cyrilzakka/clinical-trials huggingface dataset:
Study of Nitazoxanide in the Treatment of Clostridium Difficile-associated Disease

The primary objective of the study is to demonstrate non-inferiority of nitazoxanide compared to vancomycin in resolving symptoms of Clostridium difficile-associated disease (CDAD).


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years.
* Patients with new onset of disease evidenced by diarrhea (≥ 3 unformed stools within 24 hours), and one or more of the following symptoms of CDAD:

  * abdominal pain or cramps
  * peripheral leukocytosis
  * fever
* C. difficile toxin A or B detected in a stool specimen obtained within 3 days before enrollment by enzyme immunoassay.
* Patients willing to avoid the following medications during the study:

  * oral and intravenous metronidazole
  * oral vancomycin
  * anti-peristaltic drugs
  * opiates (patients on opiates may be included in the study if they were taking opiates prior to enrollment and the dose is not increased during the study)
  * Saccharomyces cerevisiae (baker's yeast)
  * Lactobacillus GG
  * cholestyramine
  * colestipol

Exclusion Criteria:

* Patients with other known causes of diarrhea or colitis (e.g., Shigella, Salmonella, Cryptosporidium parvum, Giardia lamblia, Entamoeba histolytica, inflammatory bowel disease, irritable bowel syndrome, advanced AIDS or chemotherapy for malignancy).
* Patients that commonly have 3 or more stools per day and/or severe abdominal pain in the absence of CDAD.
* Patients with severe lactose intolerance.
* Patients with more than 1 recurrence of CDAD during the 6 months prior to enrollment.
* Patients unable to take oral medications.
* Use within 1 week of enrollment of any drug or therapy with anti-C. difficile activity such as oral or intravenous metronidazole and oral vancomycin. \[Patients that have taken up to 3 doses of metronidazole or vancomycin can be included in the study\].
* Females of child bearing age who are either pregnant, breast-feeding or not using birth control and are sexually active.
* Patients who are either clinically unstable (e.g., fulminant disease patients with signs of toxic megacolon, imminent perforation, colectomy or death) or unlikely to live throughout the 31-day duration of the study due to underlying illness.
* History of hypersensitivity to nitazoxanide or vancomycin or any active ingredient in the formulations.
Musculoskeletal Plasticity After Spinal Cord Injury

Patients with spinal cord injury (SCI) experience metabolic syndrome, diabetes, obesity, pressure ulcers, and cardiovascular disease at far greater rates than the general population. A rehabilitation method to prevent or reverse the systemic metabolic consequences of SCI is a pressing need. The purpose of this study is to determine the dose of muscle activity that can enhance an oxidative muscle phenotype and improve clinical markers of metabolic health and bone turnover in patients with SCI. The long-term goal of this research is to develop exercise-based interventions to prevent secondary health conditions such as diabetes and to ultimately protect health-related quality of life (QOL). Specific Aim 1: To compare changes in skeletal muscle gene regulation in individuals who receive high frequency (HF) active-resisted stance and low frequency (LF) active-resisted stance for 3 years. Hypothesis 1: The expression of genes regulating skeletal muscle metabolism will support that HF and LF both instigate a shift toward an oxidative muscle phenotype. A novel finding will be that LF is a powerful regulator of oxidative pathways in skeletal muscle. Specific Aim 2: To compare changes in systemic markers of metabolic health and bone turnover in individuals with SCI who receive HF or LF for 3 years. Hypothesis 2: HF and LF will both reduce glucose/insulin levels and HOMA (homeostasis model assessment) score.

Secondary Aim: To measure subject-reported QOL using the EQ-5D survey metric. Hypothesis 3: HF and LF subjects will show a trend toward improved self-reported QOL after 3 years. There will be an association between metabolic improvement and improved perception of QOL. These observations will support that this intervention has strong feasibility for future clinical translation.


Eligibility Criteria:
Inclusion Criteria:

* Motor complete SCI (AIS A-B)

Exclusion Criteria:

1. Pressure ulcers
2. Chronic infection
3. Lower extremity muscle contractures
4. Deep vein thrombosis
5. Bleeding disorder
6. Recent limb fractures
7. Any comorbid disease known to affect bone metabolism (such as parathyroid dysfunction)
8. Pregnancy
9. Anti-osteoporosis medications
10. Vitamin D supplements
11. Metformin or other medications for diabetes.
Effect of Exercise Training in Lung Cancer

To determine the effects of exercise training in patients with lung cancer during chemotherapy treatment. In currently accessible literature, majority studies, met-analysis, and systemic reviews are related to surgical procedures and post-op pulmonary Rehabilitation of patients with Lung cancer. In literature, Gap related to the control group was observed also. The current study aimed to fulfill this gap by planning a structured intervention plan for the control group as well. It will also add in literature the deficiency of oncology rehab for patients receiving chemotherapy only.

Literature suggested that a pulmonary rehabilitation program for patients with non-small cell lung cancer undergoing induction chemo-radiotherapy seems to improve respiratory function. It is particularly recommended for smokers and patients with respiratory impairment.

Eligibility Criteria:
Inclusion Criteria:

- Diagnosed patients of stage 1 and 2 Non-small cell lung carcinoma (NSCLC) including Adenocarcinoma \& squamous cell carcinoma The diagnosis was established within 6 wk prior to enrollment and was confirmed by histology.

Participants are undergoing lung cancer chemotherapy Participant has the willingness to participate in training WHO physical fitness scores 0-1 Able to perform 6-minute walk test (6MWT) at baseline

Exclusion Criteria:

* • Participant with history of trauma and surgery

  * Patients with lung disease other than lung cancer
  * Uncontrolled hypertension or unstable coronary artery disease.
  * Severe OA, bone or CNS metastases.
  * hemoglobin \<10 g/dL
  * Lower than 3,500 white blood cells per microliter of blood
Effect of Iontophoresis vs. Ultrasound and Iontophoresis in Plantar Fasciitis". Plantar Fasciitis"

Plantar fasciitis is inflammation of plantar fascia.The main symptom of plantar fasciitis manifests itself as localized pain in the inner area of the foot and increases in intensity after long periods of standing or resting. Its etiology is multifactorial and risk factors include overweight, female gender, physical exercise (impact sports), biomechanical imbalances of the foot and possible dysfunction of the functional twin-ankle-plantar system.Generally speaking, conservative measures are recommended as initial treatment for plantar fasciitis, and in situations where these are ineffective, corticosteroids are sometimes administered. At the local level, the route of administration can be by infiltration or iontophoresis.Iontophoresis consists of administering a drug through the skin by applying an electric current locally. This technique can be considered as a safe and effective method within the SLTF (Transcutaneous Drug Delivery Systems). It consists of introducing ions through the skin by means of electricity using a direct current, with an electrode carrying a positive charge (anode) and a negative charge (cathode). Its administration is produced thanks to the repulsive force to carry the compound through the skin by means of galvanic current.

This study aims to assess whether treatment with iontophoresis in subjects with plantar fasciitis can show a more positive evolution in pain after a 6-week treatment period (treatment frequency: 1 time per week) versus ultrasound (3 times per week) for 6 weeks.


Eligibility Criteria:
Inclusion Criteria:

* plantar fasciitis
* fascia thickness (greater or equal to 4mm).

Exclusion Criteria:

* skin lesion
* sensory neuropathy
* current use of plantar supports
* taking pharmacological treatment (15 days) or previous infiltrations (6 months)
* previous surgery or fractures of the lower limb
* pregnancy
* allergy to the applied drugs.
Detection of Single Nucleotide Polymorphism (SNP) Rs2235371 of IRF6 Gene in Egyptian Patients with Non-Syndromic Cleft Lip and Palate

The aim of this work is to study the relation between SNP rs2235371 of IRF 6 gene and Non-Syndromic Cleft Lip and Palate in Egyptian Patients in a prospective study

Infants born with facial deformities, such as cleft lip and palate (CL/P), often face lifelong challenges, including communication issues, aesthetic concerns, and difficulty with swallowing, which impact both health and social behavior. Without treatment, these conditions require specialized care and lead to higher rates of morbidity and mortality. Surgeries, including speech and dental interventions, can help manage these conditions from early childhood . CL/P is one of the most common craniofacial birth defects, affecting populations worldwide, with Asian populations experiencing the highest prevalence at 1/500 live births.

Cleft palate (CP) results from incomplete closure of the palate shelves in early prenatal development. Depending on severity, it may range from a minor fissure to a full gap between the mouth and nasal cavity, necessitating surgical repair. CL/P is categorized as syndromic or non-syndromic, with the latter resulting from failure of palatal fusion between 4-12 weeks of embryogenesis, influenced by factors such as single-gene mutations, chromosomal abnormalities, and environmental interactions.

Key genetic mutations linked to CL/P include those in the IRF6, PVRL1, TP63, FGFR1, and TBX22 genes, with IRF6 SNPs being particularly significant . Family history increases risk, while gene-environment interactions, maternal drug use, non-gestational diabetes, and vitamin deficiencies contribute further. A multidisciplinary approach is essential for managing CL/P, supporting children's functional and aesthetic outcomes from birth through adulthood.

Eligibility Criteria:
Inclusion Criteria:

* Patients with Non-Syndromic Cleft lip or Cleft lip and palate.

Exclusion Criteria:

* Patients with Syndromic CLP.
A Study to Evaluate Lucitanib in Combination With Nivolumab in Patients With a Solid Tumor

This is an open-label, Phase 1b/2 study to determine the recommended dose of lucitanib in combination with nivolumab in patients with an advanced solid tumor (Phase 1b); followed by evaluation of the safety and efficacy of lucitanib and nivolumab in patients with an advanced gynecological solid tumor (Phase 2) and evaluate the effects of dosing under fasting or fed state (Food Effect)


Eligibility Criteria:
General Inclusion Criteria:

* ≥ 18 years of age
* Adequate organ function
* Life expectancy ≥ 3 months
* Women of childbearing potential must have a negative serum pregnancy test
* Advanced/metastatic solid tumor (Phase 1b)
* Availability of tumor tissue at screening
* ECOG performance status of 0 to 1
* Measurable disease (RECIST v1.1) (Phase 2)
* Advanced, recurrent, or metastatic gynecological solid tumor (Phase 2)
* Willing and able to fast, and to eat a high-fat breakfast (Food Effect)

General Exclusion Criteria:

* Prior treatment with lucitanib
* Active second malignancy
* Active central nervous system brain metastases
* Pre-existing duodenal stent or any gastrointestinal disorder
* Known history of HIV or AIDs; positive result of hepatitis B or C viruses
* Evidence of interstitial lung disease, active pneumonitis, myocarditis, or history of myocarditis
* Active, known or suspected autoimmune disease (eg, autoimmune hepatitis)
* Condition requiring systemic treatment with corticosteroids or other immune suppressive medications
* Unstable or uncontrolled hypertension (BP ≥ 140/90 mmHg)
* Prior treatment with a VEGFR-tyrosine kinase inhibitor (Phase 2)
A Prospective Study to Evaluate the Role of T-Cell Dysfunction in Patients Who Present Symptoms Associated With Long COVID, Lyme Disease and Myalic Encephalomyelitis / Chronic Fatigue Syndrome Using the Vira Immune Fluorospot T Cell Assay

This is a longitudinal observational study recruiting individuals that have attended three clinical sites with symptoms associated with a diagnosis of long COVID, PTLDS or ME/CFS. The study will be a multi-centre study, with up to 160 male and female participants enrolled. Participants that experience symptoms considered to be associated with a diagnosis of long COVID, PTLDS or ME/CFS will consent to the study, and attend for two study visits (at study entry and 6 months) to complete a questionnaire related to their symptoms, and to have a blood sample taken. Blood samples will be taken either at the clinical site or at the participant's home if they are unable to attend due to the severity of their illness. . Participants will be allocated to one of the following groups:

Group 1: Long COVID Group 2: ME/CFS Group 3: PTLDS Group 4: Healthy Control


Eligibility Criteria:
Persistent symptoms for groups 1-3 for consistency.

Inclusion Criteria:

1. Aged 18 years or older
2. History of acute COVID-19 infection (medically recorded)
3. Symptoms of fatigue and, shortness of breath and/or, joint pain and/or, problems with memory and concentration which have been present for more than a period of 6 months post infection
4. Nonsteroidal anti-inflammatory drugs (NSAIDs such as ibuprofen, diclofenac, aspirin, etc.) must have been stopped at least 48 hours prior to admission to the clinical research centre (evaluation through questionnaire).
5. Willing and able to sign the ICF and comply with study procedures.

Exclusion Criteria:

1. Taking immunosuppressive medication (including corticosteroids), or receiving chemotherapy, cytokine or anti-cytokine therapy, or antithrombotic medication (evaluation through questionnaire).
2. Significant and/or acute illness within 5 days prior to admission that may impact safety assessments, in the opinion of the Investigator.
3. Participants who are, in the opinion of the Investigator, not suitable for enrolment for another reason. For example, participants with: cognitive impairment or severe mental health conditions that might affect their ability to provide informed consent or follow study procedures; non-adherence risk where participants are unlikely to follow study protocols; participants with other chronic inflammatory conditions not under investigation e.g. inflammatory bowel disease, COPD that may have immune profiles that differ from the study's intended populationI
ABX464 First in Man Study

This study is an open label, parallel group, single ascending dose, exploratory study performed in a single site (Centre Cap, Montpellier, France).

This study is an open label, parallel group, single ascending dose, exploratory study performed in a single site (Centre Cap, Montpellier, France). Six subjects per dose group were enrolled into 1 of 4 groups with escalating doses of ABX464 (50, 100, 150 and 200 mg). For each dose group, a first subject was treated, if no adverse event (AE) occurred, a second subject was dosed one hour later. The four last subjects were dosed the day after if no clinically significant AE occurred. Escalation to the following dose level was decided after review of PK and safety data (laboratory results, ECG, vital signs and AEs)

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers
* Subject in good health on the basis of medical history, physical examination, vital signs, electrocardiogram (ECG) and routine laboratory safety tests
* Subject with a BMI of 18 27kg/m²
* Non smokers or light smokers of less than 10 cigarettes per day
* Having given their written informed consent

Exclusion Criteria:

* Subject with any on-going infection or disease
The Effect of Vitamin D on Bone Accretion and Turn-Over in Young Girls

Objectives To evaluate the effect of increased vitamin D intake on vitamin D status, bone mass and bone turnover in young girls aged 12-13.

More specifically the effects on the following parameters will be assessed:

* Vitamin D metabolites.
* Parathyroid hormone.
* Bone turnover.
* Bone mineral accretion.
* Serum calcium and phosphate.
* Renal handling of calcium and phosphate.

This work package will consist of a randomised double blind one-year vitamin D supplementation study. Primary effect parameter is change in bone mineral content and therefore study duration will be one year. A total of 225 subjects, 75 in each of the three groups: one control and two intervention groups, will be included Two dosages of supplementation will be used: 5 µg per day and 10 µg per day.

Eligibility Criteria:
Inclusion Criteria:

* Girls born in Denmark with Danish citizenship aged 10.0-11.0 years living in the municipals of Copenhagen and Frederiksberg

Exclusion Criteria:

* Any chronical disease with influence on bone mass or turnover
* Intake of drugs with influence on bone mass or turnover
* Intake of calcium or vitamin D other than the intervention
Open-Label, 48-Week Extension Study of Elvucitabine in Combination With Background Antiretroviral Therapy (ART) for Participants Who Have Completed Study ACH443-014A

To assess the safety of 48 weeks of treatment with 10 milligrams (mg) of elvucitabine in combination with background antiretroviral therapy (ART) in participants who completed Study ACH443-014A and meet the inclusion and exclusion criteria.

This study is an open-label extension study for participants who have completed 14 days of treatment in Study ACH443-014A and meet all inclusion and exclusion criteria. Elvucitabine treatment (10 mg) will begin on Day 1 (Day 15 following completion of Study ACH443-014A) for all consenting participants in combination with background ART as determined by the Principal Investigator. Participants will have clinical and laboratory assessments every 2 weeks for the first 8 weeks and then every 4 weeks to Week 48.

Eligibility Criteria:
Inclusion Criteria:

* Participants who have completed 14 days of treatment in Study ACH443-014A and who, in the Investigator's judgment, remain candidates to receive elvucitabine together with background ART.

Exclusion Criteria:

* Failure to meet inclusion criteria
Individualized Plan for Improving Adherence to Portable Oxygen Therapy in Patients With Respiratory Pathology

Pilot study with patients with prescription of portable oxygen therapy, to test the impact on adherence of a patient-centered empowerment program, with contents on the nature of the respiratory pathology, the symptom of dyspnea, the benefits of the therapy, adjustment expectations and beliefs, as well as health habits.

All patients were summoned to the care center, being evaluated individually by a nurse, and based on the results, a care plan adapted to the specific needs and objectives was initiated. This care plan involved monitoring using different channels (face-to-face, telephone), with the main objective of monitoring the evolution of compliance, adherence and improving the quality of life of patients. The interventions that were carried out were educational and formative (using counseling communication skills), and technological (using monitoring tools in specific cases). The empowerment program was an educational session in which the nurse discussed content about dyspnea, the benefits of therapy, etc.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (over 18 years old) with prescription of portable oxygen therapy by the Pneumology Service of the Sant Joan de Dèu Hospital in Manresa.

Exclusion Criteria:

* Psychophysical inability to carry out questionnaires or refusal to answer them.
* Severe displacement problems.
Prospective Observational Study for Determination of Minimal Clinically Important Difference of Allergic Rhinitis Symptoms Due to Grass Pollen (Equinoxe 2)

Prospective multi-center study carried out in France involving patients with allergic rhinitis. Study in usual care where no specific diagnostic or therapeutic procedure is required. The patients will be asked to fill in Questionnaires on a daily and weekly basis.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients aged between 6 and 65 years.
* Patients who have been informed of the nature and aims of the study and have given their written consent to participate in this study in accordance with local laws and requirements.
* Patient with an Grass pollen-related allergic rhinitis (immunologically and / or symptomatically treated or non treated).
* Patients presented for symptomatic management of allergic rhinitis.
* Patients having Symptoms score ≥ 6.

Exclusion Criteria:

* Patients involved in any other clinical/observational study.
* patients unable to fill in the study questionnaires.
* Patient suffering from any diagnosed disease that may interfere with the evaluation of allergic rhinoconjunctivitis' related quality of life, fatigue and daily activities.
* Patients treated with any drug that may influence the patient's fatigue and/or interfere with psychomotor performance.
* Patients suffering from persistent asthma, or asthma exacerbation during grass pollen season.
PTEN and IGFBP-3 Correlation in Ovarian Carcinoma Invasion

We have identified insulin-like growth factor binding protein (IGFBP)-3 as an invasion suppressor gene in ovarian endometrioid carcinoma, and showed association with lower cancer migration, invasion and metastasis. Recently, a novel model of ovarian EC formation from endometriosis was reported, and PTEN was found to be a major protein involved. Inactivation of PTEN has been reported in some ovarian EC tumors and methylation was suggested as one of the major epigenetic changes. This tumorigenesis model has lots of similarity to our established invasion model. Therefore, we plan to study the important of PTEN expression in ovarian EC and if inactivation of PTEN and IFGBP-3 is through methylation. Furthermore, by studying the signal transduction pathways using PTEN and IGFBP-3 transfection, we plan to study the mutual interaction between PTEN and IGFBP-3 on the suppression of tumor invasion in ovarian EC.

We have successfully established an ovarian cancer cell line (OVTW-59), which was derived from an ovarian endometrioid carcinoma (EC), and have also established an ovarian EC invasion model. By using cDNA microarray and quantitative reverse-transcriptase polymerase chain reaction, we identified insulin-like growth factor binding protein (IGFBP)-3 as an invasion suppressor gene, which were associated with lower cancer migration, invasion and metastasis. Clinically, lower IGFBP-3 was found associated with significantly higher tumor grade, advanced stage and poor survival in patients with EC tumors. Furthermore, we have proved IGFBP-3 expression correlated with lower Erk activation, but with no effect on the activation of Akt. All these two signal transduction proteins have crucial roles in cancer invasion. Recently, a novel model of ovarian EC formation from endometriosis was reported, and PTEN was found to be a major protein involved. Inactivation of PTEN has been reported in some ovarian EC tumors and methylation was suggested as one of the major epigenetic changes. This tumorigenesis model has lots of similarity to our established invasion model. Therefore, we plan to study the important of PTEN expression in ovarian EC and if inactivation of PTEN and IFGBP-3 is through methylation. Furthermore, by studying the signal transduction pathways using PTEN and IGFBP-3 transfection, we plan to study the mutual interaction between PTEN and IGFBP-3 on the suppression of tumor invasion in ovarian EC.

Eligibility Criteria:
Inclusion Criteria:

Clinical diagnosis of ovarian endometrioid carcinoma

Exclusion Criteria:

other types of ovarian epithelial carcinoma