cyrilzakka/clinical-trials huggingface dataset:
Effect of Melatonin on Sleep Disturbances in Patients With Parkinson's Disease

This clinical study is a double-blind, randomized, placebo-controlled trial to investigate the effects of melatonin on the sleep disturbance symptoms of Parkinson's disease patients, symptoms which have a significant impact on the quality of life of these patients.

After selecting patients who satisfied the inclusion criteria and were not disqualified by the exclusion criteria, through a double-blind procedure the patients are directed to orally take either the investigational drug melatonin or a placebo(allocation ratio 1:1) for 4 weeks, once daily, before going to sleep. The evaluation of efficacy and safety is performed at the first baseline and immediately after administering the drug for 4 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who meet the clinical criteria for idiopathic Parkinson's disease (United Kingdom Parkinson's Disease Brain Bank Criteria)
2. Patients who complain of sleep disturbances such as insomnia, REM sleep behavior disorder, excessive daytime sleepiness (EDS), etc.
3. Patients who have received drug treatment for at least 6 months since their diagnosis
4. Male or female patient aged 55 or older
5. Patients who have given voluntary consent after understanding the content of the clinical trial (in the case of elderly patients aged 70 or older, consent must be received from both the subject and the his or her legal representative)

Exclusion Criteria:

1. Patients with a serious cognitive disorder, behavioral disorder, or mental illness
2. Patients with a serious medical disease

   * Patients who concomitantly suffer from severe renal impairment, convulsions, stomach ulcers, moderate or more severe liver disease
   * Patients with un-controlled high blood pressure or diabetes
3. Patients who have taken another investigational products within 4 weeks prior to being enrolled in this clinical trial, or patients who are pregnant or breastfeeding
4. Patients who have a history of hypersensitivity to the investigational products or a drug similar in component or who have had heavy metal poisoning
Pregnancies Complicated by Fetal Anomalies

The focus of this research is to create a repository of ultrasonographic images and their corresponding medical data from pregnant women (the mothers of the fetuses that are imaged), focusing on fetal anomalies. These women will visit the obstetrical clinics at Regional One Health and the Le Bonheur Fetal Center.

1. Repository data will be collected from the medical record and entered into the data base after the patient has completed the appointment.
2. Data collection will continue into the postpartum period for each participant.
3. Data collection will continue for the child during the treatment of the medical condition, up to approximately 6 months of age if required by the condition.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant females

  * age 8 years to 50 years
  * who have referred to the clinic for high risks pregnancies
* Infants (male and female) born with anomalies

Exclusion Criteria:

* Non-pregnant females.
Stanford Center for Back Pain

The purpose of the Stanford Center for Back Pain is to investigate and characterize the mechanisms of four treatments for chronic low back pain. These interventions (research treatment) include real-time fMRI neurofeedback, mindfulness based stress reduction, cognitive behavioral therapy, and acupuncture treatment. The investigators plan to characterize both mechanisms of treatment effects and efficacy.

The Stanford Center for Back Pain establishes a collaborative, multidisciplinary research program to investigate CAM interventions for the treatment of chronic low back pain (CLBP). The investigators' overall goal is to characterize the shared and distinct mechanisms of four CAM interventions and translate the investigators' findings to tailored and effective treatments for CLBP. CLBP is a highly prevalent and difficult-to-treat condition for which many patients seek CAM therapies. Basic science has revealed that abnormalities in central pain modulatory and emotion regulatory systems play a crucial role in CLBP. What is not clear is how CAM therapies alter the functioning of the brain systems involved in chronic pain. The Stanford Center for Back Pain aims to fill this gap by conducting 3 projects, each aiming at elucidating mechanisms underlying different CAM therapies for CLBP.

Project 1 will focus on a promising novel alternative therapy for CLBP real-time fMRI neurofeedback which trains patients to control specific neural processes that lead to improvements in pain. Project 2 will characterize the pain modulatory and emotion regulatory effects of mindfulness based stress reduction and cognitive behavioral therapy for CLBP. Project 3 will characterize psychophysical and neuroimaging based neural mechanisms underlying verum and placebo acupuncture.

The Stanford Center for Back Pain will provide optimal collaboration and synergy within a multidisciplinary framework to identify mechanisms of CAM therapies for CLBP so that they can eventually translate them into enhance clinical care of CLBP.

Eligibility Criteria:
Inclusion Criteria:

* English Fluency
* Chronic Low Back Pain as defined by NIH task-force or Healthy Controls

Exclusion Criteria:

* MRI contraindications
* Pregnant or planning to become pregnant
* Medical conditions that would interfere with study procedures, at the discretion of the study team
* Neurologic disorder, history of seizures, stroke, or brain abnormalities, which would interfere with brain integrity, at the discretion of the study team.
* Mental health conditions or treatment for mental health problems that would interfere with study procedures, at the discretion of the study team.
* Other project specific criteria may apply.
Paired-pulse rTMS Treatment for Methamphetamine Use Disorder Based on the Frontopolar-Cerebellum

To investigate the mechanism and efficacy of a novel repetitive transcranial magnetic stimulation (rTMS) intervention model with paired frontopolar cortex (FPC) -cerebellar pulses on episodic methamphetamine use in patients on methadone maintenance treatment and to develop a novel physiotherapeutic intervention to optimise the treatment and management of addicted patients.

Numerous studies have shown that impaired FPC-cerebellar functional connectivity leads to impaired social preferences and behavioural flexibility and more persistent drug use in addicts. Cerebellar and FPC paired-pulse rTMS interventions may enhance functional connectivity, effectively modulate cerebellar-prefrontal loops, reduce craving, improve cognitive flexibility, and reduce relapse risk. The aim of this project is to explore the mechanism and efficacy of a novel FPC-cerebellar paired-pulse rTMS intervention model on occasional methamphetamine use in methadone maintenance patients, to develop novel physiotherapy interventions, and to optimise the treatment and management of addicted patients.

Eligibility Criteria:
Inclusion Criteria:

* Individuals aged between 18 and 60 years, irrespective of gender, having completed a minimum of 9 years of education and capable of effectively cooperating in questionnaire evaluations.

  * Meet the diagnostic criteria set forth by the DSM-V concerning the amphetamine-type substance addiction.
  * A history of utilizing amphetamine-type substances for a duration not less than one year, with a frequency of use being at least once per week.
  * Consent to actively cooperate in the completion of subsequent follow-up assessments.

Exclusion Criteria:

* Severe cognitive functional impairments manifested through a history of head trauma, cerebrovascular diseases, epilepsy, etc., or usage of cognitive enhancement drugs in the past 6 months; an intellectual disability with an IQ score less than 70.

  * A diagnosis of schizophrenia or other severe mental illnesses as per the DSM-5 criteria.
  * Abuse or dependence on other psychoactive substances (excluding nicotine) within the past 5 years.
  * Severe organic diseases that might compromise study participation.
  * Contraindications to rTMS, such as a history of epileptic seizures or the presence of metallic implants in proximity to the head.
A Study in Healthy Subjects to Evaluate Bioavailability of 4 Formulations of E5501

This is a study in healthy subjects. There are two parts to the study. In the first part of the study each subject will receive a single 10mg dose of each of the four formulations of E550. Based on the results from Part 1, an optimal formulation will be selected for further evaluation in Part 2.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adult men and women (age ≥ 18 to ≤ 55 years)
* Body mass index ≥ 18.0 kg/m2 and ≤ 32.0 kg/m2 at the time of screening and baseline of Treatment Period 1
* Platelet count between 120 x 109/L and 300 x 109/L at baseline of each Treatment Period 1, 3, and 5
* Women of child bearing potential must agree to use a highly effective method of contraception, other than estrogen-based hormonal contraceptives, during the Treatment Phase of the study.

In addition, other standard criteria for healthy subjects will be used.

Exclusion Criteria:

* Evidence of clinically significant cardiovascular, hepatic, gastrointestinal, renal, respiratory, endocrine, hematologic, neurologic, or psychiatric disease or abnormalities or a known history of any gastrointestinal surgery that could impact the PK of study drug
* Agents associated with thrombotic events (including oral contraceptives) must be discontinued within 30 days of first study drug administration
* Evidence of organ dysfunction or any clinically significant event or illness in the subject's medical history, e.g., history of splenectomy.
* History of arterial or venous thrombosis, including partial or complete thrombosis (e.g., stroke, transient ischemic attack, myocardial infarction, deep vein thrombosis, or pulmonary embolism). Known family history of hereditary thrombophilic disorders (e.g., Factor V Leiden, antithrombin III deficiency, etc.)
* Hemoglobin less than the lower limit of normal levels.

In addition, other standard criteria for healthy subjects will be used.
Efficacy of Peroperative Suction Drain Usage in Arthroscopic Knee Surgery

The study was designed to investigate efficacy of suction drains in arthroscopic knee surgery, rather than anterior cruciate ligament (ACL) reconstruction. two groups were randomised, and suction drain was applied to one group, and the other group as the control group without a suction drain.

The groups were compared in terms of patellar shock, knee effusion, knee scoring systems, range of motion, loss of labour, hospitalization time. Also different arthroscopic procedures such as meniscectomy, meniscus repair, synovectomy and microfracture were evaluated in terms of need for a suction drain. The controls was at 1st and 15th day, 6th week and 3rd month.

Eligibility Criteria:
Inclusion Criteria:

* Patients with knee derangement and accepted to enroll to the study

Exclusion Criteria:

* intraarticular fracture, ACL surgery, arthrotomy, bleeding disorder,
A Study to Evaluate the Analgesic Efficacy and Safety of V120083 in Subjects With Osteoarthritis (OA) of the Knee

The purpose of this study is to evaluate the analgesic efficacy of V120083 twice daily compared to placebo in subjects with moderate to severe chronic pain due to OA of the knee.


Eligibility Criteria:
Key Inclusion Criteria Include:

1. Males and females ≥ 40 and ≤ 80 years of age with moderate to severe chronic OA pain of the knee (lasting several hours daily) as their predominant pain condition for at least 6 months prior to screening
2. Diagnostic criteria for primary pain condition (American College of Rheumatology \[ACR\] clinical and radiographic criteria):

   * At least 1 of the following in addition to knee pain: age \> 50, morning stiffness \< 30 minutes, crepitus on active motion, and
   * Kellgren-Lawrence (K-L) grade 2 or 3 radiographic evidence at the screening visit as determined by a local radiologist or rheumatologist. If a radiograph is not available, one must be taken and the diagnostic criteria must be confirmed before randomization.
3. Subjects whose OA pain of the index knee is not adequately treated prior to the screening visit:

   * Subjects must have a self-reported average pain intensity rating of moderate or severe on a verbal rating scale (ie, none, mild, moderate, and severe) over the 7 days prior to the screening visit
4. The subjects must have "average pain over the last 24 hours" scores ≥ 4 and ≤ 9 on an 11-point numerical rating scale (NRS) for the index knee on ≥ 3 consecutive days during the pain assessment period and come in for randomization within 96 hours after the latest qualifying pain score entry
5. Subjects who are willing and able to stop taking any/all analgesic medications, including over-the-counter pain medications, opioids, marijuana, and topical analgesics for OA pain for the duration of the study, with the exception of study-specific rescue medication.

Key Exclusion Criteria Include:

1. Subjects with radiographic evidence of OA with K-L grade 0,1 or 4
2. Subjects with chronic pain conditions other than OA of the knee as their predominant pain condition, including gout, pseudogout, psoriatic arthritis, active Lyme disease, rheumatoid arthritis or any other inflammatory arthritis, fibromyalgia, neuropathic pain conditions, bursitis, or acute injury or signs of active infection in the target pain area
3. Subjects scheduled for surgical interventions of the disease site or any other major surgery during the study conduct period
4. Subjects with a history of a prior joint replacement of the index knee
5. Subjects who have had arthroscopy on either knee or hip within 6 months of entering the study, or open surgery on either knee or hip within 12 months of entering the study
6. Subjects with a history of significant trauma to a knee, hip or shoulder within the previous year
7. Subjects who have significant pain, other than or more than knee pain, including significant hip, back pain, that may confound the analgesic efficacy assessments of this study.
Chronic Intradialytic Exercise : a Cardioprotective Role

The main objective is to assess the effects of chronic intradialytic physical exercise on myocardial remodelling and regional function.

Background: Hemodialysis patients have a mortality rate 50 times higher than in the general population, and the cause remains cardiovascular in more than half of the cases. A deleterious morphological and functional cardiac remodelling is well established in these patients, the causes of which are both the presence of factors specific to renal disease (hemodynamic and non-hemodynamic) and co-morbidities (diabetes, hypertension, etc. .) but also to the hemodialysis (HD) procedure itself, due to the sudden hemodynamic changes it imposes, leading to repeated episodes of intradialytic hypotension (HID) and myocardial stunning. The latter are now documented as direct contributors to the increased mortality observed in HD patients compared to the general population. The introduction of intradialytic physical exercise in the therapeutic program of HD patient is now recommended and practised routinely in many countries, in Scandinavia in particular. Several meta-analyses have clearly established its safety. The beneficial role of chronic intradialytic exercise in improving dialysis efficiency, mental health and quality of life, as well as the inflammatory status of HD patients is also clearly demonstrated. Chronic intradialytic exercise is also associated with improvements in overall fitness level, a parameter closely linked to cardiovascular mortality. Applied acutely during dialysis, it could play a cardioprotective role (e.g; limiting myocardial stunning), allowing haemodynamic and cardiac functional stabilization during HD. However, to our knowledge, no study to date has investigated the long-term effects of intradialytic exercise on remodelling and overall and regional heart function.

Aims: The main objective is to assess the effects of chronic intradialytic physical exercise on myocardial remodelling and regional function. The secondary objectives are to evaluate the effect of acute intradialytic exercise on myocardial stunning as well as the effect of chronic physical exercise on macro and microcirculatory vascular function, inflammation, physical fitness and health-related quality of life.

Eligibility Criteria:
Inclusion Criteria:

* No medical contraindication to physical activity
* Life expectancy greater than 6 months
* Patients on haemodialysis for more than 3 months

Exclusion Criteria:

* Pregnancy

  * Valvular heart disease,
  * Unstable coronary artery disease
  * Arteriopathy obliterating of the lower limbs stage III and IV
  * Musculoskeletal problems
  * Severe respiratory disease
  * BMI\> 35
  * Pacemaker, cardiac stimulation and automatic implantable defibrillator
  * Heart transplant
  * Uncontrolled arterial hypertension
  * Ejection fraction \<45%
Exergaming for Health: Impact of a Community-Based Active Video Gaming Curriculum in Pediatric Weight Management

Evaluation of the effectiveness of Exergaming for Health, a community-based multifaceted weight management program in a randomized controlled trial (RCT). Primary objective: to assess impact of the program on BMI z-scores. Secondary objectives: to measure impact on cardiovascular fitness, self-worth, sedentary screen time, and the influence of exergaming component on attendance and participation.

Eighty-four overweight pediatric subjects will be enrolled sequentially and randomized 2:1 in experimental and control groups for six months of weight management programming. The experimental group and their parents/guardians will participate in ten weekly 2-hour sessions, comprised of 1 hour of exergaming or exergaming combined with traditional exercise and 1 hour of didactic classes focusing on nutrition and psychosocial behaviors related to weight management. Following these 10 weeks, they will attend monthly 1-hour maintenance didactic classes. The control group and their parents/guardians will participate only in the didactic portion of the curricula for the same duration of time, 10 weeks, followed by monthly maintenance classes for the remainder of the 6 month period. The control group will then be offered participation in the Exergaming for Health program upon study completion.

Comparisons between the two groups will be obtained through changes in the measurements of weight, height, BMI z-scores, shuttle run times, and responses to questionnaires about screen time, self-perception, and nutrition. Measurements of both groups will be obtained at baseline and 6 months and another set of measurements will be obtained on the experimental group at 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Child with BMI greater than or equal to 85th percentile.
* English speaking
* Approval by Primary Care Doctor

Exclusion Criteria:

* Participants with medical, developmental or psychiatric diagnoses which preclude participation in both the physical activity and classroom portions of the curriculum.
* Participants who are taking medications that positively or negatively affect weight.
Study of Cetuximab in Nasopharyngeal Carcinoma (NPC) With Chemoradiotherapy

This is an open, multicenter phase Ⅱ clinical trial on cetuximab (C225) combined with IMRT + concurrent chemotherapy of cisplatin in locoregionally advanced nasopharyngeal carcinoma.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent form signed prior to study entry
* Age between 18-69 years old
* Pathology approved to be nasopharyngeal carcinoma (types WHO Ⅱ-Ⅲ)
* Stage Ⅲ, Ⅳa, Ⅳb according to UICC (International Union Against Cancer) 2002 6th edition criteria
* Primary tumor measurable
* KPS score ≥80
* Expected life span ≥6 months
* Adequate bone marrow function: White Blood Cell≥4×109/L，Hemoglobin≥100g/L，Platelet≥100×109/L
* Adequate liver function: ALAT/ASAT\<1.5 × upper limit of normal (ULN), bilirubin \<1.5×ULN
* Adequate renal function: Creatinine Clearance \< 1.5×ULN

Exclusion Criteria:

* Evidence of distant metastatic disease
* Surgical procedure of the primary tumor or lymph nodes (except diagnostic biopsy)
* Previous radiotherapy for the primary tumor or lymph nodes
* Previous exposure to epidermal growth factor-targeted therapy
* Prior chemotherapy or immunotherapy for the primary tumor
* Other previous malignancy within 5 years, except non-melanoma skin cancer or pre-invasive carcinoma of the cervix
* Any investigational agent prior to the 1st study medication
* Participation in another clinical study within the 30 days prior to Inclusion in this study.
* Peripheral neuropathy \> grade 1
* Known grade 3 or 4 allergic reaction to any of the study treatment
* History of severe pulmonary or cardiac disease
* Creatinine Clearance \< 30ml/min
* Know drug abuse / alcohol abuse
* Legal incapacity or limited legal capacity
* Active systemic infection
* Medical or psychiatric illness, which in the investigators' opinions, would not permit the subject to complete or fully and completely understand the risks and potential complications of the study
* Concurrent chronic systemic immune therapy or hormone therapy not indicated in the study protocol
* Pregnancy (confirmed by serum or urine β-HCG) or lactation period
* Severe intercurrent illness, e.g. uncontrolled hypertension, cardiac failure
Adrenal Myelolipomas Case Series

Six cases (72 years old female patient, 63 years old male patient, 57 years old female patient, 61 years old female, 72 years old female and 56 years old female) of clinically and radiologically suspected cases of symptomatic adrenal myelolipoma are discussed here. All cases described, presented with flank pain radiating which was suspected as adrenal mass by Computed Tomography (CT) evaluation. All six cases were histopathologically confirmed as adrenal myelolipoma and managed by laparoscopic surgical excision.

The management in all cases was by laparoscopic adrenalectomy with transperitoneal approach. Several retrospective and comparative studies addressed the advantage of minimally invasive adrenalectomy specifically consistent in less postoperative pain, improved patients' satisfaction, shorter hospital stay and recovery time when compared to open adrenalectomy.

The laparoscopic transabdominal lateral adrenalectomy is currently the most widely used approach.

All our cases were managed by this technique. In our cases initial peritoneal access is achieved 2cm inferior to the right/left costal margin in the midclavicular line, a pressure of 15mmHg is used for CO2 insufflation. Optical access 10-12mm trocar for the endoscope is placed in the pararectal line 5cm above the umbilicus. Under direct vision, the second 10- 12 mm trocar is placed medially to the first one. The third trocar (5mm) is inserted 3 cm above the anterior superior iliac spine in the anterior axillary line. The fourth trocar (5mm) is inserted at the subcostal angle. The key factor for an adequate exposure is an effective dissection of the Toldt fascia. Vascular structures are ligated with Hem-O-Lock and subsequent dissection of the adrenal gland with ultrasonic energy. The adrenal is extracted through a Gibson-type incision, a Penrose drain was left in all cases with its removal upon discharge of the patient.

Eligibility Criteria:
Inclusion Criteria:

* Patients with adrenal myelolipoma

Exclusion Criteria:

* Patients without CT scan with myelolipoma