cyrilzakka/clinical-trials huggingface dataset:
An Expanded Access IND for the Treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

This is an Individual Patient Expanded Access IND to evaluate the safety and preliminary efficacy of autologous HB-adMSCs for treating a single patient Chronic Inflammatory Demyelinating Polyneuropathy, CIDP. The expanded access program will include a screening period of up to 28 days, a 44-week treatment period, a safety follow-up at 50, and a 52-week end-of-study visit.

An informed consent form will be given to the participant, who will sign before any procedures.

The informed consent form will include information about this expanded access and all the aspects considered during this process. The participant is required to complete the subsequent visits after they have given their informed consent.

* Visit 1 - Screening during this period, the principal investigator will determine whether the screened participant is eligible and whether the next visit can be scheduled. Once the principal investigator has evaluated the eligibility (up to 28 days), the patient will be scheduled for the first infusion.
* Visit 2 - Infusion 1 (Baseline): this visit will be a starting point for comparing participant's data. During this visit, the patient will receive the 1st investigational product via intravenous infusion, with rigorous monitoring of vital signs for a total of 2 hours.
* Visit 3 to 12 - During these visits, the patient will receive intravenous infusions of HB- adMSCs while her vital signs are precisely monitored for a total of 2 hours.
* Follow-Up Phone Call - During this safety follow-up phone call, the principal investigator will evaluate the safety of the investigational product by conducting several assessments described in the Schedule of Assessments table.
* End of Study - At the end of the expanded access program visit, the principal investigator will conduct various evaluations to determine the patient's physical condition and assess whether there have been any safety events resulting from the participation in the expanded access program.

Eligibility Criteria:
* Inclusion Criteria

  * Patient diagnosed with Chronic Inflammatory Demyelinating Polyneuropathy, CIDP, with documented medical records.
  * Patient must have banked his stem cells at Hope Biosciences LLC.
* Exclusion Criteria

  * The patient has any active infection requiring medications.
  * The patient has any suicidal ideation during the screening visit or at any point during the study.
Ultra-Processed Foods and Executive Function

The purpose of this study is to examine potential effects of a diet characterized by UPF on hunger-related hormones and executive function. It entails a two-arm, crossover, randomized controlled trial.


Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18-55
* Willing to consume an entirely ultra-processed and entirely unprocessed diet for 3 days each (6 days in total)

Exclusion Criteria:

* Chronic disease that interferes with study-related activities
* Special diet that limits adherence to the intervention diets
* Visual impairment not corrected by glasses/contacts
* Pregnant or lactating
Study of HIV-1 Rgp-160 Administered by Mucosal Routes in Healthy Volunteers

It is probable that a mucosal approach is necessary for a prophylactic HIV vaccine protecting against sexually transmitted infection. Mucosal immune responses have been almost non-existent in trials of HIV vaccine candidates in which the antigen was delivered systemically. This study will test the safety and immune response of a recombinant HIV-1gp160 by nasal and mucosal routes alone or formulated with DC-Chol in healthy volunteers.

It's probable that a mucosal approach is necessary for prophylactic HIV vaccine protecting against sexually transmitted infection. Although mucosal immune responses have been almost non-existent in trials of HIV vaccine candidates in which the antigen was delivered systematically.

Several animal models have also demonstrated the importance or a mucosal IgA response for protection against viral infections. Mucosal S IgA are essential effectors having different mechanisms of action agglutination of pathogens, interaction with cellular receptor, transcytosis of immune complexes, intracellular clearance of virus.

Gp 160 induces the majority of neutralizing Abs activity in patients serum and the immunogenicity of gp 160 can be improved by using and adjuvant such as DC-chol because of its properties to increase the permeation of the nasal epithelium and to facilitate systemic delivery of the vaccine antigen.

Before beginning mucosal vaccine trial, we previously tested and validated procedures to collect and process secretion fluids on 6 HIV-1 infected women (K. Petitprez et al, 4th European mucosal immunology group meeting, Lyon France, 8-10 october 2004).

Eligibility Criteria:
Inclusion Criteria:

* Women chosen in a uniform selection process specifically designed by the ANRS (French National Agency for Research on AIDS and Viral Hepatitis)
* For women of child-bearing age : use of effective contraception
* Normal clinical status
* Ability to accept collection of secretion fluids;
* Ability to sign informed consent

Exclusion Criteria:

* Pregnancy
Efficacy and Safety of Thrombopoietin In Patients With Severe and Very Severe Aplastic Anemia

Efficacy and Safety of Recombinant human thrombopoietin in patients with severe aplastic anemia and very severe aplastic anemia, a randomized, double-blind, placebo-controlled, II phase, multi-center clinical research.

rhTPO

Eligibility Criteria:
Inclusion Criteria:

* Able to provide written informed consent
* Have severe or very severe aplastic anemia

Exclusion Criteria:

* Have diagnosis of Fanconi anemia
* Have infection not adequately responding to appropriate therapy
* Have Paroxysmal Nocturnal Hemoglobinuria (PNH) clone size in neutrophils of greater than or equal to 50%
* Have creatinine and/or blood urea nitrogen (BUN) ≥2 times the upper limit of normal
* Have serum bilirubin ≥ 1.5 times the upper limit of normal, or ≥4.0 times the upper limit of normal if the patient has been treated with Anti-Thymocytes globulin（ATG） within three weeks of screening.
* Have glutamic-oxaloacetic transaminase （AST） and/or glutamic-pyruvic transaminase （ALT） ≥ 3 times the upper limit of normal
* Are female and are nursing or pregnant or are unwilling to take oral contraceptives or refrain from pregnancy if of childbearing potential
* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 3 or greater
* Have had other Thrombopoietin (TPO-R) agonists medication in the previous 4 weeks.
A Study to Evaluate Safety and Efficacy of Bomedemstat (MK-3543-017)

The primary purpose of the study is to transition participants into an extension study to collect long-term safety and efficacy data. The study will include participants who are safely tolerating bomedemstat, receiving clinical benefit from its use in estimation of the investigator, and have shown the following criteria:

* Participants from the IMG-7289-202/MK-3543-005 (NCT05223920) study must have received at least 6 months of treatment with bomedemstat;
* Essential thrombocythemia (ET) and polycythemia vera (PV) participants from studies other than IMG-7289-202/MK-3543-005 must have achieved confirmed hematologic remission.

No hypothesis testing will be conducted in this study.


Eligibility Criteria:
Inclusion Criteria:

* Is from a bomedemstat study sponsored by Imago BioSciences, Inc. (a subsidiary of Merck \& Co., Inc.) or MSD, and established by the Sponsor as MK-3543-017 ready
* Has received at least 6 months of treatment with bomedemstat in the IMG-7289-202/MK-3543-005 study, while safely tolerating bomedemstat, and receiving clinical benefit from its use in the estimation of the investigator
* ET and PV participants from established feeder studies other than IMG-7289- 202/MK-3543-005 must have achieved confirmed hematologic remission, must be safely tolerating bomedemstat, and must be receiving clinical benefit from its use in the estimation of the investigator
* Is not currently on a dose hold
* Participant must be able to swallow oral medication and follow instructions for at-home dosing of bomedemstat

Exclusion Criteria:

* Has received prohibited concomitant medications
* Ongoing or planned participation in another investigational study
* Has noncompliance in prior bomedemstat study receiving \<90% of assigned doses excluding suspensions or holds as assigned by the investigator
Reinfection After Eradication of Helicobacter Pylori Infection

Helicobacter pylori is closely related with gastritis, peptic ulcer, gastric cancer and gastric MALT lymphoma, and it may participate in a variety of parenteral diseases. Infection rates of Helicobacter pylori is still high, so effectively eradication is necessary. At present, the eradication therapy has achieved very good curative effect. However, relapse after eradication is unoptimistic. This study has made an analysis for reinfection after eradication of Helicobacter pylori Infection include the retrospective and prospective studies, aims to explore the epidemiological data and related risk factors of Hp reinfection in China.

In the retrospective study,we choose the people received regular eradication therapy, successfully eradicated helicobacter pylori more than six months, but 4 to 8 weeks after drug withdrawal ,the detection result of helicobacter pylori were negative to ensure that the results of the study is the reinfection, not residual. Even more noteworthy is during the treatment and detection again, the patients must not received any eradication therapy of Hp. What's more , before the detection, they also has not used antibiotics, bismuth agent and the traditional Chinese medicine with antibacterial effect in 1 monthor and has not used H2RA and PPI in 2 weeks to prevent affecting the accuracy of the results. At the same time, we also investigated the patient's general situation, conomic conditions, living conditions, personal health and lifestyle to explore related risk factors of Hp reinfection in China. In the prospective study, we detected Hp by C-UBT after regular eradication therapy of Hp for 4 weeks, 8 weeks and 6 months to prospect the reinfection of Hp.It also can make up the defects of retrospective study.

Eligibility Criteria:
Inclusion Criteria:

-1、Retrospective study：

1. Received regular eradication therapy, 4 to 8 weeks after drug withdrawal , detected of helicobacter pylori and the results were negative
2. Eradication program and original disease is unlimited
3. Without any eradication therapyof Hp during the treatment and detection again
4. before the detection has not used antibiotics, bismuth agent and the traditional Chinese medicine with antibacterial effect in 1 monthor and has not used H2RA and PPI in 2 weeks.

2、Prospective study

1. Infected with H. pylori that detected by C-UBT
2. With out alimentary tract hemorrhage,ulceration and complications of eradication
3. Eradication program and original disease is unlimited

Exclusion Criteria:

1. Pregnancy or breast-feeding women
2. With the major disease which would influence the research such as liver disease, heart disease, kidney disease, malignant tumor and alcohol poisoning
3. Participated in other drug research in the past three months
4. The patient can't express himself correctly such as mental illness and severe neurosis and can't cooperation this test
Telephone Triage Study

The advance of communication technology has changed medical practice. The concept of medical telemedicine centers receiving, assessing and managing calls from patients or their carers on a 24 hour, 7 days a week basis is spreading in the US as well as in European countries. Usually specially trained nurses using dedicated decision support software provide the service. One aspect is the so-called triage, i.e. the decision on urgency and optimal treatment path of a stated medical problem, which has the potential to contain overall treatment costs.

Despite proliferation of these services, little is known about the quality of the services provided.

In October 2000 the first 24-hour medical telemedicine centre staffed by medical doctors started operating in Switzerland. The aims of this study are to assess the quality of service provided by doctors using decision support software and to determine potential predictors of incorrect triage.


Eligibility Criteria:
Inclusion Criteria:

* Adult
* Insured with HMO Basel
* Patient of HMO practise Sternengasse
* First call to Medgate for a given medical problem
* Call is a telephone triage
* Informed consent

Exclusion Criteria:

* none
GEM 1.5 mg b.i.d. to 4.5 mg b.i.d. Versus Lorazepam in GAD (0777-026)

This study will determine the effectiveness of MK0777 GEM versus Lorazepam in the treatment of patients with generalized anxiety disorder.

This is an early phase trial and some specific protocol information is in progress and not publicly available at this time. (Full information is available to trial participants).


Eligibility Criteria:
Inclusion Criteria:

* Have been diagnosed with Generalized Anxiety Disorder
* Women of childbearing potential must use a double-barrier methods of contraception and must have a negative blood pregnancy test at the beginning of the study

Exclusion Criteria:

* History of drug or alcohol abuse
* Have previously participated in another study using MK0777
Cold Polypectomy Site Study

Removal of polyps at colonoscopy reduces colon cancer. Snare polypectomy is the conventional method for removal however the snared area after removal can occasionally appear uneven raising the possibility that complete removal has not occurred. The significance of this irregularity has not be studied. This study aims to separately sample the irregular area and determine the constituents while recording how frequently this occurs during routine colonoscopy and polypectomy. We hypothesize that the irregular areas are submucosal tissue and do not represent polyp tissue left behind.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing colonoscopy with at least one polyp identified where polypectomy is planned.

Exclusion Criteria:

* Age \< 18 years
* Patients where polypectomy is not planned to be undertaken (patients scheduled for diagnostic colonoscopy only).
Stress Management for Chronic Headaches

This interventional, randomized controlled study seeks to test the effects of a novel emotional awareness and expression intervention against relaxation training or no intervention for college students with chronic headaches. These two interventions are conceptually quite distinct, as the former seeks to activate and process anger, whereas the latter, more commonly used technique, seeks to suppress or avoid it.


Eligibility Criteria:
Inclusion Criteria:

* Undergraduate students at Wayne State University who have chronic headaches

Exclusion Criteria:

* Insufficiently frequent headaches
* Uninterested in engaging in a stress management intervention
* Headaches appear due to substance use or head trauma
PROcalcitonin Reduce Antibiotic Treatments in Acute-Ill Patients (PRORATA)

The study is a prospective, randomized, controlled intervention trial conducted in 9 centers, comparing a conventional strategy versus a PCT-guided strategy to start or to discontinue antibiotics, in patients with suspected community or hospital- acquired infection.

Clinical and laboratory signs are neither specific nor sensitive for diagnosis of sepsis in critically-ill patients. Because delaying antimicrobial therapy may be deleterious, broad-spectrum antibiotics are widely used in ICU -patients, even when they are not needed. In addition, only few well-designed studies concerning the duration of antibiotic treatment have been so far published. Consequently, many patients received antibiotics during the ICU stay. Many studies have shown that exposure to antibiotics, the so called "selection pressure" is an independent risk factor for acquisition of resistance in individual patients. Therefore, reducing antibiotic use is probably necessary to control antibiotic resistance. Many clinical studies have shown that procalcitonin (PCT) is able to distinguish the inflammatory response to infection from other types of inflammation and to distinguish bacterial from viral infections. Recent studies have shown that PCT guidance substantially and safely reduced antibiotic overuse in patients with lower respiratory tract infections. We aimed to evaluate the role of PCT in reducing the use of antibiotics in ICU adult patients. The study is a prospective, randomized, controlled intervention trial conducted in 9 centers, comparing a conventional strategy versus a PCT-guided strategy to start or to discontinue antibiotics, in patients with suspected community or hospital- acquired infection.

Eligibility Criteria:
Inclusion Criteria:

* Patient hospitalised in the ICU
* Bacterial infection suspected
* At ICU admission the patient do not receive antibiotics or receive antibiotics for less than 24hours and an interval between admission and inclusion \< 12 hours
* During ICU stay, provided that the interval between the start of suspected infection and inclusion is \< 12hours
* Written inform consent from the patient or relatives. The consent may be obtained after the enrollment if the patient is not able to give consent and if there is no relatives

Exclusion Criteria:

* Age \< 18 years
* Pregnancy
* Patient expected to remain hospitalised in the ICU for less than 3 days
* Neutropenia
* Infection or presumed infection requiring prolonged antibiotic therapy (endocarditis,osteo-articular infection, mediastinitis, deep abscess, tuberculosis, pneumocystis pneumonia, toxoplasmosis).
* Simplified Acute Physiology Score II at ICU admission (calculated during the first 12h)
* Attending physician declining to use full life support.
Safety and Efficacy of Wendan Decoction in Acute Moderated to Severe Brain Injury

Efficacy and safety of Traditional Chinese Medicine (Wendan decoction) combined with conventional neurologic intensive care in patients with acute moderated to severe brain injury in early stage - A randomized controlled study.

This study adopted a prospective, randomized controlled design. All eligible patients included in the study agreed to participated and signed the informed consent from and the study procedures were approved by the ethical committee of Taichung Tzu Chi general hospital (REC103-26). Patients were recruited from the neurosurgery department of Taichung Tzu Chi general hospital between June 2014 and July 2015. A total of 60 patients were enrolled in this study and randomized into intervention group and control group. All patients of both groups were enrolled within 14 days after episode and a follow-up interview until 6 months from the onset. The intervention group mean regular neuro-intensive care combined TCM and the intervention group mean only neuro-intensive care. But there are 7 patients in intervention group and 12 patients in control group quit out this study

Eligibility Criteria:
Inclusion Criteria:

* traumatic brain injury or spontaneously intracerebral hemorrhage within 14 days of onset;
* an initial score of 3-12 points of GCS score;
* adults between 18 to 80 years old;
* and signed informed consent form.

Exclusion Criteria:

* after 14 days of onset;
* a history of previous TBI or stroke;
* intracranial aneurysm or arteriovenous malformation ruptured;
* combination other major organ injury (heart, lung, intra-abdomen organ, pelvic fracture, major vessels);
* other severe disease such as heart or kidney failure;
* previous diagnosed cancer; and pregnant women.
A Retrospective And Multicenter Survey To Investigate The Dosage, Efficacy And Safety Of Sertraline In Posttraumatic Stress Disorder Patients

This is a multicenter retrospective study to investigate the dosage regimens of sertraline in the treatment of Posttraumatic Stress Disorder (PTSD) under current medical practice and the efficacy and safety of this drug in patients with PTSD. Data will be collected from the medical records of patients with PTSD.

Patients with PTSD who have been dosed with sertraline from July 2006 (i.e., the start of marketing of this drug in Japan) or later to before contracting with each investigational site.

Eligibility Criteria:
Inclusion Criteria:

* Patients with PTSD who have been dosed with sertraline since July 2006 or later.
* Patients must be Japanese.
* Patients should be started before the conclusion of a contract with each investigational site.

Exclusion Criteria:

* Not applicable.
Situational Problem Solving in Adolescents With Type 2 Diabetes: Enhancing a Randomized Controlled Trial (RCT)

The proposed research will test a new comprehensive disease management intervention with adolescents who have type 2 diabetes using a randomized controlled trial (RCT). Adolescents subjects with a history of Type 2 Diabetes and a parent caregiver will be consented, enrolled, and randomly assigned to either an 6-month intervention (N=44) or a "usual care" comparison (N=44). Recruitment will take place within the Vanderbilt Eskind Pediatric Diabetes Clinic. The intervention will include participation in a comprehensive disease management program that includes: (1) application of treatment algorithms, (2) phone assessment from a diabetes nurse practitioner and dietician to assess barriers and promote problem solving, treatment adherence and management, and (3) a behavioral Internet-administered self-management problem solving component. Outcomes include self-reported self-management behaviors (exercise, diet, medication adherence, etc.), blood pressure, weight/BMI, and glycated hemoglobin (A1C).


Eligibility Criteria:
Inclusion Criteria:

Patients with a diagnosis of T2DM will be included if they are:

1. Age 12-19 years
2. A clinical diagnosis of T2DM (according to the patient and their health provider in the clinic)
3. Actively receive diabetes care in the Eskind Diabetes Clinic
4. Willingness of patient and a caregiver to access the Internet to complete problem solving activities
5. Adolescent address is the same as their primary caregiver participating in the study

Exclusion Criteria:

Patients will be excluded if they meet any of the following:

1. Identify an outside practitioner as the main provider of their diabetes care
2. Have a significant psychiatric illness such as severe depression or active psychosis that would impact on the ability to participate in the study
3. Life expectancy of \<6 months
4. Unable to access the Internet from any convenient location
5. Blind or deaf

Parent Inclusion criteria:

1. Parents must be a primary caregiver of an adolescent with a diagnosis of T2DM between the ages 12-19 seen at the Eskind Clinic
2. Willingness of patient and a caregiver to access the Internet to complete problem solving activities.

Parent Exclusion criteria:

Patients will be excluded if they meet any of the following:

1. Identify an outside practitioner as the main provider of their child's diabetes care
2. Self report of significant psychiatric illness such as severe depression or active psychosis that would impact on the ability to participate in the study
3. life expectancy of \<6 months
4. unable to access the Internet from any convenient location
5. blind or deaf.

Joint Inclusion criteria:

Both the primary caregiver (parent) and adolescent must agree to participate in the research.