cyrilzakka/clinical-trials huggingface dataset:
Detection of C-peptide in Youth With Longstanding Type 1 Diabetes Mellitus

Background Type 1 diabetes is characterized by pancreatic beta-cell destruction and an inability to synthesize insulin. Connecting peptide (C-peptide) is formed from the same precursor as insulin and is produced in equimolar amounts as insulin. There are several clinical trials currently being performed to explore the possibility of beta-cell preservation or regeneration. Most children are not eligible for these trials because it is often presumed that C-peptide levels will decrease and become undetectable after years of having type 1 diabetes. Several studies in the adult population have demonstrated that C-peptide may remain measureable in patients who have had diabetes for up to 50 years after diagnosis. Recently, it was demonstrated that 10% of adult patients who have had type 1 diabetes for 31-40 years have measureable levels of serum C-peptide if measured with an ultrasensitive assay. The levels were lower in patients who had diabetes for a longer time. This pattern was also demonstrated in the Diabetes Control and Complications Trial (DCCT) and NHANES trial. No studies have been performed exclusively in pediatric patients Hypothesis The investigators hypothesize that C-peptide should be detectable in the sera of pediatric patients who have had type 1 diabetes for greater than 1 year and as far out as \> 20 years after diagnosis. The investigators also hypothesize that since their patient population has had diabetes for less time as compared to adults, the levels of C-peptide should be higher than reported for adults and that a greater proportion of patients in the pediatric population will have detectable C-peptide levels as compared to adults.

1) Objectives:

1. To determine if C-peptide is detectable in the sera of children that have had type 1 diabetes for more than 1 year using an ultrasensitive assay.
2. To correlate C-peptide levels with duration since diagnosis, current age, antibody titers at diagnosis, hemoglobin A1c, total daily insulin dosage.
3. To determine responsiveness of residual C-peptide to mixed-meal testing.

Eligibility Criteria:
Inclusion Criteria:

* Male or female
* 1-25 years of age
* Have had type 1 diabetes for more than 1 year.

Exclusion Criteria:

* Does not meet inclusion criteria
* Foster children
* Patients without primary caregiver
* Pregnant
Influence of Manual Diaphragm Release on Pulmonary Functions in Women With COVID-19

Manual noninvasive respiratory techniques gained interest to treat respiratory pathologies related to COVID 19. This study designed to determine the combined effect of manual diaphragmatic release technique with the effect of conventional breathing exercises and prone positioning on pulmonary function parameters (FVC, FEV1, PEF, FEV1/FVC, FEF25, FEF50, FEF75, FEF25/75).

Forty females were randomly assigned to two groups. Group A received manual diaphragm release with conventional breathing exercises and prone positioning. Group B received conventional breathing exercises and prone positioning. Both groups took their prescribed medications. Their ages ranged from 35 to 45 years and with moderate COVID-19 illness. Any cases with mild and severe COVID-19 illness, ICU admission, and chest diseases were excluded.

Main measures: pulmonary function parameters (FVC, FEV1, PEF, FEV1/FVC, FEF25, FEF50, FEF75, FEF25/75).

Eligibility Criteria:
Inclusion Criteria:

* women with moderate COVID-19 illness diagnosed by a physician.
* Patients with o2 saturation \>94%Nonsmoker subjects.
* age ranging from 35-45 years.
* body mass index from 25 to 34 kg/m2.

Exclusion Criteria:

* Unstable hemodynamic status.
* Acute respiratory failure requiring intubation and impaired consciousness.
* Inability to collaborate with prone positioning with refusal.
* Change of mental status hindering response to instructions.
* Poorly controlled hypertension (Mean systolic BP \> 140 mmhg and \\or diastolic BP \> 40 mmhg).
* Patients who take continuous o2 supplementation.
* Smoking.
* Other chest diseases as (COPD-asthma-tuberculosis-cancer).
* Male patients.
Relationship Between Modified Closed Kinetic Chain Upper Extremity Stability Test and Shoulder Endurance Test in Young Active and Sedentary Individuals

This study is planned to examine the relationship between Closed Kinetic Chain Upper Extremity Stability Test (CKCUEST) performance with Posterior Shoulder Endurance Test in healthy young adults. Both tests are frequently used in athletes, but their use in sedentary people is not common in the literature. The feasibility of using these tests in sedentary people is not clear.


Eligibility Criteria:
Inclusion Criteria:

* Healthy young adults aged between 18-25
* Volunteered for the study

Exclusion Criteria:

* Participants who had any injury on upper extremity in last 6 months
* Participants with moderately active results on IPAQ-SF
Influence of Carbohydrate on Amino Acid Absorption From Dietary Protein (ICADP)

10 young males will be recruited to participate in a randomized double blinded crossover study to investigate the influence of concomitant intake of two different types of carbohydrate with protein hydrolysate on the absorption kinetics of protein-derived amino acids and the impact on myofibrillar protein synthesis. During the trial days the subjects will perform a bout of whole body resistance exercise and ingest a supplement of meat hydrolysate labeled with D5-phenylalanine together with randomized and double blinded type of carbohydrate consisting of either glucose or cluster dextrin.

The primary outcome is the time to obtain peak concentration of D5-phenylalanine after intake of meat hydrolysate with either glucose or cluster dextrin.

Hypotheses:

I) The cluster dextrin will increase the absorption of the amino acids from the meat hydrolysate, and thereby result in a faster rise and a higher peak in plasma amino acid concentration in the postprandial period.

II) The meat hydrolysate will increase the protein synthesis rate to a higher extent when combined with cluster dextrin than with glucose.


Eligibility Criteria:
Inclusion Criteria:

* young healthy adults,
* organised sport/training 1-3 times per week

Exclusion Criteria:

* Subject younger than 18 years or above 30 years
* BMI \> 30
* Chronic medical diseases: active cancer, renal diseases, metabolic diseases like diabetes mellitus.
* Physical inactivity. Subjects must participate in systematized weekly exercise 1-3 times per week.
* Participating in systematized exercise more than 3 times per week.
* Vegetarian.
* Participating in a special diet which deviates from the standard of young adults.
Resting Energy Expenditure in Patients With Cystic Fibrosis: A Pilot Study

Cystic fibrosis is an inherited disorder that causes severe damage to the lungs, digestive system, and other organs in the body. Individuals with cystic fibrosis often have poor weight gain and growth that can negatively impact health further by worsening lung function. Additionally, persons with the disease typically need more than the usual calories on a daily basis.

Most institutions estimate these patients' caloric needs using weight, age, and sex based mathematical formulae. However, numerous studies show that use of these formulae often yields inaccurate caloric values. Use of indirect calorimetry may give more accurate estimates of caloric needs in patients with cystic fibrosis.

The aim of our study is to assess the accuracy of caloric estimates generated using one such widely used mathematical formula, the Harris-Benedict equation, and to compare this calorie value with that obtained from indirect calorimetry testing in pediatric and adult patients with cystic fibrosis.

Study investigators will use the newly calculated caloric requirements in dietary counseling. Changes in weight and lung function after 3 months will be compared to participants' historical changes.


Eligibility Criteria:
Inclusion Criteria:

* Patients with cystic fibrosis who are equal to or older than six years of age presenting to West Virginia University-Charleston Cystic Fibrosis Center for their regularly scheduled appointments/check-ups.
* Patients at the Cystic Fibrosis Center for at least 12 months.

Exclusion Criteria:

* Patients with cystic fibrosis who are younger than 6 years of age.
* Patients without cystic fibrosis.
* Patients currently pregnant.
* Cystic fibrosis patients with significant disease exacerbation (such as needing oral steroids or antibiotics, hospital admission within 30 days) or patients who currently having the flu or a serious upper respiratory infection.
MC-19PD1 CAR-T in Relapsed or Refractory B Cell Lymphoma

This is a single center, single arm, open-lable phase 1 study to determine the safety and efficacy of CD19-CAR-T cells in patients with relapsed or refractory B-cell lymphoma.

In this single-center, open-label, nonrandomized, no control, prospective clinical trial, appoximately 15 relapsed or refractory B-cell lymphoma patients will be enrolled. Side effects of CD19 CAR T cells therapy will be monitored. The purpose of current study is to determine the clinical efficacy and safety of CD19 CAR T cells therapy in patients with R/R B-cell lymphoma

Eligibility Criteria:
Inclusion Criteria:

（1）CD19 positive B-cell lymphoma; （2）Relapsed and refractory B-cell lymphoma: patients previously received at least first-line and second- line treatment and fail to achieve CR; （3）At least 1 measurable tumor foci according to the 2014 Lugano treatment response criteria; （4）18 to 70 Years Old, Male and female; （5）Expected to survive for more than 3 months; （6）Clinical performance status of ECOG score 0-1; （7）Important organ function is satisfied: cardiac ultrasound indicates cardiac ejection fraction ≥50%; serum Cr ≤ 1.25 times normal range or creatinine clearance calculated by Cockcroft-Gault formula ≥45ml/min; ALT and AST≤ 3 times normal range, total bilirubin ≤ 1.5times normal range; （8）hemoglobin ≥ 80 g / L, neutrophils ≥ 1.0 × 10 \^ 9 / L, platelets ≥ 50 × 10 \^ 9 / L.

（9）INR≤ 1.5times normal range; APTT≤ 1.5times normal range; （10）Women in childbearing age must be not pregnant and do not plan pregnancy within 1 year of their cell transfusion; （11）Informed consent is signed by a subject or his lineal relation.

Exclusion Criteria:

1. Recent or current use of glucocorticoid or other immunosuppressor or Drug that stimulates bone marrow hematopoiesis;
2. Uncontrolled systemic active infection: fungi, bacteria, viruses or other infections;
3. Active infection with HBV, HCV or HIV;
4. Patients with symptoms and disease history of central nervous system;
5. Pregnant or lactating female；The patient did not agree to use effective contraception during the treatment period and for the following 1 year；
6. Patients receiving allogeneic hematopoietic stem cell transplantation, or organ transplantation
7. A history of other malignant tumors;
8. Primary immunodeficiency disease, or autoimmune disease;
9. Patients treated with PD-1 inhibitors or PD-L1 inhibitors prior to enrollment;
10. Patients who participated in other clinical trials within 4 weeks before blood collection;
11. Patients who had used CD19 targeted therapy before enrollment;
12. The investigator believes that there are other factors that are not suitable for inclusion or influence the subject's participation or completion of the study.
Fluid Balance During Closure of Atrial Septal Defect

This project will evaluate fluid balance and oedema formation in children with the same congenital heart disease (Atrial Septal Defect) who will either go through heart surgery with the use of Cardio Pulmonary Bypass and hypothermia or through interventional catheterization. The investigators will measure interstitial colloid osmotic pressure, distribution of proteins and cytokines. The study hypothesis is that "Oedema developed during heart surgery is caused by reduced colloid osmotic pressure gradient through the capillary membrane".


Eligibility Criteria:
Inclusion Criteria:

* The diagnosis of Atrial Septal Defect scheduled for closure
* Informed consent

Exclusion Criteria:

* Renal failure,
* liver failure,
* coexisting cardiac malformations
Electrically Guided Bachmann's Bundle Pacing: A Lead Placement Strategy With Potential Antiarrhythmic Benefits

Despite identification of optimal ventricular pacing sites, which not only avoid dyssynchronous activation but can restore ventricular synchrony, optimal atrial pacing sites have not yet been identified. Specialized conduction tracts do not exist in the atria as they do in the ventricle. Activating the atria in a manner that preserves or improves interatrial synchrony may provide clinical benefit based on recent data. Prior site-selective right atrial septal pacing (RAS) pacing studies relied on non-specific fluoroscopic guidance during lead placement. These studies were limited by the lack of an electrogram target and electrical measures of successful atrial resynchronization. The goal of this study is to prospectively evaluate Bachmann's bundle lead placement guided by fluoroscopy and electrical markers (an endocardial electrogram target and paced P-wave criteria) and determine its anti-arrhythmic efficacy compared with right atrial appendage (RAA) pacing. Patients presenting for pacemaker placement with an indication for an atrial lead are randomized to either electrically-guided BB lead placement or RAA lead placement and then followed for 15 months.


Eligibility Criteria:
Inclusion Criteria:

* Subject is \>18 years old
* Subject is referred for permanent pacemaker implantation with an indication for an atrial lead
* Subject has either paroxysmal atrial fibrillation or baseline intra-atrial conduction delay (P-wave duration \>120ms on a 12-lead ECG)
* Subject is expected to remain available for standard-of-care pacemaker follow-up visits and study questionnaires

Exclusion Criteria:

* Subject has permanent atrial fibrillation or is in atrial fibrillation in the pre-operative area prior to the procedure (inability to assess paced P-wave morphology)
* Subject has pacemaker implantation prior to planned atrioventricular nodal ablation
* Subject has resting spontaneous sinus rate \>85 beats-per-minute
* Subject has left ventricular ejection fraction \<45%
* Subject is unable or unwilling to complete baseline or follow up quality of life questionnaires
* Subject is currently enrolled in a potentially confounding trial
* Subject is pregnant
* Subject's anticipated life expectancy is less than 1 year
A Search for Helicobacter Pylori in Localized Vulvodynia

Hypothesis: to examine a possible association between localized vulvodynia and H. pylori infection.

Subsequent sections from the paraffin blocks were prepared and stained by modified Giemsa. Immunostaining for H. pylori was done as described. In short, tissue sections were deparaffinized in xylene, rehydrated through decreasing concentrations of alcohol ending in phosphate-buffered saline (PBS), and subjected to pretreatment with Proteinase K (8 minutes). The sections were quenched with 3% hydrogen peroxidase, incubated with protein block for 15 minutes at room temperature, and washed in PBS. Tissues then were incubated with polyclonal rabbit anti-H pylori antibody (dilution, 1:10; clone ch-20 429, DAKO, Carpinteria, CA). Finally, sections were washed in 0.05% polysorbate 20 in PBS, pH 7.4, and the bound antibody was detected using streptavidin and biotinylated secondary antibody with diaminobenzidine as the chromogen. Sections were counterstained with hematoxylin, dehydrated, and mounted. Negative controls were sections treated as above, but instead of incubation with the primary antibody, they were incubated with 1% bovine serum albumin in PBS.

Vulvar biopsies of seven other women without localized vulvodynia served as healthy controls.

The positive and negative control gastric tissues for the immunohistochemical stain of the H. pylori microorganisms were obtained from the archives of the Department of Pathology.

Eligibility Criteria:
Inclusion Criteria:

* Paraffin blocks of vestibular tissues from patients with Vestibulodynia

Exclusion Criteria:

* Patients without vestibulodynia
Nutritional Strategies to Increase Nitric Oxide Signaling in Raynaud's Phenomenon

The investigators aim at comparing the efficacy of a 2 weeks supplementation by L-citrulline or beetroot juice to L-citrulline placebo or denitrated beetroot juice respectively on Raynaud's phenomenon severity. Raynaud's phenomenon severity will be assessed through the Raynaud Condition Score, daily frequency of attacks or cumulative attack duration (expressed as min) daily collected by patients in a diary. Each Volunteer will choose his own main outcome among these 3 criteria.

Raynaud's phenomenon (RP) is a clinical condition that follows an exaggerated vasoconstriction of extremities in response to a cold or emotional stress. Microvascular dysfunction and alteration of the endothelial NO-dependent vasodilatation pathway through NO synthases (NOS) represents one of the main mechanisms.

A pharmacological treatment in RP is proposed to patients when conservative measures are not efficient enough to control the symptoms: calcium channel blockers remains the first line, phosphodiesterase type 5 inhibitors as a second line treatment, while intravenous iloprost remains restricted to patients with digital ischaemia. Vasodilator therapies are commonly associated with side effects due to the non-specific systemic vasodilation that often result in permanent discontinuation. Many patients prefer complementary and alternative therapies, but none has proven its efficacy. Therefore, there is still room for improvement in the treatment of RP, and research is needed in this area.

Eligibility Criteria:
Inclusion Criteria:

* BMI \> 18
* Active Raynaud's Phenomenon characterized by a clinical history of Raynaud's

  1. Primary RP or secondary to limited (LSSc), limited or diffuse cutaneous scleroderma (lcSSc or dcSSc) according to the criteria of Leroy and Medsger.
  2. At least 1 RP attacks per week and a specific finger patient picture in RP attack (assessed over the 2 weeks preceding inclusion)
* Stable disease over the previous two months (i.e. recent diagnosis of SSc will be excluded)
* Patients insured by a social security scheme or beneficiaries of such a scheme
* Patients who have dated and signed the informed consent form

Exclusion Criteria:

* Uncontrolled hypertension, uncontrolled diabetes mellitus, uncontrolled angina
* Haemodynamic instability
* Pregnancy (or considering pregnancy in next 4 months) or breast feeding
* Subject in an exclusion period from another study,
* Subject under administrative or judicial supervision
* Subject not able to be contacted in case of emergency
A Safety and Tolerability Study of VRDN-003 in Participants With Thyroid Eye Disease (TED)

This is a clinical trial assessing the safety and tolerability of an investigational drug, VRDN-003, in participants with Thyroid Eye Disease (TED).

This is a randomized (meaning participants will be assigned to study arms by chance), double-masked (meaning study doctor and participant will not know which study arm participant is assigned to), controlled study that will include participants with TED of any duration. The key objectives of this study are to determine if VRDN-003 is safe and tolerable when administered as a series of subcutaneous (SC) injections every 4 weeks or every 8 weeks in participants with TED.

Eligibility Criteria:
Inclusion Criteria:

* Have a clinical diagnosis of TED with or without proptosis and with any CAS (0-7) and in the opinion of the Investigator may benefit from VRDN-003
* Not require immediate ophthalmological or orbital surgery in the study eye for any reason.
* Must agree to use highly effective contraception as specified in the protocol
* Female TED participants must have a negative serum pregnancy test at screening

Exclusion Criteria:

* Must not have received prior treatment with another anti-IGF-1R therapy
* Must not have received systemic corticosteroids for any condition, including TED, or selenium within 2 weeks prior to first dose.
* Must not have received other immunosuppressive drugs for any condition, including TED, or any other therapy for TED within 8 weeks prior to first dose
* Must not have received an investigational agent for any condition, including TED, within 8 weeks prior to first dose
* Must not have received radioactive iodine (RAI) treatment within 8 weeks prior to first dose
* Must not have had previous orbital irradiation or decompression surgery for TED to the study eye's orbit
* Must not have a pre-existing ophthalmic condition in the study eye which in the study doctor's opinion, would interfere with interpretation of study results
* Must not have abnormal hearing test before first dose. Must also not have a history of ear conditions considered significant by study doctor
* Must not have a history of inflammatory bowel disease
* Female TED participants must not be pregnant or breastfeeding
A Study To Assess the Adverse Effects and Change in Condition of OnabotulinumtoxinA X Injection in Adult Participants With Forehead Lines

Facial lines that develop from repeated facial expression, such as forehead lines (FHL), are typically treated by selectively weakening specific muscles with small quantities of botulinum toxin. OnabotulinumtoxinA X is being investigated as another form of treatment to treat FHL by inhibiting the release of the neurotransmitter that causes the overactivity of the muscles responsible for the severity of these facial lines. The purpose of this study is to evaluate the safety and change in condition of 3 doses of OnabotulinumtoxinA X for the treatment of moderate to severe forehead lines.

Study doctors will determine if a subject is eligible for the study. If so, the subject will be randomized into 1 of the 4 groups, called treatment arms. There is a 1 in 4 chance that a participant will be assigned to placebo. Around 120 adult participants with FHL will be enrolled in the study in approximately 10 sites in the United States.

Participants will receive either intramuscular injections of onabotulinumtoxinA X or placebo.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular monthly visits during the study at the study site.


Eligibility Criteria:
Inclusion Criteria:

* Participant has sufficient visual acuity without the use of eyeglasses (contact lens use is acceptable) to accurately assess their facial lines
* Participant has moderate or severe Forehead Lines (FHL) at maximum eyebrow elevation

Exclusion Criteria:

* History of known immunization to any botulinum toxin serotype.
* History of known hypersensitivity to any botulinum toxin serotype, or any other constituents of the study drug or its excipients, and/or other products in the same class.
* Presence or history of any medical condition that may place the participant at increased risk following exposure to OnabotulinumtoxinA X or interfere with the study evaluation, including:

Diagnosed myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis, or any other significant disease that might interfere with neuromuscular function.

* History of Facial nerve palsy.
* Infection or dermatological condition at the site of study drug injection.
Treatment of Shoulder Osteoarthritis

The purpose of this study is to learn if pain can be relieved by delivering small amounts of electricity ("electrical stimulation") to the nerves relaying sensory information to the shoulder. This study will use a device called Sprint PNS system. PNS stands for Peripheral Nerve Stimulation. This device is cleared by the FDA for up to 60 days of use for relief of chronic or acute pain.


Eligibility Criteria:
Key Inclusion Criteria:

* Diagnosed with degenerative changes within the shoulder complex

Key Exclusion Criteria:

* Pain exclusively in the anterior aspect of the shoulder
* Opioids for any condition other than shoulder pain
* Other implanted electronic device