cyrilzakka/clinical-trials huggingface dataset:
Ketogenic Diets for Symptoms of Parkinson's Disease

Parkinson's disease is a progressive condition that harms nerve cells of the brain (neurodegeneration). Current treatments for Parkinson's disease (including levodopa and deep brain stimulation) improve certain symptoms but are not thought to improve the underlying neurodegenerative disease process (they are not a "cure"). The cause of Parkinson's disease is unknown. However, some evidence suggests that tiny structures in the investigators cells called "mitochondria" might be involved. Mitochondria are the powerhouses that produce fuel for the investigators cells. Failure of these 'powerhouses' to supply the energy needs of certain nerve cells might lead to Parkinson's disease. Preliminary evidence suggests that a food called 'ketones' might be able to enhance the function of mitochondria and improve Parkinson's disease symptoms and possibly even the neurodegenerative process. In this study, the investigators would like to investigate this possibility by giving patients with Parkinson's disease dietary supplements of 'ketone esters' in a drink. The investigators will then assess if this improves symptoms of Parkinson's disease.

The study design is a prospective, double blinded, randomised, controlled trial.


Eligibility Criteria:
Inclusion Criteria:

* Patients with Primary Parkinson's disease fulfilling UK Brain Bank criteria
* Age of onset of Parkinson's disease symptoms \> 40 years old
* Duration of symptoms over 2 years

Exclusion Criteria:

* Dementia
* Active psychosis
* Deep brain stimulation or apomorphine infusion
* Severe motor fluctuations
* Significant metabolic or uncontrolled medical cormorbidity
Bioavailability Study of PF-06651600 Formulations in Healthy Participants

The study will be conducted as a Phase 1, open-label, single dose, randomized, 4-period, cross over design in a single cohort of approximately 12 healthy male or female participants at a single center. Participants will be randomized into 1 of 4 sequences of treatment.


Eligibility Criteria:
INCLUSION CRITERIA:

* Participants who are healthy as determined by medical evaluation including a detailed medical history, complete physical examination, which includes BP and pulse rate measurement, clinical laboratory tests, and 12 lead ECG.
* Participants with body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lb).

EXCLUSION CRITERIA

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, dermatological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
* Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy).
* Known immunodeficiency disorder, including positive serology for human immunodeficiency virus (HIV) at screening, or a first degree relative with a hereditary immunodeficiency.
* Infection with hepatitis B or hepatitis C viruses
Two Low-level Laser Irradiation Protocols on the Rate of Canine Retraction

Several methods aiming at the acceleration of orthodontic tooth movement have been proposed, including low-level laser therapy (LLLT), which showed promising results. However, the frequency of patient recall has been one of its major drawbacks.

A randomized controlled clinical trial will be conducted to address the aim of the study. Sixteen patients will be recruited, requiring the therapeutic extraction of the maxillary 1st premolars, with subsequent canine retraction into the extraction space. The sample will be randomly divided into 2 equal groups, each including 8 subjects.

In Group A, one side of the maxillary arch will randomly receive LLLT on days 0, 3, 7, 14, and every 2 weeks thereafter, while in Group B, one side will also be randomly chosen to receive LLLT every 3 weeks. The contralateral sides of both groups will serve as the controls. The LLLT applied will be Diode laser emitting infrared radiation at wavelength of 980 nm, in a continuous mode.

Canine retraction in both groups will be carried out bilaterally using nickel-titanium closed-coil spring, delivering 150 grams of force, and the rate of tooth movement will be checked every 3 weeks, over a period of 3 months. Other variables will be also examined including, interleukin-1β level in the gingival crevicular fluid, root resorption, and molar anchorage loss.

Eligibility Criteria:
Inclusion Criteria:

* Malocclusion requires at least the extraction of maxillary first premolars, followed by canine retraction into the extraction site.
* Normal shape and structure of the maxillary canines, with no history of root canal treatment.
* Patients with good oral hygiene, and a healthy periodontal condition.

Exclusion Criteria:

* Patients who underwent previous orthodontic treatment.
* Patients currently receiving drug therapy that may affect orthodontic tooth movement, e.g. hormonal therapy and corticosteroids.
* Patients with chronic diseases that may affect the rate of tooth movement.
* Pregnancy and lactation
Study to Evaluate the Safety and Efficacy of Stribild Versus Atripla in Human Immunodeficiency Virus, Type 1 (HIV-1) Infected, Antiretroviral Treatment-Naive Adults

To evaluate the safety and efficacy of Stribild®, a single tablet regimen (STR) containing fixed doses of elvitegravir (EVG)/cobicistat (COBI \[GS-9350\])/emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) versus efavirenz (EFV)/FTC/TDF (Atripla®) in HIV-1 infected, antiretroviral treatment-naive adults. Stribild offers an alternative STR for patients who are not candidates for non-nucleoside reverse transcriptor-based STRs.


Eligibility Criteria:
Inclusion Criteria:

* Ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures
* Plasma HIV-1 RNA levels ≥ 5,000 copies/mL
* No prior use of any approved or investigational antiretroviral drug for any length of time
* Screening genotype report must show sensitivity to FTC, TDF, and EFV
* Normal electrocardiogram (ECG)
* Adequate renal function (estimated glomerular filtration rate ≥ 70 mL/min according to the Cockcroft Gault formula)
* Hepatic transaminases (aspartate aminotransferase (AST) and alanine aminotransferase (ALT)) ≤ 5 x the upper limit of the normal range (ULN)
* Total bilirubin ≤ 1.5 mg/dL, or normal direct bilirubin
* Adequate hematologic function
* Serum amylase ≤ 5 x ULN
* Males and females of childbearing potential must agree to utilize highly effective contraception methods from screening throughout the duration of study treatment and for 12 weeks following the last dose of study drug
* Age ≥ 18 years
* Life expectancy ≥ 1 year

Exclusion Criteria:

* A new acquired immunodeficiency syndrome (AIDS)-defining condition diagnosed within the 30 days prior to screening
* Receiving drug treatment for hepatitis C, or anticipated to receive treatment for hepatitis C
* Subjects experiencing decompensated cirrhosis
* Females who are breastfeeding
* Positive serum pregnancy test (female of childbearing potential)
* Implanted defibrillator or pacemaker
* Current alcohol or substance use judged by the Investigator to potentially interfere with subject study compliance
* History of malignancy within the past 5 years or ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, noninvasive cutaneous squamous carcinoma
* Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to baseline
* Medications contraindicated for use with EVG, COBI, FTC, EFV, or TDF; or subjects with any known allergies to the excipients of Stribild or Atripla tablets
* Participation in any other clinical trial without prior approval
* Any other clinical condition or prior therapy that, in the opinion of the Investigator, would make the subject unsuitable for the study or unable to comply with the dosing requirements
Impact of Implementation of an Enhanced Recovery After Surgery Program in Laparoscopic Roux-en-Y Gastric Bypass

A prospective randomized study of patients undergoing Roux-en-Y gastric bypass will be randomized in 2 groups: those following an ERAS program and those ones following a standard protocol.

Postoperative pain 24 hours after surgery and hospital stay will be assessed.

A prospective randomized study of patients undergoing Roux-en-Y gastric bypass will be randomized in 2 groups: those following an Enhanced Recovery After Surgery (ERAS) program and those ones following a standard protocol. The ERAS program implies early liquids oral intake, early deambulation and multimodal analgesia (port sites infiltration with Bupivacain 0.5% associated with intravenous analgesia).

Postoperative pain 24 hours after surgery, as measured by Visual Analogic Scale, and hospital stay will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index (BMI) \>40 Kg/m2
* BMI \>35 Kg/m2 with obesity-associated comorbidities

Exclusion Criteria:

* Patients undergoing other bariatric procedures
* Patients undergoing bariatric revisional surgery
RM-493 Treatment Trial in Proopiomelanocortin (POMC) Deficient Patients

The purpose of this study is to evaluate the effects of a once daily subcutaneous (SC) injection of RM-493, in subjects with POMC (propiomelanocortin) or other related rare genetic mutations, on body weight, metabolic function and blood pressure. Patients who respond during the initial 84 days of treatment can enter into long-term (2-year) extensions. The study drug (RM-493) will be administered in an unblinded fashion.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Homozygous or compound heterozygous (different gene mutation on both alleles) POMC, LEPR or PCSK1 gene mutation
* Obesity (BMI \> 30 kg/m2; + 2 BMI SDS)
* No other therapeutic option, which might cure the patient (e.g. bariatric surgery (see chapter 8))
* Negative Pregnancy test
* Highly effective contraception in women (defined as pearl index \< 1), if necessary also for partners of test persons)
* No participation in other clinical trials according to AMG (Arzneimittelgesetz) (2 months before and after) at the time of this trial
* Normal or minimally elevated blood pressure (measured in 24RR monitoring or similar methods) according the guidelines of the ESH (European Society of Hypertension) and Deutsche Hochdruckliga: systolic \> 159 mmHg/diastolic 99 mmHg
* sufficient kidney and liver function (Creatinine, ALT, AST)

  * normal values Alanine-Aminotransferase (ALT) (female): \< 31 U/l
  * normal values Alanine-Aminotransferase (ALT) (male): \< 41 U/l
  * normal values Aspartate-Aminotransferase (AST) (female \> 17 years): \< 35 U/l; (female \< 17 years): 16- 46 U/l
  * normal values Aspartate-Aminotransferase (AST) (male \> 17 years): \< 50 U/l; (male \< 17 years): 16-46 U/l
  * normal values bilirubins (male and female) up to 1,2 mg/dl
  * normal values Creatinine (female \> 15 years): 0,51-0,95 mg/dl) ; (female \< 15 years): 0,46-0,77 mg/dl
  * normal values Creatinine (male \> 15 years): 0,67 - 1,17 mg/dl) ; (male \< 15 years): 0,46-0,77 mg/dl

Exclusion Criteria:

* Pregnancy or Breastfeeding
* All contraindications against study medication (including auxiliary substances)
* Interactions with study medication
* Participation of the patient in a clinical study within the last 2 months
* Intolerance against albumin
* Concomitant diseases, impaired organ functions, except for known, concurrent GI disorders or other clinical findings expected in PCSK1 or LEPR gene disorders
* Renal insufficiency (Creatinine \> 0,95 mg/dl (female), \> 1,17 mg/dl (male))
* Impaired liver function (Bilirubins \> 1.2 mg/dl)
* Neurological / psychiatric diseases
* HIV Infection
* Active Hepatitis B or C
* Melanoma or Melanoma occurrence in the family history
* Non-compliance
* Subjects who are legally detained in an official institution
Effect of Eggs and Egg Components on Cognitive Performance and Appetite in School-aged Children

The purpose of the present study is to determine the effects of eggs and egg components on cognitive performance and appetite in children aged 9-14 years, as well as to identify the underlying physiological mechanisms in this relationship.

Children will be asked to refrain from exercising the morning of their test day and inform researchers of any illness. Following a 12-hour overnight fast, children will consume a standardized breakfast of a cereal bar, fruit cup and orange juice at home (total 330 kcal). Children will be asked to avoid consumption of any other food, with the exception of water, until arrival at the laboratory 3 hours later.

At the laboratory, five treatments of: (a) 2 whole eggs, (b) 2 egg whites, (c) 2 egg yolks, (d) full fat yogurt isocaloric to the 2 whole eggs, and (e) snack skipping will be provided to children 9-14 years on separate days at least 7 days apart. Cognitive performance, subjective emotion/mood, and subjective appetite will be measured for 90-minutes following snack consumption (n=25). Cognitive performance assessments will include learning and memory, spatial memory, attention and processing speed, and executive functions. In a subgroup of individuals (n=10), glucose, insulin, incretin hormones (glucagon like peptide1(GLP1) and gastric inhibitory polypeptide (GIP)),dipeptidyl peptidase 4 (DPP4), amino acids, fatty acids, and choline will be measured for 90-minutes following snack consumption.

Eligibility Criteria:
Inclusion Criteria:

* be between 9 and 14 years of age
* be healthy, and have been born at term
* healthy body weight (between the 5th and 85th BMI percentile for age and gender)

Exclusion Criteria:

* children with food sensitivities or allergies to eggs, egg-products, dairy and wheat
* children with any diagnosed learning, emotional, or behavioral disabilities
* children on medications that may influence cognitive performance
The Multidisciplinary, Multimodality, But Minimalist Approach to Transfemoral Transcatheter Aortic Valve Replacement

The primary objective of this study is to determine the efficacy, safety and feasibility of next day discharge home in patients undergoing balloon-expandable transfemoral TAVR utilizing the Vancouver 3M Clinical Pathway in low, medium, and high volume North American centres.


Eligibility Criteria:
Inclusion Criteria:

Patients with severe symptomatic aortic stenosis undergoing elective transfemoral TAVR with a balloon expandable transcatheter heart valve

1. Considered at increased surgical risk by the Multidisciplinary Heart Team.
2. Informed written consent

Exclusion Criteria:

1. Non -cardiovascular co-morbidity reducing life expectancy to \< 3 years
2. Any factor precluding 1 year follow-up
3. Inadequate CT image acquisition to perform area-based annular CT sizing, exclude adverse root features, and determine a coaxial valve deployment angle (CT is not required for valve-in-valve procedures)
4. Predicted inability to perform uncomplicated percutaneous vascular access and closure
5. Iliofemoral diameter \< 6 mm for SAPIEN XT or \<5.5 mm for SAPIEN 3 (measured at or above the mid-femoral head)
6. Inpatient (unless clinically stable, mobilizing at baseline, and primarily in hospital for logistical reasons.
7. Significant communication barrier(s) that interfere with ability to follow peri-procedural and discharge instructions
8. MMSE \< 24/30 (unless language barrier or limited formal education), 5-metre gait \> 7 seconds (unless chronic mobility impairment not affecting ability to perform ADLs), and ADL \< 6/6
9. Insufficient social support to facilitate next day discharge
10. Airway unfavourable for emergent intubation
11. Inability to lay supine without conscious sedation or general anesthetic
12. Not receiving a balloon expandable transcatheter heart valve
Comparing the Safety and Effectiveness of Tunnel PICC Guided by EDUG and Conventional PICC

This study was designed as a prospective, multicenter, randomized controlled study, with the incidence of postoperative complications as the main observation end point. It was a superiority design.The purpose of this study was to compare the incidence of complications associated with EDUG-guided subcutaneous tunneling and conventional puncture after peripheral vein placement of PICCs


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years old;
* Immunocompromised patients, including:

  ① Patients with congenital T cell/B cell deficiency or macrophage disorder;

  ② Patients with solid malignant tumors or hematological malignancies;

  ③ Patients with AIDS;

  ④ Patients undergoing splenectomy or solid organ transplantation;

  ⑤ Patients with rheumatic diseases and treated with immunomodulatory drugs;
* Follow the doctor's advice to perform PICC catheterization for the first time;
* No serious cardiovascular disease, such as atrial fibrillation, pulmonary heart disease, severe conduction block, etc., before catheter placement;
* Patients who have not participated in other clinical studies;
* Patients who voluntarily participate in the clinical study and can cooperate with the clinical follow-up.

Exclusion Criteria:

* Known allergy to catheter material;
* History of infection, injury or radiation therapy at the puncture site;
* There is a history of venous thrombosis or surgical operation at the puncture site;
* Severe abnormal coagulation function;
* Superior vena cava compression syndrome;
* Radical mastectomy for breast cancer or axillary lymph node dissection on the operative side of the limb;
* Pacemaker and arteriovenous fistula ipsilateral limb.
Docetaxel and S-1 in Head and Neck Squamous Cell Carcinoma (HNSCC)

To assess response rate of docetaxel and S-1 combination in metastatic or recurrent head and neck squamous cell carcinoma


Eligibility Criteria:
Inclusion Criteria:

* histologically confirmed HNSCC
* adequate primary site: oral cavity, oropharynx, hypopharynx, nasal cavity, paranasal sinus, other head and neck site (except nasopharynx)
* at least one measurable lesion
* no previous palliative chemotherapy (adjuvant/neoadjuvant chemotherapy and/or radiotherapy longer than 6 months ago is permitted)
* 18 years or older
* ECOG 0 or 1
* adequate laboratory result
* written, informed consent

Exclusion Criteria:

* pregnant or lactating women (negative pregnancy test within 7 days is required for women with potential of child-bearing)
* experimental drug clinical trial within 30 days
* other malignancy (exemption: treated basal cell carcinoma of skin, CIS, cured cancer with disease-free interval with more than 5 years)
* patient with organ transplantation
* grade 2 or more peripheral neuropathy
* grade 2 or more hearing loss
* severe, medical condition
Molecular Studies and Clinical Correlations in Human Prostatic Disease

The Genitourinary Oncology/Urology Services at Memorial Sloan-Kettering Cancer Center (MSKCC) participates in research for the control, treatment, and cure of cancer. The purpose of this study is to collect normal and cancerous tissues, in addition to blood, and other body fluid samples from men with prostate cancer or prostatic disease. These samples may be stored for future use or used immediately by researchers who study prostate cancer and try to find better ways to diagnose, prevent, and treat it. We will look for genetic changes and protein markers on these cells. We hope to learn more about what makes some people get prostate cancer, why some cancers are more aggressive than others, and why some cancers respond to or resist different treatments. We may also try to grow the tumor cells in the lab. We may find a new treatment for prostate cancer based on this research.

The therapeutics program for advanced prostate cancer is based on the hypothesis that the factors contributing to and associated with progression change as the disease evolves. To categorize these changes we now consider the disease as a series of states. 1 The states represent points where an intervention might be considered to prevent cancer from developing, to eliminate established disease, or to delay progression. The states also represent clinically significant milestones that can be used to assess treatment effects.

Eligibility Criteria:
Inclusion Criteria:

Men with prostate conditions representing the following disease states:

* No Cancer Diagnosis
* Clinically Localized Disease
* Rising PSA
* Clinical Metastases: Noncastrate
* Clinical Metastases: Castrate (Testosterone ≤ 50 ng/ml)
* Signed informed consent

Exclusion Criteria:

-Patients without any prostate related problems.
Safety and Immunogenicity Study of Tdap Vaccinations for Plasma Donors

The goal of this clinical trial is to investigate the safety and tetanus antibody response to a Tdap vaccine in healthy plasma donors. The main question it aims to answer are:

* Is it safe to give this vaccine multiple times over one year to plasma donors since the package insert for this vaccine indicates that it should administered once every 10 years?
* What is the tetanus antibody response over time in these donors after receiving the vaccine multiple times during the study?

Participants will receive a Tdap vaccination every 3 months ±2 weeks for 12 months (5 vaccinations) with a 6 month follow-up after the last vaccination. After obtaining informed consent and screening for eligibility including plasmapheresis donor eligibility, subjects will have other baseline assessments performed and if eligible, will receive the scheduled vaccinations, will be assessed for adverse events (AEs) and have plasma samples collected for antibody titers each month thereafter for 11 months, and then at 1 and 6 months after the last vaccination. As these subjects are participating in a standard donor plasmapheresis donor program, assessments for donor eligibility and routine plasmapheresis will be performed; however, only the data specifically required to meet the objectives of this study will be collected.


Eligibility Criteria:
Inclusion Criteria:

* Male or female ages 18 to 63 years
* Females of childbearing potential who agree to employ highly effective birth control measures during the study
* Signed the informed consent form (ICF)
* Met all of the criteria required to be a Normal Source Plasma donor
* Subject is not participating in any other immunization program
* Subject has not had a Tdap vaccination in the last 90 days before the first study vaccination

Exclusion Criteria:

* Subject is pregnant
* Subject has a condition or abnormality that in the opinion of the Investigator would compromise the safety of the subject or the quality of the data
* Subject has repeated reactions or hypersensitivity to components in the vaccine
* Subject has history of a severe reaction to any immunization
* Subject has a history of Guillain-Barré Syndrome
* The Investigator concludes that the anticipated vaccination site (deltoid area) is not suitable for AE assessment