cyrilzakka/clinical-trials huggingface dataset:
Chiropractic for Back and Neck Pain in an Emergency Department Setting

This study aims to examine the efficacy of an Integrative approach utilizing Chiropractic as an add-on therapy for the treatment back and neck pain in an emergency department setting

Chiropractic is well established as an effective treatment for back pain. The investigators cumulative experience in Asaf Harofeh Medical Center has shown Chiropractic to be an effective therapy for simple back and neck pain in an emergency room (ER) setting.

This study will examine weather Chiropractic can decrease pain, increase range of motion and decrease anxiety in patients admitted to the Emergency Room with simple back and neck pain without neurological findings. Chiropractic will be performed as an add on therapy on top of analgesic therapy.


Eligibility Criteria:
Inclusion Criteria:

* Adult male and females age 18-60 with acute or sub acute/chronic simple back or neck pain
* Agreed to a physical examination and by an orthopedic physician and X-ray Diagnosis of simple back pain with levels of 4 \< NRS at least
* Agreed and able to fill pain, anxiety and satisfactory questioners
* Agreed and able to sign informed consent

Exclusion Criteria:

* Fracture, sprain or neurological deficit during physical examination
* Pain scale of NRS \< 4
* Active pregnancy
* Active inflammatory arthritis
* History of CVA
* Open wounds
* Acute malignancy with life expectancy of less than 5 years
* Experience with acupuncture treatments
* History of drug addiction
* History of osteoporosis
* Declined or unable to sign informed consent
* Soldiers in active military service
* Received a chiropractic treatment in the past
Juvenile Idiopathic Arthritis in Children in Estonia.

Aims of the study:

* to study the incidence rate of juvenile idiopathic arthritis (JIA) and it's clinical subtypes in Estonia for the years 1998-2000;
* to examine the course and short-term clinical outcome of JIA.

Method: a prospective population-based study carried on in 14 counties of Estonia


Eligibility Criteria:
Inclusion Criteria:

* The International League of Associations for Rheumatology (ILAR) criteria for juvenile idiopathic arthritis
* children aged 0-15 years who had arthritis of an unknown cause for at least six weeks with an onset of the disease during the study period

Exclusion Criteria:

* Children with infectious arthritis, postinfectious arthritis, traumatic arthritis and systemic connective tissue diseases
Quantification and Derivation of Metabolic Needs in Children During Burn Rehabilitation

The investigators are collecting information on the calorie needs of patients in the first year postburn. The investigators hypothesize that increased energy needs continue for up to a year following wound closure from burn injury.


Eligibility Criteria:
Inclusion Criteria:

* \>25% burn surface area
* Wounds present as 95% healed
* Admitted to Shriners Hospital Cincinnati within 7 days of injury

Exclusion Criteria:

* \<5years old
* \<25% burn injury
* admitted greater than 7 days postburn
Asthma, Smoking, Emotional Deficits

The objective of the study is to determine whether poor control of asthma is related to an emotional deficit such as alexithymia. The hypothesis is that there is a correlation between the severity of asthma, its control, and the degree of emotional deficits.


Eligibility Criteria:
Inclusion Criteria:

* Men and women (\> 18 years).
* Asthma (mild, moderate, severe).
* Beneficiary of social security

Exclusion Criteria:

* Pregnant women
* Patients who oppose their participation in the study
* Multiple drug users (psychoactive substances).
* Patients with severe psychiatric antecedents and comorbidities.
* Patients with cancer
* Patients with cognitive impairment
* Patients with speech, hearing, visual, and praxic disorders.
* Any chronic and especially respiratory pathology other than asthma (COPD, bronchiectasis), which can alter the study.
* Patients not speaking French
* Persons protected by law
Decitabine in Combination With Low-dose Cytarabine in Elderly Patients With Acute Myeloid Leukemia

This prospective multicenter clinical study was designed to assess the efficacy and safety of decitabine in combination with low-dose cytarabine induction treatment for elderly patients with newly diagnosed acute myeloid leukemia (AML).

All patients were treated with decitabine of 15 mg/ m2 intravenously over 4h for 5 consecutive days (day 1-5) for priming combined with cytarabine of 10 mg/m2 q12h for 10 days (day 4-13).

Hydroxyurea was permitted as rescue medication if white blood count (WBC) was \>20×109/L and but was discontinued at least 24h before decitabine treatment.

Supportive care including blood product transfusions, G-CSF, antiemetic medications, antiviral and antifungal medications, or empiric antibiotics may be used at the clinical discretion of the investigator.

Curative effect was evaluated after two cycles:

1. \<5% blast in the marrow, enter into maintenance therapy (Group A)
2. ≥5% blast in the marrow, continue induction therapy two cycles,

   ① \<5% blast in the marrow, enter into maintenance therapy (Group B);

   ② ≥5% blast in the marrow, dropped out of the study (Group C)
3. marrow blast decline \<60%, dropped out of the study (Group C).

Maintenance therapy regimen:

1. Ara-C 1g/m2/d iv drip d1-4 1 cycle
2. DEC 15mg/m2/d iv drip d1-5 1 cycle
3. Ara-C 1g/m2/d iv drip d1-4 1 cycle
4. DEC 15mg/m2/d iv drip d1-5 1 cycle

Eligibility Criteria:
Inclusion Criteria:

1. Patients with previously untreated non-M3 AML (diagnosed by the WHO2016 criteria).
2. Age: ≥ 60 and ≤ 75 years.
3. Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
4. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT)≤2.5x upper limit of normal (ULN), total bilirubin ≤ 1.5 ULN, serum creatinine \< 2ULN.
5. Without central nervous system symptoms.
6. Willing to accept the follow-up.
7. Normal heart function(EF\>50%). The subjects volunteer to sign the informed consent.

Exclusion Criteria:

1. With severe cardiac, renal or hepatic insufficiency.
2. With other cancers requiring treatment.
3. With other hematological diseases(e.g. Hemophilia, myelofibrosis, etc.).
4. With severe infection or metabolic disease(including tuberculosis and pulmonary aspergillosis).
5. Brain disorders or severe mental diseases which could limit compliance with study requirements.
6. Major operation within 3 weeks.
7. With HIV infection or AIDS-associated diseases.
8. Any drug abuse, medical, mental or social situations which would affect the results.
9. Hypersensitivity to cytarabine (not including drug fever or exanthema) or decitabine.
Efficacy and Safety of a Fish Oil Containing Lipid Emulsion

The purpose of the study is to compare a fish oil containing lipid emulsion against a medium-chain/long-chain triglyceride (MCT/LCT) lipid emulsion in terms of their efficacy and safety during postoperative parenteral nutrition.


Eligibility Criteria:
Inclusion Criteria:

* Patients considered for open abdominal surgery of moderate severity, e.g.. radical operation for stomach cancer or pancreaticoduodenal surgery
* Male and female patients ≥18 and \<85 years of age
* Indication for total parenteral nutrition therapy: for at least 5 consecutive days after operation
* Ability and willingness to give voluntary consent to participate in the study, following a full explanation of the nature and purpose of the study, by signing the informed consent form approved by the Institutional Review Board (IRB) prior to all evaluations, and to comply with the requirements of the study.

Exclusion Criteria:

* General contraindications for parenteral nutrition (acidosis of various geneses, untreated disorders of electrolyte and fluid intake and output, inadequate cellular oxygen supply)
* General contraindications for infusion therapy such as acute pulmonary oedema, hyperhydration and decompensated cardiac insufficiency
* Known hypersensitivity to egg-, soy-, and fish proteins or any of the ingredients
* Other
Reliability and Equivalence of Alternate Forms of the Digital Clock Drawing Test

Equivalence of DCTclock-pen and DCTclock-tablet will be tested in a randomized crossover trial.

Randomized crossover trial consisting of two test visits separated by a washout period of 3 to 5 weeks. Subjects are randomized into two equal groups. Group 1 receives the digital pen (DCTclock-pen) version of the test at the first visit, with the tablet version (DCTclock-tablet) given at the second visit; Group 2 receives DCTclock-tablet at the first visit, followed by DCTclock-pen at the second visit. At Visit 1 (day 0), eligibility is assessed and a version of the DCTclock test is administered based on the group allocation. A battery of Linus Platform tests and reference standard tests are also administered. At visit 2 (day 21-35), eligibility is assessed and the alternate version of the DCTclock test is administered based on the group allocation. A battery of Linus Platform tests is also administered, together with reference standard tests. Equivalence of DCTclock-pen and DCTclock-tablet will be tested. Linus Platform test data will also be collected to develop novel measures of cognitive and motor function and assess their accuracy in detecting impairment, construct validity, and test-retest reliability.

Eligibility Criteria:
Inclusion Criteria:

* 55-95 years old

Exclusion Criteria:

* Ineligible for written informed consent
* Impairment of the writing hand that precludes ability to perform the study tasks
* Impaired manual dexterity in the writing hand
* Impaired vision in both eyes
* Under the influence of recreational drugs or alcohol at the time of the visit.
* Current or recent participation in a clinical trial that includes the use of a drug or intervention to alter cognitive function.
* Recent (within the last 6 months) cognitive testing with a Clock Drawing Test.
* Visit 2 Only- Self-reported change (addition or discontinuation) of the following medications between visit 1 and visit 2; Timolol (eye drop), Benadryl, beta blockers, steroids or over the counter medications for sleep (PM varieties).
A Test of Behavioral Intervention for Women at High Risk for HIV Infection

The purpose of this study is to find out if it is possible to conduct a group counseling program for women at risk for HIV infection.

Women have been the fastest-growing group with new AIDS diagnoses. The need for ways to reduce HIV infection in women is urgent. It is important to reduce the risk of HIV infection through sexual contact, but it is also important to address drug use. Group counseling may be an effective method.

Women have constituted the fastest-growing group of persons with new AIDS diagnoses for several years. The need to develop and evaluate interventions to reduce the incidence of HIV infection among women is urgent. The behavioral intervention method tested in this study integrates elements from diverse theories and empirical evidence for women to feel empowered to use methods of protection against disease. Although the overall objective of the study intervention is to reduce the risk of HIV infection through sexual contact, the intervention must also address drug usage among women.

Women are randomized in a 1 to 1 ratio to either the intervention or control condition. The Intervention Group participates in 4 group sessions over the course of 1 month and then in an additional reunion session approximately 1 month after the 4th group session. Sessions are 2.5 hours long and include 6 to 10 participants. The sessions involve talking about HIV, ways to avoid HIV, and ways women can support each other. All participants complete a short-term assessment visit 1 week after the 4th group intervention session. The Control Group does not participate in group sessions. All participants are paid for their time and effort.

Eligibility Criteria:
Inclusion Criteria

Women may be eligible for this study if they:

* Are at least 18 years old.
* Took part in the VPS2 study and completed 12 months of follow-up, or each participant must meet at least 1 of the following conditions: 1) has sex with an HIV-infected male; 2) has sex with a male who has injected drugs in the last 5 years; 3) has had sex with 5 or more male partners in the last year; 4) exchanged sex for money or drugs in the last year; 5) was diagnosed with syphilis, chlamydia, gonorrhea, first episode herpes, pelvic inflammatory disease, and/or trichomonas in the last year; or 6) used crack cocaine in the last year.
* Can speak English.
* Can give information for the purpose of locating.
* Have had at least 30 percent of vaginal or anal intercourse unprotected by condoms in the 6 months before the study.
* Are HIV-negative.

Exclusion Criteria

Women will not be eligible for this study if they:

* Have had sex with only 1 man for 2 years or more who is HIV-negative and does not inject drugs. The man should not have had sex with anyone else during this time.
* Have a mental condition that would interfere with the study.
* Have any other condition that would interfere with the study.
Mohs and Immunofluorescence for Malignant Melanoma In Situ

The purpose of this study is to determine if immunofluorescence (IF) can effectively identify features of malignant melanoma in situ, on sun-damaged skin, in the setting of Mohs Micrographic Surgery.

The aim of this study is to

1. Determine the feasibility of using melanocytic markers such as Melanoma antigen recognized by T cells 1 (MART-1) with fluorescence to clear surgical margins when compared to conventional MART-1 immunohistochemistry (IHC) in the setting of MMS for LM (lentigo maligna type melanoma in situ).
2. Compare the use of a cocktail of immunofluorescent markers such as, but not limited to, Sex-determining Region Y (SRY)-box 10 (SOX10), human melanoma black 45 (HMB-45), and Kiel-67 (Ki-67) to sections only stained with fluorescent MART-1 alone.
3. Explore the value of using other combinations of immunofluorescent markers such as S-100 with Microphthalmia-associated transcription factor (MiTF), Nestin with Ki-67, and HMB-45 with Lamin.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female of any race and at least 18 years of age
2. Patient with biopsied proven Lentigo maligna (LM) in situ
3. Patient meets criteria for Mohs Micrographic Surgery (MMS)

   1. The cancer is large
   2. The edges of the cancer (clinical margins) cannot be clearly defined
   3. Prior treatment has failed, i.e. recurrent tumor
   4. The cancer is located in a cosmetically sensitive or functionally critical area of the body (such as eyelids, nose, ears, lips, fingers, toes, and genitals)
   5. The histologic pattern of the cancer is aggressive
   6. The patient is immunosuppressed
4. Patient with biopsied proven LM in situ located on an anatomic areas appropriate for MMS:

   1. Area H: ''Mask areas'' of face (central face, eyelids \[including inner/outer canthi\], eyebrows, nose, lips \[cutaneous/mucosal/vermillion\], chin, ear and periauricular skin/sulci, temple), genitalia (including perineal and perianal), hands, feet, nail units, ankles, and nipples/areola.
   2. Area M: Cheeks, forehead, scalp, neck, jawline, pretibial surface.
   3. Area L: Trunk and extremities (excluding pretibial surface, hands, feet, nail units, and ankles).
5. Patient able to tolerate surgery
6. Patient is able to comply with appointments including follow-up appointments
7. Ability to understand and willingness to sign a written informed consent document

Exclusion Criteria:

1. Patients under the age of 18
2. Patient does not meet criteria for MMS or has LM located in areas that are not accessible with MMS
3. Patient with previously diagnosed invasive LM
4. Patients unable to comply with follow-up
5. Adults unable to consent
6. Pregnant women
7. Prisoners
Oral Tofacitinib in Adult Subjects With Discoid Lupus Erythematosus (DLE) and Systemic Lupus Erythematosus (SLE)

Evaluate the activity and safety of oral tofacitinib in adult patients with discoid lupus erythematosus with or without concurrent SLE.

Discoid Lupus Erythematosus (DLE ) and systemic lupus erythematosus (SLE) can be devastating diseases with a significant impact on quality of life. DLE is currently treated with potent topical steroids, antimalarials, and immunosuppressants. Recent research has determined that DLE is a Th1 mediated disease. There is increasing evidence that JAK inhibitors such as tofacitinib can treat the Th1 mediated diseases such as alopecia areata. Therefore the goal of this study is to determine if JAK inhibitors can successfully treat DLE. Tofacitinib has not previously been studied in DLE. This will be a pilot study that is descriptive for early clinical impressions and molecular mechanisms in order to obtain initial information to potentially design an appropriately -powered phase 2 or 3 study for efficacy of JAK inhibitors that could take place in the future

Eligibility Criteria:
Inclusion Criteria:

* Adults 18 years to ≤ 65 years of age with clinical diagnosis of DLE (and at least half of patients with a diagnosis of SLE) as determined by the Principal Investigator by medical history and physical exam.
* Able to understand consent procedure
* Able to comply with protocol activities
* Have had a diagnosis of biopsy proven DLE for at least 6 months prior to Visit 1 (Baseline/Day 1).
* At Screening and Visit 1 (Baseline/Day 1), have had DLE covering at least 5% of total body surface area (BSA) or SLE with DLE covering at least 2% of BSA as determined by the hand print method (one palm is equivalent to 1% BSA).

Exclusion Criteria:

* Patients not able to understand consent procedure
* Patients unable to comply with protocol activities
* Other skin conditions at Baseline that would interfere with evaluation of DLE.
* Topical corticosteroid within the past 2 weeks
* Systemic therapy is allowed if on a stable dose and using for at least 3 months -background therapies outlined in Protocol
* Concomitant use of moderate to potent inhibitors and inducers of CYP3A4/5
* Women who are pregnant or wish to become pregnant, or who are lactating. Women of childbearing potential must use effective contraceptive methods in order to participate in tofacitinib clinical studies
* History of infection requiring hospitalization, parenteral antimicrobial therapy within 6 months prior to first dose of study drug or history of infection requiring antimicrobial therapy within 2 weeks prior to first dose of study drug
Characteristics of Intestinal Bacteria and Their Effects on Growth and Immune Function in Children at High Altitude

Microbes and the human body maintain a complex relationship of interaction and influence. Different regions, altitudes, and dietary habits have different degrees of influence on the composition of children's intestinal flora. Therefore, the development and maturation process of children's intestinal flora in plateau areas was discovered, and its relationship with children's immunity, metabolism, and growth was understood. The mechanism of action of children's intestinal flora on immunity, growth and development was further analyzed by comparing it with people in low-altitude areas, to provide a scientific basis for improving children's health in plateau areas.

This observational study aims to gain a deeper understanding of the interactions and influence of microbes on the human body. By comparing the gut microbiota composition of children in different regions, at varying altitudes, and with distinct dietary habits, the study aims to answer two key questions:

What are the characteristics of children's gut microbiota in different regions, at different altitudes, and with different dietary habits? What is the relationship between the development and maturation process of children's gut microbiota in plateau areas and their immunity, metabolism, and growth? Participants will be asked to provide fecal samples for analysis during the study. They may also be asked to answer questionnaires about their lifestyle factors such as diet and physical activity. The comparison group is included, researchers will compare the gut microbiota composition and diversity of children in low-altitude areas with those in plateau areas to assess any differences in their gut microbiota profiles. By comparing these differences, the mechanism of action of children's gut microbiota on immunity, growth and development can be further analyzed. The findings of this study aim to provide a scientific basis for improving children's health in plateau areas.

Eligibility Criteria:
Inclusion Criteria:

* Children aged 1-3 years old
* Both men and women;
* The child's legal guardian signed the informed consent to participate in the study.
* The legal guardian of the child commits to follow the study procedures and cooperate with the entire study process

Exclusion Criteria:

* Probiotics or antibiotics within 1 month
* Associated with clinically significant abnormalities in liver and kidney function, nervous system, respiratory system, and coagulation function as determined by the investigator
* Unstable vital signs;
* Have other underlying medical conditions
* Individuals deemed unsuitable for this clinical trial.
Ascending Dose Study of the Safety and Tolerability of REGN6490 in Healthy Volunteers

The primary objective of the study is to evaluate the safety and tolerability of single ascending intravenous (IV) and subcutaneous (SC) doses of REGN6490 in healthy adult participants

The secondary objectives of the study are to:

* Characterize the pharmacokinetic (PK) profile of single IV and SC doses of REGN6490 in healthy adult participants
* Assess immunogenicity of REGN6490 in healthy adult participants dosed with a single IV or SC dose of REGN6490


Eligibility Criteria:
Key Inclusion Criteria:

1. Body mass index between 18 and 31 kg/m2 (inclusive) at screening visit
2. Is judged by the investigator to be in good health based on medical history, physical examination, vital sign measurements, and ECG's performed at screening and/or prior to administration of initial dose of study drug
3. Is in good health based on laboratory safety testing obtained at the screening visit
4. Willing and able to comply with clinic visits and study-related procedures
5. Provide informed consent signed by study participant

Key Exclusion Criteria:

1. History of clinically significant cardiovascular, dermatological, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric, or neurological disease, as assessed by the investigator, that may confound the results of the study or poses an additional risk to the participant by study participation
2. Presents any concern to the study investigator that might confound the results of the study or poses an additional risk to the participant by their participation in the study
3. Has any physical examination findings and/or history of any illness that, in the opinion of the study investigator, might confound the results of the study or poses an additional risk to the participant by study participation
4. Hospitalization (\>24 hours) for any reason within 30 days of the screening visit
5. Is a current smoker, including e-cigarettes. Former smokers may be enrolled if they have stopped smoking for at least 3 months (90 days) prior to the screening visit

Note: Other protocol defined Inclusion/Exclusion criteria apply