cyrilzakka/clinical-trials huggingface dataset:
Osteopathy and Latent Hypothyroidism

This study evaluates the effectiveness of stimulating the neurological segments c8-th5 in patients with latent hypothyroidism.

One half of the participants will receive an osteopathic manuel treatment in order to stimulate the relevant segments, the other half will receive no treatment.

Patients with latent hypothyroidism show an increased hormone status in TSH and a normal hormone status in fT4. A study has shown that osteopathic treatment had positive effects to some symptoms in patients with latent hypothyroidism. The study was using the pain inventory as the instrument to measure the effect. In this study we want to evaluate the effectiveness of the treatment on the hormone status (TSH, fT4) The intervention group will receive a neurological osteopathic stimulation over 5 weeks. A parallel control group will not receive any therapy.

A follow up blood screening (TSH, fT4) will be done. The results of both groups will be compared.

Eligibility Criteria:
Inclusion Criteria:

* latent hypothyroidism

Exclusion Criteria:

* Factors that Alter Thyroxine and Triiodothyronine Binding in Serum
* Increased thyroxin-binding globulin
* Decreased thyroxin-binding globulin
* Binding inhibitors
* Inherited Salicylates
* Pregnancy
* Androgens
* Furosemide
* Neonatal state
* Anabolic steroids
* Free fatty acids
* Estrogens
* Glucocorticoids
* Phenytoin
* Hepatitis
* Severe illness
* Carbamazepine
* Porphyria
* Hepatic failure
* nonsteroidal antiinflammatory drug (variable, transient)
* Heroin
* Nephrosis
* Heparin
* Methadone
* Nicotinic acid
* Mitotane L-Asparaginase
* 5-Fluorouracil
* SERMS (e.g., tamoxifen, raloxifene)
* Perphenazine
* spinal pathologies
iMagIng pulmonaRy Aspergillosis Using Gallium-68-dEferoxamine

This is a single center open-label feasibility trial involving a single study visit for participants. The purpose of the study is to demonstrate the feasibility of \[68Ga\]Ga-DFO-B PET/CT (gallium-68-deferoxamine) for the visualization of pulmonary Aspergillus infection.

The incidence of fungal infections is on the rise and are associated with significant mortality. Diagnosis pulmonary aspergillosis can be can be challenging, often requiring invasive tests such as bronchoscopy and lung tissue biopsies. Molecular imaging, specifically using radiolabeled siderophores like \[68Ga\]Ga-DFO-B, offers a non-invasive and location-specific approach to visualize and evaluate infections. Siderophores, critical for pathogenic microbes like Aspergillus fumigatus, play a role in iron acquisition. Preclinical studies with radiolabeled deferoxamine (DFO-B) demonstrated distinct accumulation at infection sites. Additionally, \[68Ga\]Ga-DFO-B PET/CT may differentiate between Aspergillus infection and cancer, making it a promising non-invasive diagnostic tool for pulmonary aspergillosis.


Eligibility Criteria:
Inclusion Criteria:

1. The patient is at least 18 years old on the day of inclusion.
2. The patient has suspected chronic pulmonary aspergillosis or ABPA.
3. There is no significant interference with standard care and follow-up.

Exclusion Criteria:

1. The patient is pregnant or planning on becoming pregnant.
2. The patient has severe kidney dysfunction with eGFR \< 30 ml/min/kg and/or receives dialysis.
3. The patient has (chronic) iron overload.
4. The patient has been receiving antifungal treatment for more than 48 hours prior to the study day.
5. The patient is not able to lie still in the scanner.
Study for the Treatment of Ulcerative Colitis With Adacolumn

The purpose of this study is to demonstrate the safety and effectiveness of the Adacolumn Apheresis System to treat the signs and symptoms of ulcerative colitis.

Trial Features:

* Non-drug therapy
* Most patients can remain on current treatment regimen, including prednisone, budesonide and medications such as Asacol (mesalamine), Pentasa (mesalamine), Colazal (balsalazide disodium) and Dipentum (olsalazine sodium) throughout the study

Components of the Study:

* Study length is 24 weeks, which includes a screening visit, ten treatment visits over nine weeks and 4 follow-up appointments
* Physical exams, laboratory tests and disease assessments conducted at no charge to the patient
* 2:1 Randomization (treatment:sham)

Eligibility Criteria:
Key Inclusion Criteria:

* Moderate to severe active ulcerative colitis with colonic involvement with ulcerative colitis beyond 15 cm of the anal verge
* Adequate peripheral venous access to allow for completion of the apheresis treatments
* Receiving one or more of the following medical therapies:

  \*sulfasalazine, \*mesalamine and other 5-ASA agents, \*prednisone or 6-mercaptopurine or azathioprine OR Have not received the above medical therapies due to intolerance or demonstrated non-response
* Agree to participate in the required follow-up visits
* Able to complete a diary
* Signed written informed consent document and authorization for use of protected health information

Key Exclusion Criteria:

* Evidence of toxic megacolon
* Major surgery within the past 6 weeks or anticipated need for surgery within 12 weeks
* Proctocolectomy, total colectomy, ileostomy, stoma or ileal pouch-anal anastomosis
* Requiring in-patient hospitalization
* A history of allergic reaction to heparin or heparin-induced thrombocytopenia
* A history of hypersensitivity reaction associated with an apheresis procedure or intolerance of apheresis procedures
* A history of severe cardiovascular or peripheral arterial diseases
* A history of cerebral vascular diseases
* Liver diseases
* Renal insufficiency
* Insulin-dependent Type I or Type II diabetes
* Known bleeding disorder or use of concomitant anticoagulant therapy for purposes other than apheresis treatment
* Any hypercoagulable disorder
* Known infection with Hepatitis B or C, or HIV
* Severe anemia
* Leukopenia or granulocytopenia
* Evidence of current systemic infection
* Malignancy
* Pregnant, lactating or planning to become pregnant during the course of the investigational study
* Used within the last 30 days, an investigational drug, biologic or device or 5 half-lives, if known, for any investigational drug or biologic
Novel Coronavirus Induced Severe Pneumonia Treated by Dental Pulp Mesenchymal Stem Cells

Evaluation of novel coronavirus induced severe pneumonia by dental pulp mesenchymal stem cells

Open, single center, single arm test design. Plan to enroll 24 subjects. On the basis of clinical standard treatment, the injection of dental mesenchymal stem cells was increased on day 1, 3 and 7 of the trial.

Injection dose: 1.0x106 cells /kg. Injection method: slowly and quietly drop 50 mL of normal saline, then the endodontic mesenchymal stem cell injection (after 60 min), and then 50 mL of normal saline.

Eligibility Criteria:
Inclusion Criteria:

* 1. Age ≥ 18, age ≤ 75, gender unlimited;
* 2. novel coronavirus diagnosed severe pneumonia and confirmed no effective treatment plan. (severe patients meet any of the following: (1) respiratory distress, RR \> 30 times / minute; (2) resting state, oxygen saturation is less than 93%; (3) arterial oxygen partial pressure (PaO2) / oxygen inhalation (FiO2) is less than 300 mmHg (1mm Hg=0.133 kPa).
* 3. Those who voluntarily participate in the clinical study and can cooperate with researchers to carry out the study, and the patients themselves or their legal representatives voluntarily sign the informed consent.

Exclusion Criteria:

* 1. Patients with autoimmune diseases in the past or screening;
* 2. Those who have serious basic diseases that affect their survival, including: malignant tumor, hematopathy, malignant fluid, active hemorrhage, severe malnutrition, etc. which have not been controlled and can not be removed due to multiple metastasis;
* 3. Known or self-reported HIV or syphilis infected persons;
* 4. Have participated in stem cell clinical research;
* 5. Pregnant or lactating women or those who have fertility plans in the past year;
* 6. The estimated life cycle is less than 48 hours;
* 7. Those who participated in other clinical trials within 3 months before screening;
* 8. Other conditions that the researcher thinks are not suitable for participating in the experiment.
Intravenous N-acetylcysteine and Oseltamivir Versus Oseltamivir in Adults Hospitalized With Influenza and Pneumonia

Seasonal influenza epidemics are important causes of morbidity and mortality. Cytokine dysregulation, with high levels of pro-inflammatory cytokines, occurs in patients with severe influenza. Early therapy with a neuraminidase inhibitor (NAI) is associated with better outcome in patients hospitalized with influenza, but significant mortality occurs despite use of antivirals. N-acetylcysteine (NAC) is a modified form of the amino acid cysteine, with anti-oxidant properties. NAC was shown to inhibit the production of pro-inflammatory molecules in lung epithelial cells infected with influenza viruses. Previous case report showed that high dose NAC, administered as continuous intravenous infusion, was effective and safe in improving the clinical outcomes. We aim to perform a randomized controlled trial to evaluate the therapeutic role of adjunctive NAC in the clinical management of patients with influenza complicated by lower respiratory tract involvement and abnormal respiratory status. Such information when available may reveal the potential of NAC for optimization of management of severe influenza, and provide important insights into future adjunctive therapy research.


Eligibility Criteria:
Inclusion Criteria:

* influenza A and B virus infections confirmed by polymerase chain reaction (PCR) and/or immunofluorescence assays,
* hospitalized for the management of severe manifestations of influenza,
* initiation of oseltamivir,
* clinical evidence of lower respiratory tract infection (e.g. shortness of breath, tachypnea, oxygen desaturation \<93% on room air, crepitations on auscultation, infiltrations or consolidations on chest radiograph)
* written informed consent (by the subjects, or from their next of kin if the subjects are unable to provide written consent at the time of enrollment)

Exclusion Criteria:

* use of immunosuppressants (e.g. post-chemotherapy, post-transplant, autoimmune diseases) other than systemic corticosteroids
* known immuno-compromised conditions (e.g. active haematological malignancies, HIV/AIDS patients who are on antiretroviral therapy and CD4 cell count \< 200),
* pregnancy
* lactation,
* end-stage renal failure
* hepatic failure
* cardiac failure
* patients on anticoagulation (except prophylactic dose of low molecular weight heparin),
* patients with scheduled major surgery within 2 weeks (NAC may affect blood clotting),
* patients who have received macrolide antibiotics and NSAID for 1 week prior to enrolment due to their immuno-modulating effects.
* Use of investigational anti-influenza antivirals and blood products
The Applicability of Different Scoring Systems and Use of Steroids in the Treatment of Hospital Acquired Pneumonia

Cross sectional randomized clinical trial study will be done at Respiratory intensive care unit and Chest department at Assiut University Hospitals on All patients who developed hospital acquired pneumonia including ventilator associated pneumonia through two years duration to assess the prognostic value of different severity scores including (PSI, CURB65, SMART COP, IDSA/ATS and SOAR) in patients with HAP, assess platelet count as a marker for severity, evaluate efficacy and safety of adjuvant systemic steroids in patients with severe conditions and measurement of cortisol level to assess steroid response before administration.

The following parameters will be recorded:

* Demographic data: including age, sex, smoking history.
* Clinical data: Glasgow coma scales, Co-morbidities are determined by reviewing the patients' clinical histories, chest examination.
* Vital signs: including body temperature, respiratory rate, heart rate, and arterial blood pressure.
* Oxygenation data: including arterial blood gases in fixed days (at the start, 3rd day and 7th day of steroid administration), ratio of partial oxygen tension in arterial blood to fraction of inspired oxygen (PaO2/FiO2 ratio).
* Laboratory data include complete blood picture focusing on leukocytic count and platelets, kidney and liver function tests, serum electrolytes, Erythrocyte sedimentation rate, C reactive protein, sputum culture and cortisol level before steroid administration.
* Radiology data include chest X-ray and chest ultrasonography at the day of diagnosis and at 7th day of steroid administration. Chest CT will be done if possible.

Procedures: Systemic steroids will be administered early with a dosages equivalent to prednisone 40 mg/day for 7 days which is considered as a "stress dose" of systemic corticosteroids for pneumonia. The patients will also receive the appropriate initial intravenous antibiotic medication and the standard care as recommended in RICU policy. Cortisol level will be measured before steroid administration.

Eligibility Criteria:
Inclusion Criteria:

This study will be conducted on admitted patients aged ≥18 years that developed hospital acquired pneumonia including ventilator associated pneumonia. Its diagnosis is confirmed by developing pneumonia after 48 H of admission and they had new or progressive infiltrates on the chest X-ray with one of the 3 requirements of: fever more than 37.8 C or purulent sputum or leukocytosis.

Exclusion Criteria:

1. Patients having lung cancer and those who hadn't the full data for scoring fulfilled.
2. Chronically immunosuppressed patients (chemotherapy, human immunodeficiency virus infection, or other immunosuppressive agents).
3. Condition requiring prolonged steroid use \> 0.5 mg/kg/day of prednisone equivalent.
4. Major gastrointestinal bleeding within 3 months.
5. Patients with prolonged intubation and having tracheostomy.
6. Patients with neurological disorders or encephalopathy.
7. Patients with pandemic H1N1 influenza A pneumonia.
Plexus Anesthesia in Lateral, Head-Down Position for Elective Surgery of the Shoulder

The purpose of this study is to determine whether the axillary plexus block performed in lateral, head down position is effective in the perioperative analgesia in patients scheduled for elective surgery of the shoulder.


Eligibility Criteria:
Inclusion Criteria:

* patients scheduled for elective surgery of the shoulder

Exclusion Criteria:

* lateral, head down position not possible
Arginine Malaria Trial: Study of Adjunctive Arginine in Falciparum Malaria

Acute falciparum malaria is associated with low plasma arginine and impaired nitric oxide (NO) production. Both are associated with poor outcome. This study will examine the safety and effect of escalating doses of arginine in falciparum malaria. It will determine whether arginine can increase NO production and have an effect on NO-dependent physiological measurements. The hypothesis is that arginine: will be safe in falciparum malaria; will return plasma arginine concentration to normal/supranormal levels; will increase systemic and exhaled NO; reduces oxidant stress; and improves a number of NO-dependent physiological measures of relevance to malaria.


Eligibility Criteria:
Inclusion Criteria:

1. Ages 18-60 years
2. P. falciparum parasitemia (1,000-100,000 parasites/ul).
3. Clinical syndrome consistent with malaria associated with documented fever (axillary temperature \> 38℃) or self-reported history of fever in the last 48 hours with no other cause present
4. Commenced oral quinine ≤ 18 hours prior to scheduled commencement of arginine
5. An indication for hospital admission (eg relative cannot look after/supervise treatment at home but not having any warning signs or severe malaria criteria in "exclusion criteria" below)
6. Informed consent obtained

Exclusion Criteria:

1. Pregnancy or lactation
2. Mixed infection with P. falciparum and P. vivax
3. Warning signs of altered mental state and inability to sit unaided
4. Features of severe/complicated malaria
5. Diabetes
6. Systolic blood pressure (BP) \< 100 mmHg
7. Serious underlying disease (cardiac, hepatic, kidney)
8. Initial iSTAT test showing any of the following values:

   * glucose \< 4 mmol/L;
   * K+ ≥ 4.2 meq/L;
   * Cl- \> 106 meq/L;
   * HCO3- \< 20 meq/L.
9. Known allergy to L-arginine
10. Concurrent therapy with any of the following medications:

    * spironolactone;
    * oral nitrates;
    * phosphodiesterase inhibitor (eg sildenafil \[Viagra\]);
    * alpha-blocking antihypertensive agents (eg prazosin);
    * L-arginine.
Biological Therapy in Treating Patients With Myelodysplastic Syndrome

RATIONALE: Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. Combining different types of biological therapies may kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of biological therapy in treating patients who have myelodysplastic syndrome.

OBJECTIVES:

* Determine the frequency of hematologic responses in patients with myelodysplastic syndrome treated with anti-thymocyte globulin and tumor necrosis factor receptor IgG chimera.
* Correlate phenotypic, cytogenetic, and functional disease characteristics with treatment responses in these patients.
* Determine the safety of this treatment regimen in this patient population.

OUTLINE: Patients receive anti-thymocyte globulin IV over 8 hours daily for 4 days followed by tumor necrosis factor receptor IgG chimera subcutaneously twice weekly for 16 weeks.

Patients are followed at 8, 16, and 20 weeks.

PROJECTED ACCRUAL: A total of 15 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of myelodysplastic syndrome with no greater than 20% marrow blasts with:

  * Single or multilineage cytopenia (neutrophils less than 2,000/mm\^3 and/or platelet count less than 100,000/mm\^3 and/or reticulocyte count less than 18,000/mm\^3) OR
  * Transfusion requirement of at least 2 units packed red blood cells per month and one of the following:

    * Suitable marrow donor unavailable
    * Ineligible for a transplantation protocol
    * Unwilling to proceed with transplantation
* No chronic myelomonocytic leukemia

PATIENT CHARACTERISTICS:

Age:

* Any age

Performance status:

* Not specified

Life expectancy:

* Not specified

Hematopoietic:

* See Disease Characteristics

Hepatic:

* Not specified

Renal:

* Not specified

Other:

* No other severe disease that would preclude study
* No active severe infection (e.g., pneumonia or septicemia) or severe infections within the past 2 weeks

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* See Disease Characteristics
* At least 4 weeks since prior hematopoietic growth factors
* No concurrent hematopoietic growth factors

Chemotherapy:

* At least 4 weeks since prior cytotoxic therapy
* No concurrent cytotoxic therapy

Endocrine therapy:

* Not specified

Radiation therapy:

* Not specified

Surgery:

* Not specified

Other:

* At least 4 weeks since prior immunomodulatory therapy
* No concurrent immunomodulatory therapy
Measuring Health Related Quality of Life in Veterans With Stroke

Approximately 11,000 veterans annually are hospitalized with a newly acquired incident stroke. Based on American Heart Association ratios of stroke incidence and prevalence, up to 80,000 veterans may be stroke survivors. The assessment of outcomes in stroke survivors is important for clinical practice and research, yet there is no consensus on the best measures of stroke outcome in either clinical practice or research. We have developed a new stroke-specific outcome measure, the Stroke Impact Scale (SIS), to capture physical function and other dimensions of health-related quality of life.

Background:

Approximately 11,000 veterans annually are hospitalized with a newly acquired incident stroke. Based on American Heart Association ratios of stroke incidence and prevalence, up to 80,000 veterans may be stroke survivors. The assessment of outcomes in stroke survivors is important for clinical practice and research, yet there is no consensus on the best measures of stroke outcome in either clinical practice or research. We have developed a new stroke-specific outcome measure, the Stroke Impact Scale (SIS), to capture physical function and other dimensions of health-related quality of life.

Objectives:

The major research questions in this investigation are: 1) Does the SIS have concurrent and discriminate validity in a veteran stroke population when compared to the FIM, Rankin, and the SF-36V? 2) What effect does mode of administration have on response rates, bias, data quality, reliability and validity, SIS domain scores, and cost of data collection? 3) What factors differentiate responders and non-responders? 4) Will the SIS scores predict health care costs and utilization?

Methods:

Using ICD-9 discharge codes and electronic medical records, patients were screened for a valid diagnosis of stroke. At three months post-stroke, patients were randomly assigned to receive a mailed SIS instrument or SIS via telephone interview. At four months post-stroke, all respondents were evaluated using the Functional Independence Measure and SF-36V by telephone.

Status:

Completed.

Eligibility Criteria:
Inclusion Criteria:

No exclusion criteria.

Exclusion Criteria:

No exclusion criteria.
Impact of Integrated HIV/NCD Screening on HIV Testing Uptake and Engagement in HIV Care in Kisarawe, Tanzania

This study focuses on the integration of HIV and NCD screening and care. The investigators will conduct a randomized controlled trial examining the efficacy and cost-effectiveness of the intervention strategy in Kisarawe District, Tanzania, a rural area 40 KM southwest of Dar es Salaam. The study will match two similar HIV care and treatment centers (CTC) in the District, one of which will be randomized to receive the enhanced intervention which will integrate diabetes (DM) and hypertension (HTN) screening with the existing HIV testing program, and integrate care for DM and HTN into the HIV care program. Comparisons of the community HIV testing rates in the two communities, engagement in HIV care among those testing positive, and 24-month retention in HIV care will be assessed among a cohort of 107 newly enrolled patients per community.

Specifically, the aims are to determine:

1. Whether integrating DM and HTN screening with HIV testing will increase the uptake of community-level HIV testing.
2. If integrating DM/HTN care with HIV care enhances engagement in HIV care.
3. Whether integration of DM/HTN care with HIV care enhances retention in HIV care for those newly enrolled in HIV care.
4. The cost-effectiveness of integrating NCD screening and care with HIV screening and care with regard to the incremental cost per HIV infected client engaged in HIV care, and cost per newly enrolled HIV client retained in HIV care over 24-months.


Eligibility Criteria:
Eligibility Criteria for Screening:

• Be aged 18 years or above.

Inclusion Criteria for Intervention and Control Cohorts:

* Be aged 18 years or above.
* Recently enrolled in HIV care and treatment

Exclusion Criteria:

* Potentially vulnerable populations (incarcerated, under age of consent, unable to understand the procedures planned, etc.).
* Individuals under the influence of drugs or alcohol and anyone presenting with mental disability that would preclude ability to understand study procedure, risks, and benefits.
* Inability or unwillingness of subject to provide informed consent.