cyrilzakka/clinical-trials huggingface dataset:
A Prospective Study to Evaluate the Correlation Between Oculometric Measurements and Clinical Endpoints in PD Patients

This is a prospective study in a cohort of about 500 patients with Idiopathic Parkinson's disease, examined routinely in the neurological outpatient clinic.

This study aims to evaluate the correlation between oculometric measures and clinical endpoints. Subjects will be evaluated following a physician examination.The evaluations will include MDS-UPDRS examination, as well as an oculometric evaluation for eye movements. In addition, 500 healthy subjects will be evaluated.

This is a prospective study in a cohort of patients with idiopathic PD who are visiting the Parkinson's outpatient clinic. The aim of the study is to evaluate the correlation between oculometric measures and MDS-UPDRS score in subjects who meet the inclusion criteria and who provide a signed Informed Consent.

This study is designed to evaluate the correlation between oculometric measures and the Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS). Subjects will be evaluated at their visit to the clinic. The evaluations will include an MDS-UPDRS examination by a certified neurologist and other tests. In addition, all patients will undergo a NeuraLight session for oculometric evaluation along with eye-tracking recordings. All assessments will be performed during a clinic visit unless authorized to be conducted remotely. In addition, 500 healthy subjects will be evaluated, undergoing a NeuraLight session for oculometric evaluation along with eye-tracking recordings.

Eligibility Criteria:
PD patients:

Inclusion Criteria:

* Men and women with idiopathic PD (Hoehn \& Yahr scale 1-5)
* Age between 18 and 85 years old
* Normal or corrected vision
* Ability to follow instructions
* Willing and able to sign an informed consent form

Exclusion Criteria:

* Inability to sit for 20 minutes on a chair in a calm manner
* Personal or 1st degree relative history of epilepsy
* Additional neurological diseases
* Drug or alcohol abuse

Healthy subjects:

Inclusion Criteria:

* Age between 18 and 85 years old
* Normal or corrected vision
* Ability to follow instructions
* Willing and able to sign an informed consent form

Exclusion Criteria

* Inability to sit for 20 minutes on a chair in a calm manner
* Personal or 1st degree relative history of epilepsy
* Neurological diseases
* Drug or alcohol abuse
Polypharmacy in Clozapine-resistant Schizophrenia

The aim of this randomized, double-blind study is to verify the hypothesis that clozapine monotherapy is as efficient as a combination of clozapine and olanzapine therapy in treatment-resistant schizophrenia.

A third of schizophrenia patients are non -responders to medications used nowadays. These patients are usually treated with clozapine, but a large proportion of patients don't recover sufficiently. Therefore, these patients are treated with combination of two or more drugs to achieve better treatment results. Until now the scientific evidence has been insufficient to assess the utility of polypharmacy.

The aim is to study during 2009 with voluntary patients, if there is any benefit of olanzapine augmentation compared with pure clozapine monotherapy. During the study the patients are not exposed to any additional intervention. The intervention in this study is just to reduce the previously used polypharmacy.

Methods: This study lasts for 24 weeks. Participants (30) are randomized in one of two alternative interventions (A or B) before the study. After 12 weeks the intervention arms cross over (from A to B and from B to A).

Group B: In addition to clozapine, the participants receive their normal dosage of olanzapine (=the same as on the hospital ward) for 12 weeks, next the decreasing dosage of olanzapine for four weeks and subsequently placebo for 8 weeks

Group A: : In addition to clozapine the participants receive the decreasing dosage of olanzapine for four weeks, next placebo for 8 weeks, after that the increasing dosage of olanzapine for four weeks and subsequently the normal dosage of olanzapine for 8 weeks

The response for the medical treatment is assessed by Clinical Global Improvement Scale (CGIS) and Global Assessment of Functioning (GAF) -scale.

The primary outcomes are GAF and modified CGIS during the parallel phase of the study (the first 12 weeks). The second phase (the last 12 weeks) of the cross-over study is used in the secondary analysis. The use of additional medication (such as benzodiazepines) is used as a secondary outcome measure.


Eligibility Criteria:
Inclusion Criteria:

* age ≥18 years, (adult), legally competent
* the patient is able to understand the purpose of the study and is eligible to sign the written informed consent form.
* insufficient response to the valid clozapine-olanzapine -polypharmacy
* psychotropic medication has been constant (unchangeable) during the past 2 months

Exclusion Criteria:

* Pregnancy
The Effects of Low Resistance Training on the Residents in Nursing Homes

This study will examine the effects of low-resistance elastic band training on muscle strength, flexibility, quality of life and ease of care among the residents in nursing homes.

Regular exercise and dynamic life style can prevent and treat disability, as well as promote mental health and quality of life. In addition to chronic illness, reduced muscle mass and strength as part of aging, affect the daily activities of living of the elderly and their independent lifestyle. In fact, exercise had found positive effects on lower limb weakness of the elderly. Elastic band is a resistance training aid which can be used for different muscle weight training. The research results have been demonstrated elastic band resistance training is safe and effective strategy to apply in the elderly population and to improve physical fitness, and mental functioning. Therefore, this study will examine the effects of low-resistance elastic band training on muscle strength, flexibility, quality of life and ease of care among the nursing home residents. Nursing homes with more than 50 beds that will be recruited in Qingshui and Waipu district Taichung City. Nursing homes will be randomly assigned to the experimental group and the comparison group. Each group has 20 subjects. The residents in experimental group will receive a low-resistance elastic band training(30 minutes), including warm-up and cold-down period, three times per week for 10 weeks. Residents in control group will receive regular activity in nursing home. Inclusion criteria for the elderly include: (1) living in nursing home over 3 months; (2) communicating with Mandarin and Taiwanese; (3) being able to sit in a chair or wheelchair; (4) can grip elastic band by hands; (5) no severe cardiovascular disease, musculoskeletal disorders and mental illness;(6) consciousness intact and their consent to participate in this study. Two structured questionnaires and an assessment checklist of muscle strength, flexibility will be used to collect data at baseline, week 8 and week 12 of exercise. The collected data will be coded and double checked and analyzed by using SPSS Window Release 20.0. The findings of this study can be apply to develop and conduct an effective exercise program through elastic band resistance training to improve residents' strength, flexibility, quality of life and care of ease in Taiwan.

Eligibility Criteria:
Inclusion Criteria:

* living in nursing home over 3 months
* communicating with Mandarin and Taiwanese
* being able to sit in a chair or wheelchair
* can grip elastic band by hands
* consciousness intact and their consent to participate in this study

Exclusion Criteria:

* severe cardiovascular disease, musculoskeletal disorders and mental illness
Prognostic Value of AIMS65 Score to Predict Outcome in Patients With Acute Upper Gastrointestinal Bleeding

Prognostic Value of AIMS65 Score to predict outcome in patients with acute upper gastrointestinal bleeding

Gastrointestinal (GI) bleeding is one of the most important disease presentations in the emergency department. The course of the disease ranges from a self-limiting process to a life-threatening condition that requires emergency intervention. Evaluation of severity and the need for endoscopic hemostasis are matters of immediate decision. several prognostic scoring systems have been used to predict outcomes of upper GI bleeding ,such as the Rockall score, Glasgow-Blatchford score (GBS), and the AIMS65 score, among which AIMS65 is relatively easy to remember and simple to calculate by using parameters routinely available in the ED and importantly does not require endoscopic variables for calculation..

The AIMS65 score consists of five factors:

(i)albumin (1 point for value less than 3.0 g/dL (30 g/L)). (ii)INR (1 point for value greater than 1.5) . (iii)altered mental status (1 point given if Glasgow coma score was less than 14 or if disorientation, lethargy, stupor, or coma was seen) (iv)systolic blood pressure (1 point for value less than 90 mmHg). (v)age (1 point for value greater than 65 years). AIMS65 score \>1: high risk patients. AIMS65 score \>2: consider ICU management and an urgent endoscopy following adequate volume resuscitation, while AIMS65 score of 0 can be considered for outpatient management.

AIMS65 score is a simple non-endoscopic risk score that can be applied in patients of acute upper gastrointestinal bleeding to risk stratify and to predict in-patient mortality, the need for blood transfusion, endoscopic therapy or ICU admission.

In a comparative study of AIMS65 score and GBS ,they found that the AIMS65 score was superior in predicting inpatient mortality from UGIB, while the GBS was superior for predicting the need for blood transfusion. Both scores were similar in predicting the composite clinical endpoint .

Eligibility Criteria:
Inclusion Criteria:

* o Patients above 18 years of age.

  * Patients with acute UGIB presenting within 24 hours of hemorrhage onset.
  * Endoscopic evaluation done after hospital admission.

Exclusion Criteria:

* o Patients denying for consent.

  * Patients with late presentation (\>24 hours) after UGIB onset.
A Study to Evaluate the Safety and Efficacy of Inactivated Varicella-zoster Vaccine (VZV) as a Preventative Treatment for Herpes Zoster (HZ) and HZ-related Complications in Participants Undergoing Hematopoietic Cell Transplants (HCTs) (V212-001)

This is a randomized, double-blind, placebo-controlled study to assess the safety and efficacy of inactivated VZV vaccine for the prevention of HZ and HZ-related complications in adult recipients of autologous hematopoietic cell transplants (HCTs). The primary hypothesis is that vaccination with V212 vaccine will reduce the incidence of herpes zoster (HZ) compared to placebo when administered to recipients of HCT. The statistical criterion for success requires that the lower bound of the 95% confidence interval for the estimated vaccine efficacy in the V212 recipients (excluding the high-antigen lot) compared with that in the placebo recipients is \>25%.

Study participants were randomized to receive one of 3 consistency lots of V212, a high antigen lot of V212, or placebo. To comply with regulatory requests, results for all lots of V212 were combined for the primary and secondary efficacy and safety evaluations (Protocol Amendment 2); all planned comparisons between the V212 lots were exploratory and are not included in this disclosure. Further, by regulatory request, the V212 High Antigen Lot was not included in the efficacy analyses for concerns that its inclusion would inflate the efficacy estimates (Protocol Amendment 4).

Eligibility Criteria:
Inclusion Criteria:

* Has prior history of varicella, antibodies to VZV (documented prior to receipt of blood products), or residence in a country with endemic VZV infection for ≥30 years or if participant is \<30 years old, attended primary or secondary school in a country with endemic VZV infection.
* Scheduled to undergo an autologous hematopoietic cell transplant within 60 days of enrollment
* Is highly unlikely to conceive during the time period starting 2 weeks prior to enrollment through 6 months from last vaccination dose
* Female participants of childbearing potential must have a negative serum or urine

pregnancy test.

Exclusion Criteria:

* History of hypersensitivity reaction to any vaccine component
* Prior history of herpes zoster within 1 year of enrollment
* Prior receipt of any varicella or zoster vaccine
* More than 2 relapses of the underlying cancer (participants with Hodgkin's lymphoma may have had more than 2 relapses)
* Expectation of tandem transplant procedure
* Is expected to receive \>6 months (\>180 days) of prophylactic antiviral therapy post-HCT.
* Is pregnant or breastfeeding or expecting to conceive within the period of 2 weeks prior to enrollment through 6 months from last vaccination dose.
* Has received a live virus vaccine or is scheduled to receive a live virus vaccine in the period from 4 weeks prior to Dose 1 through 28 days Postdose 4.
* Has received an inactivated vaccine or is scheduled to receive an inactivated vaccine in the period between 7 days prior to and 28 days following Doses 1 through 4.
Evaluation of Psychological Impact of Group Therapy for Patients Who Have Been Hospitalized in Intensive Care During COVID-19 Pandemic: Exploratory Study

Psychological impact of intensive care hospitalization for patients has been demonstrated during the last few years: anxiety, depression and post traumatic stress disorder. Hospitalizations during COVID-19 pandemic have been marked by factors such as confinement forbidding family members visits, stress on intensive care unit ...Those factors may have a psychological impact added to factors of long hospitalization and prolonged mechanical ventilation.

For all these reasons the investigators fear that patients hospitalized in intensive care during COVID-19 pandemic develop psychological trouble with an increased risk for those who experienced COVID-19 infection. The hypothesis therapy group added to standard care might have a positive impact on psychological troubles such as anxiety, depression and post traumatic stress disorder for patients who have been hospitalized in intensive care during COVID-19 pandemic.

The investigators will compare two groups:

* group receiving standard of care
* group receiving standard of care and therapy group


Eligibility Criteria:
Inclusion Criteria:

* 18 years old and older
* hospitalized at least 72h in intensive care during COVID-19 pandemic crisis
* out of intensive care for at least 2 months and maximum 6 months
* psychological evaluation done according to local practice and standard of care
* speaking french
* patient coming alone to the therapy group
* patient agree to respect confidentiality rules and demonstrating goodwill with others participants
* patient comite to respecting barriers rules against COVID-19
* affiliated to social security system
* no juridic protection engaged

Exclusion Criteria:

* presenting psychological disease
* drug addiction
* participation to other interventional clinical trial
Steady State Kinetics of l-Methamphetamine and Validation of Sensitivity of Dose Estimation

The intent of this study is to see if the rate that the body breaks down l-methamphetamine (l-MA) could be used as an accurate estimate for the rate that the body breaks down d-methamphetamine (d-MA). l-MA is sold over the counter as a nasal decongestant where as d-MA is the commonly abused form of methamphetamine.

Subjects will screen at St. Luke's Hospital in San Francisco to determine their eligibility.

Once enrolled the study will take two weeks. During the first week subjects attend daily, hour-long outpatient visits at San Francisco General Hospital. At these visits subjects will receive an oral dose of l-methamphetamine, have their vitals read, answer questionnaires and receive a blood draw.

During the second week of the study subjects are admitted to San Francisco General Hospital for a week long inpatient stay. During this stay the subject continues to receive l-methamphetamine but also receives three doses of d-methamphetamine on three separate days. In addition the subject receives blood draws, has their urine collected, and answers questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* Healthy Males and Females Between the Ages of 18 and 50
* Must have some experience with methamphetamine
A Phase 1 Trial to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SHR-3167 Single Injection in Healthy Subjects and Patients With Type 2 Diabetes

This is a randomized, double-blind, placebo-controlled, single-dose escalation trial was designed. There are 6 dose groups and 1 optional dose group: 0.5 mg, 2 mg, 8 mg, 25mg, 50 mg, 100 mg and 150 mg (optional). Eight healthy adult subjects or T2DM patients in each dose group (except for 0.5 mg dose group, only 4 subjects will be enrolled) are randomly assigned to subcutaneously injection of SHR-3167 or placebo according to 3:1 ratio.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female, 18 years ≤ age ≤ 55 years (healthy subjects) or 18 years ≤ age ≤ 65 years (T2DM patients)
2. 18.5 kg/m2≤ Body mass index (BMI) \<26.0 kg/m2 (healthy subjects) or 18.5 kg/m2≤ BMI \<35.0kg/m2 (T2DM patients), and male weight ≥50kg and female weight ≥45kg
3. T2DM patients: 7.0% ≤ HbA1c ≤9.5%, 7.5mmol/L≤ fasting blood glucose ≤15mmol/L
4. Healthy subjects: 3.9 mmol/L\< fasting blood glucose \< 6.1mmol/L and HbA1c ≤6.0% at screening
5. Signed and dated informed consent indicating that the subject has been informed of all pertinent aspects of the study.

Exclusion Criteria:

1. History of significant multiple and/or severe drug allergies or with a known allergy to the trial product or any medicine chemically related to the trial product
2. Presence of cancer or any clinically significant cardiac, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, dermatological, venereal, hematological, neurological, or psychiatric diseases or disorders.
3. History of severe cardiovascular and cerebrovascular disease, including heart failure (NYHA class II to IV), myocardial infarction, unstable angina pectoris, stroke or transient ischemic attack, severe arrhythmia, or coronary artery bypass grafting or percutaneous coronary intervention, 6 months before screening to before randomization;
4. T2DM patients:

   a) Severe hypoglycemia, frequent hypoglycemia, ketoacidosis, or hypertonic coma from 6 months before screening to before randomization; b) Known proliferative diabetic retinopathy ordiabetic macular edema, or non-proliferative diabetic retinopathy requiring treatment during the trial;
5. Those who had a severe infection, severe trauma, or had undergone surgery in the 12 weeks prior to screening, or planned to undergo surgery during the trial
6. Participants who participated in a clinical trial of any other drug or medical device from 3 months prior to screening to before randomization or planned to participate during the study period
Cervical Ripening in Obese Women: Efficacy of 25 mcg Versus 50 mcg of Misoprostol

This is a prospective clinical trial to determine if 50 mcg versus 25 mcg po every four hours of misoprostol has improved efficacy and similar safety in obese women undergoing cesarean section.

We will perform a prospective, randomized, double-blind clinical trial with parallel assignment.

Obese women (delivery BMI 30 or more) who agree to participation will be randomly designated to receive either 25 mcg po q 4 hour (control) misoprosol versus 50 mcg po q 4 hours. Our primary outcome will be the rate of successful induction. Secondary outcomes will include ability to achieve a Bishop score greater than 7, time to active labor, and safety data including rate of tachysystole, non-reassuring fetal status, NICU admission.

Eligibility Criteria:
Inclusion Criteria:

* Labor induction, BMI of 30 or greater, English speaking

Exclusion Criteria:

* Prior cesarean section, uterine tachysystole (5 contractions/ 10 minutes) on admission, Contraindication to labor induction
Chinese Second Hip Fracture Evaluation

1. To Compare overall rates of second hip fractures in both genders,
2. To determine the effect of hip fracture on proximal femoral volumetric bone mineral density (vBMD), bone structure and muscle by quantitative computed tomography(QCT),
3. To evaluate the contribution of QCT-image analysis to the prediction of the second hip fracture risk.
4. To identify the differences between femoral neck fracture and trochanter fracture following hip fracture

Osteoporotic hip fracture is a great harm among elderly people, for whom disability and death often occurs. Furthermore, sustaining an osteoporotic hip fracture increases the risk of a subsequent fracture. However, the risk factors of subsequent hip fractures are less studied and the proximal femur bone structure and muscle changes following first hip fracture are little known.

Therefore, we propose to conduct an observational and perspective study to assess the effect of hip fracture on proximal femoral bone and muscle using quantitative computed tomography (QCT), as well as to evaluate the contribution of QCT-image analysis to the prediction of the second hip fracture risk. As hip fractures are divided into two major anatomic based types in clinical: femoral neck fractures (intracapsular) and trochanter fractures (extracapsular), the fundamental objective also includes identifying bone and muscle differences in a union activity between the two type fractures. Compared with duel-energy x-ray absorptiometry (DXA), QCT offers the advantage of selective measurement of the metabolically active and structurally important trabecular bone in the proximal femoral. Volumetric BMD and structure of proximal femoral and muscle around hip will be measured with QCT. The CT scanner will be the clinical CT scanner of the local participated center. Quality control and monitoring will be conducted by Beijing Jishuitan hospital, as well as the centralised image interpretation.

Eligibility Criteria:
Inclusion Criteria:

* a:Osteoporotic patients b:Osteoporotic hip fracture patients (femoral neck fracture and femoral trochanteric fracture) c: Be willing to and be able to join in the study and sighed the informed consent

Exclusion Criteria:

* a:Under 47years old b:Non-surgical repair of hip fracture c:Pathologic fracture d:Violence-related trauma e:Bilateral hip implants or have hip replacement on the non-fractured side