cyrilzakka/clinical-trials huggingface dataset:
Reduced Intensity Transplant in Medically Refractory Systemic Lupus Erythematosus (SLE) and Systemic Sclerosis (SSc)

The purpose of this study is to determine if a reduced intensity (RI) (non-myeloablative) chemoimmunotherapy followed by Allogeneic Stem Cell Transplantation AlloSCT (matched family donors and matched unrelated cord blood donors) will be well tolerated.

This is to test whether a reduced intensity will result in a high degree of mixed or complete donor chimerism and stabilization of autoimmune disease in a select group of patients with medically refractory SLE or SSc.

Eligibility Criteria:
Inclusion Criteria:

* Diffuse Systemic Sclerosis and variants as per ACR criteria
* Medically refractory disease
* Adequate Organ Function - Pulmonary function
* Renal function, Cardiac function defined as:
* SGOT (AST) or SGPT (ALT) \<5 x upper limit of normal
* Diagnosis of SLE - Medically refractory disease

Exclusion Criteria:

* Karnofsky/Lansky \<60%
E-health App and Lifestyle Changes During Pregnancy

The purpose of this online follow-up study is to investigate health app use in pregnant women and through a pilot intervention trial investigate whether the addition of evidence-based information on health-promoting lifestyle delivered via the health app has an effect on lifestyle habits (gestational weight, diet quality and physical activity) during pregnancy.

An online follow-up study with a 2-arm equal allocation parallel randomized controlled pilot intervention trial with pregnant women (n=1000) will be conducted. The intervention consists of non-personalized, evidence-based information on health-promoting lifestyle during pregnancy delivered via a health app. Control group uses the health app without health information.

Aims of an exploratory part of the study are to characterize the health app use and users among pregnant women and to investigate whether the frequency of the health app use during pregnancy has an effect on lifestyle habits. Aim of the pilot intervention is to investigate whether the addition of evidence-based information on health-promoting lifestyle delivered via the health app has an effect on lifestyle habits during pregnancy.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant, less than 28 pregnancy weeks
* Fluency in Finnish

Exclusion Criteria:

* Not pregnant
* No fluency in Finnish
A Clinical Trial of Recombinant COVID-19 Bivalent (XBB+Prototype) Protein Vaccine (Sf9 Cell) in Booster Vaccination

A Clinical Trial of Recombinant COVID-19 Bivalent (XBB+Prototype) Protein Vaccine (Sf9 Cell) in Booster Vaccination to evaluate safety and immunogenicity in healthy population aged 18 years old and above.

To evaluate safety of Recombinant COVID-19 Bivalent (XBB+Prototype) Protein Vaccine (Sf9 Cell) (WSK-V101C) and immunogenicity superiority of WSK-V101C to Recombinant COVID-19 vaccine (WSK-V101) after booster.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects aged 18 years and above, including those with underlying diseases and immunocompromised subjects.
2. Basic or booster immunization with COVID-19 vaccine ≥6 months.
3. ≥3 months of SARS-CoV-2 infection history, or never infected.
4. Have the ability to understand research procedures, with informed consent, voluntarily sign informed consent, and be able to comply with the requirements of clinical research protocols.

Exclusion Criteria:

1. Axillary temperature ≥37.3℃.
2. SARS-CoV-2 antigen or nucleic acid screening positive within the last 48 hours.
3. Anti-SARS-CoV-2 IgM antibody was positive during the screening period.
4. It is in the advanced stage of malignant tumor and the disease control is unstable.
5. Female pregnancy (pregnancy test results are positive), lactation period.
6. Have serious cardiovascular diseases, such as arrhythmia, conduction block, myocardial infarction, heart failure, severe hypertension, and can not be controlled by drugs.
7. Have other serious chronic conditions such as uncontrolled asthma, diabetes, chronic obstructive pulmonary disease, pulmonary embolism, chronic kidney disease requiring dialysis, cirrhosis of the liver, convulsions, epilepsy and other neurological/psychiatric conditions.
8. Have been diagnosed with congenital or acquired immunodeficiency, HIV infection.
9. People who are allergic to any component of the investigational vaccine have a history of more severe allergies or allergic reactions to the vaccine in the past.
10. Congenital or acquired angioedema/neuroedema.
11. Asplenia or functional asplenia.
12. Thrombocytopenia or other clotting disorders (which may cause intramuscular injection contraindications).
13. Received another investigational drug within 1 month prior to receiving the investigational vaccine.
14. Received subunit or inactivated vaccine within 14 days prior to receiving the investigational vaccine, or received live attenuated vaccine within 1 month.
15. Fertile female subjects did not use effective contraception within 1 month prior to enrollment.
16. Fertile female and male subjects have pregnancy plans and sperm/egg donation plans from the screening period to 3 months after immunization.
17. Abnormal laboratory test results during the screening period, which were judged by the researcher to be unsuitable for the study vaccine.
18. Medical, psychological, social, or other conditions that, in the investigator's judgment, are inconsistent with the protocol or affect the subject's signing of informed consent.
Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intrathecal Injection for ALS

This trial will study the safety and efficacy of intrathecal injection of cultured allogeneic adult umbilical cord derived mesenchymal stem cells for the treatment of amyotrophic lateral sclerosis

Amyotrophic lateral sclerosis is a devastating disease. There is evidence that mesenchymal stem cell treatment is safe and can improve the prognosis of afflicted patients. Patients with ALS will receive three intrathecal injections of cultured allogeneic adult umbilical cord derived mesenchymal stem cells. The dose for each injection will be 50 million cells and the injections will be at two-month intervals. Patients will be evaluated within one month pre treatment and at 1, 6, 12, 24, 36, and 48 months post treatment for safety and efficacy.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Amyotrophic Lateral Sclerosis.
* Understanding and willingness to sign a written informed consent document

Exclusion Criteria:

* Active infection
* Active cancer
* Chronic multisystem organ failure
* Pregnancy
* Anticoagulation medicine use
* Clinically significant Abnormalities on pre-treatment laboratory evaluation
* Medical condition that would (based on the opinion of the investigator) compromise patient's safety.
* Previous organ transplant
* Hypersensitivity to sulfur
* Continued drug abuse
* Pre-menopausal women not using contraception
Subcutaneous Testosterone Enanthate Safety in Adult Men Diagnosed With Hypogonadism

Evaluation of safety of a concentration controlled testosterone enanthate QuickShot Testosterone regimen administered subcutaneously once each week to adult males with hypogonadism.

Safety assessments, including laboratory assessments, adverse events and injection site assessments, will be conducted for all patients at scheduled intervals during the Treatment Titration Period.

Eligibility Criteria:
Inclusion Criteria:

* Adult men ≥18 and ≤75 years of age with a documented history of hypogonadism
* Total testosterone levels \< 300 ng/dL at two qualification visits
* Patients in good general health

Exclusion Criteria:

* Allergy to sesame or testosterone products
* BMI ≥ 40 kg/m2
* Hematocrit ≥ 52%
* History or current evidence of breast or prostate cancer
* Elevated prostate-specific antigen (PSA) for age.
* Abnormal digital rectal examination (DRE)
* Unstable psychiatric illnesses
* Obstructive uropathy of prostatic origin
* Poorly controlled diabetes
* Congestive heart failure
* Within 6 months of screening, myocardial infarction (MI), unstable angina leading to hospitalization, percutaneous coronary intervention, coronary artery bypass graft, uncontrolled cardiac arrhythmia, stroke transient ischemia attack, carotid revascularization, endovascular procedure, or surgical intervention for peripheral vascular disease.
* History or current treatment of thromboembolic disease.
* Use of adrenocorticotropic hormone (ACTH) or oral/depot corticosteroids within 6 weeks of screening.
* History of severe, untreated sleep apnea
* Subjects with any clinically significant medical condition which, in the opinion of the investigator, would make the subject an unsuitable candidate for enrollment in the study
* Positive serology for HIV, hepatitis B or hepatitis C
* Current evidence of drug or alcohol abuse.
* Skin conditions in injection site that could confound injection site assessments.
* Administration of other investigational compounds within one month of screening or 5 half-lives of the investigational compound, whichever is longer).
* Use of estrogen, gonadotropin-releasing hormone (GnRH) or growth hormone within 12 months of screening.
* Use of other androgens (DHEA), anabolic steroids, other sex hormones) or other substances/supplements know to affect the pharmacokinetics (PK) of testosterone enanthate
* Considered or scheduled surgical or dental procedures associated with blood loss ≥500 mL during study.
* Donation of plasma or blood within 56 days of screening or history of donation of \> 50 mL of blood or plasma within 3 months of screening.
* Donation of plasma or blood during study
Subcapsular Orchiectomy in Men With Klinefelter Syndrome

Men with Klinefelter syndrome undergo unilateral subcapsular ochiectomy, and the removed testicular tissue is examined for presence of sperm and cryopreserved in small pieces for fertility treatment and scientific purposes. Prior to operation blood samples are frozen in a biobank.


Eligibility Criteria:
Inclusion Criteria:

* Klinefelter
* 15-40 years of age

Exclusion Criteria:

* inability to understand the study
Efficacy and Safety Study of Soluble Beta-1,3/1,6-Glucan in Thermal Burns

The purpose of this study is to determine whether soluble beta-1,3/1,6-glucan is an effective and safe treatment of thermal burns and non-injured skin where skin grafts are harvested.

Hypothesis: Soluble beta-1,3/1,6-glucan will through its immunomodulating activities improve wound healing of thermal burns and non-injured skin where skin grafts are harvested.

In severe cases, burn patients commonly exhibit a clinical picture of systemic inflammation with a variety of manifestations ranging from the presence of tachycardia, tachypnea, fever and leukocytosis, and may progress to refractory hypotension. Shock and multiple organ system dysfunction may subsequently occur. Sepsis, caused by infection or bacteremia, is also a common occurrence and a major complication in burn patients.

After cooling the burned area, pain control is important. Local burn wound care starts with cleansing the wound followed by application of topical agents to prevent infection. Such agents may have adverse local or systemic effects and may impede on the wound healing process itself. The use of synthetic or biologic materials for wound covering is becoming increasingly popular, but most of the clinical information about efficacy of such products are anecdotal.

A primary objective in burn care is to have all wounds healed within 1 month. With longer healing periods, there is an increasing likelihood of developing hypertropic scaring and alterations in pigmentation. The development of an effective wound healing agent would therefore be highly beneficial for the suffering patient in terms of decreased healing time and improved cosmetic results.

Eligibility Criteria:
Inclusion Criteria:

* age \>= 18 years
* written informed consent

Group A - patients with thermal burns

* partial thickness burns (2nd degree) requiring non-surgical primary treatment
* primarily 5-15% TBSA burns, but burn patients with injury size from 1 to 40% TBSA may be included

or

Group B - patients with thermal burns

* non-grafted partial thickness burns (2nd degree) in patients requiring autotransplantation in the early phase
* primarily 5-15% TBSA burns, but burn patients with injury size from 1 to 40% TBSA may be included

or

Group C - patients with thermal burns

* donor site(s) on the ventral side of the body and limbs in deep partial thickness burns (2nd degree) and/or full thickness burns patients requiring autotransplantation during the first 1-3 weeks after injury
* primarily 5-15% TBSA burns, but burn patients with injury size from 1 to 40% TBSA may be included

Exclusion Criteria:

* inhalation injury to airways and lungs
* chemical or high voltage electrical burn
* pregnancy, lactation
* clinical signs or symptoms of acute infection
* any prescription or non-prescription topical medication administered within one week prior to study start
* hematological and clinical/chemical parameteres judged as unacceptable by the investigator
* donor sites with re-harvesting
* previous treatment with soluble beta-1,3/1,6-glucan
* participation in other clinical studies in the last 4 weeks
COVID-19 Huashi Baidu Formula Clinical Study

Combined with the regional and population characteristics of Asia and Africa, Huashi Baidu Granule was used to intervene in mild and moderate patients with COVID-19, evaluate its efficacy and safety, and clarify its characteristics of action.

In this study, a double-blind, double dummy, randomized control method was used to include 300 cases of mild and moderate COVID-19 patients in three centers at home and abroad. The clinical efficacy of Huashi Baidu Granule and Monapiravir in intervening COVID-19 patients was compared, It is proved that Huashi Baidu Granule has the same clinical efficacy and safety against COVID-19 as Monapiravir, and its characteristics of action are clarified to obtain high-level clinical evidence-based medical evidence of Huashi Baidu Granule in treating COVID-19 mild and moderate.

Eligibility Criteria:
Inclusion Criteria:

1. Conform to the diagnostic criteria for COVID-19 mild and moderate in the Guidelines for the Diagnosis and Treatment of Novel Coronavirus (COVID-19) Infection (Trial Version 10) ；
2. Age ≥ 18 years and ≤ 65 years;
3. The time from the first symptom (or confirmed onset) shall not exceed 5 days;
4. If the patient agrees to participate in the study, he/she will sign the informed consent form through paper signature, electronic signature of mobile software or voice authorization.

Exclusion Criteria:

1. Patients who cannot guarantee the compliance of taking medicine during the treatment period, and who are difficult to take medicine by oral or nasal feeding.
2. Patients with severe primary respiratory diseases or other pathogenic microorganism pneumonia that needs to be differentiated from COVID-19.
3. Pregnant women, with positive urine pregnancy test, or with pregnancy plan within 12 months.
4. Patients suffering from malignant tumors, mental diseases and other systematic malignant diseases that the researchers consider unsuitable for the study.
5. People who have ever been allergic to the test drug and who do not tolerate the drug.
6. Those who are participating in other clinical trials.
7. Non severe patients in the trial shall not enter the study again after changing the classification.
Reactogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Rotarix™ (Human Rotavirus Vaccine) in Indian Infants

This post marketing surveillance will evaluate reactogenicity and safety data of human rotavirus vaccine when administered to healthy infants according to the Prescribing Information in India.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in this PMS.
* A male or female infant, from the age of 6 weeks at the time of the first vaccination and less than 24 weeks of age at the time of second vaccination.
* Written informed consent obtained from the parent or guardian of the subject.

Exclusion Criteria:

* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
* Concurrently participating in another clinical study, at any time during the surveillance period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
* Acute disease at the time of enrolment.
* Any history of uncorrected congenital malformation of the gastrointestinal tract that would predispose the subject for intussusception.
* Known hypersensitivity after previous administration of rotavirus vaccine or to any component of the vaccine.
* Gastroenteritis within 7 days preceding vaccination.
Effect of rTMS in Combination With a Low-carbohydrate Diet in Patients With Obesity

In the present study the investigators want to evaluate if the application of rTMS can reduce the anxiety and craving in patients with obesity helping them to follow a low carb-diet, as well as, to assess the changes in weight, body mass index and quality of life before and after rTMS or sham rTMS.

Participants completed a written, informed consent and rTMS adult safety questionnaire. The inclusion criteria are:

individuals between 25 and 60 years of age with obesity in stage 1, 2 or 3. The exclusion criteria were: subjects with metabolic disorders, neurological condition, epilepsy, or pregnancy. The study conformed to the Declaration of Helsinki and was approved by the Institutional Medical Research Ethics Committee (Hospital Ajusco Medio, Mexico DF). The protocol will be applied as follows: 10 rTMS or sham sessions during two weeks. Following these two week, patients will receive 8 more sessions on weeks 4, 6, 8, 10, 12, 16, 20 and 24. Diet will be indicated during all the protocol. The sham group will receive sham rTMS sessions for two weeks, the additional sessions will be performed in the same manner thar in rTMS group.

Eligibility Criteria:
Inclusion Criteria:

* BMI \> 30

Exclusion Criteria:

* Thyroid problems, anorexia, bulimia, epilepsy, schizophrenia
Mixed Tree Nut Food Challenges

The purpose of this prospective study is twofold: 1) to establish oral tolerance to selected tree nuts and to examine potential predictors of oral tolerance and 2) to determine the usefulness of mixed tree nut allergen food challenges in more efficiently defining tree nut allergy and oral tolerance.

To evaluate the absence of tree nuts (TN) allergy, referred patients from one of the Arkansas Children's Hospital (ACH) Allergy Clinic physicians with current serum immunoglobulin E (IgE) to TNs that meet eligibility criteria will be invited to undergo a series of open mixed TN food challenges.

A questionnaire pertaining to their TN allergy will be administered

A brief physical exam will be performed.

Skin prick tests using selected nut allergen extracts along with a positive (histamine) and a negative (salt-water) control will be performed at the first oral food challenge visit.

Each food challenges will be performed to 1 to 3 TNs.

Two telephone follow-up phone calls will evaluate inclusion/exclusion of tree nuts in the diet post food challenge.

Eligibility Criteria:
Inclusion Criteria:

* Any patient between 3-21 years of age followed by the Allergy and Immunology Department at Arkansas Children's Hospital on tree nut avoidance diet.
* Has current serum IgE test within the past 12 months to major nuts in question. All TN serum IgE are \<10
* Children must have a stable baseline examination prior to undergoing challenge without significant symptoms of atopic dermatitis, allergic rhinoconjunctivitis, current urticaria or other allergic symptoms deemed important by the physician.
* Children must have stable asthma and no wheezing or repetitive cough prior to challenge, nor have been treated with oral steroids for a significant asthma exacerbation within 1 month of challenge. Asthmatics that undergo lung function testing.
* Children must have no current illness (e.g., fever or viral illness) at time of challenge.
* The subject will be asked to restrict the use of antihistamines (short acting, 72 hours: long acting, 5-7 days), (B-agonists (12 hours), theophylline (12 hours), and cromolyn (12 hours) prior to the first mixed TN food challenge. Other medications may be continued.

Exclusion Criteria:

* Any TN serum IgE ≥10.
* Life-threatening reaction (respiratory involvement requiring medications, or shock, or gastrointestinal reaction requiring intravenous fluids) to any TN.
* History of a reaction in the past year or severe reaction in the past 2 years or a history of a severe reaction anytime with a TN serum IgE \>5
* Unstable asthma, gastrointestinal disease, cardiovascular disease, chronic lung disease, beta-blocker use.
Low-dose Aspirin for Prevention of Adverse Pregnancy Outcomes in Twin Pregnancies

Twin pregnancies are associated with increased risk of perinatal adverse outcomes , including preeclampsia , fetal growth restriction , preterm premature rupture of membranes and preterm birth. Low-dose aspirin was recommend by American College of Obstetricians and Gynecologists (ACOG) during pregnancy. In this trial, the investigators suppose that aspirin used in twin-pregnancies could improve adverse pregnancy outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Twin pregnancy diagnosed by ultrasound and maternal age ranged from 18 to 55 years, Gestational age was less than 16w

Exclusion Criteria:

* Diagnosed fetal anomalies, history of cervical cerclage, contraindications of aspirin, pre-existing renal or liver diseases or abnormal functions, coagulation disorders, history of PE, preterm birth or FGR, chronic hypertension
A Prospective Study of Surgical Treatment Strategies for Goal B Type Basilar Invagination

The etiology of Goal B type basilar invagination (BI) is still not clear, and it may be related to platybasia and short slope. There is no unified standard surgical strategy for Goal B type BI, and different surgical strategies have a great influence on the surgical results of patients. The purpose of our prospective study in China is to (1) further clarify the etiology of Goal B type BI, and (2) improve the surgical outcome in these patients.


Eligibility Criteria:
Inclusion Criteria:

* Goal B type basilar invagination (BI)

Exclusion Criteria:

* Preoperative diagnosis was confirmed as not Goal B type basilar invagination (BI)
* The patient was not physically fit for surgery.
Post Injury Performance Deficits in Rink Hockey

Rink Hockey is a sport played on a 40\*20 metres rink characterized by combined periods of high intensity and short breaks, there´s a lack of epidemiological studies in this field. In line with the well-established model of sports injury prevention research proffered by van Mechelen, the first stage in this process is establishing the extent of the problem i.e. injury incidence, severity and burden.

This study will assess performance metrics from rink hockey athletes and injury epidemiology. 4 tests (to be specified yet) will evaluate players fitness during preseason and when a player suffers a non-contact injury during the season, the player will be retested to assess variability and performance deficits.

injury characteristics and exposure time will be recorded too

Eligibility Criteria:
Inclusion Criteria:

* Compete in senior league
* be uninjured during preseason

Exclusion Criteria:

* not signing the participation consent
* no participation in the performance assessment during preseason
Change of Immune Cell of ARDS Patients：an Observational Study

To evaluate change of different immune cellsduring ARDS and its impact on prognosis.


Eligibility Criteria:
Inclusion Criteria:

①sign on the acknowledged

②Diagnosis with ARDS(The Berlin definition），onset within 48hours

Exclusion Criteria:

①diagnosis of hematological or immunological disease

②treatment with chemotherapy agents or corticosteroids within 6 months prior to or during the hospitalization.