cyrilzakka/clinical-trials huggingface dataset:
Pimavanserin for Sleep in Parkinson Disease

This pilot, self-control study is for patients with Parkinson's Disease (PD) psychosis (e.g., visual hallucinations, delusions) and sleep problems.

This is a feasibility study to determine whether pimavanserin improves sleep quality in patients with PD and visual hallucinations/delusions.

Patients will complete a Screening Visit to assess eligibility to participate in the study.

For more information, please contact Sofya Glazman, a study coordinator, at sofya.glazman@downstate.edu

Eligibility Criteria:
Inclusion criteria:

1. Has a diagnosis of idiopathic PD according to UK (United Kingdom) PD Society Brain Bank diagnostic criteria
2. Has a history of hallucinations or delusions associated with PD
3. Has a history of sleep disturbance
4. Is between the ages of 40 and 85
5. Has been on a stable dose of all PD medications for at least 30 days prior to enrolment

Exclusion criteria

1. Has evidence of an atypical or secondary parkinsonian disorder
2. Has a contraindication to taking pimavanserin
3. Has contraindication to PSG
4. There has been a change to patient's neuropsychiatric medications including dopaminergic medications (Sinemet, dopamine agonists, MAO(monoamine oxidaze)-B inhibitors), SSRIs (Selective Serotonin Reuptake Inhibitors), SNRIs (Serotonin and Norepinephrine Reuptake Inhibitors), dopamine-blocking agents, anti-epileptics, anticholinergics, or benzodiazepines for at least 30 days prior to enrollment
5. Has traveled through 3 or more time zones within 60 days prior to study screening
6. Patient is a night-shift worker
PROPEL Randomized Trial

It is important for people with stroke to exercise in order to improve their overall recovery and general health. However, these individuals are less physically active than people without stroke, and they often do not achieve the recommended frequency, intensity or duration of exercise. Low levels of physical activity leads to people with stroke becoming very unfit, which can result in functional decline and increased difficulty being active. It is important to determine how to encourage people with stroke to be more active in the long-term. The transition time between the end of rehabilitation and return to the community might be an ideal time to address barriers, and to develop positive habits, knowledge and abilities for long-term participation in exercise. We developed the PROPEL program that combines exercise with self-management strategies during rehabilitation to promote physical activity after rehabilitation. Preliminary pilot findings indicate that people who completed PROPEL were more physically active after discharge than those who did not. This study aims to evaluate the effect of PROPEL on long-term participation in exercise after discharge from stroke rehabilitation. This study will take place at 6 different hospitals. Participants will either complete a control intervention (group exercise only) or the PROPEL intervention (group exercise plus self-management). Participants' adherence to exercise for 6 months after the end of the interventions will be evaluated using activity and heart rate monitors and physical activity questionnaires. We expect this study will show that a simple intervention delivered during rehabilitation will increase participation in exercise after rehabilitation. Increased participation in exercise could then lead to improved stroke recovery and overall health, and reduced risk of having another stroke.


Eligibility Criteria:
Inclusion Criteria:

* Individuals who are referred to the group aerobic exercise or PROPEL programs as part of their stroke rehabilitation.

Exclusion Criteria:

* Language or communication barrier that prevents completion of questionnaires (e.g., severe receptive or global aphasia or non-English speaking);
* Cognitive impairment that would prevent participation in unsupervised exercise;
* Attend less than 50% of group aerobic exercise/PROPEL sessions; and/or
* Attend less than 4 of the 6 group discussion sessions (for individuals referred to the PROPEL program).
The Pharmacokinetics (PK), Safety, Tolerability of SR750 (Prescription F1) in Healthy Volunteers

This is a randomized, double-blind, placebo-controlled phase I bridging study to evaluate the PK, safety and tolerability of SR750 (prescription F1) in Chinese healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy males and females who are 18 to 45 years of age.
2. Based on medical history, physical examination, laboratory examination, chest X-ray, abdominal B-ultrasound, vital signs and ECG, the investigator considered that the results were normal or abnormal but no clinical significance.
3. Bodyweight of male \> 50 kg, Bodyweight of female \> 45 kg and body mass index (BMI) between 18 and28 kg/m2
4. Male subjects must agree to use contraception methods.
5. Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.

Exclusion Criteria:

1. Known history of renal dysfunction or creatinine clearance \< 90 mL/min (calculated using the Cockcroft-Gault formula) at Screening.
2. Current or chronic history of liver disease or known hepatic or biliary abnormalities.
3. History of regular alcohol consumption within 6 months of screening defined as: an average weekly intake of \>21 units for males or \>14 units for females. One unit is equivalent to 8 g of alcohol: a half-pint (\~285 mL) of beer, 1 glass (125 mL) of wine or 1 measure (25 mL) of spirits.
4. History of significant drug abuse within one year of screening or use of soft drugs (such as marijuana) within 3 months prior to screening or hard drugs (such as cocaine, methamphetamine, crack) within 1 year prior to screening.
5. History of sensitivity to any of the investigational medicinal products (IMPs), or components thereof or a history of drug or other allergy that, in the opinion of the Investigator or Medical Monitor, contraindicates participation.
6. History of asthma (excluding resolved childhood asthma), severe allergic responses.
7. History of hypercoagulable state or history of thrombosis.
8. A positive Hepatitis B surface antigen, positive Hepatitis C antibody and positive test for human immunodeficiency virus (HIV) antibody.
9. Within 6 months of screening, Smoking more than 4 cigarettes per day (including e-cigarettes).
10. A positive drug/alcohol result at Screening or Day -1.
11. Donation or lost in excess of 500 mL of blood within 56 days of Day 1 or donation of plasma within 14 days of Day 1.
12. The subject has participated in a clinical trial within 3 months of receiving IMP.

    Use of medication other than topical products without significant systemic absorption.
13. Unable to refrain from consumption of Seville oranges, grapefruit or grapefruit juice within 24h prior to the first dose of IMP until the Safety Follow-up visit.
14. Female subjects with positive pregnancy test results.
15. The investigator will determine any conditions in which subjects are not suitable for the study.
One Research on Improving Cognitive Impairment Caused by Hypertension

Using the therapy of early intervention with Qianyang Yuyin Granules to improve cognitive impairment caused by hypertension.

Using the therapy of early intervention with Qianyang Yuyin Granules to improve cognitive impairment caused by hypertension.

The investigators designed a multi-center randomized controlled clinical trial to study the security and effectiveness of this therapy.

Eligibility Criteria:
Inclusion Criteria:

* Aged 55 to 75 years old, male or female;
* Having a history of hypertension for more than 2 years but can maintain SBP ≤ 140 mmHg and BDP ≤ 90 mmHg with medication；
* 21 ≤ MMSE \< 26, or 14 ≤ MoCA \< 26, CDR \< 0.5. Bseides, the chief complaint must happen after having hypertension；
* Meet TCM Syndrome Differentiation Standard：according to the Guidelines for the Clinical Research of Chinese Medicine New Drugs ( published by China Medical Science Press ) ：Overabundant liver-fire type：dizziness and headache, both face and eyes are red, dry mouth and bitter taste in mouth, red tongue with yellowish coating, wire and frequent pulse. Yin deficiency and yang hyperactivity type: dizziness and headache, Tinnitus and forgetfulness, sphoria with feverish sensation in chest \& palms \& soles, palpitation and insomnia, red tongue \& thin white or less coating, wiry weak and numbered pulse；
* CTMRI hint: leukoaraiosis and no sign of Cerebral infarction；
* Patients or the guardian hold the right opinions over the research and are willing to obey researcher's orders；
* Having a certain degree of education (being able to read simple newspapers in the past)；
* Patients agree to sign informed consent。

Exclusion Criteria:

* Secondary hypertension；
* Taking certain kinds of antihypertensive drugs which may damage brain cognitive function；
* Diagnosed as depression or other mental disorders according to DSM-IV；
* Diagnosed as vascular dementia according to diagnostic criteria, CDR ≥ 0.5; alzheimer disease or dementia caused by some other reasons (including mixed dementia according to diagnostic criteria for VCI); cognitive impairment due to head injury。
* Suffering from certain kinds of diseases which may interfere the assessment of cognitive function, including those who are diagnosed as alcoholics and drugs or psychotropic medicine abusers during the last 5 years according to DSM-IV；
* Accompanied with severe neurological function disorder；
* Asthma, chronic severe primary cardiovascular disease, liver lesion, hematological lesions, lung diseases, diabetes or other severe diseases may influence the patients' survival such as cancer or AIDS；
* Other: Such as poor compliance, or can not attend the follow-up visit in time for some reasons；
* Taking the same kind of medicine during the last 30 days which may influence the trial；
* Is participating in another clinical study；
* Not up to TCM Syndrome Differentiation Standard。
Effect of Cooling Therapy for Post-Operative Pain in Open Carpal Tunnel Release

This study seeks to perform an appropriately-powered study to evaluate any clinical difference between continuous cooling therapy and traditional ice for treatment of post-operative pain in open CTR surgery.

Post-operative pain control is paramount to all operative procedures and involves several modalities. Both pharmaceutical and non-pharmaceutical measures are frequently used. Carpal tunnel release (CTR) surgery is one of the most common surgeries performed in the U.S. with over 400,000 procedures per year.2 Frequently, ice is used as a treatment modality following surgical CTR.3 Several products have been developed in the past decades to improve ice therapy in the rehabilitation period. One such product is the Polar Care which provides up to 6-8 hours of continuous icing.

While there is good data supporting the use of cooling therapy (ice) for post-operative pain, there is lack of data surrounding the use of continuous cooling therapy machines such as the PolarCare following carpal tunnel release (CTR). The two papers that evaluated the efficacy of continuous cooling therapy following CTR had conflicting results on any added benefit of continuous cooling therapy over traditional icing.

There is no standard of care for post-operative icing at UCMC following CTR. Clinicians currently decide whether to give patients a PolarCare machine on the day of surgery without any algorithm. All other patients are encouraged to use traditional icing methods. This study seeks to perform an appropriately-powered study to evaluate any clinical difference between continuous cooling therapy and traditional ice for treatment of post-operative pain in open CTR surgery.

The investigators hypothesize that participants receiving continuous cooling therapy will have a statistically significantly lower pain score compared to those receiving traditional ice therapy.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 or older
2. Indicated for open carpal tunnel release
3. Able and willing to complete online questionnaires

Exclusion Criteria:

1. Prior carpal tunnel surgery for ipsilateral extremity
2. Additional procedures to be performed on ipsilateral or contralateral extremity
3. Current opioid or narcotic pain medication usage
Study of Sildenafil as a Therapy for Fatigue in Pancreatic Cancer

Investigation of the effects of daily sildenafil on patients with pancreatic or cholangiocarcinoma cancer undergoing treatment.

This is a double-blinded, placebo-controlled trial in men and women, 40-75 years old, diagnosed with pancreatic or cholangiocarcinoma cancer. Patients will receive placebo or sildenafil daily for 4 weeks during their initial chemotherapy cycle.

Eligibility Criteria:
Inclusion Criteria:

1. Men and women, aged 40-75 years.
2. Diagnosed with Stage III or IV pancreatic or cholangiocarcinoma receiving the following therapy:

   * Neoadjuvant chemotherapy
   * Surgical resection followed by chemotherapy.
3. Able to comprehend risks and sign a consent form.
4. Performance Status of 0-2.

Exclusion Criteria:

1. Significant renal or heart disease or any acute metabolic disease.
2. Evidence of hepatitis as indicated by a 3-fold increase in of 2 out of 3 liver enzymes.
3. Diabetes mellitus or other untreated endocrine disease.
4. Recent (within 3 months) treatment with anabolic steroids.
5. Ongoing anticoagulant therapy.
6. Androgen secreting tumors of the ovary and adrenal or any ovarian tumor (e.g., Sertoli-Leydig).
7. Polycystic ovary syndrome (PCOS) and/or hyperthecosis.
8. Non-classical adrenal hyperplasia.
9. Cushing's syndrome.
10. Glucocorticoid resistance.
11. Pregnancy.
12. Hyperprolactinoma, hypothyroidism.
13. Use of nitrates.
14. Use of alpha blockers.
15. Use of protease inhibitors.
16. Use of cytochrome p450 inhibitors.
17. Systolic blood pressure \<100 or \>150, diastolic blood pressure \<60 or \>90. This range is smaller than the acceptable range stated in the prescribing information for sildenafil (\>90/50 and \<170/110).
18. Peripheral vascular disease.
19. Use of a phosphodiesterase 5 inhibitor.
20. Any other circumstance deemed exclusionary by the PI or study physician.
Study of Tissue Samples in Predicting How Well Chemotherapy and Radiation Therapy Will Kill Cancer Cells in Patients With Squamous Cell Carcinoma of the Esophagus

RATIONALE: Studying samples of tumor tissue in the laboratory from patients with cancer may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.

PURPOSE: This clinical trial is studying tissue samples in predicting how well chemotherapy and radiation therapy will kill cancer cells in patients with squamous cell carcinoma of the esophagus.

OBJECTIVES:

* To search for chemoradiosensitivity-related genes using a pre-treatment biopsy sample in patients with esophageal squamous cell carcinoma treated with cisplatin, fluorouracil, and concurrent radiotherapy.
* To establish an algorithm for prediction of chemoradiosensitivity in these patients.

OUTLINE: Patients receive 1 of the following treatment regimens:

* Regimen 1: Patients receive low-dose cisplatin IV on days 1 and 29 and low-dose fluorouracil IV on days 1-4 and 29-32. Patients also undergo concurrent radiotherapy on days 1-4 and 29-32. Patients undergo salvage surgery if needed.
* Regimen 2: Patients receive high-dose cisplatin IV on days 1 and 29 and high-dose fluorouracil IV on days 1-4 and 29-32. Patients also undergo concurrent radiotherapy and salvage surgery as in regimen 1.

Pre-operative biopsy samples are analyzed by DNA microarray chip to establish an algorithm for prediction of chemoradiosensitivity.

After completion of study therapy, patients are followed at 12 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed squamous cell carcinoma of the thoracic esophagus

  * Stage IIA, IIB, or III (except T4) disease
  * Tumor diameter \< 8 cm
* No tumor extension to the cervical esophagus or cardia of the stomach
* No multiple and different histological types of cancer

PATIENT CHARACTERISTICS:

* ECOG performance status 0-1
* WBC ≥ 4,000/mm³
* Absolute neutrophil count ≥ 2,000/mm³
* Platelet count ≥ 100,000/mm³
* Hemoglobin ≥ 10 g/dL
* AST and ALT ≤ 100 IU/L
* Total serum bilirubin ≤ 1.5 mg/dL
* Creatinine ≤ 1.2 mg/dL
* Creatinine clearance ≥ 60mL/min
* SpO_2 (room air) ≥ 95%
* Not pregnant or nursing
* No abnormal ECG findings requiring treatment
* No interstitial pneumonitis or no pulmonary fibrosis
* No severe complication (e.g., heart failure, renal failure, hepatic failure, or uncontrollable diabetes mellitus)
* No collagen disease (e.g., PSS or dermatomyositis)
* No mental disease
* No active bacterial infection
* No virus infection (i.e., HBV, HCV, PTHA, or HIV)

PRIOR CONCURRENT THERAPY:

* No prior surgery for esophageal cancer
* No prior chemotherapy
* No prior chest radiotherapy
Nebulised Hypertonic Saline to Decrease Respiratory Exacerbations in Neuromuscular Disease or Neurodisability

Research Aim: This study investigates whether a 12-month treatment with hypertonic saline (salty water) can reduce antibiotic use in individuals with neuromuscular disease or cerebral palsy who frequently experience chest infections due to difficulty clearing mucus from their airways.

Methodology: Participants will be randomly assigned to receive nebulised hypertonic saline (7% salt in water) or normal saline (0.9% salt in water). The study is open-label as both participants and researchers are aware of the treatment, necessary due to the differing tastes of the solutions. Two centers, Royal Brompton Hospital in London and Queens Medical Centre in Nottingham, will conduct the research.

Before starting the treatment, participants will undergo various assessments, including questionnaires to measure quality of life and treatment satisfaction, sputum/throat swab collection, lung clearance index, forced oscillation technique, electrical impedance tomography, and lung ultrasound. Once these assessments are completed, participants will take the assigned treatment at home, administered twice daily for 12 months, with monthly follow-ups regarding difficulties and chest infections. After 12 months, the treatment will cease, and participants will repeat the assessments.

Significance: This research will provide valuable insights into the efficacy of nebulised hypertonic saline for individuals with neuromuscular disease or cerebral palsy, potentially aiding both patients and doctors in making informed treatment decisions.

Dissemination: The study's findings will be shared through publication in scientific journals and presentation at conferences.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of NMD or neurodisablity by a physician independent of the study, on standard criteria.
* Age 5 years and above, including adults.
* Must be able to tolerate nebulised 6% hypertonic saline.
* Must have a history of at least one respiratory exacerbation requiring antibiotic treatment with or without the need for hospitalisation in the 12 months prior to recruitment.

Exclusion Criteria:

* Patients with additional diagnosis, for example, CF, but those with aspiration and/or bronchiectasis secondary to respiratory complications of NMD will be included.
* Patients who are already prescribed daily HS in any concentration (i.e, 3%, 5%, 6%, 7%) will be excluded, but those who are on daily NS or have HS prescribed as part of their escalation plan (i.e., PRN) will be included.
Adaptation and Validation of Recent Life Changes Questionnaire for Measuring Stress Among Adults in Karachi, Pakistan

Stressors impair optimum function of an individual physiologically and psychologically. Overcoming stress is possible when one knows which aspects of life are the most troublesome to manage for individuals. There are certain tools available in Pakistan that can measures stress in selected populations but there are no validated tools that may quantify stress which results from events occurring in different aspects of life.

Recent Life Changes Questionnaire (RLCQ) is a tool that measures stress of individuals through life changing events. It has five categories; work, home and family, health, personal and social and financial. The objective of the study is to adapt RLCQ and validate it so that it may measure stress among people living in Karachi, Pakistan.

In order to make RLCQ a tool to measure stress within Pakistani context, we would want to adapt RLCQ and then validate it. The study design is a validation study where the construct of recent life changing events will be validated by comparing it with a gold standard to assess the extent of accuracy of measurement by exploring the agreement between them. The mode of data collection is cross-sectional by administering the adapted RLCQ and the gold standard simultaneously. Since stress is a subjective phenomenon and serves as a root cause for many neurodegenerative diseases and mental disorders, a tool for screening mental illnesses is selected against which we could compare the adapted RLCQ for validation. The Mini international neuropsychiatric Interviews (MINI) is a structured diagnostic interview developed and validated by Sheehan in 1997, Florida. It is based on the DSM IV criteria and ICD-10. The design of this study incorporates content and criterion validity as we have a pre-existing 'gold standard' which is widely accepted and is in current practice of mental health screening in Pakistan.

The study will be conducted in six phases. Phase I includes conducting qualitative interviews to explore the phenomenon. In Phase II, adaptation of RLCQ will be done and review of the adapted tool will be done with the help of subject experts. Phase III will verify the face validity of the tool by translations and back translations. In Phase IV, pre-testing of the tool will be done whereas in phase V, we will administer the tool in the community along with conducting MINI interviews. Phase VI tests the reliability of the tool.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18 years or above
* Those who would stay in the study site for at least one month
* Those who provide a written informed consent

Exclusion Criteria:

* Those who do not understand Urdu
* Those who have cognitive or hearing difficulties
* People with known psychiatric conditions and are under treatment.