cyrilzakka/clinical-trials huggingface dataset:
Treatment of Malaria With Quinine Plus Sulfadoxine-Pyrimethamine

Quinine remains the treatment of choice of hospitalised malaria cases. The long treatment duration of 7 days, and adverse reactions often hamper its adequate use. Reducing the treatment duration by adding sulfadoxine-pyrimethamine may enhance compliance and reduce side effects.

The efficacy of a 3-day treatment of quinine plus sulfadoxine-pyrimethamine for the treatment of hospitalised, uncomplicated malaria cases was assessed.

One main concern of clinicians in malaria endemic areas is to find a simple malaria treatment with short treatment duration. The concept of combination therapy, which may reduce treatment duration and delay the spread of drug resistance in addition to an increase in efficacy, has been therefore introduced.

In contrast to the outpatient treatment of malaria where emergence of resistance has lead to new drugs policies, the treatment of hospitalised malaria cases remains, in many endemic countries, intravenous quinine for 7 days. The efficacy of this regimen is well established throughout Africa. The effectiveness of the quinine treatment may be considerably lower because of discontinuation of treatment due to early discharge, the occurrence of side effects or because of the fact that patients feel better and stop the treatment. Therefore, sulfadoxine-pyrimethamine (SP) is often added at discharge. This regimen has been shown to be effective. But in Africa, where the practice seems widespread, it has been assessed in only two trials.

Since resistance of Plasmodium falciparum to SP is increasing rapidly in Africa and there is evidence that SP monotherapy induce gametocytaemia, we hypothesize that the combination quinine/SP increases SP efficacy and prevents induction of gametocytaemia. In addition, since the use of the full course of quinine therapy may be hampered by many factors (hospital cost, hospitalisation duration, availability of beds, compliance and side effects), the addition of the long acting SP to complete a short course of quinine treatment may prevent recrudescence or reinfection and may increase effectiveness of malaria treatment and reduce postdischarge morbidity.

The efficacy and safety of the short course of intravenous quinine (3-day treatment) plus a single dose of oral SP for the treatment of falciparum malaria was investigated.

Eligibility Criteria:
Inclusion Criteria:

* Uncomplicated falciparum malaria
* Asexual parasitaemia between 20,000 and 200,000/µL
* No mixed plasmodial infection
* Fever with temperature above 38 °C or history of fever during the preceding 24 hours
* No effective anti-malarial treatment for the present attack
* Informed consent

Exclusion Criteria:

* Haemoglobin \< 7 g/dL
* Packed-cell volume \< 20%
* White cell count \> 16,000/µL
* Platelet count \< 40,000/µL
* Schizontaemia \> 50/µL
* Impaired consciousness
* Convulsions or history of convulsions
* Concomitant diseases masking assessment of response
Investigation of the Acute Effects of Core Stabilization and 360-Degree Breathing Exercises on Balance and Proprioception in Individuals With Non-Specific Low Back Pain

This study is designed as a single-blind randomized controlled trial. Male and female patients aged 18-65 years with complaints of non-specific low back pain (NSLBP) lasting longer than 12 weeks will be included in the study. Participants will be randomly assigned into two parallel groups: control and intervention. The control group will perform core stabilization exercises five days a week for three weeks. In the intervention group, core stabilization exercises will be combined with 360-degree breathing exercises. To our knowledge, there is no randomized controlled trial investigating the effect of combining core stabilization with 360-degree breathing in individuals with NSLBP. The aim of this study is to examine the acute effects of combining 360-degree breathing techniques with core stabilization exercises on balance and proprioception in individuals with NSLBP.

Low back pain is a major health problem worldwide. Non-specific low back pain (NSLBP) is the most common form of back pain. The lifetime prevalence of back pain can reach up to 84%. Various non-pharmacological and non-invasive methods are used for back pain management. One such method is core stabilization exercises. Core stabilization exercises enhance trunk stability by activating the muscles around the spine and have the potential to improve balance in individuals with NSLBP. This may help overcome balance disorders associated with pain and contribute to safer movements in daily life activities. Breathing exercises, by activating the diaphragm muscle, support spinal stability and provide benefits in pain management. It is known that breathing supports trunk stability through its relationship with core muscles and strengthens balance mechanisms. Studies in this field show that stabilization exercises can provide short-term improvements, especially in balance. However, the combined effects of core stabilization and breathing exercises in individuals with NSLBP have not been fully investigated. Therefore, this study aims to investigate the acute effects of combining 360-degree breathing exercises with core stabilization exercises on balance and proprioception in individuals with NSLBP.

Eligibility Criteria:
Inclusion Criteria:

* Low back pain persisting for at least 3 months
* No neurological, rheumatological, or musculoskeletal system problems

Exclusion Criteria:

* Individuals with neurological, vestibular, or serious orthopedic conditions that may cause physical disability
* Patients with back-leg or dorsolumbar pain due to lumbar disc protrusion or fracture
* Cancer patients
* Individuals with acute infections
* Individuals with respiratory system diseases
* Individuals with any mental disorder that would prevent participation in the study assessment
* Pregnant individuals
Stem Cell Therapy: a Compassionate Use Program in Perianal Fistula

This observational study aims at assessing the safety and efficacy profiles of mesenchymal stem cell, in different formats (SVF, autologous, allogenic), to treat complex perianal fistula according to the Spanish national Compassionate-use law .

Under controlled circumstances, and approved by European and Spanish laws, a Compassionate-use Program allows the use of stem-cell therapy for patients with non-healing diseases, mostly complex fistula-in-ano, who do not meet criteria to be included in a clinical trial. Candidates had previously undergone multiple surgical interventions that had failed. The intervention consisted of surgery (with closure of the internal opening or a surgical flap performance), followed by stem cells injection. Three types of cells were used for implant: stromal vascular fraction, autologous expanded adipose-derived or allogenic adipose derived stem cells.

Healing was evaluated at 6th month follow-up. Outcome was classified as partial response or healing. Relapse was evaluated 1 year later. Maximum follow up period was 48 months.

Eligibility Criteria:
Inclusion Criteria:

* patients with complex perianal fistula
* patients who didn't meet criteria of the clinical trial (CT) in development
* foreign patients, who were not allowed to be included in the CT
* patients included in some CT control arms
* failure treatment in patients included in a CT treatment arm as a retreatment

Exclusion Criteria:

* not signature informed consent
Trichloroethylene (TCE) Exposure in an Industrial Population

This study is to follow-up with workers from a local company that had exposure to TCE that may have symptoms of Parkinson's disease. We hope to learn more about TCE exposure and Parkinson's disease. Eligible participants will be those who participated in previous research study entitled "Survey of Selected Exposures and Neurologic Symptoms in an Industrial Population"


Eligibility Criteria:
Inclusion Criteria:

* Previous participant in the research study entitled "Survey of Selected Exposures and Neurologic Symptoms in an Industrial Population"

Exclusion Criteria:

* Not a participant in the research study entitled "Survey of Selected Exposures and Neurologic Symptoms in an Industrial Population"
A Pilot Study of NY-ESO-1b Peptide Plus CpG 7909 and Montanide® ISA-51 in Patients With Cancer.

This cancer vaccine research study involves the injection of the NY-ESO-1b peptide along with 2 other agents to help stimulate the immune system. Peptides are small fragments of protein. NY- ESO-1 peptides are normally found in the testis and the placenta. They have also been found on various types of cancer cells. The purpose is to stimulate the immune system to react against the peptides that are found on cancer cells.

This is a pilot study of patients of HLA-A2 phenotype whose tumor expresses the NY-ESO-1 or LAGE-1 antigen. Patients will receive NY-ESO-1b peptide mixed with 0.5 milliliter (mL) of Montanide® ISA-51 and 1 mg of CpG 7909 given every three weeks for four doses by subcutaneous injection. There will be a three-week follow-up period after the fourth injection making the cycle 13 weeks long. In the absence of toxicity and progressive disease, a second cycle will be offered to patients who have received four vaccinations.

The primary objective is to evaluate the immune response (antibodies, CD8+ T-cells, and DTH) and safety to vaccination with NY-ESO-1b peptide mixed with CpG 7909 and Montanide® in patients with cancer expressing NY-ESO-1 or LAGE-1. The secondary objective is to document tumor responses in patients with evaluable or measurable disease.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed metastatic, measurable cancer or resected high risk Stage III/IV; resected Stage II, III, or IV non-small cell lung cancer or esophageal cancer who have declined, failed, or completed standard therapy; tumor expression of NY-ESO-1 or LAGE-1 antigen; HLA-A2 positive; Karnofsky performance status greater than or equal to 60%; hematology and biochemistry laboratory results within the limits normally expected for the patient population; age greater than or equal to 18.

Exclusion Criteria:

* Clinically significant heart disease; other serious illnesses; patients with serious intercurrent illness, requiring hospitalization; patients taking immunosuppressive drugs; autoimmune disease; known HIV positivity; other active malignancy within 1 year prior to entry into the study; participation in chemotherapy, radiation therapy, or any other clinical trial involving another investigational agent within 4 weeks prior to enrollment; pregnancy or breastfeeding; women of childbearing potential: refusal or inability to use effective means of contraception.
Efficacy of a Low FODMAP Diet According to Colonic pH in Irritable Bowel Syndrome Patients

Treatments efficacy in irritable bowel syndrome (IBS) patients is inconstant and predictive factors of their efficacy are needed. The role of dysbiosis in IBS is well-known. Another way to identify microbiota differences is to assess its metabolic activity. It has been demonstrated that colonic pH in IBS patients is lower than in healthy volunteers, reflecting a highest colonic fermentation. Colonic acidification is able to sensitize colonic mechano-receptors to distension. Microbiota profile is able to predict the response to a low Fermentable Oligo, Di, Monosaccharides And Polyols (FODMAPs) diet, but is not available in clinical routine.

The aim of our study is to assess the link between colonic fermentation (measured by colonic pH) and the efficacy of a low FODMAPs diet in IBS patients (measured by IBS severity scoring system (IBS-SSS)). We hypothesis that IBS patients with a lower colonic pH will have a better efficacy of the low FODMAPs diet. It might allow in the future personalized medicine.

50 IBS patients according to Rome IV criteria will be included in our study. All patients will have a measure of their colonic pH by wireless motility capsule. Patients will follow a low FODMAPs diet for 6 weeks after an education by a trained dietician. All participants will fill validated questionnaires before and after 6 weeks of low FODMAPs diet: IBS-SSS, Gastro Intestinal Quality of Life Index (GIQLI), Hospital Anxiety and Depression (HAD) scale. Microbiota, metabolomic and short chain fatty acid will be analysed before and after the intervention. The number of patients was calculated to assess the correlation between colonic pH and the variation of IBS-SSS before and after the intervention.


Eligibility Criteria:
Inclusion Criteria:

* IBS according to Rome IV criteria
* Normal blood test (cell blood count, C Reactive Protein, thyroid-stimulating hormone, anti transglutaminase antibodies) in the last 12 months
* IBS severity score (IBS-SSS) \>175/500
* IBS treatments stable in the last month
* Effective contraception since 1 month for women in childbearing age

Exclusion Criteria:

* Anorexia nervosa or any eating disorders deemed incompatible
* Organic gastroenterological diseases (inflammatory bowel disorder, microscopic colitis, gastrointestinal cancer, celiac disease)
* Contra-indication to the wireless motility capsule (intestinal stenosis, digestive fistula or obstruction, history of bezoar, gastrointestinal surgery in the last 3 months, acute diverticulitis, cardiac pacemaker, implanted electromedical device, magnetic resonance imaging planned in the 5 days after the wireless motility capsule, swallowing disorder)
* Breastfeeding or pregnant women
* Participation in another clinical trial in the last 2 weeks
* Patient who could not stop proton pump inhibitor treatment for 10 days
* Person with administrative or judicial decision or under legal protection measure
Treatment Patterns in Castrate Resistant Prostate Cancer Patients With Bone Metastases in a Medicare Population

The goal of the study is to provide a detailed description of treatments for CRPC (Castrate Resistant Prostate Cancer) patients with bone metastases and the resource utilization and costs associated with that diagnosis and subsequent treatments.


Eligibility Criteria:
Inclusion Criteria:

* First diagnosis for bone metastases for members diagnosed with prostate cancer found in the claims data during the identification period
* Members age ≥ 55 to 89 years at index
* Medicare members with medical and pharmacy coverage; and
* Continuously enrolled during the pre- and post-index periods.

Exclusion Criteria:

* Member with diagnosis of any other cancer (excluding melanoma (ICD-9 172.x) and other metastases (ICD-9 198.x)) before the index date; and
* Members age ≥ 89 years of age at index date
Post-market, Prospective Evaluation of PHOTO-oxidized Bovine Pericardium in Vascular Surgery

The objective of this post-market clinical follow-up study is to evaluate the clinical outcomes of patients receiving PhotoFix as a patch within a vascular repair or reconstruction procedure.

PhotoFix is prepared from bovine pericardium, which is stabilized using a dye-mediated photo-oxidation process and sterilized using aseptic processing techniques. The primary endpoint for patients with carotid artery stenosis (CAS) undergoing carotid endarterectomies (CEA) will be rate of ipsilateral central neurologic events; the primary endpoint for all other vascular procedures will be primary patency. The secondary endpoints include all-cause reoperation rate, device-related reoperation rate, explant rate, restenosis rate, secondary patency (hemodialysis access repair (HAR) only) and survival. A goal of 100 patients will be enrolled at approximately 10 sites. The enrollment period will span a minimum of 8 months from Institutional Review Board (IRB) approval and site activation. Candidates for this study are adults who require vascular repair or reconstruction surgery that necessitates the use of a patch. Patients will be consented pre-operatively and enrolled patients will be followed for approximately 6 months after PhotoFix surgery. Data will be collected at 5 time points: baseline (pre-operatively), intra-operatively, 1 month post-operatively, 3 months post-operatively, and 6 months post-operatively.

Eligibility Criteria:
Inclusion Criteria:

* Patient is undergoing a vascular procedure which falls within the indications for use and requires the use of PhotoFix Decellularized Bovine Pericardium
* Patient's surgery is anticipated to occur within 60 days of consent
* Patient is ≥18 years old
* Patient is willing and able to comply with the protocol and follow up period
* Patient is willing and able to give written informed consent

Exclusion Criteria:

* Patient's procedure is a revision of a prior arteriotomy or venotomy
* Patient's procedure requires multiple vascular patches in anatomically distinct regions or other prosthetics (e.g. stents)
* Patient has a medical history of abnormal coagulopathy, bleeding, or thromboembolic disease
* Patient has a medical history of severe immunodeficiency disease
* Patient has a medical history of cancer
* Patient has severe visceral disease in heart or active liver disease or icterus
* Patient has a history of cerebrovascular accident (completed stroke) within 3 months of planned surgery
* Patient has a history of atrial fibrillation and requires a patch for carotid endarterectomy repair
* Patient has an active or potential infection at the surgical site
* Patient has used or plans to use immunomodulatory drugs for ≥ 6 months
* Patient has a sensitivity to products of bovine origin
* Patient is currently enrolled in another study
* Patient has a life expectancy of less than 12 months
* Patient is pregnant or breastfeeding or planning on becoming pregnant or unwilling to use medically acceptable methods of birth control
* Patient's procedure is emergent
Study to Evaluate Darbepoetin Alfa in Pediatric Subjects With Anemia Due to Chronic Kidney Disease

The purpose of this study is to find out more about darbepoetin alfa in children less than 1 year of age with anemia (a decrease in red blood cells) due to kidney failure. This study will see if darbepoetin alfa is safe and well tolerated and whether it causes any side effects by taking blood samples and checking vital signs (heart rate, body temperature, and blood pressure tests) at specific times throughout the study. In addition, the study will evaluate the amount of darbepoetin alfa in the blood over time and look at special markers in the blood to evaluate how darbepoetin alfa works on anemia.

Darbepoetin alfa is approved by the United States Food and Drug Administration (FDA) and European Medicines Agency (EMA) for use in adults, but not for all ages of pediatric subjects. Therefore, studies need to be conducted in pediatric subjects (children) to determine the appropriate dose to use in younger children.


Eligibility Criteria:
Inclusion Criteria:

* Girls and boys between birth and \< 1 year of age at the time of enrollment
* Body weight ≥ 3 kg at screening and enrollment
* Diagnosis of chronic kidney disease stage 3 to 5 with an estimated Glomerular Filtration Rate \< 60 mL/min/1.73m2 without dialysis using the updated Schwartz Equation at screening; OR on dialysis at screening
* Hemoglobin ≤ 9.0 g/dL within 7 days prior to enrollment
* Transferrin saturation ≥ 20% at screening

Exclusion Criteria:

* Premature girls and boys (\< 37 weeks of gestation, counting from the first day of the mother's last menstrual period)
* Peritoneal dialysis subjects with an episode of peritonitis within 30 days prior to enrollment
* History of cardiovascular events or thromboembolism
* History of upper or lower gastrointestinal bleeding
* History of seizures
* Active liver disease or history of liver disease
* Uncontrolled hypertension defined as stage 2 hypertension or greater. This is defined as a systolic or diastolic blood pressure value greater than the 99th percentile + 5 mmHg for a subject's age
* Major surgery 12 weeks prior to enrollment
* Red blood cell transfusions 12 weeks prior to enrollment
* Use of any erythropoiesis-stimulating agent within 12 weeks prior to enrollment
* Currently receiving antibiotic therapy for systemic infection within 4 weeks prior to enrollment
* Current or prior use of immunosuppressants (excluding low-dose corticosteroids, defined as ≤ 0.5 mg/kg per day prednisone or equivalent for ≤ 5 days)
* Subject is receiving a dose higher than 0.5 mg/kg per day of prednisone (or equivalent dose of another corticosteroid) for \> 5 days within 4 weeks prior to enrollment
* Receiving or has received any investigational drug (or is currently using an investigational device) within the 30 days or 5 half-lives (whichever is longer) prior to enrollment
* Subject has known hypersensitivity to darbepoetin alfa, r-HuEPO, or to any of the excipients
Akkermansia Muciniphila Akk11 Impact on Obesity and Metabolic Health

This is a randomized, double-blinded, placebo-controlled study to evaluate the efficacy and safety of Akkermansia muciniphila Akk11 in adult obesity.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female, aged 18-50 years
2. For healthy subjects: Must have a BMI between 18.5 and 24.9 kg/m2 and normal lipid profile (Cholesterol total \<200 mg/dL; LDL-C \<100 mg/dL; HDL-C ≥ 40 mg/dL; and triglyceride \< 150 mg/dL)
3. For obese subjects: Must have a BMI ≥ 30 kg/m2, weight stable for at least 3 months (± 2 kg)
4. Subjects must be either of non-childbearing potential, or if of childbearing potential, must be abstinent or have practiced adequate contraception for the entire study
5. Subjects who have not smoked in the past 1 month prior to screening
6. Subjects or subject's legally acceptable representatives have the ability to comply with the trial protocol
7. Signed informed consent from the subject or subject's legally acceptable representatives (must be obtained before any study-related activities) -

Exclusion Criteria:

1. Male or female, aged 18-50 years
2. For healthy subjects: Must have a BMI between 18.5 and 24.9 kg/m2 and normal lipid profile (Cholesterol total \<200 mg/dL; LDL-C \<100 mg/dL; HDL-C ≥ 40 mg/dL; and triglyceride \< 150 mg/dL)
3. For obese subjects: Must have a BMI ≥ 30 kg/m2, weight stable for at least 3 months (± 2 kg)
4. Subjects must be either of non-childbearing potential, or if of childbearing potential, must be abstinent or have practiced adequate contraception for the entire study
5. Subjects who have not smoked in the past 1 month prior to screening
6. Subjects or subject's legally acceptable representatives have the ability to comply with the trial protocol
7. Signed informed consent from the subject or subject's legally acceptable representatives (must be obtained before any study-related activities) -