cyrilzakka/clinical-trials huggingface dataset:
Development of Ursodeoxycholic Acid 300 mg at Hospital Das Clinicas of the University of São Paulo School of Medicine

A manipulation and an integral part of the pharmaceutical practice, where, in addition to the supply of medicines and personalized products, they represent an alternative to the therapeutic schemes, manipulating drugs of almost all of them as therapeutic categories.

One of the products and ursodeoxycholic acid, commercially known as Ursacol, a bile acid physiologically present in human bile, approved by Agência Nacional de Vigilância Sanitária (ANVISA), among several indications, for the treatment of the symptomatic form of primary biliary cholangitis, autoimmune etiology and predominant incidence in female.

This is a prospective, cross-over, interventional and open-label study, where patients attending the inclusion and exclusion criteria are attended by the Instituto Central do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (ICHC-FMUSP) Pharmacy Division in the Pharmaceutical Care sector.

As patient information as well as the prescribed drugs, compiled by a data collection instrument from the ICHC-FMUSP Pharmacy Division and a semi-structured questionnaire.

The therapeutic efficacy of Ursodeoxycholic Acid 300 mg tablet and capsules was measured comparing the liver enzyme parameters: alkaline phosphatase, gamma glutamyl transferase, alanine aminotransferase, aspartate aminotransferase and total bilirubin in three times: before treatment begins, in the middle of treatment and at the end of treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patients with Primary biliary cholangitis (PBC) was diagnosed when at least two of the following three criteria: histologically proven early stage PBC; positive Anti-mitochondrial antibody (AMA) (titer \>1:40) and alkaline phosphatase \>1.5 times upper limit of normal at any time since diagnosis.
* Patients had to be on ursodeoxycholic acid for at least 6 months.
* Patients should be able to understand and ready to sign the informed consent form.

Exclusion Criteria:

* Patients not adherent to treatment with reference medicine.
* Known intolerance to the study drugs.
* Patients who withdrew their agreement.
Comparison of Pulmonary Function, Exercise Capacity, and Physical Activity Level Between Children with Hemophilia and Healthy Controls

Hemophilia is a rare X-linked congenital bleeding disorder characterized by deficiency of clotting factor VIII (hemophilia A) or deficiency of factor IX (hemophilia B) with complex diagnosis and management. Participation in physical activity is still limited in children with hemophilia, probably due to protective attitudes of families/patients and avoidance of activity, and possibly also as a result of chronic pain. Exercise capacity has been identified as a protective factor against joint problems in hemophilia. Aerobic fitness is associated with better pulmonary function in children. Chronic pain and decreased range of motion due to recurrent bleeding in joints and muscles in hemophilia may indirectly affect posture and respiratory mechanics, leading to impaired pulmonary function. This study aims to compare pulmonary function, exercise capacity, posture, and physical activity level between children with hemophilia and healthy controls and to investigate the relationship between these parameters.


Eligibility Criteria:
Hemophilia group

Inclusion criteria:

* Having been diagnosed with hemophilia and being clinically stable,
* Being between the ages of 8-18,
* Being on prophylaxis treatment (a routine treatment),
* Being 125 cm or taller,
* Being inhibitor negative at the time of enrollment,
* To be able to cooperate with the tests to be performed,
* Being willing to participate in the study.

Exclusion criteria:

* Being inhibitor positive at the time of enrollment,
* Having a history of acute joint bleeding,
* Being unable to bear weight on the extremities,
* Having a history of acute intramuscular bleeding,
* Having undergone radionuclide synovectomy,
* Having a history of surgery on any of the lower extremity joints,
* Having a severe cardiovascular, orthopedic or neurological problem that may affect the assessments.

Control group

Inclusion criteria:

* Not having any known internal or chronic disease
* Being male between the ages of 8-18
* Having full range of motion in the upper extremity
* Having full range of motion in the lower extremity
* Not having any history of injury or surgery in the lower extremity
* Being 125 cm or taller
* Being willing to participate in the study

Exclusion criteria:

* Having any problem that may affect the tests
* Not having full range of motion in the upper extremity
* Having a history of injury or surgery in any of the lower extremity joints
* Having a neurological deficit
* Having pain or movement limitation in the lower extremity
UARK 2006-28 Human Cord Blood Transplantation in Advanced Hematological Malignancies

The researchers want to find out if subjects treated on this study will achieve long term bone marrow recovery (engraftment) and if their tumors will respond to this treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patients with advanced hematological malignancies who have failed at least two lines of therapy.
* Karnofsky performance score \> 60, unless due to disease and then \> 50.
* Age \> 18 years.
* An expected survival of \> 3 months.
* Subjects must have signed an IRB-approved consent and been informed about the investigational nature of the study.
* Cord blood must have negative serology for HIV.
* Release of cord blood.
* The nucleated cell count of the CBU shall equal or exceed 1 x 107 per kg of recipient body weight.

Exclusion Criteria:

* Liver function: total bilirubin \> 2x ULN or AST/ALT \> 3x ULN.
* Creatinine \> 3.0 mg/dL.
Hydroxyurea Treatment for Adult Sickle Cell Anemia Patients in Kinshasa

The goal of this clinical trial is to evaluate the efficacy of hydroxyurea (HU) in improving disease severity in adult patients with sickle cell anemia in Kinshasa (Democratic Republic of Congo). This study aims to:

* assess the safety and efficacy of HU treatment in the Congolese environment;
* assess the reversibility of chronic cardiac lesions. Participants will take hydroxyurea for two years. The effects of the treatment will be evaluated periodically by clinical evaluation, biological tests, and echocardiographic exploration.

Sickle cell disease is common in sub-Saharan Africa, particularly in the Democratic Republic of the Congo (DRC). It is characterized by chronic hemolytic anemia with the need for transfusions, painful osteoarticular crises, and chronic organ damage, including the heart.

Hydroxyurea (HU) is a drug widely used in sickle cell patients in wealthy countries, while it is little used in poor countries with a high incidence of the disease.

This prospective study will focus on homozygous sickle cell participants, naïve to HU treatment. Participants will take HU in gradually increasing doses. They will be monitored for the possible occurrence of side effects. The effectiveness of the treatment will be evaluated according to the reduction in painful crises, and the need for blood transfusion; as well as based on biological changes and the reversibility or stabilization of cardiovascular complications.

Eligibility Criteria:
Inclusion Criteria:

* sickle cell anemia confirmed by DNA testing;
* moderate to severe clinical severity of sickle cell anemia;
* fetal hemoglobin lower than 15%.

Exclusion Criteria:

* poor compliance to follow-up consultation during the observational year
* participant already treated with HU
* pregnant women
* breastfeeding women
* congenital heart disease
* pulmonary disease
Effect of L-PRF and A-PRF in Ridge Preservation

A split-mouth design study will be performed regarding the use of platelet concentrates on ridge preservation: L-PRF vs A-PRF vs control. Patient needing multiple teeth extractions in the upper jaw (single-rooted teeth) will be recruited. The use of each platelet concentrate or control will be randomized by means of a computer program. The results will be analysed clinical and radiographically (CBCT). When the subject will choose for implant rehabilitation, a biopsy will be taken in the site of the preserved sockets. The region will be localized with a customized stent, fabricated with the position of the extracted teeth. VAS scales will be provided to evaluate the post-operative discomfort.


Eligibility Criteria:
Inclusion Criteria:

* 3 single-rooted teeth needed to be extracted in the upper jaw
* patient in good general health as documented by self-assessment
* patients must be committed to the study and must be willing to sing the informed consent.

Exclusion Criteria:

* any systemic medical condition that could interfere with the surgical procedure or planned treatment.
* current pregnancy or breast feeding
* radiotherapy or chemotherapy in head and neck area
* intravenous and oral bisphosphonate
* patients smoking \>20 cig/day
* unwillingness to return for the follow-up examination
Depakote ER Therapy for Mania Comorbid With Substance Abuse

The purpose of this study is to ascertain whether Depakote ER (Divalproex ER) has efficacy in the treatment of patients with bipolar disorder in the manic phase, who also have comorbid substance abuse diagnoses. It is proposed that Depakote ER will decrease scores on the Young Mania Rating Scale and the Substance Abuse Time Line Follow Back.

This study will be performed in male and female subjects with a diagnosis of bipolar disorder in the manic phase of the illness who also have a comorbid diagnosis of substance abuse. This population is selected so the efficacy of Depakote ER in this population can be tested.

Eligibility Criteria:
Inclusion Criteria:

1. Ages 19 - 65.
2. Diagnosis of mania with comorbid substance confirmed by Structured Clinical Interview for DSM-IV.
3. Comorbid diagnoses of anxiety and/or personality disorders are permitted.
4. Ability to provide signed informed consent.
5. Stable general medical health.
6. Ability to attend outpatient research clinic.

Exclusion Criteria:

1. Dangerous to self or others.
2. Pregnancy, inability or unwillingness to use approved methods of birth control.
3. Inability or unwillingness to provide signed informed consent.
4. Diagnosis of schizophrenia, major depressive disorder.
5. Inability to attend outpatient research clinic.
6. Medical conditions, which would preclude use of Depakote.
7. Need for ongoing treatment with medication other than Depakote ER, such as antipsychotic medication.
8. Medical instability defined as likelihood of needing to change prescription medication during the course of the study.
Efficacy and Safety of Aclidinium Bromide at Two Dose Levels Versus Placebo Administered in Chronic Obstructive Pulmonary Disease (COPD) Patients

The main purpose of this study is to assess the long term bronchodilator efficacy, safety and tolerability of inhaled aclidinium bromide at two dose levels compared to placebo in COPD patients and the benefits of the product in disease-related health status, COPD symptoms and COPD exacerbations.


Eligibility Criteria:
Inclusion Criteria:

* Adult male and female patients aged ≥40 with stable moderate to severe COPD (GOLD guidelines).
* Post-salbutamol (FEV1) \< 80% and ≥30% of predicted normal value and Post-salbutamol FEV1/FVC \< 70%.
* Current or ex-smokers of ≥10 pack-years.

Exclusion Criteria:

* Patients with no history or current diagnosis of asthma.
* No evidence of an exacerbation within 6 weeks prior to the screening visit.
* No evidence of clinically significant respiratory and/or cardiovascular conditions or laboratory abnormalities.
* No contraindication to use of anticholinergic drugs such as known symptomatic prostatic hypertrophy, bladder neck obstruction or narrow-angle glaucoma.
GLIM-defined Malnutrition Criteria for Postoperative Outcomes in Patients With Esophagogastric Cancer

The present study aims to investigate the prognostic value of preoperative fat-free mass index for postoperative outcomes in patients undergoing esophagogastric cancer surgery, and to explore the role of the FFMI in the Global Leadership Initiative on Malnutrition (GLIM) criteria.

The GLIM criteria of malnutrition as a consensus lack of optimal combination in clinical validation. After the publication of the GLIM consensus, few studies have examined the effect of reduced FFMI on the clinical prognosis of patients with esophagogastric cancer, and whether the FFMI can be used as an effective diagnostic criterion of malnutrition in esophagogastric cancer needs to be further studied.

Therefore, the present study aims were to investigate the prognostic value of preoperative fat-free mass index for postoperative outcomes in patients undergoing esophagogastric cancer surgery, and to explore the role of the FFMI in the GLIM consensus for malnutrition.

Eligibility Criteria:
Inclusion Criteria:

Elective surgery for esophagogastric cancer (there was a clear pathological diagnosis before surgery); NRS2002≥3; Preoperative BIA examination was performed.

Exclusion Criteria:

Discharged from a hospital within 24 hours; No BIA examination and not suitable for BIA examination (such as ascites, edema, amputation and pace-maker); Hepatic insufficiency (alanine transaminase/aspartate transaminase ratio 200% above normal range or bilirubin\>3mg/dL) ; Renal insufficiency (serum creatinine\>1.5mg/dL); Emergency operation; Pregnancy; Missing the postoperative information follow-up data.
Conquering Hypertension in Urban Vietnam

The HTN-URBAN project aims to improve hypertension (HTN) control for adults in a large northern Vietnamese city via a cluster-randomized trial design.

A Cluster-randomized, Type II Hybrid effectiveness implementation Trial will take place in 14 urban communities in 7 urban districts in Hai Phong city in northern Vietnam.

Community Eligibility Criteria: (1) located in urban Hai Phong city; (2) distance between 2 communities will be at least 10 Km; (3) no other research studies/ health programs currently being implemented; and (4) key community and clinical leaders are willing to participate in the study.

Recruitment

Residents from participating sites will be invited to attend the community screening events run by local community health center (CHC) staff and Community Health Workers (CHWs). Those meeting our pre-defined eligibility criteria will be invited to their CHCs to learn more about the study. Patients with elevated blood pressure (BP) will be invited for re-measurement over the next two weeks (at least 1 week apart). After the second BP measurement, patients with elevated BP will be invited to participate in the study.

Randomization

Fourteen communities in urban Hai Phong (700 patients with uncontrolled hypertension - HTN) will be randomly assigned either to an intervention (7 communities- 50 patients per community) or comparison group (7 communities- 50 patients per community) by a computer procedure. Patients with uncontrolled HTN will be assigned to intervention versus comparison status based on the communities in which they reside.

Intervention group: The intervention group will receive 3 components including digital Storytelling delivered via Computerized Intervention Authoring System (CIAS), home blood pressure self-monitoring and expanded CHW services (frequent contacts, visits and consultations).

Comparison group: Patients in the comparison group will receive only "Learn More" module - didactic material without HTN related stories via CIAS.

Patients in both groups will be followed up at 3, 6 and 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Aged ≥18 years old;
* Presence of uncontrolled HTN (systolic BP ≥ 140 mmHg or diastolic BP ≥ 90 mmHg) according to JNC-8;
* Willing to provide informed consent.

Exclusion Criteria:

* Participation in another study on hypertension;
* Pregnant;
* Advanced cognitive impairment;
* Previous exposure to storytelling modules;
* Participant family member;
* Participant in intervention development.
The Effects Of Progressive Muscle Relaxation Training in Women With Fibromyalgia

The purpose of the study is to examine the effects of progressive muscle relaxation training given in addition to a combined exercise program in women with fibromyalgia.

Fibromyalgia syndrome is a complex, non-inflammatory pain syndrome characterized by whole-body pain, pain at specific tender points, fatigue, and sleep disturbance

The prevalence of fibromyalgia in the world population varies between 0.2% and 6.4%, and it more frequently affects middle-aged women (30-50 years old). the etiology of fibromyalgia is not fully known.

There are no generally accepted objective clinical findings, radiographic abnormalities, or laboratory tests to assess the presence of fibromyalgia and measure fibromyalgia severity. Therefore, questionnaires measuring patients' subjective responses remain important in the evaluation of fibromyalgia patients until now.

Current treatment recommendations for fibromyalgia strongly support a multifaceted regimen, including patient education, physical therapy, massage, cognitive behavioral therapy, specific pharmacotherapy, restorative sleep, and exercise. Exercise includes aerobic exercise, strengthening and stretching.

Progressive muscle relaxation therapy is an alternative complementary therapy based on the principle of progressive tensing and relaxing of major body muscles to relieve psychological tension. The therapy has no time or space restrictions and does not require any special equipment.

Eligibility Criteria:
Inclusion Criteria:

* Women diagnosed with fibromyalgia over the age of 20
* volunteering to participate in the study.

Exclusion Criteria:

* neurological, infectious, endocrine and/or other inflammatory rheumatic diseases
* serious psychiatric illness (schizophrenia, etc.)
* any condition that prevents exercise (advanced heart, respiratory or orthopedic problems)
* Malignancy
* pregnancy
* menopause
* Participating in a physical therapy program (receiving exercise / relaxation training) in the last 6 months
A Trial of Infant Flow Biphasic Nasal Continuous Airway Pressure (NCPAP) Versus Infant Flow NCPAP for the Facilitation of Extubation in Infants </= 1250 Grams

The purpose of this study is to compare two methods of delivering Nasal Continuous Airway Pressure (NCPAP): Biphasic Mode and a continuous mode, to see which is better in getting babies off the ventilator and decreasing lung damage.

Chronic lung disease (CLD) remains a significant problem among low birth weight infants with a reported incidence of up to 26% in infants \< 1500 grams. Nasal continuous positive airway pressure (NCPAP) has been demonstrated to provide effective non-invasive respiratory support for preterm infants. The use of NCPAP is associated with a decreased need for mechanical ventilation and may impact on the incidence of CLD. There are two types of NCPAP now available, a Biphasic mode which allows for cycling at two different levels of positive pressure and a continuous mode which allows only for one level of positive pressure.

Comparisons: Biphasic NCPAP will be compared with continuous CPAP to see which better facilitates the extubation of preterm infants who weigh \</= 1250 grams at birth. The incidence of CLD, retinopathy of prematurity, sepsis, intraventricular haemorrhage, periventricular leucomalacia and necrotizing entercolitis will also be compared between the two groups.

Eligibility Criteria:
Inclusion Criteria:

* Infants \</= 1250 grams who are going to be extubated

Exclusion Criteria:

* Congenital abnormalities of the upper airway
* Acquired nasal septum injury
* Congenital Heart Disease excluding Patent Ductus arteriosus
Usefulness of Neutrophil Gelatinase-associated Lipocalin(NGAL) to Confirm Acute Kidney Function Decrease of the Patients Who Had Non-cardiac Surgery

Although post-op renal function decrease is determined by serum creatinine, serum creatinine has disadvantages that it increases a long time after renal function decrease and it has various increasing time based on the level of renal function. Neutrophil Gelatinase-associated Lipocalin (NGAL's) usefulness as an evidence for acute kidney damage occurring from post-op cardiac surgery, being critical patients and contrast medium use is already proven.

But NGAL's usefulness for renal function after non-cardiac surgery is not proven and especially, NGAL's usefulness for renal injury after non-cardiac surgery in chronic renal disease patients is not proven.Therefore, the investigators will study about renal function decrease after non-cardiac surgery with NGAL and serum creatinine.


Eligibility Criteria:
Inclusion Criteria:

* 43 patients who had non-cardiac surgery in Seoul Paik Hospital.

Exclusion Criteria:

* have viral hepatitis and Aspartate aminotransferase, Alanine aminotransferase \> 2 time of normal level
* severe lung disease
* severe heart failure ( Ejection Fraction \< 40% )
* pregnancy
Neurobiomarker for Prism Adaptation Treatment Response

Preliminary data will be collected about which individuals with spatial neglect from right hemisphere stroke (aiming vs perceptual neglect) improve with Prism Adaptation Training and if there is a particular pattern of damage in the brain that predicts both the type of neglect experienced and whether neglect is improved following Prism Adaptation Training

For preliminary data, twelve individuals with right hemisphere stroke and spatial neglect will participate. After pretesting for type of neglect and its severity, they will have an MRI with Diffusion Tensor Imaging (DTI). Then they will complete 10 sessions of Prism Adaptation Therapy and complete neglect post-testing. Response to Prism Adaptation Therapy will be assessed by comparing neglect scores pre- and post-training. Traditional lesion mapping, structural and functional lesion disconnectivity analyses, and tract-based spatial statistics of DTI measures will be used to examine whether any patterns of damage/dysfunction are related to a diagnosis of aiming neglect and response to Prism Adaptation Therapy.

Eligibility Criteria:
Inclusion Criteria:

* 1) within 1 month of right hemisphere stroke

  2) suspected of having unilateral spatial neglect

  3) able to provide consent

  4) likely to remain in rehabilitation for 10-12 days or willing to return to the University to complete 10 sessions of treatment and post-treatment testing

  5) able to have an MRI

  6) will be or has been admitted to the Craig H. Neilson Rehabilitation Hospital for rehabilitation or is able to come to the Craig H. Neilson Rehabilitation Hospital for prism adaptation therapy sessions.

  7) age 18-90 years

  8) able to sit in a wheelchair or other chair for 1 hour

  9) able to point straight ahead and hold a pen with right hand

Exclusion Criteria:

* 1) other neurologic, medical that would interfere with ability to complete the testing or training

  2) no uncorrected visual or hearing problems, other than hemianopsia

  3) contraindications to MRI

  4) unable to provide consent due to significant aphasia or cognitive impairment