cyrilzakka/clinical-trials huggingface dataset:
The Use of Exosomes In Craniofacial Neuralgia

This study is designed to evaluate the safety and efficacy of exosome deployment in patients with Craniofacial Neuralgia. Secondarily, this study is designed to rigorously evaluate for any adverse events that may be related to the administration and reception of exosomes.

The present study is designed to amplify the delivery of growth factors and anti-inflammatory agents to localized targets (determined by specific condition) by using focused transcranial ultrasound prior to intravenous infusion of exosomes. Exosomes delivered intravenously can be demonstrated to cross the blood brain barrier naturally. Exosomes are thought to play a normal physiological role in intercellular signaling, and demonstrate anti-inflammatory and pro-growth effects in preclinical models and clinical cases reports. Clinical trials have deployed exosomes intravenously and with intracerebral and intrathecal injection, and have claimed safety and clinical efficacy.

Focused ultrasound has been shown to enhance local blood flow and has been presented as a non-invasive means of targeting delivery of therapeutic agents.

Eligibility Criteria:
Inclusion Criteria:

* Male or Female at least 18 years of age
* Clinical diagnosis of craniofacial neuralgia

Exclusion Criteria:

* Subjects unable to give informed consent
* Subjects who would not be able to lay down without excessive movement in a calm environment sufficiently long enough to be able to achieve sleep
* Recent surgery or dental work within 3 months of the scheduled procedure.
* Pregnancy, women who may become pregnant or are breastfeeding
* Advanced terminal illness
* Any active cancer or chemotherapy
* Bone marrow disorder
* Myeloproliferative disorder
* Sickle cell disease
* Primary pulmonary hypertension
* Immunocompromising conditions and/or immunosuppressive therapies
* Macular degeneration
* Subjects with scalp rash or open wounds on the scalp (for example from treatment of squamous cell cancer)
* Advanced kidney, pulmonary, cardiac or liver failure
* Subjects with vascular causes of dementia
* Bleeding disorder, untreated
Effectiveness of Bronchodilator Nebulization With and Without Noninvasive Ventilation in COPD

The study aim to evaluate effectiveness of two bronchodilator nebulization strategies in patients with acute decompensated type 2 respiratory failure due to acute exacerbation of chronic obstructive pulmonary disease..

Decompensated type 2 respiratory failure during acute exacerbation of chronic obstructive pulmonary disease (COPD) is treated with non-invasive ventilation (NIV) and nebulized bronchodilators. Nebulization during NIV can be applied by two methods: in-line nebulization through NIV mask and off-NIV nebulization during which NIV mask is taken off for a short time and reapplied when nebulization is finished.

This study is a prospective randomized controlled trial to compare in-line nebulization through NIV versus off- NIV nebulization. After starting NIV in eligible COPD patients with type 2 respiratory failure, the baseline end-expiratory lung impedance (EELI) will be measured. Patient is randomized to receive either in-line or off-NIV nebulization. EELI will be measured again following completion of the nebulization, 15min after NIV is restarted (off-NIV group) or continued (in-line group). Ultrasound measurement of the thickness of the diaphragm will be recorded at baseline, 15min after NIV is restarted (off-NIV group) or continued (in-line group) and 48 hours after stopping the NIV. The main outcome measure, difference in mean end expiratory lung volume at 15min after NIV is restarted (off-NIV group) or continued (in-line group) between the two nebulization methods will be compared using independent sample T test. Thickness of the diaphragm and changes in the arterial blood gases (in terms of pH and carbon-di-oxide) will be compared between in-line nebulization and off-NIV nebulization.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥21 years.
2. Known or suspected COPD (defined by a ratio of Forced Expiratory Volume in 1 second (FEV1) to Forced Vital Capacity (FVC) of less than 0.7).
3. Acute decompensated type 2 respiratory failure (ABG pH ≤ 7.35 and PaCO2\>45mmHg).
4. Clinical decision made to start NIV.

Exclusion Criteria:

1. Other acute decompensated type 2 respiratory failure related conditions (e.g. neuromuscular, heart failure etc.).
2. Pneumonia present in the chest radiograph.
3. Other conditions which may change lung impedance (e.g. heart failure or lung fibrosis).
Maintenance Therapy: Lenalidomide Following Bendamustine and Rituximab Induction Therapy for Chronic Lymphocytic Leukemia

This study will determine whether or not Lenalidomide improves effectiveness of treatment for chronic lymphocytic leukemia following chemotherapy with two drugs commonly used to treat the disease (bendamustine and rituximab).


Eligibility Criteria:
Inclusion Criteria:

* Previous induction treatment with bendamustine and rituximab
* 18 or more years of age
* chronic lymphocytic leukemia
* ECOG performance status less than or equal to 2
* Absolute neutrophile count more than 1,000
* Platelet count more than 70,000

Exclusion Criteria:

* Serious medical condition that would prevent treatment with lenalidomide
* Evidence of tumor lysis syndrome
* Any prior treatment with lenalidomide
Analyzing Clinical Research Participation of Patients With Spinal Cord Injury

The percentages of participants in clinical studies haven't always been perfectly representative of a particular group.

This research examines the variables that affect a patient's choice to enroll in, discontinue participation in, or resume participation in a clinical trial for spinal cord injury.

It will also try to analyze data from the perspective of different demographic groups to check for recurring trends which might yield insights for the sake of future spinal cord injury research.


Eligibility Criteria:
Inclusion Criteria:

* Aged ≥ 18 years old
* Ability to understand and the willingness to sign a written informed consent document.
* Diagnosis of spinal cord injury

Exclusion Criteria:

* Is pregnant, breastfeeding or expecting to conceive within the projected duration of the study
* Has a serious medical or psychiatric illness likely to interfere with participation in this clinical study.
* Inability to provide written informed consent
A Japanese Phase 1 Trial of TH-302 in Subjects With Solid Tumors and Pancreatic Cancer

This is a Japanese Phase 1, open-label, and dose-escalating trial of TH-302 as monotherapy in subjects with solid tumors and in combination with gemcitabine in subjects with pancreatic cancer.


Eligibility Criteria:
Inclusion Criteria:

* At least 20 years of age
* Signed written informed consent form
* Histologically or cytologically confirmed advanced or metastatic solid tumor previously treated with one or more standard treatment regimen(s) or for which no effective therapy is available
* Histologically or cytologically confirmed locally advanced unresectable or metastatic pancreatic adenocarcinoma previously untreated with chemotherapy or systemic therapy
* Recovered from toxicities of prior anti-cancer treatment to Grade 1 or less
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Life expectancy of at least 3 months
* Acceptable liver function, renal function, hematologic status and coagulation status as defined in the protocol
* No clinically significant abnormalities in urinalysis
* Effective contraception for both male and female subjects if the risk of conception exists
* Other inclusion criteria apply

Exclusion Criteria:

* Prior anti-cancer treatment with more than 3 myelosuppressive cytotoxic chemotherapy regimens
* Prior treatment with gemcitabine for their advanced or metastatic pancreatic cancer, except for radiosensitizing doses of gemcitabine
* Prior radiotherapy to more than 30 percent of the bone marrow within 6 months prior to the trial entry
* Cardiac disease with New York Heart Association (NYHA) Class 3 or 4, within 6 months prior to the trial entry
* Clinically significant (that is, active) cardiovascular disease
* Seizure disorders requiring anticonvulsant therapy
* Known brain, leptomeningeal or epidural metastases (unless previously treated and well controlled for at least 3 months at the trial entry)
* Previously treated malignancies other than the current disease for at least 5 years at the trial entry
* Severe chronic obstructive or other pulmonary disease major surgery, within 4 weeks prior to the trial entry, without complete recovery
* Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy
* Anti-cancer treatment prior to trial entry
* Participation in an investigational drug or device trial within 4 weeks prior to the trial entry
* Known infection with human immunodeficiency virus (HIV), Hepatitis B, or Hepatitis C
* A history of allergic reactions
* Taking a medication that is either moderate or strong inhibitor or inducer of cytochrome P450 (CYP)3A4 or is a sensitive substrate of other cytochrome P450
* Pregnancy or lactation period
* Concomitant disease or condition that could interfere with the conduct of the trial, or that would, in the opinion of the Investigator, pose an unacceptable risk to the subject in this trial
* Unwillingness or inability to comply with the trial protocol for any reason
* Legal incapacity or limited legal capacity
* Other exclusion criteria apply
Impact of Gastric Length of Myotomy During POEM on Gastroesophageal Reflux

This observational study will be conducted among 43 patients of both sexes in each group Study participants will be of the age more than 18 years

* STUDY PROCEDURE-Pre-defined technique to avoid bias and confounding due to multiple factors
* All the poem procedures will be performed by posterior route
* Preservation of sling fibers will be attempted in all the cases to avoid heterogeneity
* Length of esophageal myotomy will be kept constant (4-6cm)
* Double scope technique will be utilized to confirm the gastric extent of myotomy

First evaluation at 1-month: based on Symptoms

• Second evaluation: at 6 months by

* Objective evaluation: UGI endoscopy, High resolution manometry, Timed barium swallow
* Eckardt score, GERD-HRQL
* 24-hour pH study with manual readings

• The primary outcome of the study is the incidence of significant reflux esophagitis (≥grade B) in cases with standard and extended gastric myotomies at 6 months after POEM

Secondary outcomes:

* Significant esophageal acid exposure (\>6%) as defined by the revised Lyon consensus
* Symptoms of GERD (GERD HRQL)
* Clinical efficacy (Eckardt score≤3)
* Esophageal emptying at 5 minutes
* High resolution manometry parameters (LES pressures and Integrated relaxation pressure in mmhg units)
* All the secondary outcomes will be assessed at 6 months after poem procedure

Eligibility:

Eligible cases with idiopathic achalasia (type I and II) will be enrolled in the study and randomized (1:1 ratio) in two groups according to the length of gastric myotomies

INCLUSION CRITERIA :

* Idiopathic achalasia (type I and II)
* Age ≥18 years
* Willing to provide informed consent and comply with the study protocol

Exclusion criteria

* Ineligibility for POEM procedure
* Spastic esophageal motility disorders
* Presence of esophageal diverticulum and hiatal hernia
* Prior hellers myotomy with or with out fundoplication

Eligibility Criteria:
Inclusion Criteria:

* Idiopathic achalasia (type I and II)
* Age ≥18 years
* Willing to provide informed consent and comply with the study protocol

Exclusion Criteria:

* Ineligibility for POEM procedure
* Spastic esophageal motility disorders
* Presence of esophageal diverticulum and hiatal hernia
* Prior hellers myotomy with or with out fundoplication
Pharmacokinetics of IAsp Following CSII in Patients With T1DM

The primary objective of the study is to compare SSPIAsp during CSII giving one bolus per hour compared with multiple boluses per hour.

The secondary objective is to compare SSPIAsp during continuous subcutaneous insulin infusion (CSII) versus continuous intravenous insulin infusion (CIII).

Rapid acting insulin, like insulin aspart, can be administered as CSII. The insulin can be administered as a basal rate with additional insulin administration from the pump related to mealtimes.

Insulin is physiologically secreted in a pulsate manner from the pancreatic β-cells with a period of 5-10 minutes, and this is responsible for plasma insulin oscillations with similar frequency. The oscillatory pattern is believed to optimize control mechanisms of insulin to enhance its action on metabolism.

Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes mellitus (T1DM)
* Insulin pump users' ≥ 48 hours, 24 h dose \< 80 U
* Insulin dose ≥ 0,4 IE/kg/24hours
* 18 years \< age \< 50 years
* Time since diagnosis of T1DM ≥ 5 years
* HbA1c ≤ 8,5 %
* Safe anticonceptive for fertile women
* Being able to understand and read Danish

Exclusion Criteria:

* Dysregulation of endocrine disorders other than type 1 diabetes mellitus
* Severe dysregulation of diabetes mellitus
* Other severe adverse disease
* Pregnancy, planning pregnancy, or nursing
Family Therapy for Adolescent Bulimia Nervosa

The primary hypotheses are:

* A procedurally distinct family therapy is an effective and essential way to reduce bingeing and purging in adolescents with BN, and leads to the long-term amelioration of bulimic symptoms.
* Family therapy is an effective way to bring about meaningful improvements in family interaction.
* Family therapy will produce significantly larger reductions in bulimic symptoms and improved family interaction in adolescents with BN compared to a control supportive psychotherapy.

Bulimia nervosa (BN) is a disabling eating disorder and affects as many as 2% of young women. It is a major source of psychiatric and medical morbidity that often impairs several areas of functioning. Even more alarming is the fact that BN is occurring with increasing frequency among adolescents and preadolescents. Applying stringent diagnostic criteria for BN, studies have found 2-5% of adolescent girls surveyed qualify for diagnosis of BN. Research specific to treatment of child and adolescent eating disorders remains limited. No psychological treatment has been systematically evaluated in the treatment of adolescents with BN. However, a series of studies from the Maudsley Hospital in London have shown that family therapy (the 'Maudsley Approach') is effective in the treatment of adolescents with anorexia nervosa (AN). These studies have shown that involving the parents and siblings in treatment has beneficial effects on reversing the course of the eating disorder as well as improving family interaction. A preliminary report from the Maudsley group has also shown that the 'Maudsley Approach' may be helpful in the treatment of adolescents with BN. Because most young adolescents still live with their families of origin, this raises the interesting clinical question that adolescent BN patients can also be successfully treated with family therapy.

The proposed study has two specific aims:

1. To adapt and pilot a recently developed family therapy manual for adolescent AN for use in the treatment of adolescent BN patients.
2. To compare the efficacy of this conceptually and procedurally distinct family therapy treatment with individual control psychotherapy.

To achieve these aims, we propose a five-year controlled treatment study to be carried out at The University of Chicago. Eighty newly referred adolescent patients meeting DSM-IV diagnostic criteria for BN will be randomly allocated to one of two groups: 1) family therapy or 2) the individual supportive control treatment. All patients will receive the same medical evaluation and monitoring throughout the study period. Assessment of psychiatric and medical outcome measures will be carried out at the onset of treatment, during treatment, at the end of treatment, and again at one-year follow-up. The clinical outcome variables assessed will include the EDE, KSADS, RSE, and EE.

Eligibility Criteria:
Inclusion Criteria:

* DSM-IV criteria for bulimia nervosa or partial bulimia nervosa

Exclusion Criteria:

* psychotic illness acute suicidality medical illness that impacts weight pregnant
A Clinical Study of Anfibatide in Acquired Thrombotic Thrombocytopenic Purpura (TTP)

This is a multicenter, randomized, double-blind, parallel, placebo-controlled phase II clinical study. It is planned to recruit 74 patients with acquired thrombotic thrombocytopenic purpura (TTP). To evaluate the efficacy and safety of Anfibatide as an adjuvant therapy for plasma exchange in patients with acquired TTP.

The study will consist of 3 periods: screening(up to 7 days), treatment and follow-up(up to 3 months). Subjects are assigned in a 1:1 ratio to Anfibatide or placebo during plasma exchange with the use of a computerized randomization schedule. The administration is 5 IU/60kg intravenous infusion and 0.002 IU/kg/h continuous intravenous infusion. Plasma exchange as the main treatment method is performed daily on the 5th day of solstice and then adjusted to every other day. Fresh frozen plasma（FFP）and cryoprecipitate-reduced plasma are preferred. Subjects will receive the study drug immediately after daily plasma exchange.

Eligibility Criteria:
Inclusion Criteria:

1. Female and male subjects with 18 years of age or older.
2. Subjects with diagnosis of TTP.
3. Necessitating plasma exchange.
4. Obtained, signed and dated informed consent.

Exclusion Criteria:

1. Platelet count greater or equal to 100\*10\^9/μL.
2. Severe heart, liver and kidney dysfunction, including those with glutamic-pyruvic transaminase ≥ 5xULN，glomerular filtration rate \<30ml/min.
3. Uncontrolled severe active infection.
4. Known congenital TTP.
5. Subjects with malignant tumors in the past 5 years.
6. Other diseases that cause microangiopathy hemolytic anemia and thrombocytopenia, such as disseminated intravascular coagulation (DIC), antiphospholipid antibody syndrome, hemolytic uremic syndrome, malignant hypertension, and transplant-related microangiopathy.
7. Pregnant or lactating women. Subjects of reproductive age, are unable to use effective contraceptive methods during the study period.
8. Severe active bleeding or progressive aggravation of bleeding symptoms.
9. Subjects who have received plasmapheresis during the treatment of the onset of the disease.
10. Subject is participating in other clinical stuy or is less than 3 months away from the end of previous clinical study.
11. Subject who have participated in other clinical trials related to Anfibatide.
12. Severe or life threatening clinical condition other than TTP that would impair participation in the trial.
13. Life expectation less than 1 week.
14. Known to be allergic to the drugs or ingredients in the study.
15. Inability to follow programme requirements and procedures.
16. Subjects who are not eligible to participate in this clinical study as determined by the investigator.
Efficacy, Safety, and Tolerability Study of Sotagliflozin as Adjunct Therapy in Adult Patients With Type 1 Diabetes Mellitus Who Have Inadequate Glycemic Control With Insulin Therapy

This Phase 3 study was intended to demonstrate superiority of either sotagliflozin high dose or low dose versus placebo on glycosylated hemoglobin A1C (A1C) reduction at Week 24 when used as an adjunct in adult participants with type 1 diabetes mellitus (T1D) who have inadequate glycemic control with insulin therapy.


Eligibility Criteria:
Inclusion Criteria:

* Participants had given written informed consent to participate in the study in accordance with local regulations.
* Adult participants 18 years and older with a diagnosis of T1D made at least 1 year prior to informed consent.
* Participants were being treated with insulin or insulin analog delivered. via continuous subcutaneous insulin infusion (CSII) or multiple daily injections (MDI).
* Willing and able to perform self-monitored blood glucose (SMBG) and complete the study diary as required per protocol.
* At the Screening Visit, A1C must be between 7.0% to 11.0%.
* Females of childbearing potential must use an adequate method of contraception and have a negative pregnancy test .

Exclusion Criteria:

* Use of antidiabetic agent other than insulin or insulin analog at the time of screening.
* Use of sodium-glucose cotransporter (SGLT) inhibitors within 8 weeks prior to randomization.
* Chronic systemic corticosteroid use.
* Type 2 diabetes mellitus (T2D), or severely uncontrolled T1D as determined by the Investigator.
Evaluate The Efficacy, Safety, Pharmacokinetics And Pharmacodynamics Of EVER001

EVER001 is a highly selective, oral, reversable, covalent Bruton tyrosine kinase (BTK) inhibitor with high selectivity over other kinases, which is being developed to treat proteinuric glomerular diseases.

The overall aim of the study is to evaluate the efficacy, safety, pharmacokinetics and pharmacodynamics of EVER001 in subjects with selected proteinuric glomerular diseases. The first targeted is primary membranous nephropathy.


Eligibility Criteria:
Inclusion Criteria:

1. Having clinical diagnosis of primary membranous nephropathy, as verified by biopsy.
2. Have positive anti-PLA2R autoantibody test results \> 20 relative units (RU)/ml.
3. During screening at least one testing of proteinuria must be \>3.5 g/24h.
4. Have nephrotic range proteinuria for at least 8 weeks prior to Day 1 and no improvement (\<50% reduction) despite supportive therapy of ACE inhibitor or ARB unless contraindicated, for patients who have two tests of proteinuria during screening ≥8.0g/24h, the duration of nephrotic range proteinuria for at least 8 weeks is not required.

Exclusion Criteria:

1. Non-primary membranous nephropathy or other condition affecting the kidney.
2. eGFR at screening \< 45 mL/min/1.73m2 or kidney function not stable .
3. Uncontrolled hypertension .
4. Serum albumin level at screening # 25g/l.
5. Have received: B-cell targeted therapy except rituximab at any time;Rituximab and the biosimilars within 2 years (participants with rituximab treatment between 1 and 2 years prior to Day 1 are eligible if there is documented evidence of B-cell repopulation to \>90% of Lower Limits of Normal Range.); Cyclophosphamide or Chlorambucil within 180 days;other immunosuppressive/immunomodulatory agents within 90 days;greater than 30mg/day prednisone or equivalence within 30 days.
6. Acute or chronic infection,including positivity of tuberculosis infection test.
7. Positive serology for TP,HIV, HBV, or HCV.
8. Lab testing abnormality as: WBC\< 3000/mm³, Lymphocyte \< 1000/ mm³, neutrophil \<1500/mm³, Hb \< 80g/L, Platelet count \<100×10e9/ L, Prothrombin time\>1.5×ULN, Activated partial thromboplastin time ≥1.5×ULN, Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≥ 1.5×ULN, alkaline phosphatase and bilirubin \>1.5×ULN.
9. Judged by the investigator that the participant is unlikely to comply with study procedures, restrictions, and requirements.