cyrilzakka/clinical-trials huggingface dataset:
A Study of TAK-341 in Treatment of Multiple System Atrophy

The main aim is to see how TAK-341 works after 52 weeks in participants with multiple system atrophy as measured by the Unified Multiple System Atrophy Rating Scale Part I (UMSARS).

The study will enroll approximately 138 patients. Participants will receive a total of 13 intravenous infusions every 4 weeks approximately, these may be either of TAK-341 or placebo, after each infusion some blood samplings will be taken and other assessments completed.

This trial will be conducted in North America, Europe and Asia.

The drug being tested in this study is called TAK-341. The study will evaluate the efficacy, safety, tolerability, pharmacokinetics (PK), and pharmacodynamics of intravenous (IV) TAK-341 in participants with multiple system atrophy (MSA).

The study will enroll approximately 138 participants. The study comprises a screening period of up to 42 days (6 weeks), a 52-week double-blind treatment period, and a follow-up safety visit. Participants will be randomly assigned (by chance, like flipping a coin) to one of the treatment schedules-which will remain undisclosed to the participant, care provider and investigator during the study:

* Early PK Cohort: TAK-341
* Early PK Cohort: Placebo
* Main Cohort: TAK-341
* Main Cohort: Placebo

The change from baseline in UMSARS will be measured at Week 52 post-dose.

This multi-center trial will be conducted worldwide. The duration of treatment in this study will be 52 weeks. Participants will make a follow-up visit to the site after approximately 90 days after the last dose of study treatment.

Eligibility Criteria:
Inclusion criteria:

Diagnostic:

1. The participant has a diagnosis of possible or probable MSA using the modified Gilman et al, 2008 diagnostic criteria.
2. The participant's onset of first MSA symptoms occurred ≤4 years before screening, as assessed by the investigator.
3. Evidence of MSA specific symptoms and deficits as measured by the UMSARS scale.

Exclusion criteria:

Medical History:

1. The participant has any contraindication to study procedures.

Diagnostic Assessments:

1. Presence of confounding diagnosis and/or conditions that could affect participant's safety during the study per investigator judgement.
2. The participant's participation in a previous study of a disease-modifying therapy (with proven receipt of active treatment) will compromise the interpretability of the data from the present study, per consultation with medical monitor or designee.

Other:

1. The participant has participated in another study investigating active or passive immunization against α-synuclein (αSYN) for progressive disease (PD) or MSA, or has had immunoglobulin G therapy, within 6 months before screening.
Registry on the Use of HaemoCER-Plus in the Treatment and Prevention of Post-resectional Bleeding

Gastrointestinal bleeding is defined as clinical evidence of bleeding manifested by melena, hematochezia that required endoscopic hemostasis. GI bleeding associated to endoscopic procedure is defined as clinical evidence of bleeding and a drop in hemoglobin of ≥ 2g/dL on the day of the procedure (early bleeding) or up to 14 days after the procedure (delayed bleeding).GI bleeding is, nevertheless, a common complication of endoscopic procedures, such as endoscopic mucosal resection (EMR) and endoscopic sub mucosal dissection (ESD). For example, colorectal ESD, which is technically more difficult than gastric or esophageal ESD because of the anatomical features of the colon, present an increased risk of delayed bleeding. According to literature, early bleeding occurs on average in 5,3% of endoscopic resections of the whole digestive tract, with bleeding rates per location as follows: esophagus 9.4%, stomach 9.1%, duodenum 3.6%, colon 3.4%. Concerning delayed bleeding, it is assessed to complicate 3.1% of endoscopic resection procedures. The bleeding rate in the duodenum is usually the highest (6.3%), followed by colon at (3.6%), stomach (1.5%) and esophagus (0.9%). Age, lesion size and piecemeal resection are associated with an increased risk of bleeding. Usage of aspirin or NSAIDs seems to not increase risk of post-polypectomy bleeding, while clopidogrel and warfarin do and should be discontinued in the periprocedural period to prevent the occurrence of post-polypectomy bleeding. Direct oral anticoagulants (DOAC) administration shows similar post-procedural gastrointestinal bleeding risk to anti-vitamin K antagonists (VKA) administration in patients undergoing endoscopic procedures.


Eligibility Criteria:
Inclusion Criteria:

* patients who had authorized to use and process their personal details for the purpose of research;
* patients able to express their consent;
* age \>18 years;
* endoscopic procedures where HaemoCer-PLUS has been used for hemostasis or prevention of bleeding

Exclusion Criteria:

* hemostatic therapies other than HaemoCer-PLUS
* Known coagulopathy likely to affect risk of bleeding.
Evaluation of Heel Offloading Devices for Reducing Heel Contact Pressures in Healthy Volunteers

Prevention of heel pressure ulceration is a major clinical concern. Clinical research has shown that heel-offloading devices are effective at preventing heel ulceration when compared to no offloading or sub-optimal offloading methods (i.e. use of a hospital pillow to offload the heel). As a result, a plethora of heel-offloading devices have been developed that utilize different designs and materials to offload the heel. Despite the availability of these devices, some healthcare facilities still employ no heel offloading or utilize sub-optimal heel offloading strategies. It is also difficult for clinicians to compare the effectiveness of different heel offloading device without conducting extensive clinical evaluations. Pressure mapping of the pressure experienced by the heel while offloaded offers a potential method to assess the effectiveness of different heel offloading strategies.

The primary hypothesis of this study is that the three tested heel offloading devices will significantly decrease the heel contact forces compared to no offloading and sub-optimal heel offloading conditions. The secondary objective is to quantify differences in heel contact forces experienced by the heel when placed in each heel offloading device to demonstrate the utility of pressure mapping as a tool to evaluate the effectiveness of different heel offloading devices.

The study will recruit 21 healthy volunteers as research subjects with 7 having a normal BMI, 7 having an overweight BMI, and 7 having an obese BMI. Pressure mapping will be conducted on each research subject for seven randomly applied conditions while the patient lies comfortably in a hospital bed. The seven conditions include no heel offloading, 3 sub-optimal offloading conditions, and offloading in 3 different heel-offloading devices. Pressure measurements corresponding to the heel will be used to determine the average peak pressure contact force for each research subject in each condition.


Eligibility Criteria:
Inclusion Criteria:

* 18 years old or older
* No musculoskeletal injury in the past month
* Body Mass Index (BMI) between 18.5 and 39.9

Exclusion Criteria:

* 17 years old or younger
* Musculoskeletal injury in the past month
* Pregnant or lactating female
* History of heel pressure ulceration
* BMI below 18.5 or above 39.9
A Safety and Efficacy Follow-up Study With Levetiracetam in Children (4-17 Years Old) Suffering From Absence Seizures

This long-term open label follow-up trial gave pediatric subjects suffering from typical absences in CAE or JAE the opportunity to continue levetiracetam treatment after participation in the pilot study (study N162) or the double-blind study (study N163). Safety and efficacy data were obtained.


Eligibility Criteria:
Inclusion Criteria:

* Male/female 4-17 years old having participated in study N162 or in study N163
* suffering from typical absences with 3 Hz spike-wave discharges, with or without tonic-clonic seizures, in CAE or JAE
* expected reasonable benefit (efficacy and tolerability) of levetiracetam long term administration

Exclusion Criteria:

* allergy/intolerance to pyrrolidine derivatives and/or excipients
* use of \> 2 concomitant antiepileptic treatment or valproate, ethosuximide or lamotrigine
TACE Combined With "Target Immune" Therapy for First-line Treatment in the Treatment of Intrahepatic Cholangiocarcinoma

This study is a prospective, multicenter, open, real-world clinical study. All eligible patients were assigned to experimental group (TACE combined with multi-target drugs and PD-1 inhibitors), and control group (conventional intravenous chemotherapy), to explore the efficacy and safety of TACE combined with multi-target drugs and PD-1 inhibitors as first-line treatment compared with traditional systemic intravenous chemotherapy in the treatment of unresectable intrahepatic cholangiocarcinoma (ICC).

This study is a prospective, multi-center, open, and double-arm clinical study in the real world, which belongs to a practical clinical trial. The type of comparison is the non-inferiority test. This study enrolls 98 patients with unresectable intrahepatic cholangiocarcinoma at multiple centers across the country. In the experimental group, 49 patients will receive TACE combined with immune checkpoint inhibitors and multi-target drugs; In the control group, 49 patients will receive traditional systemic intravenous chemotherapy with GEMOX regimen.

Eligibility Criteria:
Inclusion Criteria:

* Patients shall be older than 18 years old and have no gender limitation;
* Patients with intrahepatic cholangiocarcinoma confirmed by histopathology or clinical diagnosis and treatment standards who are inoperable or unwilling to undergo surgery at first diagnosis or who cannot be resected after recurrence;
* Patients with measurable lesions that can be observed and evaluated and whose diameter≥1cm are accurately measured by MRI enhancement or Computed Tomography (CT) enhancement according to mRECIST criteria;
* Patients with Child-Pugh A or B liver function grade and basically normal heart function;
* ECOG PS score≤1;
* Patients with expected survival \> 3 months;
* Patients who have voluntarily participated in the study, signed informed consent, had good compliance, and cooperated with follow-up;
* There is no active HBV-DNA replication before enrollment (HBV-DNA\<2000IU/mL), and HBV-positive patients have received anti-HBV treatment before enrollment.

Exclusion Criteria:

* Pregnant women, breast-feeding women or patients of childbearing age planning;
* Patients with severe heart, liver, and renal insufficiency and thyroid dysfunction;
* Patients scheduled for liver transplantation;
* Patients who have had or are currently suffering from other malignant tumors within five years, except cured cervical carcinoma in situ, non-melanoma skin cancer, and superficial bladder tumor;
* Patients with pleural effusion or ascites, causing respiratory syndrome (≥ CTCAE grade 2 dyspnea);
* Patients with unmitigated toxicity higher than CTCAE level 1 (5.0) due to any prior treatment;
* Patients with multiple factors affecting oral medication (such as inability to swallow, chronic diarrhea, etc.);
* Patients with symptoms and signs of interstitial diseases.
Prospectively Predict the Efficacy of Treatment of Gastrointestinal Tumors Based on Peripheral Multi-omics Liquid Biopsy

To vertify the function of EV-score on predicting \& monitoring immunotherapeutic outcomes of GC

Our previous work identified four plasma EV-derived proteins and combined them to generate a signature score that robustly predicting immunotherapeutic outcomes at baseline and dynamically monitoring disease progressions along with the whole treatment.

Hence in this stuty, we plan to recruit a prospective cohort to support our conclusions, and provide possible method to realize predicting and monitoring immunotherapeutic outcomes of GC.

Eligibility Criteria:
Inclusion Criteria:

* Having signed informed consent
* Age≥ 18 years old
* Histologically confirmed gastric adenocarcinoma
* Unresectable recurrent or metastatic disease
* Measurable disease according to the RECIST criteria
* Life expectancy of ≥3 month
* No prior chemotherapy of the study more than 4 weeks
* Immunotherapy regimens were included in the treatment

Exclusion Criteria:

* Other previous malignancy within 5 year
* Surgery (excluding diagnostic biopsy) within 4 weeks prior to study
* Pregnancy or lactation period
* Legal incapacity
Acceptance and Commitment Therapy and Test Anxiety

The aim of this study is to evaluate the effect of acceptance and commitment therapy-based psychoeducation on test anxiety, study skills and psychological flexibility on adolescents. test anxiety scale, study skills scale and psychological flexibility scale are data collection tools. The pretest-posttest is a randomized controlled trial. Experimental and control groups were formed. A 6-week psychoeducation will be applied to the experimental group.

The aim of this study is to determine the effect of acceptance and commitment therapy-based psychoeducation given to adolescents on test anxiety, study skills and psychological flexibility.The research was designed as a randomized controlled study with pretest, posttest, experimental and control groups aiming to examine the results of Acceptance and Commitment Therapy (ACT) based psychoeducation for test anxiety and study skills. The number of effects of the study was targeted by the randomization method among the adolescents who met the inclusion criteria and accepted the application. In the power analysis, the evaluation of the number of increase is aimed at 0.05 aggression level at the 95% confidence interval, and 52 adolescents, 26 experimental and 26 control groups, to reach 80% power. Randomization methods were used so that individuals could be assigned to the experimental groups with equal chance, similar to the scores they obtained from the laboratory test anxiety periods. 52 adolescents who met the clinical research criteria for randomization were divided into 2 groups using the irregular numbers table, this group was named as the experimental and control groups by drawing lots. The group that came out first in the lottery at this stage was accepted as the experimental group. Psychoeducation is planned to be held between December 2022 and February 2023.

Eligibility Criteria:
Inclusion Criteria:

* Students' willingness to participate in research
* Students being 11th graders
* Getting a score of 50 or more on the test anxiety scale

Exclusion Criteria:

* Any degree of cognitive decline or impairment
* Presence of depressive disorder
* Presence of serious psychiatric disorder
* Being under treatment for a psychiatric condition
Safety and Efficacy of Exemestane Plus Dasatinib Versus Placebo for Advanced ER+ Breast Cancer

The purpose of this study is to determine whether exemestane plus dasatinib will be well-tolerated and will increase progression-free survival (PFS) in the treatment of advanced estrogen-receptor positive (ER+) breast cancer after disease progression (PD) on a non-steroidal aromatase inhibitor (NSAI).


Eligibility Criteria:
Inclusion Criteria:

* Histologically-documented invasive estrogen receptor positive breast cancer , with tumor tissue from prior surgery available for analysis
* Prior therapy with a non-steroidal aromatase inhibitor
* Recurrent or progressive advanced breast cancer (locally-advanced or metastatic)
* Documented breast cancer with tumor ≤ 28 days prior to study entry
* Women who are NOT of childbearing potential
* Must be able to take oral medication
* Performance Status 0 or 1

Exclusion Criteria:

* Pleural or pericardial effusion or ascites (of any etiology; Grade ≥ 1) within 6 months prior to study entry
* Any chemotherapy, immunotherapy \< 6 months before study entry. Any targeted therapy (eg. lapatinib) \< 6 months before study entry, unless given in combination with an NSAI
* Any antitumor therapy, including radiotherapy or hormonal therapy, within 15 days prior to study entry
* Prior exposure to exemestane, any Src-family kinase inhibitor including dasatinib, to agents intended to control osteolytic disease other than bisphosphonates, or to any investigational agent for breast cancer
* Concurrent or previous malignant disease requiring chemotherapy or radiation treatment within the prior 3 years
* Significant bleeding disorder, or ongoing or recent clinically-significant gastrointestinal bleeding
* Any serious cardiac condition, including congestive heart failure or myocardial infarction within 6 months, uncontrolled angina, or Class III or IV heart disease as defined by the New York Heart Association, baseline ejection fraction ≤ 40%, diagnosed congenital long QT syndrome, clinically-significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsades de Pointes), QTc interval \> 450 msec at baseline (Fridericia correction)
* Hematologic abnormality Grade ≥ 2
* Hypocalcemia of Grade ≥ 1
* Any Chemistry abnormality of Grade ≥ 2 \[except Grade 2 indirect bilirubin permitted if diagnosed Gilbert's disease\]
* Pregnant Women and Women of Childbearing Potential (WOCBP)
* Extremely lactose intolerant, in the judgment of treating physician (100 mg dasatinib contains 135 mg lactose, posing a problem only if intolerance is severe)
* Receiving any of the following concomitant medications: Category I drugs that are generally accepted to have a risk of causing Torsades de Pointes including: (Subjects must discontinue drug use at least 7 days prior to starting dasatinib)
* Potent inhibitors of CYP3A4 isoenzyme
* Prisoners or subjects who are involuntarily incarcerated; or subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness
Efficacy and Safety of Androgel in the Treatment of Hypogonadal and Low Testosterone Men With Type 2 Diabetes

This study is to investigate how well Androgel, when tested against placebo gel, helps to control blood sugar levels in males with type 2 diabetes who have low testosterone (the main male hormone) blood levels and are taking oral diabetic medicines alone or in combination with insulin.


Eligibility Criteria:
Inclusion Criteria:

1. Able to read and write
2. Males
3. Between 30-80 years old
4. Have type 2 diabetes
5. Diagnoses of hypogonadism or low testosterone

Exclusion Criteria:

1. On insulin monotherapy
2. Use of testosterone therapy within the last 6 months
3. Male breast cancer
4. History of prostate cancer
5. History of clinically significant sleep apnea
Effects of Dexmedetomidine on the Liver Injury After Hepatectomy

To investigate whether dexmedetomidine reduce liver injury after hepatectomy. During hepatectomy, surgeons always took inflow occlusion to reduce blood loss with Pringle maneuver. A few clinical studies had shown dexmedetomidine could reduce ischaemia/reperfusion (IR) injury caused by the secretion of reactive oxygen species and inflammatory cytokines. Glutathione-S-transferase (GST) was a sensitive and specific marker for hepatic injury in several studies before. So the investigator decided to use it as the primary endpoint. Besides, in our center, there are some liver resection surgeries that didn't need occlusion. So it can serve the best placebo for determine the the actual effect of dexmedetomidine on the IR injury in further subgroup analysis.

The purpose of our study is to compare liver injury with dexmedetomidine. The enrolled patients were randomized into two group. In the study group, dexmedetomidine, diluted in 0.9% sodium chloride with the concentration of 4 ug ml-1 is administered with an loading dose of 0.5ug kg-1 of 10 min, and maintained with infusion rate of 0.5 ug kg-1 h-1. While, 0.9% sodium chloride serves as the placebo with the same loading dose and infusion rate in the control group. The infusion is ceased after the resection of the hepatic issues.

GST is a sensitive and specific marker for hepatic injury in several studies before and is taken as the primary endpoint. And the investigator use other inflammatory cytokines reflecting the systemic inflammatory response in serum. Besides these, the investigator observe the hemodynamic changes during the operation time and complications related with anesthesia and surgery.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) I\~III
* selected to have hepatectomy in our hospital, Child-Pugh A
* patient's consent

Exclusion Criteria:

* refusing to attend or attending in other clinical study
* having severe cardio-pulmonary disease, ejection fraction (EF)\<40%, having cardiac infarction in recent three months, chronic obstructive pulmonary disease (COPD) (PaO2\<60mmHg)
* pregnant or lactating women
* having neuropsychiatric disorders
* emergent surgeries，hemorrhage shock，
* rupture and hemorrhage of liver tumor
A Lifestyle Program on Healthy Weight in Postpartum Period

The aim of this study is to examine the impact of lifestyle intervention on postpartum weight loss. So the investigators will have two groups in this study. In Experimental group women will receive the Healthy Lifestyle Intervention. This intervention will have been delivered during 12 weeks. In Control group women will receive general information via pamphlet about postpartum period and tips for stress management.

This study will be conducted in two phases. In the first phase , the investigators will conduct a cross-sectional study to assess factors related to the healthy lifestyle after childbirth based on the PRECEDE model. Regarding results of the study, the investigators will plan and implement a lifestyle promoting intervention and will evaluate the effect of the intervention on weight reduction among postpartum women.

Eligibility Criteria:
Inclusion Criteria:

* Singleton pregnancy
* Lactating
* Non-smoking
* Full-term birth
* Lack of medical problems
* Lack of any pregnancy-related complications (eg, multiple pregnancy, fetal anomalies, fetal or maternal complications in current or previous pregnancy, and hypertension in pregnancy).
* Nonparticipation in other studies which may affect the results.
* 18.5≤ BMI≤29 before pregnancy
* Women who are sedentary according to the International Physical Activity Questionnaire.

Exclusion Criteria:

* Unwilling to continue participation in the study
* Pregnancy during the study
* Suffering physical problems during the study
* Smoking after birth