cyrilzakka/clinical-trials huggingface dataset:
Sildenafil (Viagra) for the Treatment of Dyskinesias in Parkinson's Disease

This study is to determine if Viagra is effective in reducing dyskinesias in patients with Parkinson's Disease.

Inclusion Criteria:

1. Diagnosis of idiopathic Parkinson's disease.
2. Age \> 40 years.
3. willingness and ability to comply with the study requirements and give informed consent.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of idiopathic Parkinson's disease, Hoehn and Yahr stage 2.0 to 4.0.
2. Presence of drug-induced dyskinesias
3. Age\>40 years.
4. Willingness and ability to comply with the study requirements and give informed consent.

Exclusion Criteria:

1. Atypical parkinsonian syndrome due to drugs, metabolic disorders, encephalitis, or degenerative diseases.
2. History of stereotaxic brain surgery.
3. Clinical history of dementia.
4. Known major psychiatric disorder, major depression, schizophrenia. Known alcoholism or substance dependence within previous 12 months.
5. History of major hematological, renal, or hepatic abnormalities.
6. Known coronary artery disease including angina or myocardial infarction within the last 6 months. Significant cardiovascular disease including cardiac failure, unstable angina or life-threatening arrhythmia within the last 6 months.
7. History of stroke within the last 6 months.
8. Abnormal EKG consistent with cardiac ischemia.
9. Treatment with nitrates. Nitrates or any NO donors in any dosage form (oral, sublingual, transdermal, inhalation, or aerosols).
10. Malignant hypertension or SBP . 180 or \<90, or DBP .110 or \<50.
11. History of priapism.
12. Known history of retinitis pigmentosa.
13. Positive pregnancy test.
14. History of bleeding disorder.
15. Patients with active peptic ulcer disease associated with bleeding.
16. Unwillingness to use adequate contraceptive methods if of childbearing potential.
17. Patients with medical or psychological condition or social circumstances that would impair their ability to participate in the study.
18. Use of Viagra or any experimental drugs within 30 days of screening visit.
A Clinical Study of SPH7854 Granules in Healthy Subjects.

To evaluate the safety of SPH7854 in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

1. Volunteer to participate in clinical research; Fully understand and know the study and sign the informed consent；
2. Healthy volunteers;
3. Before receiving the investigational drug, the examination results were normal or clinically insignificant;
4. Subjects who have no fertility plan/sperm donation/egg donation plan and voluntarily take effective contraceptive measures, from signing the informed consent to the prescribed time after the last dosing.

Exclusion Criteria:

1. Female subjects who are breastfeeding or have positive pregnancy results;
2. Subjects with chronic, unstable, or recurrent disease or surgery history who are judged by the investigator to be ineligible before signing informed consent;
3. Subjects suffering from allergic diseases or having a history of severe allergies;
4. Subjects who took the drug or food prohibited by the protocol prior to the first dose;
5. Subjects with evidence of infection who could not be enrolled according to the investigator's judgement;
6. Other circumstances that meet the protocol exclusion criteria.
Use of New Generation Fetoscopes in Pregnancies Affected by Fetal Diseases Amenable to Fetoscopy Therapy

The Researchers are trying to determine feasibility and safety of performing surgery in the womb with the Karl Storz fetoscopes (a tool used to access the baby in the body of the mother). This are new and improved fetoscopes that are not yet approved by the FDA.


Eligibility Criteria:
Inclusion Criteria:

* Patient is a pregnant woman 18 and older
* The mother must be healthy enough to have surgery
* The mother must be scheduled for surgery
* Patient provides signed informed consent that details the maternal and fetal risks involved with the procedure

Exclusion Criteria:

* Age \<18 years
* Contraindication to abdominal surgery, fetoscopic surgery, or general anesthesia
* Preterm labor, preeclampsia, or uterine anomaly (e.g., large fibroid tumor) in the index pregnancy.
* Fetal aneuploidy, any significant pathogenic or likely significant pathogenic findings on Karyotype or Microarray (if available, but not required), other major fetal anomalies that impacts significantly the fetal/neonatal survival.
A Study of Tesetaxel Plus Capecitabine in Patients With Solid Tumors

This study is being performed to confirm the safety of tesetaxel 27 mg/m2 (Day 1) in combination with capecitabine 2000/mg/m2/day (in 2 equally divided doses on Days 1 through 14) in a 21-day cycle.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Confirmed diagnosis of a solid tumor malignancy, excluding lymphoma
* Chemotherapy-naïve or previously treated with not more than 1 non-taxane-containing chemotherapy (Enrollment of patients with a history of prior taxane therapy in the adjuvant setting is allowed provided at least 6 months have passed since the conclusion of that therapy.)
* ECOG performance status of 0 or 1
* Adequate bone marrow, hepatic, and renal function
* At least 3 weeks and recovery from effects of prior surgery and anticancer therapy, with resolution of any toxicity to not more than Grade 1

Exclusion Criteria:

* Brain metastasis or leptomeningeal disease
* Second cancer (except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which patient has been disease-free for 5 or more years)
* Known history of human immunodeficiency virus infection or hepatitis B or hepatitis C infection
* Recurrent diarrhea, defined as more than 3 episodes than is usual in any 24-hour period within the 30 days prior to enrollment in this study
* Significant medical disease other than cancer
* Neuropathy at least Grade 2
* Difficulty swallowing
* Malabsorptive disorder
* Need for other anticancer treatment while receiving study medication
* Need to continue any regularly-taken medication that is a potent inhibitor or inducer of the CYP3A pathway or P-glycoprotein activity. A washout period of at least 2 weeks is required prior to the first dose of study medication.
* Pregnancy or lactation
* History of hypersensitivity to tesetaxel, capecitabine, 5-fluorouracil, or any of their components
CT Evaluating the Efficacy of Pre-incisional Local Analgesia With Ropivacaine + Dexamethasone in Pain Management After Tonsillectomy

This study is a randomized, controlled, double-blind clinical trial to evaluate the effect of local infiltration of ropivacaine and dexamethasone, alone or in association, in the reduction of pain and the need for supplementary analgesia, after tonsillectomy, in the immediate and late postoperative period, in individuals aged 18 to 65 years.

The present clinical trial will include 4 study groups, each with different content of infiltration into the amygdaline locus. One group will have ropivacaine in the infiltration, the other will have dexamethasone and another the association of these two drugs. In order to better understand the effectiveness of these drugs, there will also be a control group, in which saline solution will be infiltrated.

Approximately 104 individuals, aged 18 to 65 years, proposed for tonsillectomy will be included in the study, i.e., 26 subjects in each study group.

Postoperative pain will be characterized by self-assessment through the Visual Analog Scale (VAS, 100mm) at various moments of the study, namely in the preoperative consultation, in the pre-anesthetic consultation, at hospital admission and in the postoperative period until the 15th day after the surgery.

The aim of this study is not to eliminate intra and postoperative analgesia, but rather account for the need for analgesia depending on the different infiltration content peramygdalin. For this, in the postoperative period, a careful pain monitoring, having first-line analgesic and rescue medication for use immediate response in the face of minimal pain assessed by validated pain scales. It is intended, therefore, to record which analgesic drugs and in what doses were necessary.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status I-II;
* Surgical proposal of tonsillectomy;
* Tonsillectomy performed by the cold shedding technique;
* History of recurrent tonsillitis, caseous tonsillitis and / or peritonsillar abscess;

Exclusion Criteria:

* Use of chronic analgesic medication;
* ASA III-IV;
* Coagulation disorders, such as von Willebrand disease or diagnosis of other platelet disorders, haemophilia A and B, or diseases that may develop with hemostatic dysfunction;
* Intolerance or allergy to any of the drugs used in the study;
* Suspicious or confirmed diagnosis of neoplastic disease;
* Fever or acute respiratory tract infection in the last 3 weeks;
Low Frequency, Ultra-low Tidal Volume Ventilation in Patients With ARDS and ECMO

The acute respiratory distress syndrome (ARDS) is the most severe form of respiratory failure, presented in 10% of all intensive care patients and carrying a high mortality rate. Extracorporeal membrane oxygenation (ECMO) is a rescue treatment for patients with severe ARDS. Mechanical ventilator settings in patients with severe ARDS during ECMO therapy are not clearly defined at the moment.

The aim of this study is to assess the effect of a rigorous low breathing frequency and ultra-low tidal volume ventilation strategy on clinical outcome, compared to standard ventilator settings following the recent guidelines in patients with severe ARDS treated with ECMO.

The hypothesis is that a low breathing frequency and ultra-low tidal volume ventilation strategy is more protective for the ARDS challenged lung and reduces the duration of mechanical ventilation and so increases the ventilator free days in patients with severe ARDS treated with ECMO.

Eligibility Criteria:
Inclusion Criteria:

* Moderate to severe ARDS - Partial pressure of oxygen/Fraction of inspired oxygen (PaO2/FiO2) \< 200 mmHg
* ECMO \< 24 hours in situ
* Gender-matched
* Age-matched

Exclusion Criteria:

* BMI \> 40
* Expected weaning of ECMO \< 3 days (postoperative ECMO)
* Combustion
* Restrictive chest wall impairment
* Pregnancy
Health-promoting Lifestyle in a Genetic Counseling Clinic

This was a cross-seThis was a cross-sectional study, which aimed to describe the health-promoting lifestyle of breast cancer patients and family members in a Chinese genetic counseling clinic, and to explore its various levels with different socio-economic variables. 259 patients conformed to the inclusion and exclusion criteria were enrolled. Participants were sent a questionnaire web-link to be invited to finish this survey. 140 participants were finally included in this study. Finally, a good level of health-promoting lifestyle of breast cancer patients and family members was acquired. More education and intervention should be tailored to enhance and encourage health-promoting lifestyle behaviors in participants with low monthly family income. Additionally, developing nutritional curriculum and strengthening the publicity of nutritional popular science were priorities in the future improvement measures.ctional study

Purpose: This study aimed to describe the health-promoting lifestyle of breast cancer patients and family members in a Chinese genetic counseling clinic, and to explore its various levels with different socio-economic variables.

Method: This was a cross-sectional study. The participants in this study originated from a genetic counseling clinic of a cancer center in Shanghai, China. 259 patients conformed to the inclusion and exclusion criteria were screened and contact from November 2019 to March 2022. Participants agreed to participate were sent a questionnaire web-link to be invited to finish this survey. Two questionnaires were included in the link, one referring to the socio-economic information, the other referring to the health-promoting lifestyle. Chinese Health-promoting lifestyle profile-Ⅱ(HPLP-Ⅱ) was used to evaluate the health-promoting lifestyle.

Eligibility Criteria:
Inclusion Criteria:

* over 18 years old;
* with a diagnosis of breast cancer or having a family history of breast cancer
* the first time to take genetic testing in our clinic
* ECOG\<2.

Exclusion Criteria:

* diagnosed with psychiatric or intellectual impairment
* having a history of genetic testing previously
Bupivacaine Versus Lidocaine on Inflammatory Regulation

This study is testing a local anesthetic (numbing medicine) to suppress pain. Bupivacaine and lidocaine are FDA approved local anesthetics that may decrease pain following surgery. Patients will receive either 2% lidocaine, 0.5% bupivacaine, or placebo with epinephrine 1:200,000 as a numbing medicine at the end of root canal surgery. Small pieces of gum will be taken before and after surgery and 2 days later to analyze chemicals that may be related to pain sensation.

We hypothesize that the use of the LLA bupivacaine will promote local inflammation leading to increased pain and central sensitization as evaluated by increase in pain at later time points. Hence our main hypothesis to be evaluated and statistically tested for our primary endpoint (Aim 1) is:

HO: There is no difference in mean levels of biochemical mediators of inflammation between groups.

HA: The bupivacaine group has higher levels of biochemical mediators following surgery.

Eligibility Criteria:
Inclusion Criteria:

* Male or female volunteers referred for endodontic surgery willing to undergo 2 visits: 1 surgical appointment, and 1 follow-up research-related appointment
* Ages of 18 and older
* Willing to undergo observation for 1/2 hour post-operatively
* Willing to complete a 100 mm visual analog scale and record analgesic intake over 48 hrs period
* Willing to have a preoperative and postoperative biopsy on the day of surgery
* Willing to return at 48 hours post-operation to turn in completed pain diaries and for the third biopsy

Exclusion Criteria:

* Allergy to or other contraindications to use of aspirin, sulfites, amide anesthetics, or acetaminophen
* Chronic use of medications confounding the assessment of the inflammatory response or analgesia, for example, NSAIDS, COX-2 inhibitors, antihistamines, steroids, antidepressants
* Medications contraindicated with bupivacaine: MAO inhibitors and anti-depressants
* Diseases such as diabetes mellitus, liver disease, chronic infections, rheumatoid arthritis or any other systemic disease that compromises the immune system
* Unusual surgical difficulty
Epidural Electrical Stimulation for Stroke Patients - Improve Motor and Sensory Function and Alleviate Pain

This study aims to verify whether epidural electrical stimulation (EES) of the cervical spinal cord can activate muscles of the upper limbs in people with hemiplegia following a stroke.

The purpose of this study is to verify whether epidural electrical stimulation (EES) of the cervical spinal cord can activate muscles of the arm and hand in people with hemiplegia following stroke. Participants will undergo a surgical procedure to implant a system that provides epidural electrical stimulation (EES) of the cervical spinal cord. After surgery, Participants will undergo a structured physical rehabilitation program and electrical stimulation. Researchers will quantify the motor potentials in the arm and hand muscles generated by EES of the cervical spinal cord, tune optimal stimulation parameters to induced arm and hand movement, and assess participant motor function of the upper limb with standard clinical tests and simple motor tasks.

Eligibility Criteria:
Inclusion Criteria:

* Between 20 and 70 years of age
* First-ever clinical manifest stroke
* Right or left hemiparesis
* Scores higher than 7 and lower than 45 on the Fugl-Meyer scale.
* Expected will undergo spinal cord stimulation surgery.
* Able to comply with procedures and follow up.
* Stable medical condition without cardiopulmonary disease or dysautonomia that would contraindicate participation in upper extremity rehabilitation or testing activities.

Exclusion Criteria:

* Pregnancy or breast feeding.
* Have Major depressive disorder.
* Had a mental illness within one year or been treated in the past.
* Have significant cognitive impairment (MMSE\<24) or serious disease that could affect the ability to participate in study activities.
* Cardiovascular or musculoskeletal disease or injury that would prevent full participation in physical therapy intervention.
* Receiving anticoagulant, anti-spasticity or anti-epileptic medications prior to or throughout the duration of the study.
* Unable to read and/or comprehend the consent form.
* Have concerns about this trial and do not sign consent.
* Presence of joint contractures deemed by study clinician/investigator to be too severe to participate in study activities.
Association Between TMD and LBP Back Pain

Investigate the relationships between temporomandibular disorder and low back pain

Some patients with chronic low back pain reveal temporomandibular disorder,and others do not. So the aims of my study were to find out the risk factors that contribute to the concurrence of temporomandibular disorder.

Eligibility Criteria:
Inclusion Criteria:

* unilateral LBP for more than 1 year

Exclusion Criteria:

* sensory or neurologic disorders; structural defect of the spine or lower extremities; a history of spine or TMD surgery; recent hip, knee, or ankle pain; any medication that could affect balance; a history of uncorrected visual impairment; and vestibular disorders.
Randomized Trial of Alternative HPV Vaccination Schedules in Males in a University Setting

The investigators propose a randomized, open label trial of the immunogenicity of HPV vaccine among males 18-24 years old, comparing an on-time administration of the third dose with delayed administration of the third dose. All participants would receive the first and second doses according to schedule. They would be randomized to either Dose 3 at 6 months or Dose 3 at 12 months.

Hypothesis: The Geometric mean titers in the 12 month test group (T) are non-inferior to the usual timing control group (C):

H0: δ ≤ -δ0 versus H1: δ \> -δ0 where δ = log (GMTT )- log (GMTC) and δ0 is the pre-specified non-inferiority margin

1. Specific Aims and Overview: The investigators propose a randomized, open label trial of HPV vaccine among males 18-24 years old, comparing an on-time administration of the third dose with delayed administration of the third dose. All participants would receive the first and second doses according to schedule. They would be randomized to either Dose 3 at 6 months or Dose 3 at 12 months.

Blood would be drawn for titers at twice from all participants: pre-dose 1 and one month post Dose 3.

No cytology studies or DNA studies will be conducted.

1.1 Aims:

1. Determine if delay in the third dose is immunologically non-inferior to the standard administration schedule (1 month post-dose 3).
2. Determine the side effect profile of a delayed third dose, in comparison to the standard schedule.
3. Determine the preference and compliance of the men for the timing of the third dose.

1.2 Hypothesis for non- inferiority:

The GMTs in the test group (T) are non-inferior to the usual timing control group (C):

H0: δ ≤ -δ0 versus H1: δ \> -δ0 where δ = log (GMTT )- log (GMTC) and δ0 is the pre-specified non-inferiority margin.

Eligibility Criteria:
Inclusion Criteria:

* Males age 18-26

Exclusion Criteria:

* Hospitalization within the past year
* Previous HPV vaccination

  \>/=5 sexual partners (i.e., insertive intercourse) No other drug studies within 30 days of proposed HPV vaccination
* History of genital warts
* Immunosuppression
* Other vaccines within 8 days of proposed HPV vaccination
* Hypersensitivity to yeast or HPV vaccine components
* Known autoimmune disorders
* Receipt of immunoglobulins or blood product within 90 days of enrollment (may defer until 90 days completed)
* Serious Adverse Reaction to HPV vaccine
Snapshot Study on Patients With Heart Failure

The goal of this observational study is to provide a better understanding of medical practice for heart failure management based on real-world data, collected both across Europe and the rest of the world, using robust methodology and representativeness within each country.

Standard management of patients will be the diagnostic and therapeutic interventions routinely performed in each center for patients presenting with signs and symptoms of chronic/acute heart failure.


Eligibility Criteria:
Inclusion Criteria:

Adult patients with chronic or acute Heart Failure (HF), regardless of ejection fraction, either:

• Outpatient with chronic HF (including first-time diagnosis), according to the clinical judgment.

OR

• Patients admitted to hospital or presenting to Emergency Department or Acute out-patient care for acute HF for whom an IV (diuretics, inotropes, vasodilators) or mechanical therapy for HF (mechanical circulatory support) is administered.

Exclusion Criteria:

* Age \<18 years
* Patients unwilling to consent (or patient's legally authorized representative unwilling to consent, if the patient is unable to consent).
EASINESS-TRIAL - Enhancing Safety in Epilepsy Surgery

To conduct a retrospective multicenter cohort study to define surgical benchmark values for best achievable outcomes following surgery for mesial temporal lobe epilepsy. Established benchmark serve as reference values for the evaluation of future surgical strategies and approaches.

Surgeons strive for the best possible outcome of their surgeries with the greatest possible chance for recovery of the patients. Therefore, monitoring and quality improvement is increasingly important in surgery. For this purpose, different concepts were developed with the aim to assess best achievable results for several surgical procedures and reduce unwarranted variation between different centers. The most common used concept in surgery is a combination of various clinical indicators with a focus on treatment and adverse events which offers a more reliable analysis than single-outcome indicators. The concept of a benchmark establishes reference values which represents the best possible outcome of high-volume centers and can be used for comparison and improvement. Benchmark values are established within a patients' cohort for which the best possible outcome can be expected. The aim of our study is the establishment of robust and standardized outcome references after amygdalohippocampectomy for temporal lobe epilepsy. After successful implantation of benchmarks from an international cohort of renowned centers, these data serve as reference values for the evaluation of novel surgical techniques and comparisons among centers or future clinical trials.

Eligibility Criteria:
Inclusion Criteria:

* Centres with ≥30 seizure-specific resections (excluding vagus nerve stimulation) as an average per year during the 5-year study period
* Patients who went through mesial temporal lobe epilepsy surgery

Exclusion Criteria:

* Only neocortical temporal resection
* Recurrent resection