cyrilzakka/clinical-trials huggingface dataset:
Glycemic Response to Low Sugar Apple Juice

Primary objective of this study is to investigate the effect of sugar reduction (starting from glucose and sucrose, respectively) on postprandial glycemic response to apple juice by comparing the reference food item apple juice (control) with the test product (apple juice with low sugar content) in male humans with impaired fasting glucose (IFG) (5.6-6.9mmol/l resp. 100-125mg/dL) (Kerner and Brückel, 2012 (DDG recommendation)) Secondary objective of this study is to investigate the effect of sugar reduction on postprandial insulinemic response.

Exploratory objectives are to investigate further characteristics of postprandial glucose and insulin response and insulin sensitivity, gastrointestinal side effects and safety aspects.

Objectives:

Investigating the effect of sugar reduction in apple juice on glycemic and insulin response to ingestion of this drink.

Subjects/Methods:

In a double-blind randomized placebo-controlled clinical trial with cross-over design 30 male adults with impaired fasting glucose (IFG) received an oral drink of 500mL: 1. Verum: Apple juice, treated (low sugar content); 2. Control: Untreated apple juice (normal sugar content). Capillary blood glucose and venous plasma insulin were measured twice at baseline and then at times 0 (start of drink), 15, 30, 45, 60, 90 and 120 min.

Eligibility Criteria:
Inclusion Criteria:

1. Males aged ≥ 18y
2. diagnosed impaired fasting glucose (IFG)
3. Written informed consent

Exclusion Criteria:

1. Subjects currently enrolled in another clinical study
2. Subjects having finished another clinical study within the last 4 weeks before inclusion
3. Hypersensitivity, allergy or idiosyncratic reaction to apple, apple juice or other apple containing food
4. Acute or chronic infections
5. Renal insufficiency
6. Gastrointestinal illness
7. History of gastrointestinal surgery
8. Known fructose intolerance
9. Overt Diabetes mellitus
10. Endocrine disorders
11. Any disease or condition which might compromise significantly the hematopoietic, renal, endocrine, pulmonary, hepatic, cardiovascular, immunological, central nervous, dermatological or any other body System with the exception of the conditions defined by the inclusion criteria
12. History of hepatitis B and C
13. History of HIV infection
14. History of coagulation disorders or pharmaceutical anti-coagulation (with the exception of acetylsalicylic acid)
15. Regular medical treatment including OTC, which may have impact on the study aims (e.g. antidiabetic drugs, laxatives etc.)
16. Major cognitive or psychiatric disorders
17. Subjects who are scheduled to undergo hospitalization during the study period
18. Eating disorders (e.g. anorexia, bulimia) or special diets (e.g. vegan, vegetarian)
19. Present drug abuse or alcoholism
20. Legal incapacity
Reduced Toxicity Fludarabine (Flu) + Cyclophosphamide (CPM) + Rabbit Antithymocyte Globulin (rATG) Conditioning Regimen for Unrelated Donor Transplantation in Severe Aplastic Anemia (SAA)

Anti-thymocyte globulin (ATG) has been used in severe aplastic anemia as a part of the conditioning regimen. Among the many kinds of ATG preparations, thymoglobulin had been found to be more effective in preventing graft versus host disease (GVHD) and rejection of organ transplants. As the fludarabine based conditioning regimens without total body irradiation have been reported to be promising for transplantation from alternative donors in SAA, thymoglobulin was added to fludarabine and cyclophosphamide conditioning to reduce GVHD and to allow good engraftment in unrelated donor transplantation. Our previous phase II study of fludarabine, cyclophosphamide plus thymoglobulin conditioning resulted in good engraftment (100%) and survival rate (74%). But grade III/IV toxicities occurred in 25% of patients and all events were treatment related mortalities. As cyclophosphamide is more toxic agent than fludarabine, we plan a new phase II study re; 'reduced toxicity fludarabine, cyclophosphamide plus thymoglobulin conditioning regimen for unrelated donor transplantation in severe aplastic anemia' by reducing dosage of cyclophosphamide and increasing dosage of fludarabine.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of severe aplastic anemia defined by any two or three peripheral blood criteria and either marrow criterion.

   * Peripheral blood

     1. Neutrophils \< 0.5 x 109/l
     2. Platelets \< 20 x 109/l
     3. Corrected reticulocytes \< 1%
   * Bone marrow

     1. Severe hypocellularity (\< 25%)
     2. Moderate hypocellularity (25-30%) with hematopoietic cells representing \< 30% of residual cells
2. No prior hematopoietic stem cell transplantation.
3. Age: no limits.
4. Performance status: ECOG 0-2.
5. Patients must be free of significant functional deficits in major organs, but the following eligibility criteria may be modified in individual cases:

   * Heart: a shortening fraction \> 30% and ejection fraction \> 45%.
   * Liver: total bilirubin \< 2 × upper limit of normal; ALT \< 3 × upper
   * Kidney: creatinine \<2 × normal or a creatinine clearance (GFR) \> 60 ml/min/1.73m2.
6. Patients must lack any active viral infections or active fungal infection.
7. Appropriate donor is available: Matched in 6/6 of A, B, DR loci.
8. Patients (or one of parents if patients age \< 19) should sign informed consent.

Exclusion Criteria:

1. Pregnant or nursing women.
2. Malignant or nonmalignant illness that is uncontrolled or whose control may be jeopardized by complications of study therapy.
3. Psychiatric disorder that would preclude compliance.
4. Congenital aplastic anemia including Fanconi anemia.
5. Manipulated bone marrow.
ConnectedNest: a Digital Platform Connecting Individuals With Cancer to Social Care

Social determinants of health (SDoH) such as housing instability, food insecurity, and financial burden largely shape the health and well-being of individuals, create health inequities, and drive a large portion of avoidable adverse health outcomes and healthcare costs. With new advancements in treatment and rising out-of-pocket expenses, individuals facing cancer are especially vulnerable to the adverse effects of SDoH. To address these barriers, a novel solution is needed to support oncology patients, clinical teams, and community-based organizations (CBOs) across the cancer continuum. In a Phase I contract award, XanthosHealth developed ConnectedNest, a novel electronic social care referral platform to screen for SDoH needs and connect individuals with cancer to social and community services provided by CBOs while engaging the oncology team in the SDoH referral process. Through additional funding, a pilot study was completed in Minneapolis, Minnesota, in partnership with Minnesota Cancer Alliance, involving the collaboration of 14 CBOs focused on cancer. 50 cancer survivors from these CBOs were enrolled to utilize the ConnectedNest platform for a 90-day duration. Our study involved the collection and analysis of crucial metrics related to patient and CBO engagement, SDoH needs, and the volume of feasible social care referrals. In Phase II, the technical features and integration capabilities of ConnectedNest will be enhanced based on learnings in Phase I and completed pilot study. The platform will be implemented and tested among patients seen at multiple oncology clinics, evaluating health outcomes of patients who use the platform.


Eligibility Criteria:
Inclusion Criteria:

* Adults, age 18 and over
* undergoing active cancer therapy or in survivorship
* must be able to read and write in English
* Seen in a participating Minnesota oncology clinic

Exclusion Criteria:

* Children
Abdominal Muscles Strengthening And Pelvic Floor Muscle Strengthening Exercises In Females With Urinary Incontinence

Urinary incontinence is common females., it badly affects their performance and result in psychosocial problems in addition to the barriers that already have been resulted from incontinence. This study combines simple regime of hip adductor a strengthening with pelvic floor muscles. The theme is to test if pelvic floor muscle training can be augmented by incorporating adductor muscle strengthening. If this comes out to be effective, this can be great contribution to gym doing females to improve their urinary incontinence related impairments. Woman would be encouraged to continue regular exercise. This will be randomized clinical trial. There are two groups for the compression of adductors strengthening and pelvic floor muscle strengthening.

The collected data will be entered in SPSS 20.0, Descriptive and Inferential statists will be applied. Results and conclusion will be drawn.

Urinary incontinence is common females., it badly affects their performance and result in psychosocial problems in addition to the barriers that already have been resulted from incontinence. This study combines simple regime of hip adductor a strengthening with pelvic floor muscles. The theme is to test if pelvic floor muscle training can be augmented by incorporating adductor muscle strengthening. If this comes out to be effective, this can be great contribution to gym doing females to improve their urinary incontinence related impairments. Woman would be encouraged to continue regular exercise. This will be randomized clinical trial. There are two groups for the compression of adductors strengthening and pelvic floor muscle strengthening.

Group A: with pelvic floor muscle strengthening is strengthening. Group B: abdominal muscles strengthening exercises. The collected data will be entered in SPSS 20.0, Descriptive and Inferential statists will be applied. Results and conclusion will be drawn.

Eligibility Criteria:
Inclusion Criteria:

* Women aged 25-45 years of age
* Females with abdominal muscles weakness
* Females with pelvic floor muscles weakness
* Females with urinary incontinence

Exclusion Criteria:

* Pregnant females
* Females having any history of trauma
* Any neurological disorders affecting bowl bladder
* Any malignancy in lower abdominal area
Evaluation of Efficacy and Safety of PLN-74809 in Patients With Idiopathic Pulmonary Fibrosis

A Phase 2a, multicenter, 4-part, randomized, double-blind, dose-ranging, placebo-controlled study to evaluate the safety, tolerability, and PK of once-daily treatment with PLN-74809 in participants with idiopathic pulmonary fibrosis.

Four part study:

Part A - 4 week treatment period evaluating PLN-74809 or matching placebo

Part B - 12 week treatment period evaluating PLN-74809 or matching placebo

Part C - 12 week treatment period evaluating up to two intermediatery PLN-74809 doses or matching placebo

Part D - ≥ 24 week treatment period evaluating higher PLN-74809 dose or matching placebo

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of IPF based upon the Fleischner Society guidelines within 3 years from Screening (Part A) or based on ATS/ERS/JRS/ALAT 2018 guidelines within 5 years from Screening (Part B, C \& D)
* FVC % of predicted ≥45%
* DLco (hemoglobin-adjusted) ≥30%
* Participants receiving treatment for IPF with nintedanib or pirfenidone are allowed, if on a stable dose for at least 3 months

Exclusion Criteria:

* Currently receiving or planning to initiate treatment for IPF (fibrosis) with agents not approved for that indication by the FDA
* Forced expiratory volume during the first seconds of the forced breath (FEV1)/FVC ratio \<0.7 at Screening
* Clinical evidence of active infection, including but not limited to bronchitis, pneumonia, sinusitis that can affect FVC measurement or IPF progression
* Known acute IPF exacerbation or suspicion by the Investigator of such, within 6 months of Screening
* Smoking of any kind within 3 months of Screening
Pharmacogenetics of Gastrointestinal Bleeding

Gastrointestinal bleeding is a severe adverse effect occurring in subjects secondary to the use of nonsteroidal anti-inflammatory drugs (NSAIDs). The enzyme CYP2C9 is responsible for the elimination of several NSAIDs. This protein is inactive in 12% of the subjects because of genetic mutations. We hypothesized that individuals carrying such mutations should be at higher risk of gastrointestinal bleeding since they display decreased NSAIDs elimination.

Gastrointestinal bleeding is a severe adverse effect occurring in subjects secondary to the use of nonsteroidal anti-inflammatory drugs (NSAIDs). The enzyme CYP2C9 is responsible for the elimination of most NSAIDs. Several polymorphisms have been observed in CYP2C9. Of these, the CYP2C9\*3 allele, found in 12% of caucasian subjects, leads to reduced function of the enzyme.

We hypothesized that individuals carrying this mutation should be at higher risk of gastrointestinal bleeding since they display decreased elimination of some NSAIDs.

The purpose of this study is to determine whether the frequency for CYP2C9\*3 variant allele is increased in subjects using NSAIDs metabolized by CYP2C9 in comparison with subjects under NSAIDs not metabolized by this enzyme.

The study groups consist of 200 patients suffering from gastrointestinal bleeding after NSAIDs use, divided in 100 patients using NSAIDs metabolized by CYP2C9 and 100 patients using other NSAIDs.

Eligibility Criteria:
Inclusion Criteria:

* Upper gastrointestinal bleeding revealed by hematemesis, melena or lowering of at least 2g/dl of haemoglobin
* Endoscopic report of gastrointestinal ulcer or haemorrhagic lesion
* Immediate antecedents of NSAID therapy

Exclusion Criteria:

* Cirrhosis (Child B or C)
* Coma
* Concomitant therapy with substrates or inhibitors of CYP2C9 : ketoconazole, itraconazole, ritonavir, phenobarbital, rifampicin, depakine, phenytoin, St John's worts
* Patients treated by a NSAID metabolized by CYP2C9 and a NSAID not metabolized by CYP2C9
Connective Tissue Graft From Tuberosity Area and L-PRF Associated With Coronally Advanced Flap for Root Coverage

The aim of the present randomized controlled clinical study is to compare the efficacy of subepithelial connective tissue graft harvested from the maxillary retromolar tubeosity area and L-PRF membranes in the treatment of RT1 recessions by coronally advanced flap.

A total of 30 patients will be recruited and randomly assigned to the test group treated with CAF+tSCTG or the control group treated with (CAF+L-PRF). For each experimental site the parameters of gingival recession (GR), pocket depth (PD), clinical attachment level (CAL), keratinized gingiva width (KT) and gingival thickness (GT) will be analyzed at baseline (T0) and at 12 months after the surgical procedure (T1). In addition, was also evaluated the different morbidity of the two surgical techniques, using the VAS scale values recorded in the first 2 weeks following surgery. It was checked the Patient Related Esthetic Score and Dentine hypersensivite reduction.


Eligibility Criteria:
Inclusion Criteria:

* Presence of a class RT1 recession;
* age \> 18 years;
* systemic health conditions that do not affect the periodontium;
* Non smoker;
* FMPS and FMBS values \< 20% before the surgical procedure;
* absence of implants or subgingival restorations in the sites to be treated;
* presence of adequate tissue distal to the last maxillary molar.
Study to Evaluate Satisfaction After Treatment With Kysse

Open-label, phase IV, post-marketing study to evaluate aesthetic improvement and satisfaction after treatment with Kysse.


Eligibility Criteria:
Inclusion Criteria:

* Signed and dated informed consent to participate in the study
* Adult women and men who intend to undergo lip augmentation

Exclusion Criteria:

* Subjects presenting with known allergy to HA (hyaluronic acid) filler or amide local anesthetics
* Subjects with a previous implant other than HA in or near the intended treatment site
* Participation in any other clinical study within three (3) months before treatment
Cardiorespiratory Assessment and Quality of Life After Surgical Correction of Congenital Wall Malformations

The main objective of this study is to characterize the cardiorespiratory functional gain in patients with pectus excavatum following corrective surgery.

The secondary objectives are:

* To measure the quality of life of patients operated on for pectus excavatum
* Identify and describe post-operative complications
* Follow-up on the body mass index changes post-surgery
* Evaluate intraoperative hemodynamic parameters before and after the retrosternal bar is placed non-invasively

Eligibility Criteria:
Inclusion Criteria:

* Patient with pectus excavatum
* The patient received corrective surgery within four years of enrollment and is scheduled for a follow-up visit --OR-- the patient is scheduled for corrective surgery during the inclusion period
* Collection of informed written consent (patient and legal guardian, if applicable)
* Obligation of affiliation or beneficiary of a social security programme

Exclusion Criteria:

* Impossibility for the patient to participate in his/her next annual follow-up visit
* Absence of exercise test data AND respiratory function test data performed during the preoperative check-up
* Subject in exclusion period required by another protocol
* Pregnant or lactating woman, patient unable to give consent, protected adult, vulnerable persons (according to French Health Code articles L.1121-6, L.1121-7, L.1211-8, L.1211-9)
* Subject deprived of liberty by judicial or administrative decision
* Participation of the subject in another interventional protocol
* Failure to properly inform the patient (e.g. a language barrier)
Mucopolysaccharidosis VII Disease Monitoring Program

The objectives of this study are to characterize MPS VII disease presentation and progression and assess long-term effectiveness and safety, including hypersensitivity reactions and immunogenicity of vestronidase alfa.

The Mucopolysaccharidosis VII Disease Monitoring Program (MPS VII DMP) is a global, prospective, multicenter, longitudinal protocol designed to characterize MPS VII disease presentation and progression, assess long-term effectiveness and safety of vestronidase alfa, including hypersensitivity reactions and immunogenicity , as well as prospectively investigate longitudinal change across biomarker(s), clinical assessments, and patient/ caregiver-reported outcome measures in a representative population. The aim of this DMP is to collect data on patients with MPS VII to provide a comprehensive dataset on the clinical presentation, heterogeneity, and disease progression, and meaningful standardized ICH GCP-quality data collected in-clinic across multiple sites globally. The DMP is not a randomized study and both treated and untreated patients will be enrolled.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of MPS VII based on laboratory diagnosis, including either enzymatic or mutation analysis.
* Willing and able to provide written informed consent or, in the case of patients under the age of 18 (or below adult ages as defined by local laws and regulations) or patients \>18 years of age who have cognitive deficiencies, provide written assent (if required) and written informed consent by a legally authorized representative after the nature of the DMP has been explained, and prior to any research-related procedures.
* Willing to comply with DMP visit schedule.

Exclusion Criteria:

* Concurrent participation in other pharmaceutical company-sponsored interventional clinical trial unless approved by Ultragenyx.
Importance of Early Rehabilitation in Stroke Patients

Stroke is one of the leading health problems in the community and it is the most common life-threatening neurological disease impairing the quality of life. Early rehabilitation of stroke is very important. The purpose of our study was to evaluate, through clinical examination, whether there was any difference between patients who underwent early rehabilitation and those who underwent late rehabilitation in terms of improvements in motor and functional impairment after rehabilitation, and also to evaluate this difference objectively by analyzing white-matter pathways (corticospinal tracts) using DTI.

Methods: Twenty-eight (28) adults (12 women, 16 men, average age 58 years) with first-time stroke who met the study criteria were divided into two groups depending on the duration of their stroke at the time of their presentation to our facility. Group 1 consisted of patients who underwent rehabilitation program within the first 1-4 weeks after stroke, whereas Group 2 consisted of patients who underwent rehabilitation program within 5-8 weeks after stroke. Both groups were evaluated using the BRS, FMA scale, FAC and BI scales. For cranial imaging, DTI was obtained 1 day before and 1 day after treatment. FA and ADC values of corticospinal tracts were performed using DTI.

Intervention: Patients were enrolled in a rehabilitation program, which was designed for a total of 4 weeks, with daily sessions lasting a total of 1 h on 5 days of a week.

Eligibility Criteria:
Inclusion Criteria:

* Patients suffering cerebrovascular accident (CVA)-associated stroke for the first time with a cortical or subcortical unilateral ischemia or hemorrhage
* The patients aged 35-75 years
* Patiients with ability to understand and follow the instructions
* Patients with the absence of serious cognitive deficits.

Exclusion Criteria:

* Patients who had spinal-cord lesion
* Patients who had history of traumatic brain injury,
* Patients who had accompanying neurological disease (multiple sclerosis, Parkinson's disease, dementia)
* Patients who had tumor
* Patients who had history of convulsions
Prevalence of NAFLD in ACS Patients

Addressing CVD risk in patients with NAFLD is the aspect of the disease most amenable to medical management and so improving long-term clinical outcomes. Almost no studies have been done concerning the prevalence of NAFLD in CVD patients, most of the conducted studies have been done in already diagnosed NAFLD patients to estimate the risk of CVD development. Currently, there are no data available about the prevalence of NAFLD in CVD, more specifically patients with an acute cardiovascular event (ACE) in Belgium.


Eligibility Criteria:
Inclusion Criteria:

* \>18 years
* having acute cardiovascular syndrome
* able to understand Dutch
* able to understand the informed consent

Exclusion Criteria:

* excessive alcohol abuse
* other liver disease
* secondary causes of steatosis
Improving Care Coordination for Adolescents and Young Adults With Cancer

The purpose of this research is to test an intervention designed to identify cancer needs and connect patients with services that address those needs. Participation in this research will involve completing 2 online surveys over the course of 1 month; each should take about 15 minutes to complete.

Adolescents and young Adults (AYA) Needs Assessment \& Service Bridge (AYA NA-SB) includes a holistic Patient Reported Outcome Measures (PROM) assessing AYAs' physical, psychosocial and practical needs and a collection of referral pathways for connecting AYAs to services and resources based on the needs they report.

To assess the implementation of AYA NA-SB, the study team will pilot AYA NA-SB in the North Carolina Cancer Hospital (NCCH)/ UNC Children's Hospital, with a primary focus on implementation outcomes (i.e., feasibility, acceptability, appropriateness, fidelity). To establish proof-of-concept for AYA NA-SB, the study team will use pilot data to generate preliminary evidence on the extent to which AYA NA-SB addresses AYAs' reported needs.

Eligibility Criteria:
Inclusion Criteria:

* AYAs with cancer ages 18 through 39 currently undergoing cancer treatment at the North Carolina Cancer Hospital/ UNC Children's Hospital

Exclusion Criteria:

* Patients who decline to participate in the study