cyrilzakka/clinical-trials huggingface dataset:
Phase 2a Study of Efficacy and Safety of OpSCF in Moderate to Severe Atopic Dermatitis

The purpose of this study is to determine the efficacy and safety of a monoclonal antibody, OpSCF, in the treatment of adults with moderate to severe Atopic Dermatitis (Eczema). OpSCF will be compared to a placebo.

OpSCF or placebo will be administered every 2 weeks for 14 weeks, and the efficacy will be assessed two weeks later. After that, subjects may choose to enter an Open Label Extension phase in which all subjects will receive OpSCF every 4 weeks for 40 additional weeks.


Eligibility Criteria:
Inclusion Criteria:

* Subject has clinically confirmed diagnosis of active AD
* Subject has at least a 6-month history of AD
* Subject is willing to use effective birth control

Exclusion Criteria:

* Subject is a female who is breastfeeding, pregnant, or who is planning to become pregnant during the study.
* Subject has any clinically significant medical condition that would put the subject at undue risk or interfere with interpretation of study results.
* Subject has used dupilumab within 26 weeks prior to Day 1
* Subject has used tralokinumab within 12 weeks prior to Day 1
The Efficacy of Primary Total Mesorectal Excision (TME) Surgery Versus Neoadjuvant Chemotherapy Combined With TME Surgery in Low-risk Locally Advanced Rectal Cancer

Comparative analysis of the clinical efficacy between primary Total Mesorectal Excision (TME) surgery and neoadjuvant chemotherapy combined with TME surgery for low-risk locally advanced rectal cancer. Randomly enrolling eligible patients into either the control group receiving neoadjuvant chemotherapy combined with TME surgery or the experimental group receiving primary TME surgery, and subsequently comparing the clinical outcomes of the two groups


Eligibility Criteria:
Inclusion Criteria:

1. Newly diagnosed patients, aged 18 to 75 years;
2. Pathologically confirmed rectal adenocarcinoma;
3. Distance of the lower margin of the rectal tumor lesion from the anal margin \<15cm;
4. High-resolution MRI indicates low-risk locally advanced rectal cancer: T1-3bN1-2 or T3aN0 or T3bN0; no involvement of the anal sphincter; negative mesorectal fascia (MRF) status; negative extramural vascular invasion (EMVI); no cancer nodules;
5. Exclusion of patients with non-local recurrence or distant metastases;
6. Absence of synchronous colorectal multiple primary cancers;
7. Adequate physical condition to tolerate surgery and neoadjuvant chemotherapy, including cardiac, pulmonary, hepatic, and renal functions;
8. The study physician assessed no difficulty in sphincter preservation;
9. patients and their families will be willing to participate in this study and provide written informed consent.

Exclusion Criteria:

1. Patients with concurrent other malignancies or a history of malignant tumors in the past;
2. Patients with intestinal obstruction, intestinal perforation, intestinal bleeding, or other conditions requiring emergency surgery;
3. Patients with tumor invasion into the external sphincter or levator ani muscles, or involvement of adjacent organs necessitating combined organ resection;
4. Patients with poor anal function or fecal incontinence before surgery;
5. Patients with a history of inflammatory bowel disease or familial adenomatous polyposis;
6. Patients recently diagnosed with other malignancies;
7. Patients with ASA grade ≥ IV and/or ECOG performance status score \> 2;
8. Patients with severe liver or kidney dysfunction, significant cardiopulmonary impairment, coagulation disorders, or those with extreme underlying conditions unable to tolerate surgery;
9. Patients with a history of severe mental illness;
10. Pregnant or lactating women;
11. Patients with uncontrolled infections before surgery;
12. Patients with other clinical or laboratory conditions, as determined by the investigator, that render them unsuitable for participation in this trial.
Study to Evaluate Efficacy and Safety in Chinese Patients With Late Onset Pompe Disease With Alglucosidase Alfa Treatmen

Primary Objective:

To evaluate the effect of one-year Alglucosidase alfa treatment on motor function \[Six-minute walk test (6MWT) and lung function predicted Forced vital capacity (FVC)\] among Chinese Late Onset Pompe Disease patients above 5 years old.

To evaluate the safety of Myozyme 20mg/kg, IV biweekly in Chinese LOPD patients above 3 years old.

Secondary Objective:

To evaluate the effect of one-year treatment with Alglucosidase alfa on improvement of manual muscle test (MMT), Maximal inspiratory and expiratory pressure (MIP and MEP)\], Quick Motor Function Test scores, and health-related quality of life (SF-12) among LOPD patients over 5 years old.

Study duration per participants is approximatively 56 weeks including a 52-week treatment period.

Eligibility Criteria:
Inclusion criteria :

* Patients (or and patient's legal guardian) must provide written informed consent prior to any study-related procedures
* The patient must be ≥ 3 years of age at the time of enrollment.

  1. For patient ≥ 3-year and \< 5-year old: must be able to walk 10 meters or climb 4-step stairs independently.
  2. For patients ≥5-year old

  i. Must be able to ambulate 40 meters in 6 minutes without assistance ii. Must be able to successfully perform repeated forced vital capacity (VC) measurements in upright position of ≥ 30% predicted and ≤85% predicted.
* The patient has confirmed Pompe's Disease with at least 2 of the following condition,

  1. GAA enzyme deficiency from any tissue source.
  2. 2 confirmed GAA gene mutations.
  3. muscle pathology meet the diagnosis of Pompe disease.
* The patient (and patient's legal guardian if patient is legally minor as defined by local regulation) must have the ability to comply with the clinical protocol.
* The patient, if female and of childbearing potential, must have a negative pregnancy test (beta-human chorionic gonadotropin) at baseline.

Exclusion criteria:

* Use of invasive ventilatory support (Invasive ventilation is defined as any form of ventilatory support applied with the use of an endotracheal tube.)
* Use of non-invasive ventilatory support while awake and in an upright position. (Non-invasive ventilation is defined as any form of ventilatory support applied without the use of an endotracheal tube.)
* Previously treated with Enzyme Replacement Treatment.
* A Female patient of childbearing potential with a positive pregnancy test.
* Wheelchair dependent.
* The patient has a major congenital anomaly.
* The patient has a medical condition, serious intercurrent illness, or other extenuating circumstance, in the opinion of the Investigator, may significantly interfere with study compliance, including all prescribed evaluations and follow-up activities.
* The patients with ≥5-year old are unable to ambulate 40 meters without assistance or unable to successfully perform repeated FVC of \>30% and \<85% predicted (upright).

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Acoustic Cluster Therapy (ACT) with Chemotherapy for the Treatment of Locally Advanced Pancreatic Cancer

The purpose of the study is to assess the efficacy and safety of Acoustic Cluster Therapy (ACT) when given in addition to chemotherapy for treatment of Locally Advanced Pancreatic Cancer.

Patients with Locally Advanced Pancreatic Cancer who have not received prior treatment to their pancreatic cancer will receive ACT treatment (the drug PS101 and ultrasound application to the tumor) with up to eight 2-week cycles of modified FOLFIRINOX chemotherapy.

ACT treatment will be given on Day 1 of each cycle of chemotherapy. Patients' well-being and side effects will be assessed at the same visits. The objective efficacy of the treatment will be assessed by CT scans every 8 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Not deemed suitable for primary curative surgery and have radiographic and pathological disease consistent with inoperable LAPC or borderline resectable pancreatic cancer.
* Suitable to receive treatment with mFOLFIRINOX according to the Investigator's assessment.

Exclusion Criteria:

• Any prior anti-cancer treatment for pancreatic cancer (e.g. chemotherapy, surgery, radiation). Palliative bypass procedure and bile duct stenting are allowed.
Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis

This is a parallel group, double blind, vehicle-controlled study to assess the safety and efficacy of roflumilast (ARQ-151) cream vs vehicle applied once daily (qd) for 4 weeks by participants with atopic dermatitis (eczema).


Eligibility Criteria:
Inclusion Criteria:

1. Participants legally competent to sign and give informed consent and, if appropriate, assent as required by local laws.
2. Males and females, ages 6 years and older at time of signing Informed Consent (Screening). Only subjects 18 years and older will be enrolled at sites located in the province of Québec in Canada.
3. Diagnosed with atopic dermatitis 6 months duration (3 months for children), as determined by the Investigator. Stable disease for the past 4 weeks with no significant flares in atopic dermatitis before screening.
4. Females of childbearing potential (FOCBP) must have a negative serum pregnancy test at Screening and a negative urine pregnancy test at Baseline/Day 1. In addition, sexually active FOCBP must agree to use at least one form of a highly effective or barrier method of contraception throughout the trial.
5. In good health as judged by the Investigator.
6. Subjects considered reliable and capable of adhering to the Protocol and visit schedule, according to the judgment of the Investigator.

Exclusion Criteria:

1. Subjects with any serious medical condition or clinically significant abnormality that would prevent study participation or place the subject at significant risk, as judged by the Investigator
2. Has unstable AD or any consistent requirement for high potency topical steroids.
3. Subjects who are unwilling to refrain from prolonged sun exposure and from using a tanning bed or other artificial light emitting devices (LEDs) for 4 weeks prior to Baseline/Day 1 and during the study.
4. Females who are pregnant, wishing to become pregnant during the study, or are breast-feeding.
5. Previous treatment with ARQ-151.
6. Subjects with a history of chronic alcohol or drug abuse within 6 months prior to Screening.
7. Parent(s)/legal guardian(s) who are unable to communicate, read, or understand the local language(s). Subjects who are unable to communicate, read or understand the local language, or who display another condition, which in the Investigator's opinion, makes them unsuitable for clinical study participation.
8. Subjects who are family members of the clinical study site, clinical study staff, or sponsor, or family members of enrolled subjects living in the same house.
Factors Affecting Rehabilitation Time for Postoperative Complications Among Breast Cancer Patients

Breast cancer patients who had undergone surgery, chemotherapy and radiotherapy suffered from complications, including shoulder stiffness, lymphedema and scar contracture. These symptoms impaired one's ADL function. Rehabilitation may relieved symptoms. However, it is difficult to estimate how long one should receive rehabilitation. The study is trying to establish a machine-learning based model in order to predict the period of rehabilitation.

Breast cancer survivors suffered from complications after surgery, chemotherapy and radiotherapy. These complications include shoulder stiffness, upper limb lymphedema and scar contracture, which altogether impaired one's ADL function. Rehabilitation had been approved to relieved these symptoms effectively. However, many factor may interfere the patient's participation of rehabilitation, making it difficult to estimate how long one should receive rehabilitation. In Taiwan, National Health Insurance provides affordable, accessible and unlimited health care and medical service for all citizens, eliminating many social-economic barriers. Thus we are trying to establish a machine-learning based model in order to predict the period of rehabilitation.

Our study is a retrospective case-control study. The objectives are breast cancer survivors who attended post-surgery rehabilitation at least once for complications. The following data are collected from e-HIS system:

1. Patient characteristic: age, unilateral or bilateral cancer.
2. Surgery type: total, partial or simple mastectomy.
3. Lymphatic surgery: ALND and SLNB
4. Other surgical procedure: breast reconstruction, flap surgery.
5. Combined therapy: chemotherapy, radiotherapy or hormone therapy.
6. Complications: shoulder stiffness, lymphedema, scar contracture (ex., Axillary web syndrome), neurological deficit.
7. The first between operation and first time of rehabilitation.

The primary outcome is the total rehabilitation time, which will be divided as short term (less than 360 min) and long time (more than 360 min).

The data will be processed using WEKA and machine learning algorithms, including Logistic regression, supportive vector machine, K-nearest neighbors, decision tree and random forest.

Eligibility Criteria:
Inclusion Criteria:

* patients who received operation for breast cancer
* attended rehabilitation at least once for breast cancer related complications

Exclusion Criteria:

* patients who received rehabilitation for other reasons rather than surgical complications
* patients who are transfered to other hospital for rehabilitation
An Eval of Neurocognitive Function, Oxidative Damage, and Their Association With Outcomes in METH and Cocaine Abusers.

The purpose of this study is to determine whether performance on neurocognitive measures predicts treatment outcomes in individuals with substance abuse disorders. A second purpose is to compare the risk of damage, as well as actual damage, to DNA and other cell parts in people with substance abuse disorders to that of people who do not have substance abuse disorders.

The primary objective of this study is to replicate the finding that performance on the Stroop color-word interference task is predictive of treatment completion in participants with cocaine use disorders and to extend this finding to participants with Methamphetamine use disorders. Secondary objectives include evaluating whether:

1. performance on various neurocognitive measures, including the Stroop, Rey Auditory-Verbal Learning Test (RAVLT), Iowa Gambling Task (GT), Wisconsin Card Sorting Task (WCST), the Barratt Impulsiveness Scale version -11 (BIS-11), and the Frontal Systems Behavior Scale (FrSBe) is predictive of treatment attrition and stimulant use outcomes in METH/cocaine abusers;
2. neurocognitive test performance is associated with oxidative damage, a severe consequence of oxidative stress, in METH/cocaine abusers;
3. oxidative damage is predictive of treatment attrition and substance use outcomes in METH/cocaine abusers,
4. oxidative damage in METH/cocaine abusers is significantly greater than that of a normal comparison group and
5. exploratory analyses reveal a significant relationship among oxidative stress, neurocognitive function, and treatment outcomes in METH/cocaine abusers.

Eligibility Criteria:
Inclusion Criteria (METH and/or Cocaine Dependent Group):

* be randomized into the CTN-0031 (STAGE-12) trial
* current abuse or dependence for METH and/or cocaine
* endorse METH and/or cocaine as the primary drug of choice
* able to correctly distinguish the colored stimuli on the Stoop task.

Exclusion Criteria (METH and/or Cocaine Dependent Group):

* history of stroke
* history of a seizure disorder

Inclusion Criteria (Non-METH and/or Cocaine Dependent Group):

* be 18 years of age or older
* be able to understand the study and provide written informed consent in English

Exclusion Criteria (Non-METH and/or Cocaine Dependent Group):

* history of stroke
* history of a seizure disorder
* positive urine toxicology screen
* screen positive for Major Depressive Syndrome, other Depressive Syndrome, Panic Syndrome, or other Anxiety Syndrome
* meet criteria for ADHD
* have HIV/AIDS
* history of an injury in which consciousness was lost for more than 30 minutes
* meet DSM-IV criteria for dependence (either current or lifetime) for any psychoactive substance other than nicotine or for abuse (both current and lifetime) for any psychoactive substance other than nicotine or for alcohol for which a life-time history of abuse is allowed
Absorption, Distribution, Metabolism and Excretion (ADME) Study With Single Oral Administration of [14C] NKTR-118

Study to Assess the Absorption, Metabolism and Excretion of \[14C\] NKTR-118 after a Single-Dose Oral Administration.


Eligibility Criteria:
Inclusion Criteria:

* Have a body mass index (BMI) of ≥18 and ≤30 kg/m2 and a minimum weight of 50 kg
* Regular daily bowel movements (ie, production of at least 1 stool per day).
* Non-smoker or ex-smoker who has not used tobacco or nicotine products for ≥3 months prior to Visit 1

Exclusion Criteria:

* Healthy volunteers who have been exposed to radiation levels above background (eg, through X-ray examination) of \>5 mSv in the last year, \>10 mSv in the last 5 years, or a cumulative total of \>1 mSv per year of life
* Participation in any prior radiolabelled study within 12 months of screening visit 1
* Excessive intake of caffeine containing drinks e.g., coffee, tea, caffeine containing energy drinks and cola (more than 5 cups of coffee or equivalent per day
Phase 3 Study of ALXN1850 in Treatment-Naïve Pediatric Participants With HPP

The primary purpose of this study is to evaluate the efficacy of ALXN1850 versus placebo on radiographic outcomes in pediatric participants with HPP who have not previously been treated with asfotase alfa.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of HPP documented in the medical records, and the following criteria fulfilled without other probable cause than HPP:

  1. Presence of HPP-related rickets on skeletal X-rays during the Screening Period, with a minimum Rickets Severity Score (RSS) of 1.0 AND
  2. Serum ALP activity below the age- and sex-adjusted normal range during the Screening Period as measured by the Central Laboratory OR 2 documented serum ALP activity results, at least 15 days apart, below the age- and sex-adjusted local laboratory normal range during the 24 months before the Day 1 Visit. Note: Local laboratories need to be Clinical Laboratory Improvement Amendments (CLIA) or ISO 15189 certified, or have other local equivalent laboratory certification with Alexion's approval.
* Must meet 1 of the following criteria:

  1. Documented ALPL gene variant (pathogenic, likely pathogenic, or variant of unknown significance) from a CLIA certified laboratory (Section 8.7)
  2. Plasma PLP above the upper limit of normal (ULN) during the Screening Period (central or local laboratory results allowed per local regulations)
* Tanner stage 2 or less during the Screening Period

Exclusion Criteria:

* History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, neurological disorders, or any other disorders that are capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data as determined by the Investigator
* Diagnosis of primary or secondary hyperparathyroidism
* Hypoparathyroidism, unless secondary to HPP
* Any new fracture within 12 weeks before Day 1 (excluding pseudofractures)
* Planned surgical intervention which may impact the results of study assessments (in the opinion of the Investigator) during the Randomized Evaluation Period
* History of allergy or hypersensitivity to any ingredient contained in ALXN1850 or the placebo comparator
Postpartum Hemorrhage: Incidence and Risk Factors

Postpartum hemorrhage(PPH) is a major cause of maternal morbidity and mortality across the world. Incidence of PPH varies in the literature from 2 to 10%, most recent studies find around 10% of PPH and 2% of severe PPH.

In this study, the incidence of PPH in the maternal ward of the CHU Brugmann will be analyzed. This is a tertiary maternal ward with a high proportion of high risk pregnancies with around 3000 admissions per year.

Primary aim of this study is to evaluate the epidemiology of PPH in the CHU Brugmann, incidence and possible underlying causes will be identified and compared to the current literature. A data mining technique will be used to construct a prediction model for PPH.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women who have given birth vaginally or by cesarean section at the CHU Brugmann between January 1, 2020 and August 31, 2022
* ≥ 18 years

Exclusion Criteria:

* Age ≤ 18 years
* Age \> 60 years
* delivery before 25th week of pregnancy
* delivery outside of the hospital
* abortion
Psilocybin-assisted Group Therapy for Demoralization in Long-term AIDS Survivors

The purpose of this study is to determine whether psilocybin-assisted group psychotherapy is a safe and feasible treatment for demoralization in long-term AIDS survivors (LTAS).

This study is an open-label mixed-methods pilot study of an individual oral psilocybin drug session combined with ten sessions of an evidence-based, manualized brief group psychotherapy for existential distress in palliative care patients.

Eligibility Criteria:
Inclusion Criterion:

* Older individuals who are long-term AIDS survivors and suffer from moderate-to-severe demoralization.

Exclusion Criteria:

* A physical, neurological or cognitive condition that makes participating in the study unsafe or unfeasible.
* Regular psychotropic medication use.
* Personal or family history of serious mental illness.
* Severe depression requiring immediate standard-of-care treatment.
* Exclusion by the clinical judgment of the study investigators.
The Effects of Different Doses of Dexmedetomidine on Propofol Requirement for Loss of Consciousness Undergoing Bispectral Index: a Double-blinded, Placebo-controlled Trial

The purpose of this study is to evaluate the effects of different dexmedetomidine on the propofol requirement for loss of consciousness undergoing bispectral index.

It has been shown that dexmedetomidine was an efficacious and safe adjuvant in general anaesthesia. Administration of dexmedetomidine during the preoperative period has been demonstrated to reduce the requirement of opioid analgesics and other sedative and hypnotic drugs.Therefore, the study is designed to measure the effect of intravenous dexmedetomidine premedication on the propofol dose requirement and bispectral index at loss of consciousness.

Eligibility Criteria:
Inclusion Criteria:

* ASA physical status I-II
* Aged 18-65 years
* Body Mass Index 18.0～24.5 kg/m2
* Without hearing impairment

Exclusion Criteria:

* Bradycardia
* Atrioventricular block
* Neurologic disorder and recent use of psychoactive medication
* Allergic to the drugs