cyrilzakka/clinical-trials huggingface dataset:
An Evaluation of the Pharmacokinetics and Pharmacodynamics of AP09004 in Patients With Parkinson's Disease

The purpose of this study is to evaluate blood level profiles of multiple oral doses of AP09004 vs. active control and to determine its safety and efficacy in Parkinson's patients.


Eligibility Criteria:
* Subjects between the ages of 18 and 75 years of age inclusive;
* For early patients only: Subject with Parkinson's disease with a stable response to Levodopa (not suffering from "wearing off") and currently treated with IR-Carbidopa/Levodopa containing 300-500mg Levodopa per day up to 4 doses per day.
* For group 3 only: Subject with Parkinson's disease experiencing predictable motor fluctuations, end of dose "wearing off", defined by the patient's report of at least two episodes daily of a decline in function from peak benefit, with at least 2-3 hours OFF a day at the discretion of the PI (does not include early morning akinesia). Only patients with end of dose wearing off for at least 3 months will be included.
* For moderate patients only: patients who are currently treated with IR-Carbidopa/Levodopa containing 600-900mg Levodopa, in divided dose, per day.
* Subject has been stable at current CD/LD dose for at least 1 months
* Hoehn and Yahr stages I-III
* If subject is taking dopamine agonists, the dose has been stable for at least 1 month
* Other then Parkinson's disease, the subject is in satisfactory health, as assessed by physical examination, blood test (biochemistry and hematology). No abnormality on clinical examination and blood tests that in the opinion of the Physician responsible will compromise safety or interfere with study procedures.

Exclusion Criteria:

* Subjects who have participated in another clinical trial within the last 30 days;
* Subjects with atypical Parkinsonism
* Subject has significant history of cardiac, pulmonary, hepatic or renal disease or other condition or any major complication/illness which, in the opinion of the physician responsible, contraindicates his/her participation.
* Subject with symptomatic gastroparesis with frequent vomiting (at least once a week).
* Subjects with a history of clinically defined GERD, peptic ulcer or any gastrointestinal surgery other than appendectomy or herniotomy, or with any gastrointestinal disorder likely to influence drug absorption, or with any history of inflammatory bowel disease, irritable bowel syndrome, severe gastrointestinal narrowing, or frequent nausea or emesis, regardless of etiology.
* Prior gastro-intestinal surgery or current gastrointestinal conditions of clinical significance including ulcers, diarrhea, vomiting, bleeding, intestinal obstruction or inflammatory bowel disease, which, in the opinion of the physician responsible, contraindicates his/her participation.
* History of drug or alcohol abuse.
* Subject has a history of allergy to any component of the dosage form or any other allergy, which, in the opinion of the physician responsible, contraindicates his/her participation.
* Subjects suffering from psychological disorders that in the opinion of the physician responsible may interfere with full participation.
Plasma Rich in Growth Factors in Post-extraction Sockets

The purpose of this study is to compare the clinical success, radiographical volume maintenance and histological bone regeneration after using either a bovine bone xenograft or an autogenous platelet rich plasma enrich in growth factors, known as Endoret®-PRGF®.


Eligibility Criteria:
Inclusion Criteria:

* Upper or lower premolar or molar tooth in need of extraction and later restoration by dental implant.
* Adjacent and opposing natural teeth present and healthy.
* At least 3 mm from the tip of the dental root to the maxillary sinus or the inferior alveolar canal.

Exclusion Criteria:

* Active local infection.
* Uncontrolled diabetes mellitus.
* Long term (\>10 years) use of oral bisphosphonates.
* Use of intravenous bisphosphonates.
* Recent use (\<3 months) of antibiotics, antiinflammatories or analgesics drugs.
* Pregnancy.
* Smokers of more than 10 cigarettes per day.
* Any oral pathology that needs to be treated before tooth extraction, particularly the presence of more than 25% of sites with bleeding on probing.
Hyperbaric Oxygen Therapy for Optic Neuropathies

The purpose of the study is to evaluate the neuroprotective efficacy of hyperbaric oxygen for the treatment in patients with optic neuropathy.


Eligibility Criteria:
Inclusion Criteria:

* Patients must meet all of the following criteria to join the study (all eligibility criteria must be met at the screening and baseline visits unless otherwise noted):
* Participant must be at least 18.
* Participant must has the ability to comply with the requirements of the study and complete the schedule of events (SOE).
* Participant's with clinical evidence of optic neuropathy.
* Participant must understand and sign the informed consent. If the participant's vision is impaired to the point where he/she cannot read the informed consent document, the document will be read to the participant in its entirety.

Exclusion Criteria:

* Participant is unable to comply with study procedures or follow-up visits.
* Participant has evidence of corneal opacification or lack of optical clarity.
* Participant is currently participating in or has within the last 3 months participated in any other clinical trial of a drug by ocular (if in the study eye) or systemic administration.
* Participant is pregnant or lactating.
* Participant has, in the opinion of the investigator, any physical or mental condition that would increase the risk of participation in the study or may interfere with the study procedures, evaluations and outcome assessments.
* Children and comatose patients.
* Participant abusing drugs or alcohol.
* Prior treatment with hyperbaric oxygen within the last 6 months.
* Participant with claustrophobia or that cannot decompress properly.
Delayed Embryo Transfer in Poor Responders

Poor ovarian response indicates inadequate ovarian response to ovarian stimulation. In the current study the investigators will attempt to compare antagonist and short protocols regarding oocyte as well as embryo quantity and quality. Frozen embryo transfer will be performed in order to abolish iatrogenic effect of stimulation drugs on implantation. Still implantation and pregnancy rates are considered secondary outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Patient selection is based on the ESHRE consensus group 2011 definition of poor ovarian response (POR) (Bologna criteria):
* At least two of the following three features must be present:

  1. Advanced maternal age (≥40 years) or any other risk factor for POR;
  2. A previous POR (≤3 oocytes with a conventional stimulation protocol);
  3. An abnormal ovarian reserve test (i.e. Antral follicle count (AFC) \<5-7 follicles or Antimullerian hormone (AMH) \<0.5-1.1 ng/ml).

Two episodes of POR after maximal stimulation are sufficient to define a patient as poor responder in the absence of advanced maternal age or abnormal Ovarian reserve test (ORT). By definition, the term POR refers to the ovarian response and, therefore, one stimulated cycle is considered essential for the diagnosis of POR. However, patients over 40 years of age with an abnormal ORT may be classified as poor responders since both advanced age and an abnormal ORT may indicate reduced ovarian reserve and act as a surrogate of ovarian stimulation cycle. In this case, the patients should be more properly defined as expected PORs.

Exclusion Criteria:

* Women with endometriosis, endocrinal problems, uterine abnormalities as well as male azospermia.
Clinical Study Evaluating Targeted Biopsies and Cytological Imprints in Prostate Cancer

The investigators will evaluate the accuracy of performing cytological imprints of targeted biopsies when diagnosing prostate cancer.

It is useful to know whether the biopsy is cancer or not, in order to know when to stop sampling and when to continue.

The strategy is used in other types of cancer, e.g lung, breast etc

Background:

When substituting a random biopsy procedure with a few targeted biopsies, it is of outmost importance to know immediately if the biopsy is positive or not. A recent study has demonstrated a high sensitivity and specificity of imprint cytology of random biopsies.

Aim:

The correlation between cytological imprints and histology of targeted prostate biopsies

Material\&Method:

All patients in this study are already participating in an ongoing randomized biopsy study (NCT01455792) comparing:

1. Preoperative MRI and targeted biopsies + random biopsies .
2. Random biopsies (gold standard).

Only patients with a positive MRI were included in this collateral study.

The cytological imprints (negative/positive) of each targeted biopsy is compared to the histology (negative/positive) and Gleason score.

Eligibility Criteria:
Inclusion Criteria:

* Prostate specific antigene (PSA) 4-20ng/ml, and/or abnormal digital rectal examination
* No previous prostate biopsies
* Positive MRI
* Signed letter of informed concent

Exclusion Criteria:

* Contraindications to MRI
* Previous prostate biopsies
Assessment of the INVOcell Culture Device When Used for up to Five-Day Incubation

The INVOcell Culture Device received de novo request for 3-day intravaginal incubation. The device is held in place with the intravaginal cavity by a Retention Device. The clinical study will assess the ability of a modified Retention Device to hold INVOcell in place during 5-day vaginal incubation as well as comfort and vaginal irritation as secondary endpoints.

This is a single center, open label non-comparative prospective trial to evaluate the retention of the INVOcell IVC with the Retention Device over the vaginal incubation period of up to 5 days.

The purpose of this study is to assess the retention of the INVOcell IVC device with the Retention Device over the vaginal incubation period of up to 5 days.

Primary Endpoint

• Retention of the INVOcell IVC device with the Retention Device over the vaginal incubation period of up to 5 days.

Secondary Endpoint

* Comfort of the INVOcell IVC and Retention Device
* Vaginal tissue reactions during the vaginal incubation
* Optical clarity and the ability to visualize the embryos after the incubation

Eligibility Criteria:
Inclusion Criteria:

* Have been informed about the study and have given their written consent.
* Patients 18 years to 42 years
* Women who are scheduled for an oocyte retrieval in anticipation of INVOcell IVF.

Exclusion Criteria:

* Inability to read and speak English fluently
* Identified vaginal infection
* Recent pelvic surgery based on clinical history and physical examination.
* History of toxic shock syndrome
* Inability to tolerate the placement or wearing of the INVOcell IVC or INVOcell Retention Device.
* Inability to tolerate a speculum examination
* Unwilling or unable to wear the INVO Retention (diaphragm) during the incubation.
* Unable or unwilling to sign informed consent or abide by study follow up assessment requirements.
CCTG 594: Engagement and Retention in Care for HIV+

CCTG 594 is a controlled, unblinded, two-arm, randomized (1:1) clinical trial to evaluate the effectiveness of a clinic-based HIV ALERT specialist on improving endpoints of retention in care and maintenance of ART as compared to the current standard of care (SoC) in HIV primary care clinics.

Design: CCTG 594 is a controlled, unblinded, two-arm, randomized (1:1) clinical trial to evaluate the effectiveness of a clinic-based HIV ALERT specialist on improving endpoints of retention in care and maintenance of ART as compared to the current standard of care (SoC) in HIV primary care clinics.

Duration: Each subject will receive follow-up of at least 48 weeks.

Sample Size: A total of 300 subjects will be randomized, 150 per arm.

Study Population: Eligible subjects will include 1) newly diagnosed HIV-infected individuals entering primary HIV care at one of the CCTG clinics, or 2) previously diagnosed HIV-infected individuals who are "out of care" defined as having no visit with a prescribing HIV provider in the last 180 days and not on a stable ARV regimen.

Stratification: Subjects will be stratified based on study site and if they are newly diagnosed or returning to care.

Eligibility Criteria:
Inclusion Criteria:

* HIV-1 infection, as documented by any licensed screening antibody test, such as ELISA, and confirmed by a second antibody test, such as Western blot, or detectable plasma HIV-1 RNA at any time prior to study entry. If an ELISA or Western blot is not available, HIV infection may be documented by two HIV RNA values ≥2000 copies/mL, drawn at least 24 hours apart. The RNA assays must have been run at a CLIA-approved laboratory or equivalent.
* 18 years of age or older.
* Able to give written informed consent.
* New patient to the clinic (defined as someone who has never engaged in HIV care) or a patient returning to care (defined as a patient previously seen at least once by a prescribing HIV provider who has not seen a prescribing HIV provider in the last 180 days and is not on a stable ARV regimen).
* English or Spanish Speaking.
* Registered to receive HIV primary care services at one of the identified CCTG-affiliated clinic, i.e. the Owen Clinic at UC San Diego Health System, Harbor-UCLA Medical Center clinic or Rand Schrader clinic at USC.

Exclusion Criteria:

* Unstable neurologic, psychiatric, or physical condition which, in the opinion of the investigator, would limit participation with study procedures for the duration of the study.
* A level of drug or alcohol use that, in the opinion of the investigator, would preclude safe participation in the study.
* Resident of nursing home or skilled facility.
* Pregnant or breastfeeding.
* Patient's first primary care visit (for new patients) or return to care visit (for patients returning to care) occurred \> 60 days ago.
The Role of Neuroactive Steroids in Stress, Drug Craving and Drug Use in Cocaine Use Disorders

To use pregnenolone (PREG; 300; 500mg) daily versus placebo (PLA) as a probe to assess the role of neuroactive steroids in individuals with cocaine use disorder (CUD).

This experimental study aims to examine the effects of PREG on a) repeated cocaine craving, mood and neurobiological reactivity to brief, guided imagery exposure to stress, drug cues and neutral situations in the laboratory and b) daily cocaine intake, craving, cognition and mood in men and women with CUD; and c) sex differences in all of these outcomes. The study's hypothesis is that PREG vs PLA will dose-specifically decrease stress-induced and drug-cue induced cocaine craving, improve mood and cognitive performance, and normalize hypothalamic pituitary adrenal (HPA) axis response to stress and drug-cue imagery, and reduce cocaine intake and craving in daily life in individuals with CUD.

Eligibility Criteria:
Inclusion Criteria:

* Male or female individuals, ages 18 to 60.
* Subjects must meet current DSM-V criteria for cocaine use disorder; documented positive urine toxicology screen for cocaine at intake or collateral information from family members, significant others, room-mates etc., on recent use.
* Subject has voluntarily given informed consent and signed the informed consent document.
* Able to read English and complete study evaluations.

Exclusion Criteria:

* Women who are pregnant, or nursing or are of childbearing potential and not practicing an effective means of birth control.
* Meet current criteria for use disorder on another psychoactive substance, such as, heroin, amphetamines, hallucinogens/PCP, excluding alcohol and nicotine.
* Any current use of opiates or past history of opiate use disorder.
* Current use of any psychoactive drugs, including anxiolytics, antidepressants, naltrexone or antabuse.
* Any psychotic disorder or current Axis I psychiatric symptoms requiring specific attention, including need for psychiatric medications for current major depression and anxiety disorders.
* Significant underlying medical conditions such as cerebral, renal, thyroid or cardiac pathology which in the opinion of study physician would preclude patient from fully cooperating or be of potential harm during the course of the study.
* Abstinent from cocaine for more than two weeks prior to admission.
* Hypotensive individuals with sitting blood pressure below 90/50 mmHG.
Efficacy of Probiotic ES1 for the Treatment of Non-Celiac Gluten Sensitivity

Study to demonstrate the efficacy of Probiotic ES1 in alleviating symptoms of gluten sensitivity in non-celiac gluten sensitive subjects exposed to a small, fixed amount of gluten.

This is a randomized, double-blind, placebo-controlled study. Sixty non-celiac gluten sensitive subjects will be randomized into one of two groups; Probiotic ES1 or placebo. For the duration of the study, subjects must adhere to a gluten-free diet, apart from a scheduled fixed gluten exposure of two slices of bread once daily. Subjects will be required to take 1 capsule before and after consuming the two slices of bread and score the severity of their symptoms in a diary provided for the duration of the study (7 days).

Eligibility Criteria:
Inclusion Criteria:

* Age: 18-65
* Male or non-pregnant, non-lactating females.
* Documented or self-diagnosed gluten sensitivity that is well-controlled.
* Negative celiac serology to eliminate Celiac Disease at screening.
* Written informed consent prior to any screening procedure.
* Ability and willingness to comply with study requirements.
* Adherence to a gluten-free diet during period of the study and 1 week prior to the first dose.
* BMI \< 35 kg/m2.

Exclusion Criteria:

* History of diagnosis of Celiac Disease.
* Positive pregnancy test at screening.
* Positive HIV, Hepatitis, or Tuberculosis infection.
* History of substance abuse within last 5 years.
* Alcohol consumption of \> 2 standard drink equivalents per day.
* Recent myocardial infarction within past 3 months, recent stroke within past 12 months, recent abdominal surgery within past 12 months, history of any malignancies and/or active treatment for a psychiatric disorder.
* Use of systemic biologics within 6 months of the study.
* Use of oral probiotics within 2 weeks of the study.
* Use of NSAIDS or aspirin within 7 days of the study.
* Use of immunosuppressants within 30 days of the study.
* Family history (first degree relative) of Celiac Disease.
* Received an investigational product within 1 month of study.
* History of digestive enzyme deficiencies.
* History of severe reactions to low doses of gluten/accidental exposure to gluten.
* History of wheat allergy (positive reactions to the skin-prick test or the IgE blood test).
* History of lactose, milk protein and/or FODMAP allergies.
* Subjects who have an immune-compromised condition.
A Study To Investigate Two 3-dose Schedules Of A Clostridium Difficile Vaccine In Healthy Adults Aged 65 to 85 Years

This study will investigate a Clostridium difficile vaccine in healthy adults aged 65-85 years. Each subject will initially receive 3 doses of vaccine on 1 of 2 vaccination schedules. The study will assess the safety and tolerability of the vaccine as well as the subjects' immune response to the vaccine. One year after the third dose subjects that did not receive placebo will be randomized to receive a fourth dose. Subjects will be followed for up to 4 years after their third vaccination.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female subjects
* Aged 65 to 85 years

Additional Inclusion Criteria for the extension Stage:

* Receipt of all 3 doses of C difficile vaccine (100 µg or 200 µg antigen dose level) in the original portion of the study.

Exclusion Criteria:

* Proven or suspected prior episode of Clostridium difficile associated diarrhea
* Unstable chronic medical condition
* Disease requiring significant change in therapy or hospitalization for worsening disease within 8 weeks before receipt of study vaccine
* Serious chronic disorders
* Congenital or acquired immunodeficiency disorders
* Rheumatologic disorders or other illnesses requiring chronic treatment with known immunosuppressant medications.
* Active or treated leukemia or lymphoma or bone marrow disorder
* Any contraindication to vaccination or vaccine components including previous anaphylactic reaction to any vaccine or vaccine-related components

Additional Exclusion Criteria for the Extension Stage:

* Subjects originally randomized to placebo during the original portion of the study.
* Subjects who have already completed Visit 9 prior to study unblinding.
The Effects of Whey Protein Supplements on Markers of Exercise-induced Muscle Damage in Resistance-trained Individuals

Intense exercise can bring about various side effects to one's body. Less range of motion, increased pain sensitivity, increased muscle swelling, and decreased muscle strength can occur immediately after exercise. These side effects can be referred to exercise induced muscle damage (EIMD) and can sometimes last many days. This study's goal is to evaluate the effects of various protein supplements on EIMD symptoms as well as on blood vessel health during the recovery period after muscle damaging exercise.

Eccentric exercise can result in exercise induced muscle damage (EIMD), which can cause an abundance of ultrastructural muscular disruption and pro-inflammatory and pro-oxidant activity in the body, leading to an impairment of muscular force production and range of motion, along with elevated pain sensitivity, increased swelling, and arterial stiffness. Pasture-raised dairy products, obtained from strictly grass-fed cows, have been shown to possess more anti-inflammatory-, antioxidant-, and antihypertensive-like biochemicals compared with conventional products (i.e., with a different nutrient composition from a diet rich in grains versus grasses). However, human research trials on these products, such as whey protein concentrate (WPC), are neglected. This study addresses this gap, with a double-blind, randomized, placebo-controlled trial that compares the effect of conventional WPC versus WPC supplementation reported to be derived from pasture-raised cows on vascular function and indirect markers of muscle damage and inflammation in response to eccentric EIMD in healthy, young, resistance-trained women and men. Thirty resistance-trained individuals will complete an intense EIMD bout consisting of eccentric barbell back squats and then will be assessed 24, 48, and 72 hours post-EIMD for muscle soreness, range of motion, maximal isometric voluntary contraction, peripheral fatigue via magnetic stimulation, countermovement jump, barbell back squat velocity, and vascular function (i.e., arterial stiffness via carotid femoral pulse wave velocity). Subjects will be grouped into a conventional WPC, pasture-raised WPC, and placebo supplementation group and consume their respective supplementation thrice daily immediately post-EIMD until the study's completion.

Eligibility Criteria:
Inclusion Criteria:

* Men and women 18-40 years old
* ≥3 months uninterrupted training of ≥3 days/week of resistance training
* Self-reported to be healthy

Exclusion Criteria:

* Not within defined age range
* History of allergy to dairy products
* History of experiencing pain while exercising in the lower extremities (i.e., hips/knees)
* Current use of anti-inflammatory/anti-pain medication (i.e., nonsteroidal anti-inflammatory drugs (NSAIDs) such as Tylenol, Advil, or Aleve
* Are pregnant or could possibly be pregnant by self-report
* People who answer 'yes' to any of the pre-participation screening questions on the PAR-Q questionnaire.