cyrilzakka/clinical-trials huggingface dataset:
A Study of GZR18 Injection in Chinese Obese/Overweight Patients

The study was a multicenter, randomized, double-blind, placebo-controlled phase Ib/IIa clinical study to evaluate the safety, tolerability, pharmacokinetics and efficacy of GZR18 injection in Chinese adult obese/overweight patients. This study is divided into Part A and Part B, which are to be conducted simultaneously.


Eligibility Criteria:
Inclusion Criteria:

* 1. Male or female aged 18-65 years (inclusive);

  2. Obese subjects: BMI ≥ 28.0 kg/m2; or overweight subjects: 24.0 ≤ BMI \< 28.0 kg/m2 with at least one comorbidity;

  3. Able to understand the procedures and methods in this study; willing to complete the study in strict accordance with the clinical study protocol and sign the ICF voluntarily.

Exclusion Criteria:

* 1. Suspicion that the subject may be allergic to any study drug or ingredient or congener from the investigator.

  2. Subjects with body weight change \> 5.0% for any reason (diet, exercise, etc.) within 12 weeks prior to screening.

  3. Heart rate \< 50 beats/min or \> 100 beats/min on 12-lead ECG at screening.

  4. Presence of the following clinically significant 12-lead ECG abnormalities at screening.

  5. Alcohol abuse within 6 months prior to screening, or reluctance to stop alcohol abuse throughout the study, or a positive breath alcohol test result at screening.
Study of Hemostasis During the Atrial Fibrillation Ablation Procedure

Anticoagulation monitoring is done by monitoring the ACT (Activated Clotting Time) with an objective greater than 300 s. Until now, treatment with direct oral anticoagulant (for the prevention of thromboembolic events of atrial fibrillation) was interrupted a few days before the procedure in order to limit the risk of per-procedural bleeding. However, 3 recent randomized studies concerning the 3 DOACs available suggest that treatment should not be interrupted during the entire operative period. The operation therefore takes place under double anticoagulation with a direct oral anticoagulant and unfractionated heparin. Under these conditions, ACT monitoring can no longer be considered a reliable means of measuring the level of anticoagulation. It was therefore necessary to explore the hemostasis of these patients in a broad way in order to avoid any risk of overdose of UFH (Unfractionated Heparin) during the procedure.


Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years-old
* with an atrial fibrillation
* Operated for an atrial fibrillation procedure in the University hospital of Strasbourg
* Without interruption of the direct oral anticoagulant
* For whom extended biological assessment has been made in routine practice

Exclusion Criteria:

* Patients who refused the use of their data for this study
Observational Study of Swallowing Function After Treatment of Advanced Laryngeal Cancer

The purpose of this prospective, multi-institutional, observational cohort study is to determine if an initial surgical approach leads to better function and quality of life than primary chemoradiation in a subset of patients with advanced hypopharyngeal and laryngeal cancers.

At the time of registration patients will be categorized into 2 groups based on the initial treatment plan as either chemoradiation-based or surgically-based (laryngectomy). Treatment will be assigned by the patient's physician, it will not be assigned by the study.

Patients will be asked to complete a series of 4 questionnaires addressing swallowing function, generic health status, head and neck cancer-specific quality of life, and self-reported speech function at 3 time points (baseline, 6 months and 12 months after the end of treatment). The treating physician will provide basic clinical information at these same time points. In centers where swallowing and voice assessments are done as part of standard of care, data from these studies will also be provided.

Study entry is open to all adults regardless of gender or ethnic background. Specific information regarding the definitive treatment (surgery or chemoradiation) will be provided to the patient by the treating physician as part of the routine standard of care. Any treatment related side effects, as well as the duration of therapy and follow-up will be managed by the treating physician. Participation in this study will have no effect on the initial treatment decisions or the course of care.

Eligibility Criteria:
Inclusion Criteria:

* Willingness and ability to complete self-administered follow-up questionnaires over the course of one year as determined by a member of the research team
* Voluntary written informed consent with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care
* Must be at least 18 years of age

Exclusion Criteria:

* Require a resection that would involve more than the standard laryngectomy (total pharyngectomy, esophagectomy)
* Undergo partial laryngectomy, when open or endoscopic
* Have previously altered anatomy of the upper aerodigestive tract
* Have pre-existing dysphagia unrelated to the tumor, or neurologic disorders that could affect swallowing (Parkinson's, cerebrovascular accidents)
* Have prior malignant disease of the upper aerodigestive tract
* Have prior radiation therapy to the head and neck region
* Metastatic disease
* Unable to complete self-administered questionnaires written in simple English for cognitive, psychiatric, or other reasons that in the opinion of the enrolling investigator is likely to interfere with participation in this clinical study.
NEUROMOdulation Pain Therapy in Combination With Intensive Physiotherapy

In this project, the aim is to verify that neuromodulation therapy (spinal cord stimulation) in combination with intensive physiotherapy on a neurophysiological basis will lead to the restoration of mobility of lower limbs.

So far, posterior spinal cord neurostimulation (NM SCS) has been applied as a standard in patients with the most severe forms of pharmacoresistant neuropathic pain. The most recent research of the last 1-2 years brings clinical findings that, in a mode and modified arrangement, it could even induce rhythmic muscle activity of the lower limbs and help in verticalization and assisted bipedal locomotion.

In this project, the aim is to verify that neuromodulation therapy SCS (spinal cord stimulation) in combination with intensive physiotherapy on a neurophysiological basis will lead to the restoration of mobility of lower limbs.

In the therapy, the neuronal circuits of the lumbosacral region, where the so-called central pattern generators for locomotion are located will be targeted. Neurostimulation of this area will generate motor movement patterns corresponding to the previous mapping of the corresponding muscle groups. These will be supported by intensive physiotherapy on a neurophysiological basis - thanks to it and the facilitation of movement by neurostimulation, global motor patterns will be triggered, and motor programs stored at the subcortical level will be activated. Their memorization and subsequent spontaneous retrieval will facilitate sensorimotor learning techniques.

Current research further shows that neurostimulation stimulates neurons in Rexed laminae 3-5, specifically a group of neurons designated as SC VSX2 and subsequently proprioceptive fibres. Physiotherapy will enhance the effect of neuromodulation by stimulating proprioceptors using soft and neurophysiologically based techniques. Proprioceptive fibres make connections to motoneurons and also ascend through the spinal cord to the brain, and thus reflex motor movements can be triggered. Information about them is carried to the brain by ascending pathways, and thus a free awareness of the movement facilitated by the neurostimulator occurs. All these mechanisms should potentiate plasticity (and lead to the restoration of locomotion.

Eligibility Criteria:
Inclusion Criteria:

spinal cord lesion

Exclusion Criteria:

other neurological conditions
Therapy for Reading Problems in Adults After Brain Injury

Adults who sustain brain damage due to stroke, head injury, or traumatic surgery may develop difficulty reading. This study examines the effectiveness of behavior-based programs to improve reading ability in these individuals.

Acquired disorders of reading (acquired dyslexia) are common in patients with aphasia subsequent to left hemisphere stroke. Even when language functions recover sufficiently to enable the patient to return to work, continuing dyslexia often interferes significantly with job performance. This study will evaluate cognitive therapies for the treatment of acquired dyslexia.

Each therapy is based upon a cognitive neuropsychological model of reading; the therapies target specific types of reading deficit and stem from the question of re-learning versus re-organization of function. The therapies focus on dyslexic disorders stemming from the following underlying deficits: 1) impaired access to the orthographic word form from the visual modality (pure alexia); 2) impaired orthographic/phonologic connections (phonologic/deep dyslexia); and 3) decreased ability to hold phonologic codes in memory (phonologic text alexia).

Participants in this study will undergo a comprehensive and detailed battery of reading and reading-related tests to determine the underlying impairment causing the reading deficit. Based upon the results of these tests, the patient's dyslexic disorder will be characterized and, if appropriate, the patient will be assigned to one of the treatment programs devised specifically for that type of deficit. Treatment programs are evaluated for efficacy by comparing the accuracy and speed of reading pre- and post-treatment.

Eligibility Criteria:
Inclusion Criteria

* Reading deficit subsequent to stroke, traumatic brain injury, brain surgery, or other brain damage
* Ability to attend 2-3 sessions per week for several months at Georgetown University in Washington, DC

Exclusion Criteria

* History of developmental dyslexia or learning disabilities
* Best corrected vision less than 20/40
* Less than 10 years of formal education
* Significant memory or comprehension problems
Treatment of Multiple System Atrophy Using Intravenous Immunoglobulins

Multiple System Atrophy (MSA) is a progressive sporadic neurodegenerative disorder leading to widespread loss of brain cells that results in parkinsonian, cerebellar and autonomic dysfunction. The cause of the MSA remains unclear. Available treatment is symptomatic only and does not alter the course of disease.

Although the cause of MSA remains unclear, there is evidence of presence of common neuroinflammatory mechanisms in the MSA brains including activation of microglia and production of toxic cytokines. This research protocol is based on hypothesis that the MSA progression can be altered by blocking the neuroinflammatory activity.

This protocol includes administration of intravenous immunoglobulin (IVIg). IVIg contains antibodies derived from human plasma which can block the inflammatory responses in the brain that can lead to loss of brain cells.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female older than 17 years.
2. Clinical diagnosis of probable multiple system atrophy
3. Provide written informed consent to participate in the study
4. Understand that they may withdraw their consent at any time

Exclusion Criteria:

1. Women who are pregnant or lactating
2. In the investigator's opinion, have any other significant systemic, hepatic, cardiac or renal illness.
3. In the investigator's opinion, the subjects are significantly dehydrated, as determined by clinical evaluation including measurement of skin turgor, blood urea nitrogen and creatinine values.
Dexmedetomidine Nasal Spray and Pediatric Bronchoscopy

To observe the sedative effect of using dexmedetomidine nasal spray combined with remimazolam for pediatric bronchoscopy diagnosis and treatment, provide a safer and more comfortable anesthesia plan for pediatric bronchoscopy diagnosis and treatment

Dexmedetorimidine nasal spray is a new dosage form, which is simple and easy to achieve sedative and anti-anxiety effects by nasal spray mucosa. In the dose range from 50 to 100 μ g, the sedation effect increased dose-dependent, with\> 2 μ g / kg administered, and the child could be successfully separated within 45min.Our study is to observe the sedative effect of using dexmedetomidine nasal spray combined with remimazolam for pediatric bronchoscopy diagnosis and treatment, provide a safer and more comfortable anesthesia plan for pediatric bronchoscopy diagnosis and treatment

Eligibility Criteria:
Inclusion Criteria:

* Age 2-6 years old (24\~72 months);
* ASA I-II;
* sign the informed consent.

Exclusion Criteria:

* Severe rhinitis, nasal deformity;
* abnormal liver and kidney function;
* severe dehydration, severe malnutrition, hypoproteinemia or anaemia Hb \<10 g/dl;
* children with neurological disease;
* history of allergy to the study drug;
* recent participation in other clinical studies.
Effect of Pravastatin on Endothelial Dysfunction Following a Single High Fat Meal

There is significant evidence that HMG-CoA reductase inhibitors, a commonly used class of cholesterol lowering medications, reduce the risk of death from coronary disease. Although these medicines lower cholesterol levels, other studies suggest that they have an additional effect on improving blood vessel functioning. It has also been shown that consumption of a fatty meal temporarily alters blood vessel functioning, causing endothelial dysfunction. This study will examine if pravastatin, an HMG-CoA reductase inhibitor, improves blood vessel functioning after a fatty meal. We plan on enrolling 32 subjects, aged 18-40 years, who are healthy with no history of diabetes, smoking, high blood pressure, or heart disease. These subjects will be randomly assigned to initially receive four days of pravastatin or an inactive substance, and then crossed over to the other group. Blood vessel functioning will be monitored by a technique called flow mediated vasoactivity, which uses ultrasound measurement of the forearm artery and its response to temporary occlusion. This primary measure of flow mediated vasoactivity will be done before and after consumption of a fatty meal. We hope to show that treatment with pravastatin prevents the blood vessel dysfunction known to occur after a high fat meal. Secondary outcomes will include measurement of endothelin-l, a mediator of blood vessel functioning, and assessment of changes in lipid profiles. If pravastatin does prevent endothelial dysfunction in this setting, it could lead to further studies about their use in more acute medical settings, including heart attacks or strokes.


Eligibility Criteria:
Inclusion Criteria:

* No history of the following: hypertension, diabetes mellitus, smoking, and coronary artery disease
Laterality Discrimination in Patients With Non-specific Chronic Neck Pain

Chronic neck pain is one of the most common causes of pain, affecting 15% of the adult population, and the fourth leading cause of disability. The recognition of laterality is the ability to recognize a part of the body that belongs to the left or right which is used as a tool to create a normal process of motor planning.

The most consistent data come from the investigation of the primary motor cortex, in which the cortical representations of the altered body part are affected when there is chronic pain. Occasionally, the primary motor cortex is smaller on the affected side than on the contralateral side.

Recognition of the body schema is altered in the presence of painful disorders. The most common way of assessing the body schema is by motor imagery through the laterality discrimination of the left and right.

Eligibility Criteria:
Inclusion Criteria:

* The inclusion criteria were as follows: a) men and women aged between 18- and 65-years b) medical diagnosis of Non-Specific Chronic Neck Pain with more than 6 months of evolution of neck pain.

Exclusion Criteria:

* Exclusion criteria included the following: a) patients with rheumatic diseases, cervical hernia, cervical whiplash syndrome, neck surgeries or history of arthrodesis, b) systemic diseases, c) vision, hearing or vestibular problems, d) Severe trauma or traffic accident which has had an impact on the cervical area.
Safety and Tolerability Study of BMS-986177 in Healthy Subjects

The purpose of this study is to determine the safety, tolerability, and pharmacokinetics of BMS-986177 in healthy subjects


Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs and clinical laboratory determinations
* Body Mass Index (BMI) of 18 to 30 kg/m2 inclusive. BMI = weight (kg)/ \[height (m)\]2
* Females who are not of childbearing potential (i.e., who are post-menopausal or surgically sterile) and men ages 18 to 55, inclusive

Exclusion Criteria:

* Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations beyond what is consistent with the target population
* Any condition that could affect drug absorption
* Other protocol-defined exclusion criteria could apply
Early Hydrogen-Oxygen Gas Mixture Inhalation in Patients With Aneurysmal Subarachnoid Hemorrhage (HOMA)

This was a randomized, single-center trial. On the basis of standard-of-care, patients in the treatment group inhaled H2-O2 (66% hydrogen; 33% oxygen) at 3 L/min via nasal cannula by using the Hydrogen/Oxygen Generator (model AMS-H-03, Shanghai Asclepius Meditech Co., Ltd., China) during a 7-day stay in the intensive care unit. Patients in the control group received standard-of-care (consisting of oxygen therapy) alone. This study intends to apply Hydrogen/Oxygen Generator in clinical patients with aneurysmal subarachnoid hemorrhage (aSAH), exploring the role of hydrogen-oxygen mixed gas inhalation therapy in early brain injury, and the prevention of cerebral vasospasm and delayed cerebral ischemia, finally providing a scientific basis for hydrogen treatment of aSAH.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years
2. Signed informed consent
3. Must be admitted within 72 hours after aneurysm rupture

Exclusion Criteria:

1. physical disability caused by any reason before the onset of the disease
2. dementia or mental illness before the onset of the disease
3. more than 72 hours after aneurysm rupture admitted to hospital for treatment
4. do not cooperate with the treatment
Unstable Dorsally Displaced Fractures of the Distal Radius in the Elderly

The purpose of this study is to examine whether operation and fixation with a metal plate gives better result from the patient's perspective than plaster treatment in elderly patients with a displaced wrist fracture.

We will perform a prospective randomized clinical trial comparing open reduction and internal fixation with a volar plate with closed reduction and plaster treatment in elderly patients with a displaced Colles' fracture in order to test the null hypothesis that the patient-perceived result is equal after conservative or operative treatment. Secondary outcomes are objective physical measurements.

Eligibility Criteria:
Inclusion Criteria:

* Unilateral unstable dislocated dorsally angulated fracture of the distal radius (radial shortening ≥4 mm and/or dorsal angulation ≥20°).

Exclusion Criteria:

* Previous displaced fracture of the distal radius.
* Additional fractures of the upper extremities, an open fracture, terminal disease, patient not fit for surgery, unwilling or unable to co-operate with follow-up (advanced dementia (SPMSQ\<5), psychiatric illness, alcohol abuse).
Frozen Embryo Transfer With GnRH-antagonist Trial

The fertility treatment in vitro fertilisation (IVF), sometimes including intra-cytoplasmic sperm injection (ICSI), involves the creation of embryos in a laboratory. These embryos are then transferred into the womb of the patient with the hope of a resulting pregnancy and live birth. Embryos can also be cryopreserved (frozen) and stored, and then later replaced in a cycle called frozen embryo transfer (FET). There are several methods of preparing the patient's womb to receive the frozen-thawed embryo(s) but commonly embryos are replaced during a medicated cycle. Usually oestrogen and progesterone are administered to prepare the womb lining for embryo transfer at the appropriate time, and in addition a drug called a GnRH antagonist is administered to prevent a women's own hormones from interfering with this process as it is thought this might lead to higher numbers of cycles being cancelled. However, there is some suspicion that this drug (GnRH antagonist) may not be required and that women are using this drug unnecessarily.

Some clinics do not use GnRH antagonists in FET cycles, but the investigators do not know if they have higher rates of cancelled cycles as a result.

This pilot study aims to compare cycles of medicated FET using oestrogen and progesterone, either with or without pituitary suppression in the form of GnRH antagonist (Cetrotide), in patients over the next 18 months who are planning FET cycles at Oxford Fertility, UK to find out if both give the same chance of having a baby, which treatment is better for patients and to assess the feasibility of undertaking a future larger study. Cetrotide is a marketed and well-known medication and any risk or serious adverse effects are unlikely. The study is an open label prospective randomised controlled trial. Funding for the medication (Cetrotide) is provided by Oxford Fertility.


Eligibility Criteria:
Inclusion Criteria:

* Willing and able to give informed consent for participation in the study.
* Planning to undergo medicated FET
* Blastocyst embryo in storage available for transfer

Exclusion Criteria:

* Previously randomised into the trial.
* A history of 3 or more consecutive implantation failures (after fresh or frozen embryo transfer).
* A history of recurrent miscarriage (3 or more consecutive miscarriages).
* Contraindication to the use of medications for FET cycle.
* Biopsied embryos.
* Donor embryos or eggs (use of donor sperm is not excluded).
Study of Recombinant Human N-acetylgalactosamine 4-sulfatase (rhASB) in Patients With MPS VI

The purpose of the study is to evaluate the ability of rhASB versus placebo to enhance endurance in patients with Mucopolysaccharidosis VI (MPS VI), as evidenced by an increase in the number of meters walked in the 12 minute walk test at Week 24 compared with baseline.


Eligibility Criteria:
Inclusion Criteria

* Patient consent
* Patient must be seven years of age or older
* Patient must have documented biochemical or genetic proof of MPS VI
* The patient must be able to walk independently at least 5 meters and no more than 270 meters in the first 6 minutes, or no more then 400 meters total in 12 minutes, in the screening 12-minute walk test
* If female of childbearing potential, patient must have a negative pregnancy test

Exclusion Criteria

* Patient is under consideration for or has undergone a successful bone marrow transplant (BMT)
* Patient refuses or is unable to complete all screening evaluations
* Pregnant or lactating patient
* Patient has received an investigational drug within 30 days prior to study enrollment
* Patient has been previously treated with rhASB
* Patient has a medical condition, serious intercurrent illness, or other extenuating circumstance that may significantly confound study results or decrease study compliance
* The patient has clinically significant spinal cord compression
* The patient has known hypersensitivity to rhASB or to components of the active or placebo test solutions