cyrilzakka/clinical-trials huggingface dataset:
Platelet-Rich Protein and the Endometrium

Platelet-rich plasma (PRP) may promote the endometrial growth and improve pregnancy outcome of patients with thin endometrium undergoing ART treatments.


Eligibility Criteria:
Inclusion Criteria:

* Women undergoing a frozen thawed embryo transfer cycle with poor endometrial response to estrogen (\< 7 mm) after at least two standard preparation protocols, of which one was canceled due to thin endometrium

Exclusion Criteria:

* none
Borderline Resectable Pancreatic Cancer Neoadjuvant Chemoradiotherapy Clinicaltrial-1

This study is to investigate whether neoadjuvant chemotherapy plus SBRT results in better outcomes compared with neoadjuvant chemotherapy alone and also compare the efficacy of gemcitabine plus nab-paclitaxel with SBRT and S-1 plus nab-paclitaxel with SBRT.

This research study is a Phase II clinical trial that investigate whether neoadjuvant chemotherapy plus SBRT results in better outcomes compared with neoadjuvant chemotherapy alone and also compare the efficacy of gemcitabine plus nab-paclitaxel with SBRT and S-1 plus nab-paclitaxel with SBRT. It is known that neoadjuvant therapy is vital for improved survival, which has been confirmed in previous studies that neoadjuvant chemotherapy with or without radiotherapy provides superior overall compared with upfront surgery. However, question of whether the addition of radiotherapy to neoadjuvant chemotherapy can improve prognosis compared with chemotherapy alone is a challenging matter. Also, no studies have evaluated the efficacy of S-1 as the neoadjuvant chemotherapy regimen for BRPC albeit similar prognosis has been found between S-1 and gemcitabine in advanced pancreatic cancer. In this trial, patients with biopsy and radiographically confirmed BRPC will be randomly allocated into three groups: neoadjuvant gemcitabine plus nab-paclitaxel, neoadjuvant gemcitabine plus nab-paclitaxel with SBRT and neoadjuvant S-1 plus nab-paclitaxel with SBRT. Surgical resection will be performed 3 weeks after SBRT. The primary endpoint is overall survival. The secondary outcomes are progression free survival, pathological complete response rate, R0 resection rate and incidence of adverse effects. If results show the survival benefits of neoadjuvant chemotherapy plus SBRT and similar outcomes between S-1 and gemcitabine, it may provide evidence of clinical practice of this modality for BRPC.

Eligibility Criteria:
Inclusion Criteria:

* Age≥18 years old and ≤80 years old;
* Histological proven pancreatic adenocarcinoma;
* Borderline resectable pancreatic cancer proven by imaging examinations via multidisciplinary approaches according to NCCN guidelines;
* No prior chemotherapy or radiotherapy;
* ECOG of 0 or 1;
* Routine blood test: absolute neutrophil count\>1500/mm3, platelet\>100000/mm3;
* Normal liver function: serum total bilirubin≤2.0mg/dl, ALT and AST\<2.5 times of the upper limit of normal value;
* Normal kidney function: serum creatinine\<1.5 times of the upper limit of normal value or creatinine clearance rate\>45ml/min;
* No severe comorbidities.

Exclusion Criteria:

* Metastatic pancreatic cancer;
* Patients who had surgeries, chemotherapy or other treatments before inclusion;
* Impaired organ functions: heart failure (New York Heart Association III-IV), coronary heart disease, myocardial infarction within 6 months, severe cardiac arrhythmia and respiratory failure;
* Confirmed other cancer within 5 years;
* Pregnant women or lactating women;
* Patients enrolled in other clinical trials or incompliant of regular follow up;
* Patients who did not provide an informed consent.
The Weight of Cardiovascular Disease

The purpose of this study is to evaluate the impact of a cardiometabolic clinic on percent body weight loss, body mass index (BMI), and visceral adiposity distribution in obese adults with cardiovascular disease (CVD) at 12 months.


Eligibility Criteria:
Inclusion Criteria:

* BMI ≥30 kg/m2
* At least one of the following CVD: atrial fibrillation (AF), coronary artery disease (CAD), HFpEF (heart failure with preserved ejection fraction), HFrEF (heart failure with reduced ejection fraction), ACHD (adult congenital heart disease), or valvular heart disease
* Patients evaluated in the Cardiometabolic clinic
* Willingness to complete questionnaires/surveys
* Ability to complete monthly self-assessments at home

Exclusion Criteria:

* BMI \<30 kg/m2
* Pregnancy or lactating women
* Hemodynamically unstable CVD
* Active malignancy
* Autoimmune or systemic inflammatory diseases
* Severe renal or hepatic failure
* Being considered unsafe to participate as determined by the study physician
* Taking medications affecting weight or energy intake/energy expenditure in the last 6 months, including weight loss medications, antipsychotic medications, or other medications as determined by the study NP or physician
* Patients with active psychosis, mania, or substance use disorders
A Study of 18F-AlF-NOTA-Neurotensin PET/CT for Imaging Prostate Cancer

The aim of this study is to investigate the clinical value of \[18F\]aluminum fluoride-1,4,7-triazacyclononane-1,4,7-triacetic acid-neurotensin（18F-AlF-NOTA-neurotensin）positron emission tomography / computed tomography (PET/CT) in patients with prostate cancer (PCa).

18F-AlF-NOTA-neurotensin is a radioligand targeting the neurotensinreceptor, which is widely expressed on the cell surface of PCa. The radioligand can be used for the diagnosis and stage of the PCa. A total of 5 volunteers and 60 PCa patients will be subjected to a 18F-AlF-NOTA-neurotensin PET/CT scan. The uptake of 18F-AlF-NOTA-neurotensin in organs and tumor lesions will be quantified as Standardized Uptake Values (SUVmax/SUVmean).

Eligibility Criteria:
Inclusion Criteria:

1. Histologically and/or clinically confirmed and/or suspicious of PCa.
2. Signed informed consent.

Exclusion Criteria:

Claustrophobia (unable to accept PET/CT scanning)
VALID: Study to Compare the Reduction of Predialysis Systolic Blood Pressure With Valsartan Compared to Irbesartan in Patients With Mild to Moderate Hypertension on Long-term Hemodialysis

The purpose of the study is to compare the efficacy, safety and tolerability of valsartan 80 mg (with a starting dose of 40 mg) to irbesartan 150 mg (with a starting dose of 75 mg) in patients on long-term haemodialysis with mild to moderate increased mean supine systolic blood pressure (MSSBP).


Eligibility Criteria:
Inclusion Criteria:

* Patients with mild and moderate hypertension defined by a MSSBP ≥ 140 mmHG and \< 180 mmHG at Visits 1 and 2 for treated and untreated patients
* Chronic hemodialysis for at least 6 months prior to Visit 1 as substitution therapy.
* If treated with epoetin: patients with a stable hematocrit ≤ 40% (± 5%).

Exclusion Criteria:

* Inability to discontinue angiotensin II receptor blockers (ARBs) safely for a period of 1 week, as required by the protocol.
* Treatment with more than 3 different compounds for the treatment of hypertension at Visit 1.
* Atrial fibrillation

Other protocol-defined exclusion criteria may apply.
Head and Neck Melanoma; Access to Staging and Surgical Treatment

Melanoma is a serious type of skin cancer and is the 5th most common cancer in the United Kingdom (UK). It can affect anywhere on the skin including on the head and neck. The cancer often is first noticed as an abnormal mole. Treatment is by removing the cancer with surgery. Early spread of the cancer can be found by testing nearby glands called lymph nodes. This operation is called a sentinel lymph node biopsy (SLNB). If the cancer has spread then new treatments, such as immunotherapy, can be given to help the person live for longer.

The sentinel lymph nodes are usually in the armpits or groin for melanoma on the body, arms or legs. For cancers in the head and neck the sentinel lymph nodes will usually be in the neck. For several reasons SLNB in the neck is not offered in every hospital that manages patients with melanoma. The problem with this is that some patients who could benefit are not offered the new treatments that extend life because it is not known that their cancer has spread.

In this study we aim to gather national data on the management of melanoma of the head and neck including variation in practice between different hospitals. We will use routinely collected anonymous data called 'Hospital Episode Statistics' to look at who is offered SLNB after melanoma of the head or neck, what treatments they have, if their melanoma comes back and how long they survive for.

By doing this, we hope to identify whether SLNB should be made available to everyone diagnosed with melanoma of the head and neck.


Eligibility Criteria:
Inclusion Criteria:

We will use recorded ICD-10 codes to identify patients for the study. All patients over 18 years of age will be included in the study if they have been coded as:

C43.0 Malignant melanoma of lip C43.1 Malignant melanoma of eyelid, including canthus C43.2 Malignant melanoma of ear and external auricular canal C43.3 Malignant melanoma of other and unspecified parts of face C43.4 Malignant melanoma of scalp and neck C43.5 Malignant melanoma of trunk C43.6 Malignant melanoma of upper limb, including shoulder C43.7 Malignant melanoma of lower limb, including hip

Exclusion Criteria:

N/A
Dec+Flu+Bu Conditioning Regimen for Elderly AML in CR Undergoing Allo-HSCT

Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is reported to be able to improve the outcomes for elderly acute myeloid leukemia (AML) in complete remission (CR). At present, the best conditioning regimen for elderly AML in CR remains in discussion. In this prospective study, the safety and efficacy of Dec+Flu+Bu myeloablative conditioning regimens in patients with elderly AML in CR undergoing allo-HSCT are evaluated.

Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is reported to be able to improve the outcomes for elderly AML(older than 60 years) in complete remission (CR). At present, the best conditioning regimen for elderly AML in CR remains in discussion. Flu+Bu conditioning regimen is the most commonly used regimen for elderly AML in CR undergoing allo-HSCT. However, it appears to have higher relapse rate. To reduce the relapse rate, decitabine is added in the conditioning regimen. In this prospective study, the safety and efficacy of Decitabine+ Fludarabine+Busulfan myeloablative conditioning regimens in patients with elderly AML in CR undergoing allo-HSCT are evaluated.

Eligibility Criteria:
Inclusion Criteria:

* AML patients older than 60 years, younger than 80 years
* In complete remission before transplantation
* With HLA-matched sibling donors

Exclusion Criteria:

* Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure)
* Patients with any conditions not suitable for the trial (investigators' decision)
Phase 1/1b Study of MGCD516 in Patients With Advanced Cancer

MGCD516 is a receptor tyrosine kinase (RTK) inhibitor shown in preclinical models to inhibit a closely related spectrum of RTKs including MET, AXL, MER, and members of the VEGFR, PDGFR, DDR2, TRK and Eph families. In this study, MGCD516 is orally administered to patients with advanced solid tumor malignancies to evaluate its safety, pharmacokinetic, metabolism, pharmacodynamic and clinical activity profiles.

During the Phase 1 segment, the dose and regimen of MGCD516 will be assessed; during the Phase 1b segment, the clinical activity of MGCD516 will be evaluated in selected patient populations.

Patients anticipated to be enrolled in Phase 1b will be selected based upon having a tumor type, including but not limited to, non small cell lung cancer and head and neck cancer positive for specific activating MET, NTRK2, NTRK3, or DDR2 mutations, MET or KIT/PDGFRA/KDR gene amplification, selected gene rearrangements involving the MET, RET, AXL, NTRK1, or NTRK3 gene loci, or having loss of function mutations in the CBL gene. In addition patients with clear cell renal cell carcinoma refractory to angiogenesis inhibitors or metastatic prostate cancer with bone metastasis will be enrolled.

During the Phase 1 segment, the dose and regimen of MGCD516 will be assessed.

During the Phase 1b segment, the clinical activity of MGCD516 will be evaluated in selected patient populations. Patients anticipated to be enrolled in Phase 1b will be selected based upon the following cancer diagnosis:

Non-small cell lung cancer with genetic alterations in MET, AXL, RET, TRK, DDR2, KDR, PDGFRA, KIT or CBL.

Head and neck squamous cell carcinoma with genetic alterations in MET.

Clear cell renal cell carcinoma refractory to angiogenesis inhibitors.

Metastatic prostate cancer with bone metastases.

Other cancer diagnosis having a selected genetic alteration in MGCD516 target RTKs.

Eligibility Criteria:
Inclusion Criteria:

* Metastatic or unresectable solid tumor malignancy
* Standard treatment is not available
* Adequate bone marrow and organ function

Exclusion Criteria:

* History of a significant cardiovascular illness
* Prolonged corrected QT (QTc) interval
* Left ventricular ejection fraction \< 40%
* Symptomatic or uncontrolled brain metastases
* Other active cancer
High Dose Icotinib in Advanced Non-small Cell Lung Cancer With EGFR 21 Exon Mutation

This randomized, open-label study is aimed to evaluate the efficacy of high-dose icotinib in treating advanced non-small cell lung cancer patients with positive EGFR 21 exon mutation.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed stage IIIB/IV lung cancer(exclude patients confirmed by sputum cytology)
* Positive EGFR 21 exon mutation or 19 exon deletion
* Age 18-75 years old with performance status of 0 to 2
* With a measurable disease(longest diameters \>=10mm with Spiral computed tomography (CT)and \>=20mm with conventional CT) according to RECIST Criteria
* Adequate hematological, biochemical and organ functions.

Exclusion Criteria:

* Severe systemic disease out of control such as unstable or uncompensated respiratory,cardiac,liver,renal diseases.
* Evidence of interstitial lung diseases
* Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study
the Effect of Probiotics on Aging Population

This study intends to recruit aging population (over 65 years old). The investigators use 16 SrDNA sequencing technology, genome sequencing technology, metabonomics, random forest forecast model, analysing and selecting specific age-related intestinal flora. The investigators select probiotics slowing down senility. Then the investigators use the probiotics to intervene in the aging population. Finally the investigators observe whether the probiotics can delay aging.

This project plans to recruit the aging population (aged over 65 years old) and comprehensively analyze the public database and self-sequencing clinical big data by using 16 srDNA sequencing technology, metagenomic sequencing technology, metabonomics methods and Random Forest (R) prediction model to judge the key bacterial communities and related functional pathways related to aging.Based on the analysis results, the probiotics with the potential to alleviate aging were selected for intervention evaluation of aging population. This topic aims to explore the change process of intestinal flora structure and composition related to aging process.Identify the key intestinal bacteria genera/species/strains associated with aging, and target the pathway and metabolic characteristic spectrum of the key bacterial communities associated with aging;And select and breed specific intestinal bacterial strains related to aging.The aim is to reduce the age-related metabolic abnormalities and chronic inflammation, reduce medical treatment, rationally allocate medical resources, reduce medical costs and improve the quality of life.

Eligibility Criteria:
Inclusion Criteria:

1. Over 65 years old
2. Frail scale score above 3 points

Exclusion Criteria:

1. Severe impairment of liver and kidney function
2. The tumor is advanced and life expectancy is less than 2 years
3. Severe cognitive impairment and inability to cooperate
4. Unable to give informed consent
5. Have participated in other study before
Sexual Timing in Couples Actively Trying to Conceive

This study will asses the effectiveness of two strategies for timed intercourse in couples actively trying to conceive


Eligibility Criteria:
Note: age limits are for female age only

Inclusion Criteria:

* Childless couples trying to conceive
* Relationship length \> one year

Exclusion Criteria:

* Couples that already had achieved a successful pregnancy
* Couples with children
Prevalence of the Wire Syndrome

The Wire Syndrome problem referred to dental displacements that can be described as aberrant, inaccurate, unexplained, or excessive on teeth still contained by an intact orthodontic wire, without detachment or fracture, leading to evolving dental and periodontal, aesthetic and/or functional consequences. The objective of this study was to define the prevalence of mandibular wire syndrome and the associated risk factors.


Eligibility Criteria:
Inclusion Criteria:-students in their 4th, 5th, and 6th year of dental studies at the Côte d'Azur University

- have undergone orthodontic treatment and are wearing a fixed mandibular retainer from canine to canine.

Exclusion Criteria:'- orthodontic treatment in progress

* absence/fracture of orthodontic fixed mandibular retainer
* wearing a removable mandibular retainer.
Effects of Creatine Supplementation in Rett Syndrome

Creatine supplementation in RTT: a randomized controlled trial

Rett Syndrome (RTT) is a neurodevelopmental disorder characterised by apparently normal early development (stage 1 of RTT) followed by loss of purposeful hand use, distinctive hand stereotypes, slow brain growth, loss of language, respiratory irregularities, gastrointestinal disturbances, gait abnormalities, seizures, and mental retardation. These symptoms typically appear between 6 and 18 months of age (stage 2). Subsequently, there is gradual stabilisation of severe mental retardation and motor compromise (stage 3). The majority (70% to 80%) of patients show mutations in the methyl-CpG-binding-protein-2 (MeCP2) gene, located on chromosome Xq28. MeCP2 encodes a transcription repressor protein that is ubiquitously expressed in all tissues.

As RTT primarily affects females, only very few males with mutations in MeCP2 have been identified. Mutations in MeCP2 have also been identified in children with X-linked mental retardation, autism and a clinical phenotype that resembles Angelman Syndrome.

The aim of this study is to investigate the effects of a dietary supplement on the biochemical and clinical parameter of RTT. About 80 % of labile methyl groups generated through the re-methylation cycle are used for the synthesis of creatine within the human organism. Supplementation of creatine will therefore increase the availability of labile methyl groups for different methylation reactions including methylation of DNA.

The study will be double blind and cross-over. The patients will get creatine monophosphate (200 mg/kg/d in three dosages per day) or placebo. After 6 months and a wash-out period of 4 weeks the groups are changed for the next 6 months.

All participants with RTT and mutations in MeCP2 will undergo physical and neurological exam, quantitative EEG, behavioral assessment, laboratory testing, and neuropsychological evaluations. Participants will have a follow-up after 3, 6, 10, 13 and 16 months (3 months after finishing the study), which will include similar assessments.


Eligibility Criteria:
Inclusion Criteria:

* RTT Syndrome, diagnosed by current consensus criteria

Exclusion Criteria:

* taking supplements containing either folic acid or vitamin B12 or knowingly consuming any vitamin-fortified food items
A Study of Recombinant AAV2/6 Human Factor 8 Gene Therapy SB-525 (PF-07055480) in Subjects With Severe Hemophilia A

The purpose of the study is to evaluate the safety, tolerability and time-course profile of FVIII activity after dosing with SB-525 (PF-07055480)

The proposed clinical study uses a recombinant adeno-associated virus 2/6 (AAV2/6) vector encoding the cDNA for the B-domain deleted human F8 (hF8). The secreted FVIII has the same amino acid sequence as approved recombinant anti hemophilic factors (Refacto® and Xyntha®). The SB-525 (PF-07055480) vector encodes a liver-specific promotor module and AAV2/6 exhibits liver tropism, thus providing the potential for long-term hepatic production of FVIII in hemophilia A subjects.

The constant production of FVIII after a single SB-525 (PF-07055480) administration may provide potential benefit in durable protection against bleeding and the complications thereof without lifelong repetitive IV factor replacement administration.

Eligibility Criteria:
Inclusion Criteria:

* Male ≥18 years of age
* Severe hemophilia A (past evidence of circulating FVIII activity of \< 1% normal)
* Treated or exposed to FVIII concentrates or cryoprecipitate for at least 150 exposure days
* ≥12 bleeding episodes if receiving on-demand therapy over the preceding 12 months
* Agree to use double barrier contraceptive until at least 3 consecutive semen samples are negative for AAV 2/6 after SB-525 infusion

Exclusion Criteria:

* Presence of neutralizing antibodies
* Current inhibitor, or history of FVIII inhibitor (except for transient low titer inhibitor detected in childhood)
* History of hypersensitivity response to FVIII
* History of Hepatitis B or HIV-1/2 infection
* History of Hepatitis C, unless viral assays in two samples, collected at least 6 months apart, are negative
* Evidence of any bleeding disorder in addition to hemophilia A
* Markers of hepatic inflammation or overt or occult cirrhosis
* History of chronic renal disease or creatinine ≥ 1.5 mg/dL
* Presence of liver mass on magnetic resonance imaging (MRI), or, positive alpha fetoprotein
* Presence of \> grade 2 liver fibrosis on elastography for subjects with history of treated Hepatitis C or suspicion of chronic liver disease
Construction of the Training Mode Adjustable Equipment Sitting Volleyball

The individual adapted sport modalities concentrate most of the technological development for equipment and auxiliary devices, the collective modalities need implements that aid in the development of training and the game.

The individual adapted sport modalities concentrate most of the technological development for equipment and auxiliary devices, the collective modalities need implements that support, in the development of training and the game. It was developed equipment to assist in the training of technical fundamentals and to improve the efficiency of the motor gesture required for the practice of sitting volleyball in athletes with physical disabilities. Ten athletes, sitting volleyball players, were selected to perform a set of technical fundamentals and their variations. Lift the ball (with two variations), attack and serve, and reception. After the analysis of the movements the equipment was elaborated and constructed based on the measurements made with the athletes, such as contact height with the ball, perimeter, speed and parabola.

Eligibility Criteria:
Inclusion Criteria:

* Have functional classification in national or international level,
* Practice experience of sitting volleyball mode of at least five years
* Participate in weekly training at least three times a week.

Exclusion Criteria:

* Non-acceptance of the athlete to participate in the survey
* Does not have the functional classification for the practice of sport