cyrilzakka/clinical-trials huggingface dataset:
A Study of Lu AF82422 in Participants With Multiple System Atrophy

To find out the effect of Lu AF82422 on disease progression in participants with multiple system atrophy.

This study will consist of a double-blind period (DBP) and will include an optional open-label treatment extension (OLE) period. Participants in the DBP will be randomized to Lu AF82422 or placebo (2:1). All participants entering the OLE will receive Lu AF82422 during the OLE.

Eligibility Criteria:
Key Inclusion Criteria:

* The participant is diagnosed with possible or probable MSA of the multiple system atrophy parkinsonian type (MSA-P) or multiple system atrophy cerebellar type (MSA-C) sub-type at the Screening Visit.
* The participant had onset of motor and/or autonomic (orthostatic or urinary) MSA symptoms within 5 years prior to the Screening Visit in the judgement of the investigator.
* The participant has an UMSARS Part I score ≤16 (omitting item 11 on sexual function) at the Screening Visit.
* The participant has a cognitive performance evaluated by the Montreal Cognitive Assessment (MoCA) with a score ≥22 at the Screening Visit.

Open-label Extension Entry Criteria

* The participant has completed the EoT Visit and did not withdraw in the DBP.
* The participant has consented to participate in the OLE.
* The participant has completed the DBP within the last 5 months and will be enrolled into the OLE no later than end of Q1 2024.
* The participant is, in the Investigator's opinion, likely to comply with the protocol.
* The participant has not received any other Investigational product since the EOoTDBP Visit.

Key Exclusion Criteria:

* The participant has been treated with an anti-α-synuclein monoclonal antibody, mesenchymal stem cells or an inhibitor of α-synuclein aggregation within the last 12 months.
* The participant has any past or current treatment with an active vaccine targeting α-synuclein.
* The participant has 2 or more blood relatives with a history of MSA.
* The participant has evidence (clinically or on MRI) and/or history of any clinically significant disease or condition other than MSA (for example, serious neurological disorder, other intracranial disease, or systemic disease).
* The participant has a current diagnosis of movement disorders that could mimic MSA (for example, Parkinson' disease, dementia with Lewy bodies, essential tremor, progressive supranuclear palsy, spinocerebellar ataxia, spastic paraparesis, corticobasal degeneration, or vascular, pharmacological, or post-encephalitic parkinsonism), per investigator discretion.

Other inclusion and exclusion criteria may apply.
Electrical Stimulation of the Dentate Nucleus for Upper Extremity Hemiparesis Due to Ischemic Stroke

This clinical trial will evaluate if Deep Brain Stimulation (DBS) is safe for the treatment of stroke and will help understand if DBS improves motor recovery for patients who continue to have significant impairment.

The proposed study is a safety and feasibility study intended to provide preliminary data to design a future pilot study. The objective of this study is to document the safety and patient outcomes of electrical stimulation of the dentate nucleus area for the management of chronic, moderate to severe upper extremity hemiparesis due to ischemic stroke.

Eligibility Criteria:
Key Inclusion Criteria:

* One-time stroke that occurred 1-3 years ago (i.e. index stroke 12-36 months)
* Stroke due to a blocked blood vessel (i.e. unilateral MCA stroke)
* Moderate to severe weakness in one arm (i.e. unilateral upper-extremity hemiparesis)

Key Exclusion Criteria:

* Seizures since time of stroke (i.e. seizures or seizure disorder)
* Unable to have an MRI (i.e. contraindicated for MRI)
Inflammatory Response and Pregnancy Outcome in Women With Type 2 Diabetes or Overweight

Purpose:

The purpose of this study is to determine if disturbances in cytokines or factors of the metabolic syndrome, can predict complications in pregnancy, birth, and the perinatal period in pregnant women with type 2 diabetes or who are overweight. At the same time we, the investigators at Rigshospitalet, want to determine if physical activity in the overweight pregnant woman can influence these factors in a favourable way and, with that, improve the progress of pregnancy and birth.

Material and Method:

This study falls in two fields:

First 80 pregnant women with type 2 diabetes are followed with determination of cytokines and factors of the metabolic syndrome throughout the pregnancy. The correlation between these variables and the pregnancy and delivery progress is evaluated.

280 overweight (body mass index \[BMI\] \> 30 kg/m2) pregnant women with no medical conditions are examined in the same way. The women are randomized in week 14 to either continue their habitual physical activity or to elevate it by participating in a training program with other pregnant women 3 times weekly.

Both groups will get blood samples taken during fasting approximately 50 ml 3-4 times during the pregnancy.

Eligibility Criteria:
Inclusion Criteria:

* BMI \> 30 kg/m2
* BMI \< 45 kg/m2
* Healthy
* Over 18 years of age
* No earlier preterm delivery (before 37)
* Singleton pregnancy
* 14 weeks +/- 1 week of gestation

Exclusion Criteria:

* BMI \> 45 kg/m2
* Earlier preterm delivery (before 37)
* Not singleton pregnancy
* Medically treated diseases
Effect of Circuit Training on Calcium Level and Physical Fittness in Pregnant Women

This study will be conducted to determine the effect of circuit weight training on calcium level and physical fitness in pregnant

During pregnancy, hem-dilution causes the serum albumin and hemoglobin to decrease. This fall in albumin causes the total serum calcium to fall to levels normally associated with symptomatic hypocalcaemia. The deficiency also occurs due to low dietary intake of calcium .This deficiency has a negative effect on both the mother and the fetus, as high blood pressure , maternal hypocalcemia, abortion, numbness and tingling in the fingers, muscle and leg cramps, poor appetite, heart problems, premature birth, low birth weight, perinatal death, and neonatal tetany .

General physical exercises specially circuit weight training will aids to increase calcium level as it plays a major role in increasing bone density not only through mechanical loading ,but also through blood PH and biomechanical changes in free ionized calcium, which can positively affect bone density . Circuit weight training exercises can improve the health related physical fitness variables namely cardiovascular fitness , muscular strength, muscular endurance, flexibility , balance and speed

Various studies investigated the effect of circuit weight training on bone mineral density and its effect on improving general fitness but there is a gap in the literature of review about its effect on calcium level and physical fitness in gravid women .So, this study will be of valuable benefits for medical service organizations and increase body of knowledge for physical therapists in women's health field.

Eligibility Criteria:
Inclusion Criteria:

* pregnant women suffering from a decrease in blood calcium level, (\<500 mg) dietary intake as recorded by food frequency questionnaire.
* They will be selected at second trimester (18th-24thweeks).
* Their age will range from (20 to 35) years old.
* Their BMI will be (35.00 to39.99) Kg/m2 in the second trimester.

Exclusion Criteria:

* Highly risk pregnant women (gestational diabetes \&pre-eclampsia).
* Pregnant women with risk for pre-term labor.
* Pregnant women with a history of habitual abortion.
* Pregnant women with thyroid, kidney and liver dysfunction and women with cardiovascular diseases.
A Drug Safety and Dose-exploratory Clinical Study of Azvudine Tablets in Patients Who Have Not Received Anti-HIV Treatment

The primary objective of this trial was to evaluate the safety and preliminary evaluation of Azvudine tablets (FNC) in combination with reverse transcriptase inhibitors therapy in treatment-naive patients with HIV infection.; the secondary objective is to explore the effective dose of clinical use of Azvudine (FNC) tablets .

Azvudine (FNC), a new class I drug with independent intellectual property rights, is a novel nucleoside reverse transcriptase inhibitor with good inhibitory activity against HIV-1 and obtained the National Medical Products Administration(NMPA) approved for clinical research.

In this trial, 172 patients who had not received anti-HIV treatment were enrolled, including FNC4mg group, FNC3mg group, FNC2mg group, and 3TC control group, 43 cases, 5 research centers, and each research center was simultaneously engaged and competing. The enrolled subjects underwent 7 visits including baseline visits, and HIV -1RNA and CD4 cell counts were tested and statistically analyzed for each visit.

Eligibility Criteria:
Inclusion Criteria:

1.18-65 years old, regardless of gender; 2.Confirmed HIV positive with a report; 3.Have not received anti-hiv antiviral treatment; 4.HIV viral load ≥1000 copies/mL; 5.Who have no recent family planning and agree to take effective non-drug contraceptive measures during the trial period and within 3 months after the end of administration; 6.The subjects could fully understand the purpose, nature, method and possible adverse reactions of the test, and voluntarily participate in and sign the informed consent.

Exclusion Criteria:

1. Patients who have received anti-HIV treatment;
2. Suffering from a serious opportunistic infection or opportunistic tumor;
3. Abnormal blood routine examination (white blood cells \<3 × 109 / L, hemoglobin \<90g / L, neutrophils \<1.5 × 109 / L, platelets \<75 × 109 / L);
4. Have a definite liver disease (hepatitis B surface antigen/HCV antibody positive), or abnormal liver function test (alanine aminotransferase and/or aspartate aminotransferase exceeds the upper limit of normal value by 3 times, or total bilirubin exceeds the upper limit of normal value 2 times);
5. Renal insufficiency (glomerular filtration rate \<70ml/min, or creatinine above the upper limit of normal);
6. Now suffering from more serious chronic diseases, metabolic diseases (such as diabetes), neurological and psychiatric diseases;
7. Has suffered from pancreatitis;
8. Women during pregnancy and lactation;
9. allergic constitution or known to be allergic to the pharmaceutical ingredients and the basic drugs prescribed in this program;
10. Suspect or determine the history of alcohol and drug abuse;
11. Participated in other drug clinical trials (excluding Chinese medicine) within the first three months of screening;
12. Other factors that are not suitable for entering the trial.
Mindful Moms in Recovery

The purpose of this study is to evaluate the initial efficacy of a yoga-mindfulness intervention to promote ongoing recovery for pregnant and parenting women with Opioid Use Disorder (OUD) receiving perinatal services and medication treatment for OUD from maternity care practices in New Hampshire.

In this R33 project, the study team will conduct a randomized controlled trial to evaluate the efficacy and implementation of the Mindful Moms intervention (MMORE) with a group of pregnant women with identified OUD receiving medication treatment for OUD at partner maternity care practices. The study team will evaluate the impact of Mindful Moms as an adjunct to treatment as usual on retention in medication for opioid use disorder (MOUD) treatment, substance use, and relapse-related risks.

This study has three Specific Aims:

Aim 1: Evaluate MMORE in a randomized controlled study with pregnant women as an adjunct to MOUD treatment as usual care for impact on treatment retention, opioid abstinence, and relapse risks.

Aim 2: Examine mechanisms of effect of MMORE on outcomes.

Aim 3: Evaluate barriers and facilitators to sustainable implementation of MMORE as an adjunct to MOUD for pregnant and parenting women.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older.
* English-speaking.
* Singleton pregnancy.
* Receiving comprehensive medication treatment for opioid use disorder as part of prenatal care at a partner maternity care practice.

Exclusion Criteria:

* Cognitive or psychiatric impairments that prohibit being able to provide informed consent.
* Any physical conditions that prohibit activity such as gentle yoga.
Transition of Inflammatory Bowel Disease (IBD) Patients From Pediatric to Adult Gastroenterologist (GI)

The purpose of this study is to determine if the program that has been made to ease the transition of care for adolescent patients with IBD from pediatric gastroenterology to adult gastroenterology is effective to reduce the risk of disease flare during this period. Patient satisfaction with this program will also be assessed.

Approximately 15 to 25% of patients with inflammatory bowel disease are diagnosed prior to the age of 18. The chronic course of this disease means that approximately one quarter of all IBD patients will need to transition from being cared for by a pediatric gastroenterologist to an adult gastroenterologist. Studies in other chronic disease states have identified several problems with the current means of transitioning care from a pediatrician to the adult caregiver including lack of adherence with the proposed treatment, lack of knowledge about the disease, and limited self-care skills. Even without IBD, this can be a time of tremendous turmoil for the adolescent patient. For the chronically ill IBD patient, this stress is further intensified by the underlying illness. Several studies have shown that the risk of flare is increased by non-adherence with medical treatment. The main factors associated with poor adherence include young age and either being under the doctor's care for less than one year or being a new patient for that doctor. Therefore, young adults transferring care from a pediatric gastroenterologist to an adult gastroenterologist are at the highest risk for a bad outcome.

Several recommendations have been published on how to best transition the adolescent IBD patient from pediatric to adult care. The general consensus is that there should be a gradual age specific increase in patient autonomy and involvement in their care prior to being transitioned to an adult gastroenterologist. No study however has incorporated combined clinic visits for the patient with both the pediatric and adult IBD specialist. Furthermore, although these recommendations make logical sense, they have not been assessed objectively.

Eligibility Criteria:
Inclusion Criteria:

A patient may be considered for study participation if all of the following apply:

1. Outpatient of either sex aged ≥ 16 years or older.
2. The patient has a confirmed diagnosis of IBD.
3. No plans to move \> 200 miles from Nashville in the subsequent 12 months.
4. The patient has read, understood and signed a written informed consent form. Permission of a minor participant will be obtained via a parent consent form.

Exclusion Criteria:

The patients will be excluded from the study if one or more of the following apply:

1. Unable to give consent.
2. Does not meet inclusion criteria above.
Avapritinib in CBF-AML With KIT Mutations

AML with t(8; 21)(q22; q22) or inv(16)(p13; q22)/t(16; 16)(p13; q22) is known as CBF-AML. KIT mutations are common in CBF-AML, which have a worse prognosis.This study is aimed to evaluate the efficacy of Avapritinib, an highly specific inhibitor of the KIT gene, in CBF-AML with KIT mutations.

Acute Myeloid Leukemia (AML) with the chromosomal abnormality of t(8; 21)(q22; q22) or inv(16)(p13; q22)/t(16; 16)(p13; q22) is known as the Core Binding Factor AML (CBF-AML). KIT mutation is a common mutation in CBF-AML, which is more likely to relapse and have a worse prognosis.

Avapritinib is an oral tyrosine kinase inhibitor (TKI) with selective inhibitory activity against KIT and PDGFRA. Avapritinib has been approved by FDA for the treatment of gastrointestinal stromal tumors(GIST) with PDGFRA mutations and Advanced systemic mastocytosis (AdvSM). However, the efficacy of avapritinib in AML with KIT mutations is uncertain.

This prospective, multicenter clinical study of the efficacy and safety of avapritinib in relapsed refractory or molecular minimal residual disease (MRD)-positive AML with KIT mutations.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with acute myeloid leukemia accompanied by t(8; 21)/RUNX1-RUNX1T1, or inv(16)/t(16; 16)/CBFβ-MYH11;
2. Accompanied by KIT mutation
3. Disease recurrence after the first remission, or the mol-MRD remains positive after the morphologic remission of AML.
4. No active infection.
5. Liver function: TBIL≤ 2×ULN,ALT/AST≤ 3×ULN, CCr ≥ 50ml/min，NYHA grading ≤2; SaO2 \>92%.
6. ECOG \<2;

(11) Predicted survival \> 12 weeks.

Exclusion Criteria:

1. Accept other AML targeted therapies, such as dasatinib, sorafenib, gilteritinib, etc. simultaneously;
2. The presence of uncontrolled and active infections (including bacterial, fungal or viral infections).
3. Underlying diseases such as myocardial infarction, chronic heart failure, decompensated liver dysfunction, renal failure, etc.
4. Pregnant or lactating women;
5. Accompanied by other malignant tumors requiring treatment;
6. Other interventional clinical studies have been enrolled.
The Mass Balance and Biotransformation of [14C]Donafenib in Healthy Adult Man

This study was designed to evaluate the mass balance and biotransformation after single-dose of \[14C\]Donafenib orally in Chinese healthy adult male volunteers, revealing the overall pharmacokinetic characteristics of Donafenib in humans, and providing a reference for the rational administration.


Eligibility Criteria:
Inclusion Criteria:

* A healthy male adult.
* Age is between 18 and 45, inclusive.
* Body mass index is between 19 and 26, inclusive.
* Voluntarily to provide informed consent form.
* Willing and able to communicate with investigators and complete the trial according to clinical trial protocol.

Exclusion Criteria:

* Any abnormal and clinical significant findings.
* A positive examination result of HBsAg/HBeAg, HIV antibody and treponema pallidum antibody.
* Volunteers who had participated in a radiolabeled clinical study or were exposed to significant levels of radiation for any reasons within the 12 months prior to the study.
* Volunteers who had used of prescription or herbal products that may affect the drug metabolism within 30 days before the study.
* Volunteers who had blood loss/donation up to 400 mL within 3 months before the screening, or received blood transfusion within 1 month.
Feasibility Trial of Neoadjuvant Chemoradiotherapy for Locally Advanced Gastric Cancer

Because locally far-advanced gastric cancer combined with adjacent tissue invasion has a poor prognosis, some phase 2 and 3 clinical trials of neoadjuvant chemotherapy (NAC) are performed in Japan. However, neoadjuvant chemoradiotherapy (NACRT) achieves superior local tumor control compared with NAC. This feasibility trial explored the feasibility and safety of neoadjuvant chemoradiotherapy (NACRT) in this type of gastric cancer.

Since S-1 (combined drug of tegafur, 5-chloro-2,4-dihydroxypyridine and potassium oxonate) was approved in Japan in 1999 after a large-scale clinical trial, adjuvant chemotherapy with S-1 has been the standard treatment for stage II/III gastric cancer. However, for far-advanced gastric cancer, various adjuvant chemotherapies, including S-1, have not achieved satisfactory results. Therefore, Japan Clinical Oncology Group (JCOG) is currently performing phase 2 and 3 clinical trials of neoadjuvant chemotherapy (NAC) for locally far-advanced gastric cancer. However, previous studies of NAC have reported a pathological response rate of 15-50% for the main lesion, indicating no significant effect on local tumor control.

On the other hand, other studies have reported that anticancer drugs, including S-1, have a radiosensitizing effect, and that neoadjuvant chemoradiotherapy (NACRT) achieves superior local tumor control compared with NAC. Therefore, we conducted a feasibility trial of NACRT with S-1 for locally far-advanced gastric cancer combined with adjacent tissue invasion.

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven gastric adenocarcinoma
* Tumor invasion of adjacent structures (T4) and/or tumors with bulky nodal metastases
* No metastases outside of Group 2 lymph nodes
* Neither peritoneal metastasis nor liver metastasis
* No other distant metastasis
* An Eastern cooperative oncology group performance status of between 0 and 2
* No prior radiation therapy
* Sufficient organ function

Exclusion Criteria:

* A synchronous or previously active malignancy
* Insufficient oral intake
* A history of severe allergy
* Watery diarrhea
* Severe co-morbidities
* Requiring therapy for pericardial effusion or pleural effusion
* Contraindications to S-1 or radiotherapy.
Nursing Interventions for Alzheimer's Patients During PET/CT Imaging

The impact of nursing Interventions during PET/CT imaging in Alzheimer's patients on image quality and patient satisfaction will be assessed in 200 patients.

This study will analyze clinical data from 200 Alzheimer's disease (AD) patients who underwent PET imaging and were admitted to Sichuan Provincial People's Hospital over a period of six months. The control group will receive routine nursing intervention, while the observation group will receive a refined specialized nursing intervention. We will meticulously compare various performance aspects in both groups to assess the impact of refined specialized nursing intervention on patients' image quality and patient satisfaction.

Eligibility Criteria:
Inclusion Criteria:

* Meet the criteria for diagnosing dementia as described in the fourth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-R), Use the diagnostic criteria for AD from the National Institute of Neurology, Speech and Communication Disorders and Stroke - Alzheimer's Disease and Related Disorders (NINCDS-ADRDA) or the National Institute on Aging and Alzheimer's Disease Association (NIA-AA).

Exclusion Criteria:

* Patients with a history of stroke and focal neurological signs, and imaging findings consistent with small cerebral vascular disease (Fazekas score ≥2);
* The presence of other neurological disorders that can cause brain dysfunction (e.g., depression, brain tumors, Parkinson's disease, metabolic encephalopathy, encephalitis, multiple sclerosis, epilepsy, brain trauma, Normal facial pressure hydrocephalus);
* The presence of other systemic diseases that can cause cognitive impairment (such as liver insufficiency, renal insufficiency, thyroid dysfunction, severe anemia, folic acid or vitamin B12 deficiency, syphilis, HIV infection, alcohol and drug abuse, etc.);
* There is mental and neurological retardation.
* There are other diseases that are known to cause cognitive impairment.
Comparison Between Non-invasive Heat-flux and Invasive Core Temperature Monitoring

The body core temperature drops during general anesthesia. To maintain homeostasis, patients require warming measures. Different methods to measure body core temperature exist, which are either highly accurate but invasive, or non-invasive but non-accurate. A new monitoring device, Tcore(TM), enables a non-invasive but accurate core temperature assessment.

This study is performed to quantify accuracy and bias of the Tcore system in comparison with the blood temperature, which is the gold standard of core temperature measurement.


Eligibility Criteria:
Inclusion Criteria:

* Patients with invasive femoral artery temperature monitoring

Exclusion Criteria:

* Pregnancy
Gene Therapy for Achromatopsia (CNGB3)

A clinical trial of AAV - CNGB3 retinal gene therapy for patients with achromatopsia

CNGB3 retinal gene therapy for patients with achromatopsia

Eligibility Criteria:
Inclusion Criteria:

* Are aged 3 years or older
* Have achromatopsia confirmed by a retinal specialist (CI or PI)

Exclusion Criteria:

* Are females who are pregnant or breastfeeding
* Have participated in another research study involving an investigational medicinal therapy for ocular disease within the last 6 months
* Have any other condition that the CI/PI considers makes them inappropriate for entry into the trial