cyrilzakka/clinical-trials huggingface dataset:
Effects of Black Bean Pasta Consumption on Biomarkers in Young Adults

The study purpose is to determine the effect of eating three (3) different pasta flour formulations made from 100% black beans (Zenith) in a meal matrix (spaghetti sauce) on postprandial glycemic response in healthy adults.

The 5 test treatments (white bread (negative control), whole black beans (positive control), and 3 different pasta formulations) will be administered randomly over five weeks. Meals will be combined with spaghetti sauce for a total available carbohydrate amount of 50g.

Venous blood samples will be collected for glucose and insulin analysis at time 0 (fasting) and at 30, 60, 90, 120, and 180 minutes post-treatment (timing of the post-treatment blood draws started at time 0 \[post-treatment\], which is when the participant starts consuming the treatment meal). Blood analysis was completed by a reputable biomarker diagnostics laboratory, Quest Diagnostics.

Anthropometric measures such as weight, height, waist circumference, and blood pressure were collected at screening and at the start of each test day. Thirteen hours before testing, participants consumed a standardized frozen meal to reduce the potential variation in glycemic responses on test day due to varying pre-evening dietary intakes. This control meal was selected by each participant before the start of the study. Each participant was provided the same frozen meal every time, since the subjects serve as their own controls. The day before test day, participants completed a 24 hour food recall, satiety, and gastrointestinal questionnaires. The morning of each test day participants completed the International Physical Activity Questionnaire (IPAQ), satiety, and gastrointestinal questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* normal blood glucose
* BMI between 20-29.9 kg/m2.
* Chronic health conditions, e.g., hypertension, gastrointestinal disease.

Exclusion Criteria:

* Weight changes of \>10% of body weight within previous 6 months
* Pregnant or breastfeeding
* Allergy to peas, beans, lentils, tomatoes, gluten, or latex
* Unwillingness or inability to follow study protocol
A Study to Investigate Using Inhaled Fexlamose to Treat Adult Participants Who Have Moderate to Severe COPD

AER-01-002 is a Phase 2a study being conducted to determine if inhaled fexlamose is an effective and safe treatment for adults with moderate to severe COPD.

Study will compare active drug to placebo.


Eligibility Criteria:
Main Inclusion Criteria

Each participant must meet all the following criteria to be enrolled in this study:

* Participant is male or female ≥40 to ≤80 years of age.
* Participant has a verified diagnosis of cigarette smoking-related COPD FEV1 that is \>25% and \<60% of predicted normal at Visit 1.
* Participant meets the following spirometry performance criteria:

  * Acceptability: Participant can perform acceptable spirometry (ie, meet ATS/ERS acceptability criteria) at Visits 1 and 2.
  * Repeatability: Participant can perform technically acceptable spirometry meeting repeatability criteria for FEV1 during at least 1 of the prebronchodilator assessments at Visits 1 and 2.
* Participant is on stable maintenance COPD medications with no dose adjustments for ≥4 weeks prior to Screening and during the Screening Period.
* Participant has had ≤2 COPD exacerbations requiring hospitalization in the past year.

Main Exclusion Criteria

Participants meeting any of the following criteria will be excluded from the study:

* Participant has an active uncontrolled medical condition
* Participant has a diagnosis of current asthma
* Participant has primary diagnosis of bronchiectasis, primary ciliary dyskinesia, allergic bronchopulmonary aspergillosis, or CF.
* Participant has had a COPD exacerbation in the 6 weeks prior to Visit 1
* Participant has active lung infection
* Participant has received any vaccine within 7 days prior to Day 1.
* Participant is taking a protein therapeutic for control of COPD or asthma: eg, dupilumab, tezepelumab, benralizumab, mepolizumab, omalizumab.
Observational, Passive Surveillance Program to Collect Information on Women and Their Offspring Exposed to MenQuadfi® During Pregnancy, in United States (US)

Primary Objective:

To assess maternal, obstetrical, pregnancy, and neonatal and infant outcomes among women vaccinated with MenQuadfi® during pregnancy or in the 30 days preceding their Last Menstrual Period (LMP).

This study is a prospective pregnancy registry to collect and analyze the outcome of exposure to MenQuadfi™ during pregnancy or within 30 days prior to their LMP. The registry will encourage prospective registration, which is defined as registration of a pregnancy exposure prior to knowledge or perceived knowledge of the pregnancy outcome.

Exposed pregnant women will be followed up to the end of their pregnancy, and the offspring(s) will be followed up to 1 year of age.

Eligibility Criteria:
Inclusion Criteria:

The eligible population will include pregnant women and their offspring residing in the US and its territories who are exposed to MenQuadfi® during their pregnancy or within 30 days prior to their LMP, for whom the exposure is reported to the pregnancy registry.

Reports of MenQuadfi® pregnancy exposure must contain the following information:

* Sufficient evidence to confirm that vaccination occurred during the pregnancy or in the 30 days preceding the LMP;
* Vaccine name (brand or generic) is provided (i.e., MenQuadfi®, Meningococcal vaccine, MenACWY conjugate vaccine), or not specified (eg, meningococcal vaccine from an unknown manufacturer).

Exclusion Criteria:

Only post-marketing spontaneous case reports will be included; reports from clinical trials will not be part of the registry.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Influence of Pregnancy and Post-partum Feeding Method (Breastfeeding Versus Bottlefeeding) on Maternal Hemodynamics (Central and Peripheral) and Vascular Function

This study will evaluate the physiological and pathophysiological determinants of pregnancy and feeding method on the maternal cardiovascular system. This includes non-invasive measurements.


Eligibility Criteria:
Inclusion Criteria:

* Age between 20 and 40 years old
* Singleton pregnancy
* First pregnancy at the minimum age of 18 years
* In good health, especially no cardiovascular diseases, diabetes or a BMI \> 30 kg/m2
* Capable in understanding properly the ICF and the investigators

Exclusion Criteria:

* On chronic medication, especially antihypertensive or antidiabetical drugs
* Multiple pregnancy
* First pregnancy before the age of 18 years old
* Smoking more than 10 cigarettes/day, drinking more than 3 units of alcohol/day or more than 5-6 units of caffeine-containing drinks
* The use of any extralegally drugs
* Not able to have reliable blood pressure or hemodynamic data at screening
Different Types of Cupping Therapy and Ankle Range of Motion

The purpose of this study was to determine the acute effects of different manual cupping therapy protocols on ankle range of motion, compared to sham treatments, in generally healthy adults with limited ankle range of motion (i.e., ankle dorsiflexion less than 40 degrees).

The purpose of this study was to determine the acute effects of different manual cupping therapy protocols on ankle range of motion, compared to sham treatments, in generally healthy adults with limited ankle range of motion (i.e., ankle dorsiflexion less than 40 degrees). Participants had their baseline ankle dorsiflexion measured with a digital inclinometer in a weight-bearing modified lunge position by a certified athletic trainer. Participants who were eligible for the study were then randomly assigned to one of 4 groups; 2 of which were intervention groups (i.e., dynamic cupping, static cupping) and 2 of which were sham treatments (i.e., static sham cupping, dynamic sham cupping). Each participant was blinded to the therapy they were randomized to and all received a total of 10 minutes of the cupping therapy (either actual or sham). In general, cupping therapy consisted of creating a negative pressure in four 2" diameter plastic cups placed on the gastrocnemius. Sham cups had small holes in them allowing air to leak out. Cups were also attached with adhesive tape to all participants to ensure blinding. Depending on the treatment received, participants either were asked to lie still in the prone position or perform ankle exercises during the 10 minutes while the cups were attached. Immediately after receiving treatment, participants had their ankle dorsiflexion measured again using the same procedure described for baseline measurement.

Eligibility Criteria:
Inclusion Criteria:

* Limited ankle dorsiflexion (less than 40 degrees of weight bearing ankle dorsiflexion at baselines)
* Never received cupping therapy prior to the study
* No lower extremity injuries in the past 6 months
* No contraindications associated with cupping therapy (e.g., deep vein thrombosis, pregnancy, bone fracture, or sunburn/rash)
* Generally healthy

Exclusion Criteria:

* Ankle dorsiflexion greater than or equal to 40 degrees during weight bearing ankle dorsiflexion at baseline
* Received cupping therapy in the past
* Has a lower extremity injury or has had a lower extremity injury in the past 6 months
* Self-reported a contraindication associated with cupping therapy (e.g., deep vein thrombosis, pregnancy, bone fracture, or sunburn/rash).
Effectiveness Study of Physical Therapy As an Adjunct to a Lumbar Therapeutic Selective Nerve Root Block

The purpose of this study is to determine if participation in physical therapy in conjunction with a selective nerve root block in the lumbar spine is more effective than just receiving the injection alone for patients with low back and leg pain from a disk herniation (sciatica).

Recent reviews report moderate to strong evidence for short-term relief but limited evidence for long-term improvement. Anecdotal reports and case studies suggest good outcomes with various physical therapy interventions however well-designed research studies examining treatments in combination are lacking. The management of lumbar radicular pain often includes the combination of physical therapy and therapeutic selective nerve root blocks with the rationale that reducing inflammation and pain will permit greater participation in physical therapy. The effectiveness of this combination of treatment has not been studied and is the purpose of this pilot study.

Eligibility Criteria:
Inclusion Criteria:

* MRI evidence of disk herniation in the lumbar spine consistent with clinical presentation
* Pain and/or paresthesia in the lumbar spine and a distribution extending distal to the gluteal fold within 24 hours of enrollment
* Scheduled to receive a therapeutic selective nerve root block

Exclusion Criteria:

* Any lumbar surgery within six months of the baseline examination
* Any prior lumbar surgery involving fusion
* Medical red flags indicating a serious pathology such as neoplasm, infection, or fracture
Extracorporeal Membrane Oxygenation (ECMO)

Since the 1970s, extracorporeal membrane oxygenation (ECMO) support has been used to support gas exchange for children with severe acute respiratory failure who fail mechanical ventilation. ECMO is more expensive than each of these other procedures.But its action is unclear

Since 1974, eight randomized controlled trials have been reported in ECMO for respiratory failure, and none have included non-neonatal pediatric patients. Cochrane systematic reviews of this evidence concluded that ECMO for neonatal respiratory failure had a survival advantage, but there was insufficient evidence to demonstrate a survival advantage for ECMO used to support respiratory failure in adults. Moreover, these trials were performed prior to 2009, and since then advances in ECMO technology have enhanced the delivery of ECMO support, and new research has changed conventional management of severe acute respiratory distress syndrome (ARDS)

Eligibility Criteria:
Inclusion Criteria:

1. ECMO group:

1. Oxygenation Index \> 40 for \>4 hours
2. Failure to wean from 100% oxygen despite prolonged (\> 48h) maximal medical therapy or persistent episodes of decompensation
3. Severe hypoxic respiratory failure with acute decompensation (PaO2 \<40) unresponsive to intervention
4. Severe pulmonary hypertension with evidence of right ventricular dysfunction and/or left ventricular dysfunction. The pulmonary artery pressure \> 60mmHg evaluated by the Echo, arterial duct keeps open and the blood flow was either by-level shunt or completely shunt from right side to left side.

2. Non-ECMO group:

1. Oxygenation Index \> 16 and reach the Montreux definition of severe respiratory distress syndrome
2. Vasoactive-inotropic score (VIS) ≥ 40 \[VIS=dopamine dose (μg/kg/min)×1 + dobutamine dose (μg/kg/min)×1 + milrinone dose (μg/kg/min)×10 + amrinone dose (μg/kg/min)×10 + epinephrine dose (μg/kg/min)×100 + isoprenaline dose (μg/kg/min)×100\]

Exclusion Criteria:

1. Gestational age \< 36 weeks, birth weight \< 2 kg, day post-birth \> 28 days.
2. lethal chromosomal disorder (includes trisomy 13, 18 but not 21) or any other lethal anomaly
3. irreversible brain damage
4. uncontrolled bleeding
5. Grade III or greater intraventricular hemorrhage
6. ventilator days ≥ 15 days.
Exubera Large Simple Trial To Evaluate Long-Term Pulmonary And Cardiovascular Safety

The purpose of this study is to evaluate the long-term pulmonary and cardiovascular safety of Exubera in routine clinical practice.

Pfizer announced in October 2007 that it would stop marketing Exubera. At that time, Pfizer committed to continued marketing until it returned the licensing rights for the technology to Nektar. Following the announcement, enrollment was halted. Subjects already enrolled and receiving treatment at the time of the halt in enrollment could continue in the study in accordance with the protocol. Nektar, the company from which Pfizer licensed Exubera, announced on April 9, 2008 that it had stopped its search for a new marketing partner. Accordingly, there will be no commercial availability of Exubera. As a result, an amendment was filed on April 16, 2008 specifying that all subjects randomized to Exubera had to be transitioned to usual diabetes care, and all study subjects followed for serious adverse events for 6 months. In accordance with this amendment, study A2171069 was terminated on April 29, 2009. Neither safety nor efficacy reasons were the cause of the study termination.

Eligibility Criteria:
Inclusion Criteria:

* Eligible for receiving Exubera treatment based on the approved local label

Exclusion Criteria:

* Pregnant or lactating
* Have a progressive fatal disease or a life expectancy that prohibits them from participating in a five-year research study
Calibration of the Average Breathing Rate Measurement of the Cloud DX Pulsewave Health Monitor (PAD-2A) Device (CCV-3)

The purpose of this study is to calibrate the average breathing rate measurement of the PAD-2A device to be within ±2 breaths per minute of clinical capnography breathing rate measurements.

The plan for this study is to calibrate the average breathing rate measurement of the PAD-2A device with the breathing rate measurement of a standard clinical capnography device. The data will be collected and analyzed in order to calibrate the PAD-2A device via the capnography measures by adjusting the device algorithm for the breathing rate measurements to be within ±2 breaths per minute. Additionally, the secondary objective of this study is to compare the clinical standard respiratory rate measurement of capnography with the respiratory rate measurements of other standard clinical respiratory devices (i.e. nasal pressure transducer, thermistor, and the respiratory inductance plethysmography (RIP) belts of the chest and abdomen).

Eligibility Criteria:
Inclusion Criteria:

* Adults ≥ 19 years of age (minimum 30% male/female)
* Wrist circumference between 13.5cm - 23cm (5.3 in. - 9.1in.)

  * Specifically for this test device, the wrist size of the consented participants will be distributed accordingly for a Gaussian distribution:

Lowest Octile: ≥ 13.5cm to \< 14.7cm Lower Quarter: ≥ 13.5cm to \< 15.9cm Lower-Middle Quarter: ≥ 15.9cm to \< 18.3cm Upper-Middle Quarter: ≥ 18.3cm to \< 20.7cm Upper Quarter: ≥ 20.7cm to ≤ 23.0cm Highest Octile: ≥ 21.9cm to ≤ 23.0cm

• Willing to volunteer to participate and to sign the study specific informed consent form

Exclusion Criteria:

* Wrist circumference less than 13.5cm (5.3 in.) or greater than 23cm (9.1 in)
* Hand or body tremors
* Canadian Cardiovascular Society (CCS) grade III or IV angina pectoris (chest pain)
* Unexplained shortness of breath at rest
* History of seizures (except childhood febrile seizures)
* Epilepsy
* History of unexplained syncope (fainting)
* Pregnant
* A musculoskeletal disorder that prevents a non-invasive device to be inflated/deflated on the arm
* Unwilling to volunteer to participate and to sign the study specific informed consent form
Efficacy Study for Development and Use of Neurofeedback-trainings for Patients Suffering From Chronic Tinnitus

Chronic tinnitus affects about 10-15% of the population in industrialized countries. Investigations of the brain activity by using electroencephalography (EEG) showed that in localized regions of the hearing system brain activity was decreased. This reduction of activity is thought to be one of the reasons that keep the perception of the tinnitus going. Recent studies have shown that neurofeedback is a viable option for treatment of chronic tinnitus. By using neurofeedback it is possible to train brain functions by the simple principle of rewarding wanted changes and punishing unwanted ones. The purpose of the investigators study is to show the efficacy of specific localized neurofeedback training in comparison to global relaxing neurofeedback training. In order to achieve decreased tinnitus symptoms or even disappearance of the tinnitus, 15 neurofeedback trainings are planned. Before and up to 6 month after the training EEG-recordings are performed.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-75
* Chronic Tinnitus \> 0.5 years
* Informed Consent
* Fluent in German language

Exclusion Criteria:

* Psychological and neurological disorders other than tinnitus
* Drug- or Alcohol abuse
* Tranquilizer, antiepileptic drugs, antipsychotics or anesthetics intake
* Impairing hearing loss or Cochlea Implant
Types of Resistant Starch and Their Effect on Appetite

Investigators are interested in learning how appetite responds to certain types of starch and fiber mixtures. In this research study, subjects will be asked to consume cookie bars containing different types of starch and fiber mixtures, then describe their feelings of hunger, fullness and desire to eat for the 3 hour study period. Subjects will be asked to do this on four separate occasions. Following the 3 hour study period, a deli-style lunch will be served. Investigators want to see how appetite responds to these four different starch and fiber mixtures.

This study will require one initial screening visit (approximately 1 hour) and four study visits each lasting approximately 4 hours. All visits should be done in 2 months. We are looking for healthy, non-smoking, premenopausal female volunteers older than 18 with no medical history of diabetics, heart, lung, kidney, stomach, or liver disease.

The initial screening visit will determine subject eligibility through height, weight and waist circumference measurements, blood glucose finger prick and eating, health and mood surveys.

If willing and eligible to participate, subjects will have four study visits. All study visits will be scheduled according to each individual subject's menstrual cycle. At each visit subject will be asked to eat the cookie bar and then answer questions about their feelings of hunger, fullness and desire to eat. Subject will continue to answer questions about their feelings of hunger, fullness and desire to eat at specific time points up to 3 hours after eating the yogurt. After 3 hours a lunch meal will be served. The lunch meal consists of typical deli items, such as pasta, rolls, salad, etc. Subject will be allowed to eat as much or as little of the lunch as they'd like.

Eligibility Criteria:
Inclusion Criteria:

* Premenopausal females
* 18 years of age and older
* BMI (body mass index) between 18.5 and 24.9 kg/m2 inclusive
* No clinical evidence of cardiovascular, metabolic, respiratory, renal, gastrointestinal or hepatic disease
* unrestrained eater (score \< 10 on the Three Factor Eating Questionnaire)

Exclusion Criteria:

* Pregnant and/or lactating or planning for pregnancy
* Allergies or intolerances to foods consumed in the study
* Fasting blood glucose \> 110 mg/dL. Subjects identified with elevated fasting blood glucose levels will be will be advised to contact their primary care physician for appropriate follow-up care.
* Taking over the counter fiber supplements or other supplements that may interfere with the study procedures or endpoints
* Taking prescription medications that may interfere with study procedures or endpoints (medications that affect appetite)
* Subjects with unusual dietary habits (e.g. pica)
* Actively losing weight or trying to lose weight (unstable body weight fluctuations of \> 5 kg in a 60 day period)
* Excessive exercisers or trained athletes
* Addicted to drugs and/or alcohol
* Medically documented psychiatric or neurological disturbances
* Smoker (past smoker may be allowed if cessation is \> 2 years)
Stimulating Engagement in Daily and Physical Activities Among Older Adults Receiving Homecare Services (Part of Basic Care Revisited)

Most older adults want to stay at home for as long as possible. To reach this aim it is important to maintain their mobility and self-care abilities. However, many older adults are at risk to lose their abilities, as they have an inactive lifestyle. In this study, homecare professionals learn to motivate their clients to be more active in daily and physical activities. Examples of these activities are washing and dressing, household chores or going for a walk.

The primary aim of this exploratory study is to evaluate the implementation of the 'Stay Active at Home' program (process evaluation). The secondary aim is to get insight into the potential effectiveness of the program with regard to several primary and secondary outcomes measures (effect evaluation). The tertiary aim is to test the feasibility of the proposed study design.


Eligibility Criteria:
Inclusion Criteria:

* ≥65 years
* Community-dwelling
* Indication for homecare
* ≥10 hours sedentary behaviour/day (measured with LASA vragenlijst questionnaire)
* Written informed consent

Exclusion Criteria:

* Terminal
* Serious cognitive or psychological problems
* Not able to speak Dutch
Cicatricial Upper Eyelid Entropion Management

Suture-less technique will be used in treatment for cicatricial upper eyelid entropion to detect its long-term efficacy


Eligibility Criteria:
Inclusion Criteria:

* Upper eyelid cicatricial entropion with no history of previous surgery.
* Cooperative patients older then 16 years old.

Exclusion Criteria:

* Previous lid surgery.
* Senile and mechanical entropion.
Effect of Multi-Purpose Solutions on Ex-Vivo Wetting Angles

To clinically evaluate the effect of a new multi-purpose disinfecting solution compared to a marketed multi-purpose solution on wettability of soft contact lenses worn for 30 days.


Eligibility Criteria:
* Successful daily wear of FDA Group I or IV soft contact lenses for at least one week.
* Vision correctable to 20/30.
* Normal eyes - no current ocular abnormalities that prevent successful contact lens wear.
* No corneal surgery within the past 12 months.
* No systemic disease that affects that eye or that could be worsened by the use of contact lenses or solutions.
* No over-the-counter or prescription ocular medication.