cyrilzakka/clinical-trials huggingface dataset:
Prognosis of Failure Treatment of Amebic Liver Abscess

Amebic liver abscess is the most frequent extra-intestinal form of the amoebiasis; actually the factors for predicting failure in the medical treatment are not clear. We conducted trial for determining the clinical value of paraclinical factor in this issue.


Eligibility Criteria:
Inclusion Criteria:

1. Clinical, ultrasonographic and serologic diagnosis (ELISA) of amebic liver abscess.
2. Both genders
3. Older 15 years

Exclusion Criteria:

1. Clinically suspected piogenous liver abscess
2. Positive hemoculture
3. Negative ELISA for amoebic antigens
4. Immunosupresion (HIV)
5. Abdominal or biliary surgery antecedents
6. Abdominal neoplasia antecedents
Prospective, Assessment of Vitamin D and Calcium Supplementation, Improvement of Nutritional Status and Preoperative Rehabilitation in Patients Before Knee Arthroplasty.

Prospective randomized study of 150 patients qualified for knee arthroplasty between 2015 and 2017. Patients were randomized into 3 groups receiving vitamin D and calcium supplementation, increased protein supply and preoperative rehabilitation, respectively.

Following factors were analyzed: changes in vitamin D3, calcium, total protein, albumin and CRP levels during preparation for surgery, nutritional status on the Subjective Global Assessment (SGA) scale, osteoporosis risk assessment according to the Osteoporosis Risk SCORE, level of pain felt on the scale VAS and the number of analgesics used, the result of the Duke Activity Status Index, the result of the following scales: Cardiac Risk Index for Orthopedic Surgery (Lee), Knee injury and Osteoarthritis Outcome Score (KOOS), Fear Avoidance Beliefs Questionnaire (FABQ) about Physical Activity, The Quality of Life Scale (QOLS). Additionally, the occurrence of perioperative complications was analyzed (e.g. venous thrombosis and pulmonary embolism, wound or joint infection, excessive bleeding, loosening of the implant, bone fracture or fracture, pain).


Eligibility Criteria:
Inclusion Criteria:

* with a disease lasting more than 5 years and without total limitation of physical fitness,
* reporting pain\> 5 on the VAS scale (Visual Analogue Scale)
* general fitness according to the ASA (Amercican Society of Anestesiology) scale up to 3

Exclusion Criteria:

* patients with metabolic and systemic disorders with contraindications for calcium substitution, vitamin D3 and protein supply,
* intolerance of physical effort\> 2, 5 MET (Metabolic Equivalent of Task)
* limitation of the degree overall efficiency\> 3 in the ASA classification
Lifestyle Modifications and the Progression of Chronic Kidney Disease

Aerobic training has been shown to favorably alter several of the known risk factors for coronary artery disease including hypertension, dyslipidemia, obesity, and diabetes (1). It seems logical that if these risk factors were aggressively controlled in patients with chronic kidney disease (CKD) by implementing lifestyle changes (e.g., diet and exercise training) to support the pharmacologic interventions that are necessary for the control of the disease, then the rate of progression of the disease may be altered. However, to date, there is no clear research evidence to support this hypothesis. Therefore the aims of the proposed study are:

1. To test the hypothesis that lifestyle interventions (i.e., dietary modification and regular, long-term aerobic exercise training) will favorably alter the natural progression of CKD in a sample of patients compared to a control group who will receive the current standard care.
2. To explore possible mechanisms that could contribute to the observed changes.


Eligibility Criteria:
Inclusion Criteria:

* Stages 2-4 CKD

Exclusion Criteria:

* CAD
* MI
Diabetes Prevention Program for Obese Latino Youth

The purpose of this study is to examine the effects of 12 week lifestyle intervention on diabetes risk in obese Latino adolescents.

Obesity in the United States has reached epidemic proportions and Latinos youth are disproportionally impacted. Pediatric obesity is associated with several chronic health conditions including insulin resistance and type 2 diabetes. However, very few interventions specifically targeting diabetes prevention for obese Latino adolescents have been developed.

Therefore, the purpose of this study is to examine the effects a culturally-grounded, community-based lifestyle intervention on psychosocial and health outcomes among obese Latino adolescents. Eligible participants of this study will be randomly selected to the intervention group or the delayed-intervention group (control group) after an initial health screening for eligibility.

Participants selected to the intervention group will attend weekly healthy lifestyle education sessions with their parent(s)/guardian(s) and three physical activity sessions / week with other youth. After which, participants will attend monthly booster group meetings for three months.

All participants will be assessed at baseline, 3 months, 6 months, and 12 months for insulin sensitivity, glucose tolerance, quality of life, fitness, and nutrition and physical activity behaviors.

Eligibility Criteria:
Inclusion Criteria:

* Latino: self-report by parents
* Age: 14-16
* Obese: BMI percentile \>= 95th percentile for age and gender or BMI \>= 30 kg/m\^2

Exclusion Criteria:

* Taking medication(s) or diagnosed with a condition that could influence carbohydrate metabolism, physical activity, and/or cognition
* Type 2 diabetes: Fasting plasma glucose \>= 126 mg/dL or 2-hour plasma glucose \>= 200 mg/dL (youth found to be diabetic through study's procedures will be referred for follow up care and excluded)
* Recent hospitalizations (previous 2 months)
* Currently enrolled in (or with in previous 6 months) a formal weight loss program
* Diagnosed depression or other condition that may impact QoL
A Multilevel Intervention in the Hunger Relief Network to Improve Diet Among Adults Experiencing Food Insecurity

The investigator proposes an evaluation of a randomized, sustainable intervention in 8 intervention and 8 control pantries. We will enroll a sample clients at the food pantry at baseline and follow them for 1 year to assess changes in overall diet quality (the primary outcome) and cardiovascular health. We will also enroll a sample of clients at follow-up to assess to assess the nutritional quality of food selected at the pantry.

Evaluate the health impact of an intervention targeting the hunger relief network and the clients with food insecurity it serves. The long-term goal of this work is to reduce nutrition-related health disparities by intervening on a system that serves individuals at high risk for chronic disease. In 2014, an estimated 14% of U.S. households experienced food insecurity (i.e., they lacked access to enough food for an active, healthy life for all household members). Large numbers of low-income, racial/ethnic minority, and immigrant families who experience food insecurity rely on a hunger relief network that includes food banks and food pantries. Pantry clients have demonstrated poor nutritional outcomes, high chronic disease rates, and dissatisfaction with the quality and cultural-appropriateness of food offered. Unlike other food assistance programs, there are currently no standards on the nutritional quality of pantry offerings, but recent work by our study team demonstrated the need to improve the healthfulness of hunger relief network inventory. We proposed an evaluation of a randomized, sustainable intervention in 8 intervention and 8 control pantries. We will enroll clients at baseline and follow them for 1 year to assess changes in overall diet quality (the primary outcome). Working with our food bank partners, the intervention at the pantry level targets the supply of nutritious foods. At the client level, the intervention targets healthy food demand. Measured outcomes include overall diet quality (the primary outcome), as assessed by the Healthy Eating Index-2015 (HEI), the nutritional quality of foods selected at the food shelf visit, and cardiovascular disease health (assessed by the American Heart Association's Life's Simple 7 scores). The study will also evaluate the impact of a multilevel intervention on the nutritional quality of pantry offerings. The study also aims to improve implementation of practices that promote a nutrition-focused hunger relief network.

Eligibility Criteria:
Inclusion Criteria:

-≥18 years old

* Mentally capable of consent and participation
* Speak English, Spanish, or Somali
* Have access to a phone

Exclusion Criteria:

* Not capable of consent or participation
* Speak only languages other than English, Spanish or Somali
* Not a food pantry user
Prostaglandin F2alpha in a Human Headache Model

The hypothesis of this study is that PGF2alpha does not induce headache or dilatation of brain vessels.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers

Exclusion Criteria:

* Primary Headache
* Headache on the day of the investigation
* Hypertension
* Hypotension
* Pregnant/nursing
* Daily intake of medication (except oral contraceptives)
* Cardiovascular or central nervous system (CNS) disease
* Drug/alcohol abuse
* Psychiatric disease
Perforated Appendicitis With Delayed Presentation

There is no consensus among pediatric surgeons regarding the optimal treatment for children with complicated appendicitis with delayed diagnosis. With the development of broad-spectrum antibiotics, some surgeons have advocated expectant management for these children. However, there is little evidence to determine which children are most likely to benefit from this approach. Prior attempts to determine the effectiveness of expectant management for perforated appendicitis with delayed diagnosis often have not controlled for inherent differences in the clinical status of patients treated non-operatively vs. those treated with immediate appendectomy.

The ability of clinical practice guidelines to improve clinical practice and optimize resource utilization continues to be substantiated in the literature. To be effective, clinical practice guidelines must be developed from reliable and reproducible data.

This trial prospectively compares expectant management versus immediate laparoscopic or open appendectomy for perforated appendicitis in children with a delayed diagnosis. The primary outcome measure is length of hospital stay.

Eligibility Criteria:
Inclusion Criteria:

* All children with a delayed diagnosis of perforated appendicitis. Delayed diagnosis will be defined as symptoms for 4 or more days. Duration of symptoms will be defined as the time pain started.
* Confirmed diagnosis of perforated appendicitis. The diagnosis of perforated appendicitis will be based on diagnostic imaging (CT scan or ultrasound), showing an established appendiceal abscess or phlegmon.
* Consent to participate

Exclusion Criteria:

* Uncertainty about the diagnosis.
* The need for laparotomy for another reason.
* Free intraperitoneal air on imaging.
* Perforated appendicitis with diffuse abdominal fluid on imaging associated with a clinical picture of severe sepsis.
* Children with other medical condition that may affect the decision to operate e.g: children with inflammatory bowel disease.
Pyruvate Kinase Deficiency Epidemiological Study (PIECE)

Pyruvate kinase deficiency (PKD) is the most common red cell glycolytic enzyme defect causing hereditary non-spherocytic hemolytic anemia, caused by mutations in the PKLR gene. The main goal of this study is the diagnosis of pyruvate kinase deficiency in patients who exhibit chronic anaemia and/or splenomegaly and/or judiance and/or hyperbilirubinemia and/or history of prolonged neonatal jaundice and/ or cholelithiasis of undetermined aetiology.

Pyruvate kinase deficiency is the most common red cell glycolytic enzyme defect causing hereditary non-spherocytic hemolytic anemia, caused by mutations in the PKLR gene. PKLR encodes a pyruvate kinase that catalyzes the transphosphorylation of phosphoenolpyruvate into pyruvate and ATP. The current treatment options are red cell transfusions, chelation and splenectomy.

This is an international, multicentre, epidemiological and observational study.

The patients fulfilling the inclusion criteria will be enrolled into the Study and genetically tested for PKLR mutations via Next generation sequencing (NGS). Any mutation being detected by NGS, will be confirmed by Sanger sequencing.

PKLR-positive samples (homozygous or compound heterozygous for pathogenic variants) will be analysed for the identification of potential biomarkers via liquid chromatography multiple reaction-monitoring mass spectrometry (LC/MRM-MS) and compared to a merged control samples in order establish a PKD specific biomarker.

Eligibility Criteria:
INCLUSION CRITERIA:

* Informed consent is obtained from the participant or legal representative
* The participant is equal or older than 5 years or equal or younger than 30 years old
* The participant exhibits the following symptoms of no obvious etiology:
* chronic anaemia and/or
* splenomegaly and/or
* jaundice and/or
* cholelithiasis and/or
* cholecystitis and/or
* hyperbilirubinemia and/or
* history of prolonged neonatal jaundice
* The participant is clinically diagnosed with PK deficiency

EXCLUSION CRITERIA:

* Inability to provide informed consent
* The participant does not suffer from chronic anaemia and splenomegaly and jaundice and cholelithiasis and cholecystitis and hyperbilirubinemia and history of prolonged neonatal jaundice
* The etiology of chronic anaemia or splenomegaly or jaundice or cholelithiasis or cholecystitis or kernicterus is clearly determined and is not due to PK deficiency
* The participant is younger than 5 years or older than 30 years old
* Previously enrolled in the PIECE Study
* Participant in custody
A Study to Evaluate the Efficacy and Safety Study of Povorcitinib in Participants With Prurigo Nodularis (STOP-PN1)

The purpose of this study is to evaluate effect of povorcitinib on itch and skin lesions in participants with prurigo nodularis.


Eligibility Criteria:
Inclusion Criteria:

* Male and female participants 18 to 75 years of age.
* Clinical diagnosis of PN for at least 3 months prior to Screening visit.
* Pruritus, defined as an average Itch NRS score ≥ 7 during the 7 days prior to Day 1/Baseline.
* Total of ≥ 20 pruriginous lesions on ≥ 2 different body regions (both legs, and/or both arms, and/or trunk) at Screening and Day 1/Baseline.
* Documented history of treatment failure, demonstrated intolerance, or contraindication to a previous PN treatment.
* Willingness to avoid pregnancy or fathering children.

Exclusion Criteria:

* Chronic pruritus due to a condition other than PN or neuropathic and psychogenic pruritus.
* Diagnosis of PN secondary to medications.
* Active AD lesions (signs and symptoms other than dry skin) within 3 months prior to Screening visit.
* Women who are pregnant (or are considering pregnancy) or breastfeeding.
* Medical history including thrombocytopenia, coagulopathy or platelet dysfunction; venous and arterial thrombosis, deep vein thrombosis, pulmonary embolism, stroke, moderate to severe heart failure, cerebrovascular accident, myocardial infarction, or other significant cardiovascular diseases; Q-wave interval abnormalities; disseminated herpes zoster or dermatomal herpes zoster; disseminated herpes simplex; chronic/recurrent infections; malignancies.
* Evidence of infection with TB, HBV, HCV or HIV.
* History of failure to any topical or systemic JAK or TYK2 inhibitor as treatment of PN or any inflammatory disease.
* Laboratory values outside of the protocol-defined ranges.

Other protocol-defined Inclusion/Exclusion Criteria apply.
PET-MR for Prediction and Monitoring of Response to Neoadjuvant Chemotherapy in Breast Cancer

The purpose of this study is:

To validate the efficacy of multiparametric MRI, FDG-PET, RGD-PET, and PET-MR fusion imaging in the prediction and monitoring response to neoadjuvant chemotherapy of locally advanced breast cancer patients.

To identify the optimal combination parameters of MR spectroscopy, diffusion-weighted MRI, dynamic contrast-enhanced MRI, FDG-PET, and RGD-PET in the prediction and monitoring response to neoadjuvant chemotherapy of locally advanced breast cancer patients.

To compare the performances of dynamic contrast-enhanced MRI using parametric response map analysis versus those of pharmacokinetic parameters (Ktrans, kep, or Ve) in the early prediction of pathological responsiveness to neoadjuvant chemotherapy in breast cancer patients

Enrolled women with breast cancers who had received an anthracycline-taxane regimen and subsequent surgery were prospectively enrolled. DCE-MRI and FDG-PET scan were performed before and after the 1st cycle of chemotherapy. MR imaging parameters and SUV on PET scan within a tumor were analyzed. Clinicopathologic (age, clinical tumor stage, hormonal receptor status, and surgery type) and imaging parameters were compared according to the pathological response.

Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed breast cancer
* Clinical stage IIb, IIIa, IIIb, IIIc
* Must have measurable disease
* Performance status of ECOG 0-2
* Adequate, bone marrow, liver, heart, and renal function
* Who did not receive chemotherapy for breast cancer
* Must agree with and signed informed consent

Exclusion Criteria:

* Prior history of cancer besides breast cancer
* Active bacterial infection
* Pregnant or lactating women
* Psychological disease or seizure
* History of arrhythmia, congestive heart failure, myocardial infarct, or unstable angina
* Male breast cancer
* Who had a pacemaker or history of open heart surgery
Study to Evaluate the Safety and Tolerability of ASP8062 in Healthy Japanese Male and Female Subjects

The purpose of this study is to evaluate the safety and tolerability and evaluate pharmacokinetics of single and multiple ascending oral doses of ASP8062 in nonelderly Japanese male and female subjects.


Eligibility Criteria:
Inclusion Criteria:

* Body weight at screening: ≥ 50.0 kg and \< 80.0 kg for male, ≥ 40.0 kg and \< 70.0 kg for female.
* Body Mass Index (BMI) at screening: ≥ 17.6 kg/m\^2 and \< 26.4 kg/m\^2 \[BMI = Body weight (kg) ÷ {Body height (m)\^2}\].
* Female subjects must agree to consistently use 2 forms of highly effective birth control starting at screening and throughout the study period and for 28 days after the final study drug administration.
* Female subjects must not donate ova starting at informed consent and throughout the clinical study period, and for 28 days after the final study drug administration.
* Male subjects and female spouse/partners who are of childbearing potential must be using condom and one of the highly effective birth control starting informed consent throughout the clinical study period and for 90 days after final study drug, if vasectomy is not performed for male subjects.
* Male subjects must not donate sperm starting at informed consent and throughout the clinical study period, and for 90 days after study drug administration.

Exclusion Criteria:

* Subjects who participated or are scheduled to participate in any clinical trials or post-marketing studies within 120 days before screening test or during the screening test to the hospital admission (Day -2).
* Subjects who received or is scheduled to receive any medications (including over-the-counter drugs) within seven days before the hospital admission.
* Any deviation from the normal range of blood pressure, pulse, body temperature, or routine 12-lead ECG at screening or on the day of hospital admission (Day -1).
* Subjects who meet any of the criterion for laboratory tests at screening or on the day of hospital admission (Day -2).
* Any deviation from the normal range of routine 12-lead ECG at screening.
* Subjects with a complication or history of drug allergies.
* Subjects who developed upper gastrointestinal symptoms (nausea, vomiting, stomachache, etc.) within seven days before the hospital admission.
* Subjects with a history of gastrointestinal resection except for appendicitis.
* Subjects with a complication or history of hepatic disease, cardiac disease, respiratory disease, gastrointestinal disease, renal disease, endocrine disease, cerebrovascular disease or malignant tumor.
* Subjects who received ASP8062 previously.
* Subject has a relevant history of suicide attempt or suicidal behavior.
Direct Superior Approach (DSA) vs Posterior Approach (PA) in THA

Total Hip Arthroplasty (THA) is a highly effective treatment for patients with symptomatic hip osteoarthritis. The surgical approach in THA is important as it influences postoperative clinical recovery, functional outcomes, and implant positioning \[1\]. The evolution of surgical techniques in THA has led to the development of minimally invasive surgery, which is performed through smaller skin incisions, reduced soft tissue disruption and greater muscle preservation \[2-10\]. This prospective, randomised control study compares clinical and radiological outcomes in THA performed using the standard posterior approach (PA) and its less invasive modification, the direct superior approach (DSA). The study will include 80 patients with hip osteoarthritis undergoing THA. Following informed consent, patients will be randomised to one of the two treatment groups, and undergo THA using either the PA or DSA. The control group includes patients undergoing THA through the PA while the investigation group includes patients undergoing THA with the DSA. A further 25 patients randomly selected from each treatment group will undergo radiosteriometric analysis (RSA) to assess differences in early implant migration between PA and DSA groups.

Clinical and radiological outcomes of interest will be recorded by blinded observers at regular intervals for 2 years after surgery. The findings of this study will enable an improved understanding of differences in postoperative clinical recovery, functional outcomes, and implant positioning in THA performed using the DSA compared to the PA approach.


Eligibility Criteria:
Inclusion Criteria:

* Patient has hip osteoarthritis requiring primary THA

  * Patient and surgeon are in agreement that THA is the most appropriate treatment
  * Patient is fit for surgical intervention following review by surgeon and anaesthetist
  * Patient age: Patients 18-80 years of age inclusive
  * Gender: male and female
  * Patient must be capable of giving informed consent and agree to comply with the postoperative review program
  * Patient must be a permanent resident in an area accessible to the study site
  * Patient must have sufficient postoperative mobility to attend follow-up clinics and allow for radiographs to be taken

Exclusion Criteria:

* Patient is not suitable for primary THA e.g. patient requires revision surgery for previously failed THA

  * Patient is not medically fit for surgical intervention
  * Patients under the age of 18 or over 80 years of age
  * Patient is immobile or has another neurological condition affecting musculoskeletal function
  * Patient is already enrolled on another concurrent clinical trial
  * Patient is unable or unwilling to sign the informed consent form specific to this study
  * Patient is unable to attend the follow-up programme
  * Patient is non-resident in local area or expected to leave the catchment area postoperatively