two weeks (Post-test 2) after completion of the 10-day intervention. Qualitative focus group interview data would be collected after Post-test 2 .

Eligibility Criteria:
Inclusion criteria of psychiatric in-patients are:

1. Hong Kong Chinese residents, aged 18 to 64 years;
2. satisfied with Rome III diagnostic criteria for constipation; and
3. mentally stable and competent for self-care and learning acupressure, as recommended by their attending psychiatrists.

Exclusion criteria of those in-patients are:

1. anatomical and physiological disorders of gastrointestinal tract such as malrotation, fistula and colonic neuropathies;
2. metabolic and endocrine diseases;
3. lead poisoning and vitamin D intoxication;
4. previous training in acupressure;
5. physical disability involved the upper limbs;
6. planned surgery undergoing during study period; and
7. pregnancy.
Exercise Training as Medicine for Substance Use Disorder Patients

This study compares the effects of high dose and low dose, high intensity, endurance training and strength training in substance use disorder patients. The hypothesis is that the increase in endurance (measured as maximal oxygen uptake) and strength (measured as maximal strength) will be similar in both the high dose and low dose training groups after 24 training sessions over eight weeks. The rationale for this assumption is based on the patient groups poor physical capacity, supporting that a lesser physical workload is needed to achieve a substantial increase in physical capacity. The practical implication could be higher training attendance, because it is likely easier to motivate the patient group when they only have to perform half the workload. It is paramount for this patient group to increase their physical capacity and consequently augment their physical health status since they are in a high-risk group for developing life-threatening lifestyle related diseases.


Eligibility Criteria:
Inclusion Criteria:

* Being an inpatient at the clinic
* Free of known cardiovascular disease, pulmonary disease and cancer

Exclusion Criteria:

* Not able to perform a maximal treadmill test
* Not able to perform a maximal strength test in hack squat
Effect of Therapeutic Touch at Different Times on Infantile Colic According to Watson's Theory

Aim: The purpose of the study is to determine the effect of therapeutic touch applied to infants with infantile colic at different times on infant colic scale score, crying and sleep duration, according to Watson's theory of human care. Thus, it is aimed to contribute to the development of an effective care approach in eliminating or reducing the symptoms in infants with infantile colic.

Method: The study will be conducted as a single-blind, randomized controlled trial. The population of the study will be infants who come to the Pediatrics Outpatient Clinic and are diagnosed as infantile colic according to the evaluation of the pediatrician and have no other health problems. The infants will be divided into three groups as intervention (The first group; the group in which therapeutic touch was applied for one week and the second group; the group in which the therapeutic touch was applied for two weeks) and control groups according to stratified block randomization in the computer environment. After the randomization, therapeutic touch will be applied to the intervention group. No method will be applied to the control group.

The research will be carried out with three groups as intervention (The first group; the group in which therapeutic touch was applied for one week and the second group; the group in which the therapeutic touch was applied for two weeks) and control groups. Sample size of the study has been determined by the power analysis, in line with the results obtained from the studies which have been conducted using a similar research method. According to the analysis results, it has been calculated as 32 for each group and 96 in total. Mothers of the infants meeting the study inclusion criteria will be informed both in written and verbally. Written consent will be obtained. The infants will be divided into three groups according to block randomization in the computer environment. The randomization, therapeutic touch will be applied to the intervention group (The first group; the group in which therapeutic touch was applied for one week and the second group; the group in which the therapeutic touch was applied for two weeks). No method will be applied to the control group by the researcher. In obtaining research data, 4 tools will be used: "Mother-infant Information Form", "Infantile Colic Scale", Crying Time Registration Form and Sleep Time Registration Form.

Eligibility Criteria:
Inclusion Criteria:

* Family volunteering to participate in the research
* The infant was born at term
* The infant is between 4 weeks and 8 weeks
* The birth weight is between 2500-4500 g
* The infant has been diagnosed with infantile colic by a physician
* Mothers' ability to read, write and speak Turkish
* New diagnosis of infantile colic

Exclusion Criteria:

* The baby has any chronic disease
* The baby has a congenital anomaly
* The mother has a diagnosed mental and mental problem
* Mother's smoking
* The diagnosis of infants with lactose intolerance by the physician
Use of Transcranial Photobiomodulation to Improve Cognition and Self-Reported Outcomes in Survivors of Childhood Cancer

Survivors of childhood cancer are at greater risk for long-term cognitive impairments that include attention, executive function, intelligence, memory, and processing speed. The participants are a survivor of acute lymphoblastic leukemia (ALL) or Hodgkin's lymphoma (HL). Because of your treatment the participant may have developed trouble with thinking and learning.

Primary Objective

To evaluate the feasibility of using home-based tPBM paired with remote cognitive training to improve cognitive performance in survivors of ALL and HL.

Secondary Objectives

To estimate the potential efficacy of alpha and gamma frequency tPBM on cognitive performance in survivors of ALL and HL.

Exploratory Objectives

To estimate the effects of home-based tPBM paired with remote cognitive training on patient reported symptoms of executive dysfunction, sleep, depression, anxiety, fatigue, and pain in survivors of ALL and HL.

Survivors with ALL and HL with identified executive function impairment will be randomized to receive stimulation with alpha tPBM + cognitive training, gamma tPBM + cognitive training or sham tPBM + cognitive training three days per week for a 2-month intervention period The tPBM will be applied to nodes in the default mode network.

Eligibility Criteria:
Inclusion Criteria:

* Completed treatment for acute lymphoblastic leukemia (ALL) or Hodgkin's Lymphoma (HL) at SJCRH.
* Enrolled in SJLIFE, and less than 21 years of age at diagnosis.
* 18 years of age or older at time of enrollment.
* 2 years or greater post-treatment completion of cancer directed therapy and not currently receiving any cancer directed therapy.
* English language proficiency.
* Access to WiFi.
* Executive dysfunction defined as having an age-adjusted standard score less than 16th percentile on objectively assessed cognitive test or patient-reported executive dysfunction defined as having a standard score greater than 84th percentile within 3 years of time of enrollment.

Exclusion Criteria:

* Estimated intelligence score less than 80.
* Currently taking medication intended to treat neurocognitive impairment (i.e., stimulants).
* Major psychiatric condition.
* Alcohol abuse in the past year (AUDIT) \[greater than or equal to 13 for women and greater than or equal to 15 for men\]. The Alcohol Use Disorders Identification Test (AUDIT) will be used to screen for individuals who have active alcohol-use disorders.
* Drug abuse in the past year (DAST-10) \[ greater than or equal to 3 for women or men\] The Drug Abuse Screen Test (DAST-10) will be used to screen for individuals with active drug abuse.
* History of neurologic condition or genetic disorder associated with neurocognitive impairment unrelated to cancer diagnosis or treatment.
* Enrolled on another independent cognitive intervention protocol within the last year.
* Female participants who are pregnant or lactating (determined by participant self-report due to the remote nature of this study)
* Tattoo or artificial marking in the area where the device will be positioned.
Pilot Pragmatic Randomized Controlled Trial: Horticultural Therapy for Inpatient Older Adults in an Acute Care Hospital

This study aims to investigate the feasibility and effectiveness of Horticultural Therapy (HT) on engagement, mood, and quality of life (QoL) of older adults in geriatric acute care in Singapore. Investigators will also assess the effectiveness of HT on mobility and hospitalisation experience. This pilot study could inform how HT can be implemented in geriatric acute care and its effect on hospitalisation experience and recovery of function.

Horticultural therapy (HT) is a non-pharmacological treatment utilizing plant-related activities as a form of alternative medicine to achieve specific goals that lead to person's well-being. Geriatric patients in acute care wards are at risk of functional decline related to acute illness and prolonged bed rest during hospitalization. HT can complement medical treatment to ameliorate the adverse effects of hospitalisation in older adults. There is evidence that HT can improve the physical and psychological well-being of the older adults in different settings. The beneficial effects of HT have mostly been documented in nursing homes, community rehabilitation facilities and senior activity centres, but not in geriatric acute care settings. There is also a need to harness available knowledge and implement it where appropriate. This study aims to investigate the feasibility and effectiveness of HT on engagement, mood, and quality of life (QoL) of older adults in geriatric acute care in Singapore. Investigators will also assess the effectiveness of HT on mobility and hospitalisation experience. This pilot study could inform how HT can be implemented in geriatric acute care and its effect on hospitalisation experience and recovery of function.

Eligibility Criteria:
Inclusion Criteria:

* 70 years old and above
* an inpatient in Khoo Teck Puat Hospital
* able to understand simple instructions (with abbreviated mental test's score of 6 and above)
* have stable vital signs - blood pressure, heart rate and peripheral capillary oxygen saturation - to take part in horticultural therapy activities

Exclusion Criteria:

* on contact or droplet precaution
* diagnosed with severe auditory-visual impairments
* have major depressive disorder
* have endocrine disorders
* on steroid-based medications such as asthma and allergies that might affect the salivary cortisol level
* on the Dangerously Ill List