cyrilzakka/clinical-trials huggingface dataset:
Trial of the Effectiveness of AQ/AS, SP/AQ and SP/CQ for Uncomplicated Malaria in Gambian Children

The purpose of this trial is to compare the effectiveness of three combination treatments for uncomplicated malaria when given in operational settings, without supervision of doses other than the first dose.

Children aged 0.5-10 years presenting at health centres with fever or history of fever and other symptoms suggestive of malaria will be screened; children found to have uncomplicated Plasmodium falciparum malaria will be randomized to receive treatment with AS/AQ, SP/AQ or SP/CQ. A drug dispenser will supervise the first dose of medication and subsequent doses will be given to the child's parent to be administered at home, unsupervised by the study team. Patients will be visited at home three days later. Unused medication will be counted and the mother will be asked about the number of doses the child received and any side effects. Children will be seen again 2 and 4 weeks after treatment to collect finger prick samples for packed cell volume (PCV) and malaria microscopy. The primary endpoint is clinical failure by day 28. Analysis will be by intention to treat.

Eligibility Criteria:
Inclusion Criteria:

* Presentation at health centre with febrile illness
* Monoinfection with P. falciparum
* Parasitaemia \>=500/microlitre
* Fever or history of fever

Exclusion Criteria:

* Signs of severe or complicated malaria (persistent vomiting with or without dehydration, history of convulsion during the present illness, inability to sit or stand, parasitaemia \>200,000/ul)
* Severe malnutrition
* Clinically evident concomitant disease
* PCV \<20%
* History of allergy to the study medications
* Residence outside the study area and hence difficult to follow up
Supervised Aerobic Training During or After Chemotherapy for Operable Breast Cancer

The purpose of this study is to compare the effects of aerobic exercise training during and after chemotherapy for women who have recently been diagnosed with early-stage breast cancer.

The participant will be instructed to self-report the session information to ExOnc staff at or before their next scheduled visit. If the participant's next scheduled visit is greater than 72 hours following an unsupervised session, ExOnc staff may reach out to the participant to retrieve the session information. Unsupervised session details will be source documented by ExOnc staff.


Eligibility Criteria:
Inclusion Criteria:

* Aged 21-80 years
* Female
* MSK histologically confirmed early-stage operable breast cancer
* Scheduled to receive chemotherapy in the neoadjuvant or adjuvant setting
* ECOG status of 0 or 1
* Performing less than 150 minutes of structured moderate-intensity or strenuous intensity exercise per week
* If a female of child-bearing potential, must not be pregnant or planning to become pregnant during the study.

  a. Women \< 50 years old must have a negative pregnancy test (urine HCG or serum βHCG) within 2 weeks of beginning chemotherapy.
* Able to complete an acceptable baseline cardiopulmonary exercise test (CPET), in the absence of high risk ECG findings or other inappropriate response to exercise as determined by the investigator.
* Able to achieve an acceptable peak baseline CPET, as defined by any of the following criteria:

  * Achieving a plateau in oxygen consumption, concurrent with an increase in power output;
  * A respiratory exchange ratio ≥ 1.10;
  * Attainment of maximal predicted heart rate (HRmax) (i.e., within 10 bpm of age-predicted HRmax \[HRmax = 220-Age\[years\]);
  * Volitional exhaustion, as measured by a rating of perceived exertion (RPE) ≥ 18 on the BORG scale.
* Willingness to be randomized to one of the study arms

Exclusion Criteria:

* Presence of any other concurrent, actively treated malignancy
* History of any other malignancy treated within the past 3 years (other than non-melanoma skin cancer)
* Presence of metastatic disease
* Any of the following contraindications to cardiopulmonary exercise testing:
* Acute myocardial infarction within 3-5 days of any planned study procedures)
* Unstable angina
* Uncontrolled arrhythmia causing symptoms or hemodynamic compromise;
* Recurrent syncope
* Active endocarditis
* Acute myocarditis or pericarditis
* Symptomatic severe aortic stenosis
* Uncontrolled heart failure
* Acute pulmonary embolus or pulmonary infarction within 3 months of any planned study procedures;
* Thrombosis of lower extremities
* Suspected dissecting aneurysm
* Uncontrolled asthma
* Pulmonary edema
* Respiratory failure
* Acute non-cardiopulmonary disorders that may affect exercise performance or be aggravated by exercise (i.e., infection, renal failure, thyrotoxicosis) or
* Room air desaturation at rest ≤ 85%
* Mental impairment leading to inability to cooperate.
* Any other condition or intercurrent illness that, in the opinion of the investigator, makes the participant a poor candidate for the trial
Scleroderma Treatment With Celution Processed Adipose Derived Regenerative Cells (STAR)

The primary objective of this study is to assess the safety and efficacy of the Celution Device in the processing of an autologous graft consisting of adipose derived regenerative cells (ADRCs) in the treatment of hand dysfunction due to scleroderma.

The STAR Trial is a prospective, randomized, multi-center device trial intended to assess safety and efficacy of subcutaneous administration of Celution processed ADRCs into fingers of patients with hand dysfunction due to scleroderma.

Following informed consent and screening evaluations, eligible subjects will undergo pre-operative testing. Subjects will then undergo fat harvest through small volume liposuction under local anesthesia. Lipoaspirate will be processed in the Celution System to isolate and concentrate ADRCs for immediate subcutaneous administration under local anesthesia. Subjects will be randomly assigned to receive ADRCs (40 million cells) or a visually-matched placebo in a 1:1 ratio. All subjects will receive subcutaneous administration of test substance (ADRC or placebo) into all fingers of both hands. Following completion of all 48 week visits and database lock, placebo treated subjects will be offered treatment with their ADRCs cells should they continue to qualify according to the inclusion/exclusion criteria and should they wish to be treated with ADRCs and agree to the fat harvest procedure.

Eligibility Criteria:
Key Inclusion Criteria:

1. Males or females ≥ 18 and ≤ 70 years of age
2. Diagnosis of diffuse cutaneous scleroderma (duration \> 5 years) or limited cutaneous scleroderma.
3. Cochin score ≥ 20 units
4. Ability to safely undergo liposuction
5. Symptoms consistent with Raynaud's Phemomena
6. Compliant with standard preventative recommendations

Key Exclusion Criteria:

1. Body Mass Index \< 18 kg/m2
2. Active infection in any finger during screening period or infection in any finger requiring antibiotics in the 30 days prior to the Screening Visit
3. Active infection at the potential site(s) of fat harvest during the screening period
4. Contractures of any finger or ulceration at point of injection precluding completion of injection procedure
5. Amputation of any finger proximal to the proximal interphalangeal joint or any amputation in more than one finger
6. Diagnosis of Rheumatoid Arthritis
7. Inflammatory arthritis of the hand, including significant osteoarthritis, that is not due to scleroderma or significant acute inflammation in the hand that is due to scleroderma, as per the investigator's clinical judgment
8. Oral cyclophosphamide exceeding 2 mg/kg/day, any intravenous cyclophosphamide, methotrexate exceeding 25 mg/week, mycophenolate mofetil exceeding 3 gm/day, hydoxychloroquine exceeding 7 mg/kg/day or azathioprine exceeding 300 mg/day or any other immunosuppressive medication in the 90 days prior to the Screening Visit
Optimising Nutrition, Oral Health and Medication for Older Home Care Clients (NutOrMed)

The aim of the study is to evaluate the impact of six month long nutritional and oral health intervention on nutritional status, oral health, functional performance and hospital admission/costs on older persons using home care services. Additionally, participants are interviewed at home regarding their drugs use and this information will be compared with medication information in electronic patient records.


Eligibility Criteria:
Inclusion Criteria:

* home care clients

Exclusion Criteria:

* under 75 years
Financial Navigation Study Among Young Adult Blood Cancer Survivors

Young adult cancer survivors (18-39y) are at increased risk of financial distress. This study seeks to better understand the financial challenges experienced by these individuals via quantitative serial assessments, study-based financial navigator encounters and an end of study qualitative interview.

This fully remote, multi-site study will evaluate the role of financial navigators in relieving financial distress in young adults (18-39y) who have completed treatment for blood cancer at least three years ago. Serial Assessments at study entry, 3-months, and 6-months measure financial distress measured using the study's primary outcome measure the Personal Financial Wellness Scale™ (PFW) (see below), hypothesized effect modifiers (emotional distress, self-efficacy, cognitive functioning), as well as care seeking, household finances and insurance characteristics. Randomization will occur following completion of baseline measures (see below for description of study arms). In addition to a formal evaluation of the intervention at 3- and 6-months, an optional interview will occur following the 6-month assessment/navigation intervention period to gain further insight from participants about the acceptability of the intervention. For ethical considerations related to the topic of study, all participants will be provided with the Leukemia \& Lymphoma Society's information specialist hotline.

Eligibility Criteria:
Inclusion Criteria:

1. Previous diagnosis and treatment of blood cancer (leukemia, lymphoma, myeloma, myelodysplastic syndrome, or myeloproliferative neoplasm)
2. Current age between 18-39 years old
3. Blood cancer diagnosis during childhood (0-17 years of age) or young adulthood (18-36 years of age)
4. At least three years post blood cancer diagnosis
5. Off treatment for blood cancer or on a long-term regimen with an oral anti-cancer medication with stable disease
6. Off treatment for a second cancer (non-blood cancer) or on a stable long-term regimen, such as hormone therapy or hormone replacement therapy
7. Primary residence in United States
8. Able to understand and read the English language

Exclusion Criteria:

* On parent or guardian's insurance
Effects of Progressive Relaxation Exercises

When the literature is examined, it is observed that the effects of progressive relaxation exercises on pain, anxiety and sleep quality have been frequently investigated in different populations. Studies conducted with nursing students focus on dysmonorrhea and clinical anxiety and stress . A limited number of studies have focused on the quality of life of students . There is no study examining the effects of progressive relaxation exercises on sleep quality, psychological endurance and quality of life together. Therefore, the aim of our study is to examine the effects of progressive relaxation exercises applied to nursing students on sleep quality, psychological endurance and quality of life. It is thought that our study results will contribute to the literature in terms of their originality.

This research is a randomized controlled trial planned to examine the effects of progressive relaxation exercises on sleep quality, psychological resilience and quality of life in nursing students.

Eligibility Criteria:
Inclusion Criteria:

* Being a student in the Department of Nursing

  * Being willing to participate in the study
  * Not having a chronic disease that may prevent exercise (COPD, heart failure, etc.)
  * Not having a hearing problem
  * Not having a psychiatric diagnosis (major depression, anxiety disorders, etc.) and not using medication for anxiety or depression
  * Having a computer and technological devices at home
  * Being able to use a mobile phone (IOS-Android)
  * Having internet access
  * Being able to speak Turkish
  * Not having used techniques such as meditation, hypnosis, yoga for the last 6 months before the study
  * Not having a neurological, systemic, or psychiatric disease.

Exclusion Criteria:

* • Nursing students who do not volunteer to participate in the study,

  * Those who have any health problems during the application process,
  * Those who cannot continue the study for any reason,
  * Those who want to withdraw from the study with their own consent
Sintilimab and Decitabine for Patients With Relapsed/Refractory or Advanced NK/T-cell Lymphoma

The purpose of this study is to evaluate the efficacy and safety of Sintilimab in combination with decitabine in the treatment of Relapsed/Refractory or advanced NK/T-cell lymphoma patients

Previous study has confirmed the efficacy of anti-PD-1 antibodies (including pembrolizumab or sintilimab). However, the CR rate of PD-1 antibody monotherapy is too low. Previous studies have demonstrated that decitabine may activate the T cells and enhance the efficacy of PD-1 antibodies in Hodgkin Lymphoma. Thus, the investigators aim to evaluate the efficacy and safety of sintilimab in combination with decitabine in the treatment of NK/T cell lymphoma.

Eligibility Criteria:
Inclusion Criteria:

Histopathology and immunohistochemistry confirmed diagnosis of NK/Tcell lymphoma according to WHO 2016 criteria.

* refractory or relapsed after initial remission, or stage III-IV de novo patients
* PET/CT or CT/MRI with at least one objectively evaluable lesion.
* General status ECOG score 0-3 points.
* The laboratory test within 1 week before enrollment meets the following conditions: Blood routine: Hb\>80g/L, PLT\>50×10e9/L. Liver function: ALT, AST, TBIL ≤2 times the upper limit of normal. Renal function: Cr is normal. Cardiac function: LVEF≥50%, ECG does not suggest any acute myocardial infarction, arrhythmia or atrioventricular conduction above I Blocking.
* Sign the informed consent form

Exclusion Criteria:

Active infection requires ICU treatment. Concomitant HIV infection or active infection with HBV, HCV. Patients who are infected with HBV but not active hepatitis at the same time are notexcluded.

Significant organ dysfunction Pregnant and lactating women. Had a history of autoimmune diseases, and disease was active in the last 6 months.

Those who were known to be allergic to drugs in the study regimen. Patients with other tumors who require surgery or chemotherapy within 6 months.

• Other experimental drugs are being used.
Programmed Flexor-extensor Alternating Electrical Acupiont Stimulation on Limb Functional Reconstruction After Stroke

The purpose of this study is to study the effect mechanism of programmed flexor-extensor alternating electrical acupiont stimulation on upper limb functional reconstruction after stroke.

After being informed about the study and potential risks, all patients who meet the inclusion criteria, after signing the informed consent, will be randamized divided into two groups in a blind manner. The patients will undergo a 3-week treatment (6 days per week and 1 day for rest, a total of 18 days of treatment). Those in the control group are treated with conventional flexor-extensor alternating electrical acupiont stimulation, and in the treatment group, programmed stimulation will be adopted (30 minutes, once a day). Besides, data from healthy participants will be collected and processed for reference and control purposes.

Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria for patients

  1. Meet the diagnostic criteria of stroke;
  2. Age: 35 \~75 years old, male and female;
  3. Course of disease: 2 weeks to 3 months after stroke, stable vital signs, basically normal cognitive function, can cooperate to complete the test;
  4. Manual muscle test (MMT) ≥2, modified Ashworth (MAS) of paralyzed upper limbs was graded Ⅰ\~Ⅱ;
  5. BMI ≤28;
  6. No serious heart, lung, kidney and other functional damage and serious underlying diseases, no pain in the affected side of the upper limb joint;
  7. The informed consent was signed by the patient and/or his/her family members. Note: Patients who meet the above 7 criteria can be included in this study.
* Inclusion criteria for healthy subjects:

  1. Those who have been proved to be healthy by physical examination and have no organic lesions or obvious functional diseases;
  2. Age: 35 \~75 years old, male and female;
  3. No cold, fever, cough, headache and other physical abnormalities during the test;
  4. Did not take any excitatory drugs in the past one month, no recent treatment related to experimental content;
  5. No history of mental or nervous system;
  6. The subject agrees and signs the informed consent.
* Exclusion Criteria:

  1. Severe cognitive dysfunction, severe aphasia, can not cooperate with the whole treatment or testing process;
  2. Patients with serious primary diseases such as heart, lung, kidney, liver and endocrine system;
  3. Neurological or musculoskeletal diseases affecting functional recovery before onset;
  4. Cerebral stem stroke or bilateral stroke;
  5. Patients with severe anxiety, depression, affective disorders, schizophrenia and other serious mental disorders;
  6. Examination confirmed by brain tumor, brain trauma, brain parasitic diseases, metabolic disorders, rheumatic heart disease, coronary heart disease and other heart disease with atrial fibrillation caused by cerebral embolism;
  7. Patients with skin damage, infection or deformity at the treatment site.
Active Monitoring And Determinants of Incidence Infection of COVDI-19

7. Objectives To apply e-health methods to perform active monitoring and assess determinants of incident Infection of COVID-19 in a hospital population.

8. Study design Prospective, Single-centre, observational clinical study. 9. Disease or disorder under study Healthy people in risk of COVID-19 infection. 10. Main variable. Symptoms related to infection caused by SARS-Cov2. 11. Study population and total number of patients Men and women in general god health status aged between 18 and 80 years that currently are employees of Hospital de La Princesa .

12. Duration of treatment Each subject will be monitored, since its recruitment, for a period of 12 weeks.

13. Timetable and expected date of completion The overall duration of the study is estimated at about 6 months, from patient recruitment to the last data recorded by last subject. The aim is to carry out this study from March 2020 onwards.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female subject age ≥ 18 years.
2. The subject has no symptoms in last week of COVID-19 infection such as:

   * Body temperature ≤ 37, 1 ºC.
   * Normal lung and breath functions.
3. The subject belongs to the Hospital de La Princesa workforce.

Exclusion Criteria:

1. People with any symptom suspicious of COVID-19 infection.
The Effect of Terazosin and Tolterodine on Ureteral Stent Related Symptoms

The aim of the investigators study is to evaluate whether alpha-blockers such as terazosin and anti-cholinergics such as tolterodine can be relieve the DJ-stent related symptoms.

Ureteral stent (US) has been as essential tool in the urologist's surgeries and is useful instruments that its indications increase due to new stent technologies and improvement of patient's comfort.

US associated with discomfort complications that include lower urinary tract symptoms (LUTS) as frequency, urgency, dysuria, incomplete emptying, flanks and suprapubic's pain, incontinence, hematuria, movement of stent, infection and encrustation of stent. US related symptoms are as same as LUTS due to benign prostate hyperplasia and overactive bladder which relieve with alpha-blockers and anticholinergic. The purpose of our study is to investigate the effect of terazosin and tolterodine lonely and together in comparison of placebo on US related symptoms.

The investigators study will be done prospectively. The patients who underwent indwelling Double-j stent distributed into four groups: 1)receive placebo 2)receive terazosin 2mg twice 3)receive tolterodine 2mg daily 4) receive terazosin 2mg twice and tolterodine 2mg daily. All of the patients receive prophylactic antibiotic and on demand analgesic. After entrance to study, they fulfill the International Prostatic Symptoms Score (IPSS) and Visual Analog Scale (VAS) on the before indwelling US, two weeks after indwelling US and US removal time, then the investigators will evaluate the drug's effect on US related symptoms.

Eligibility Criteria:
Inclusion Criteria:

If a patient does not meet any exclusion criteria and to be undergone double-J stent indwelling.

Exclusion Criteria:

1. Prior history of pelvic surgery
2. Prior history of Transurethral Resection of the either Prostate or Bladder Tumor
3. Benign prostate hyperplasia
4. Recent or recurrent urinary tract infection
5. Chronic medication with beta-blockers or Anti-cholinergic
6. Pregnancy
7. Prostatitis
8. Prostate cancer
9. Bilateral ureteroscopy or ureteral stenting
10. Age \< 18 and \> 55
11. Stone size \> 20 mm
12. Diabetes
13. Bladder Outlet Obstruction
Minimum Effective Concentration of Ropivacaine for Brachial Plexus Block Via the Supraclavicular and Infraclavicular Approach, Femoral Nerve Block, Sciatic Nerve Block Via the Popliteal and Parasacral Approach

This is a dose finding study to identify the minimum effective anesthetic concentration (MEAC) of ropivacaine to produce insensate body parts sufficient for surgery in supraclavicular and infraclavicular approaches to the brachial plexus, parasacral and popliteal approaches to the sciatic nerve, femoral nerve and transversus abdominis plane (TAP) blocks in adults.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists physical status I to III (patients may be healthy or have systemic disease, but any disease does not pose a constant threat to life, and patients are neither moribund, nor not expected to survive without the operation).
* Age 18 or above
* Undergoing elective ambulatory surgery of the upper limb (excluding the shoulder), lower limb (excluding the hip), or lower abdomen with sensory blockade as part of the pain management plan.

Exclusion Criteria:

* Body mass index of \>35 kg/m2 (higher chance of failure)
* Deformities of the leg (for patients in the parasacral, femoral, and popliteal groups), or the chest or shoulder (for patients in the supraclavicular, infraclavicular, and TAP groups)
* Preexisting infection at the injection site
* Existing neurologic disease
* Allergy to local anesthetic agents
* Severe respiratory disease
* Coagulopathy
* Any other contraindication to the block being considered
* Patients requiring total motor blockade as well as sensory blockade