cyrilzakka/clinical-trials huggingface dataset:
Dynamic and Static Stretching on Postural Stability, Reaction Time and Countermovement Jump of Sprinters

All the athletes should perform a warm-up consisting of five minutes of jogging and static stretching (Experimental Group 1) or dynamic stretching (Experimental Group 2). Before the beginning of the study and right after performing the stretching protocol, the investigators evaluated the unipedal postural stability, the acustic reaction time, the joint position sense of the knee and the countermovement jump of the athletes.


Eligibility Criteria:
Inclusion Criteria:

* National level Sprinters
* Two years or more of experience

Exclusion Criteria:

* Free of injuries in the last six months
Registry for Analysis of Compliance in Colombian Participants With Rheumatoid Arthritis Exposed to Golimumab

The purpose of this study is to describe adherence to golimumab in Colombian participants with rheumatoid arthritis (RA) experiencing adequate treatment response, in a real-world clinical settings.

This is a multi-center (when more than one hospital or medical school team work on a medical research study), non-interventional, prospective cohort study that will enroll participants with RA in Colombia, for whom the treating physician has decided to treat with golimumab prior to enrolment. All participants will be observed for adherence to golimumab treatment for 24 months from study start (Week 0), and recommended follow up assessments will be every 3 months. Any changes including addition of new medications or dose modifications of existing medications will be entirely according to the treating physician's judgment. Participants' safety will be monitored throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* Participants with moderate to severe RA for whom the physician had decided to treat with golimumab according to the local product label, with the first dose being administered between 12 and 26 weeks prior to study enrollment
* Participants who have achieved an adequate therapeutic response to regular doses of golimumab, within 12 to 26 weeks of treatment
* Participants should be evaluated for tuberculosis (TB) exposure/risk factors or managed for active and latent TB (per local requirements and according to the local product label)
* Participants who have been evaluated for active/latent hepatitis B virus (HBV) and hepatitis C virus (HCV)
* Participants for whom, since golimumab initiation, a complete medical record is available

Exclusion criteria:

* Participants who have received and terminated golimumab treatment in the past
* Participants that have been treated with golimumab for more than 26 weeks prior to enrolment in the study
* Participants with use of any other investigational agent less than or equal to 30 days before starting treatment with golimumab
* Participants with suspected latent TB, having not received prophylactic treatment of at least 4 weeks
* Participants with suspected or active TB
* Participants with active/latent HBV or HCV
Treatment of Retinal Vein Occlusion (RVO) With Open-Label Anecortave Acetate (15mg.)

Retinal Vein Occlusion is a blockage of the blood vessels that drain out of the retina. Complications of retinal vein occlusion which threaten vision include neovascularization(growth of new blood vessels)and macular edema ( accumulation of fluid "leaking" from abnormal blood vessels). Currently, the treatment of retinal vein occlusion is laser photocoagulation. This treatment has found to have limited use in this type of condition.Anecortave Acetate is being considered as an attempt to control the growth of the abnormal blood vessels.


Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosis of patients Retinal Vein Occlusion.
2. Patients must be 18 years of age or older to receive treatment.
3. Visual acuity of 20/30 to 20/320 Study Eye on the ETDRS visual acuity chart.
4. Visual acuity of 20/800 or better Fellow Eye on the ETDRS visual acuity chart.

Exclusion Criteria:

1. Patient with significantly compromised visual acuity in the study eye due to concomitant ocular conditions.
2. Patients who have undergone intraocular surgery within last 2 months.
3. Patient participating in any other investigational drug study.
4. Use of an investigational drug or treatment related or unrelated to their condition within 30 days prior to receipt of study medication.
5. Inability to obtain photographs to document CNV (including difficulty with venous access).
6. Patient with significant liver disease or uremia.
7. Patient with known adverse reaction to fluorescein and indocyanine green or iodine.
8. Patient has a history of any medical condition which would preclude scheduled visits or completion of study.
9. Patient has had insertion of scleral buckle in the study eye.
10. Patient has received radiation treatment.
11. Patient is on anticoagulant therapy with the exception of aspirin.
12. Patient is pregnant or nursing.
Tolerability and Efficacy of AM and PM Once Daily Dosing With Extended-release Guanfacine Hydrochloride in Children 6-12 With Attention-Deficit/Hyperactivity Disorder (ADHD) (The ADHD Tempo Study)

The primary purpose is to assess the efficacy of once daily dosing with optimized SPD503 (1, 2, 3 and 4mg/day), dosed either in the morning or evening, compared to placebo, in children with ADHD as measured by change from baseline score at endpoint on the ADHD-RS-IV.


Eligibility Criteria:
Inclusion Criteria:

* 6-12 years old
* ADHD diagnosis
* ADHD-RS-IV minimum score of 28
* CGI-S score \> or = 4

Exclusion Criteria:

* Current, controlled or uncontrolled, comorbid psychiatric diagnosis
* Condition or illness which represent inappropriate risk to subject
* Known history or presence of structural cardiac abnormalities, serious heart rhythm abnormalities, syncope, cardiac conduction problems, exercise-related cardiac events, or clinically significant bradycardia; orthostatic hypotension or controlled or uncontrolled hypertension
* Use of prohibited medication that have CNS effects or affect cognitive performance
* History of alcohol or substance abuse within 6 months
* Current use of medication that affect BP or heart rate
* Significantly overweight
* Weight of less than 55 lbs
* Known allergy to SPD503
* Abnormal urine drug and alcohol screen
Selepressin Evaluation Programme for Sepsis-Induced Shock - Adaptive Clinical Trial

This is a double-blind, randomised, placebo-controlled, two-part adaptive clinical trial. The trial is designed to investigate the efficacy and safety of multiple dosing regimens of selepressin and to confirm the efficacy and safety of one dosing regimen in treatment of adult patients with septic shock requiring vasopressor.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Proven or suspected infection
* Septic shock defined as hypotension requiring vasopressor treatment despite adequate fluid resuscitation
* Informed consent obtained in accordance with local regulations

Exclusion Criteria:

* Not possible to initiate trial drug treatment within 12 hours from onset of vasopressor treatment for septic shock
* Primary cause of hypotension not due to sepsis
* Previous severe sepsis with intensive care unit admission within this hospital stay
* Known/suspected acute mesenteric ischaemia
* Suspicion of concomitant acute coronary syndrome based on clinical symptoms and/or ECG during this episode of septic shock
* Chronic mechanical ventilation for any reason OR severe chronic obstructive pulmonary disease (COPD) requiring either continuous daily oxygen use during the preceding 30 days or mechanical ventilation (for acute exacerbation of COPD) during the preceding 30 days
* Received bone marrow transplant during the preceding 6 months or chemotherapy during the preceding 30 days for lymphoma or leukemia
* Known to be pregnant
* Decision to limit full care taken before obtaining informed consent
* Use of vasopressin in the past 12 hours prior to start of trial drug treatment or use of terlipressin within 7 days prior to start of trial drug treatment
* Prior enrolment in the trial
* Prior use of an investigational medicinal product within the last month OR planned or concurrent participation in a clinical trial for any investigational drug or investigational device
IPREP Study #2: Evaluating Enhanced PrEP Packages for Young Female Sex Workers in Kisumu, Kenya

This is an open-label randomized controlled trial (n=200) in which HIV-negative young female sex workers (FSW) will be randomized to receive oral PrEP combined with specific behavioral and structural adherence interventions, either: (1) Intensive Peer Support (PS) or (2) Reminders and Resource Transfer (RRT).Respondent-driven sampling (RDS) will be used to recruit FSW as potential study participants.The study adherence interventions will be delivered over the first 12-month period in conjunction with PrEP. Thereafter, the study-specific adherence interventions will be withdrawn and PrEP continued for an additional 12 months with standard support as per national guidelines. Trial participants will be followed for a total of 24 months and attend 11 study visits over this period.

The overall aim of the proposed study is to compare the effectiveness, feasibility and acceptability of two adherence support interventions, peer support (PS) and reminders plus resource transfer (RRT), in combination with daily oral pre-exposure prophylaxis (PrEP) to optimize PrEP adherence among young in Kisumu, Kenya. Pre-exposure prophylaxis (PrEP) is a promising biomedical HIV prevention intervention. Findings from placebo-controlled efficacy trials highlight the need for adherence support to achieve PrEP efficacy and public health impact.

Eligibility Criteria:
Inclusion Criteria:

* Report no previous diagnosis of HIV infection
* Report being a cisgender female or transgender female
* Report being between 18-24 years of age
* Report living or working in study area
* Report intention to stay in study area for 24 months
* Report exchange sex with men for goods, money, favors or other services in past 3 months
* Report no previous or recent (within the last 3 months) PrEP use
* Able to complete study procedures in English, Kiswahili or Dholuo
* Willingness to be randomized and adhere to study interventions according to eligibility, including PrEP

Exclusion Criteria:

* Ineligible for PrEP according to Guidelines on Use of Antiretroviral Drugs for Treating and Preventing HIV Infection in Kenya - 2018 Edition (National AIDS and STI Control Program, 2018)
* Unable to provide informed consent for study procedures
* Any medical, psychiatric, or social condition, or occupational or other responsibility that, in the judgment of the principle investigators, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.
* Reports plan to leave area in the next 24 months
Treatment of Paradoxical Vocal Fold Motion Disorder (PVFMD) With a Form of Respiratory Retraining Technique

Paradoxical Vocal Fold Motion Disorder (PVFMD), otherwise known as vocal cord dysfunction (VCD) is a laryngeal breathing disorder that has several potential causes. In some individuals, exertion is the predominant trigger. PVFMD can present like an asthma attack, but asthma medication is ineffective in treating it. The effects of untreated PVFMD can be devastating, leading to harmful, invasive, and ineffective treatments over a period of years. Numerous anecdotal reports indicate that several behavioral techniques, may be surprisingly effective and even curative. However, data are lacking. The form of respiratory retraining technique tested in the current study educates people with PVFMD about breathing and teaches them a number of breathing exercises specially designed to restore normal breathing patterns.

This case series study will use a dyspnea perception questionnaire, patient daily logs, and physiological measurements of heart rate and breathing to examine whether this form of therapy can improve exertion-induced PVFMD symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Otherwise healthy according to available medical history or by patient and parent report on the health questionnaire
* Patients with no history of asthma, or well-controlled asthma
* A diagnosis of PVFMD by an otolaryngologist based on set criteria in-line with the National Jewish PVFMD diagnostics protocol (based on Hicks, 2008; Hoyte, 2013, Martin, 1987), to be confirmed by an additional otolaryngologist blinded to the initial diagnosis
* A score of three or more on the dyspnea index (DI)

Exclusion Criteria:

* A score of less than three on the DI
* People diagnosed with hypertension, cardiac disorders or severe pulmonary diseases which affect blood oxygen saturation
* Uncontrolled asthma
Improvements by a Protein-Rich Plant-Based Diet and Resistance Exercise Program for Active Ageing

High-protein intake and physical activity are important approaches to preserve muscle mass. Consuming high levels of high-quality proteins to preserve muscle mass is challenging with a plant-based diet. The healthy, older participants will follow a twelve-week high-protein vegetarian diet or high-protein omnivorous diet both in combination with a resistance training program. The change in protein intake and muscle mass will be assessed.


Eligibility Criteria:
Inclusion Criteria:

* Aged 55 years or older
* BMI 18.5-30 kg/m2
* Living independently
* Ability and willingness to comply with the protocol
* Written an informed consent
* Consent of the study physician

Exclusion Criteria:

* Alcohol abuse (more than 14 glasses per week (women) or more than 21 glasses per week (men)) or drug abuse in the opinion of the study physician (CBS et al., 2017)
* Inability to understand the Dutch language
* Cognitive impairment (MMSE more than 25)
* Diagnosed chronic disease that may interfere with protocol (e.g., cardiovascular, gastrointestinal, neurological, known renal diseases (eGFR more than 60 mL/min (Levey \&amp;amp; Coresh, 2012), and/or diabetes)
* Current enrolment in an exercise program or other intervention study
* Planned a holiday during the intervention period and is unable to attend training sessions for more than 1 week
Randomized Study of Growth Hormone on Bone Mineral Density in Patients With Adult Onset Growth Hormone Deficiency

OBJECTIVES: I. Compare whether the bone tissue in the spine and hip improves in patients with adult onset growth hormone deficiency treated with growth hormone (GH) vs placebo.

II. Determine whether the blood samples of these patients show evidence of beneficial bone effects after treatment with GH.

III. Compare the quality of life of these patients treated with these 2 regimens.

IV. Determine the side effects of GH in these patients.

PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled, multicenter study. Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients receive growth hormone subcutaneously (SC) daily for 2 years. Arm II: Patients receive placebo SC daily for 2 years. Quality of life is assessed at the initial eligibility screening, then again within 1 month after the initial screening, and then at 1, 3, and 6 months during study therapy.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

* Diagnosis of adult onset growth hormone deficiency

--Patient Characteristics--

* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
Rate of Total Joint Infection 90-day After Surgery Following Irrigation With Next Science No-Rinse Solution vs SOC Alone

A prospective, single-site, double-arm, parallel, interventional, randomized, controlled clinical trial to assess 90-day rate of joint infections in subjects undergoing primary hip replacements after administration of Next Science No-Rinse Solution (hereby referred to as NS) vs SOC (saline irrigation). The Next Science treatment arm will exhibit greater reduction in rate of 90-day post-operative joint infection than SOC (saline) arm


Eligibility Criteria:
Inclusion Criteria:

1. Adult that meets at least one of the below criteria at time of screening:

   * American Society of Anesthesiologists (ASA) 3 2
   * BMI \>35
   * Patient with functional limitations as a result of disease1:

     * Poorly treated hypertension
     * Poorly treated diabetes
     * Chronic renal failure
     * Bronchospastic disease
     * Disease with intermittent exacerbations
     * Stable angina
     * Implanted pacemaker
   * Known history as an active nicotine use (smoker)
   * Known history of uncontrolled diabetes mellitus (HgbA1C \> 7.0)
   * Known history of end stage organ disease
   * Known history of inflammatory arthritis and currently on rheumatological medication (DMARDs)
   * Known history of current active cancer treatment (chemotherapy)
   * Venous Disease (Surgical Risk Calculator from ACS-NSQIP)
   * Charleston Comorbidity Score \> 2
   * Elixhauser Score \>11
   * Age 65 or older
2. Subject is scheduled to primary joint replacement.
3. Subject is willing and able to comply with all study procedures including transportation to the study site for all scheduled visits and be available for the duration of the study.
4. Subject has understood, signed, and dated the informed consent form.

Exclusion Criteria:

1. Unable to provide signed and dated informed consent.
2. Unable or unwilling to comply with all study-related procedures.
3. Known history of allergic reaction to any of the study products or its components, including any products used for standard of care (such as dressings or any coverings)
4. Subject has contraindications to general anesthesia
5. Any subject positive for Covid-19 virus at time of surgical screening
6. Subjects have evidence of prolonged QT segment, per EKG.
7. Subjects from a vulnerable population, in accordance with 45 CFR 46 Subparts B, C, and D
Early Limited Formula for Treating Lactation Concerns

This is a randomized, controlled trial designed to evaluate a new strategy for promoting continued breastfeeding for mothers and babies who initiated breastfeeding in the newborn period. The new strategy, called Early Limited Formula (ELF), consists of 10mL of formula fed to each baby by syringe after each breastfeeding prior to the onset of mature milk production. The study intervention is discontinued at the onset of mature milk production, and the investigators will then follow mothers and infants for 12 months to assess the effect of ELF on breastfeeding duration, maternal experience and healthcare utilization.


Eligibility Criteria:
Inclusion Criteria:

1. Full term, healthy singleton infant (≥ 37 0/7 weeks gestational age) in well newborn nursery
2. Exclusively breastfeeding (has not received any feedings other than breast milk)
3. Infant is 18-72 hours old
4. Infant has weight loss of ≥75th percentile on delivery mode specific nomogram documented at 12-72 hours of age
5. English-speaking mother

Exclusion Criteria:

1. Mothers or infants for whom breastfeeding is not recommended by the clinical team
2. Mothers who have already begun to produce mature breast milk
3. Any formula or water feeding prior to enrollment
4. Infants who have already lost ≥10% of their birth weight
5. Family with no active telephone number (home or cellular)
6. Plan for infant adoption or foster care
7. Mothers \<18 years of age
8. Infant receiving scoring for Narcotic Abstinence Syndrome -
The Effect of Obesity in COPD Mechanically Ventilated Patients

Study the relationship between the body mass index and duration of mechanical ventilation \& complications in mechanically ventilated COPD patients.

Study the effect of obesity on mortality rate of COPD mechanically ventilated patients.

Determine prevalence of obesity in mechanically ventilated COPD patients.

Obesity has become a global epidemic with prevalence rising both in developed and developing countries. The percentage of patients with obesity in the intensive care unit (ICU) can be expected to increase concomitantly or even more since obesity increases the risk for a more severe disease course with more need for ICU admission and mechanical ventilation .

Obesity, especially abdominal obesity (android fat distribution) and severe obesity, results in altered respiratory anatomy and physiology and, therefore, complicated airway management and adapted ventilator settings during mechanical ventilation. Obesity appears to be associated with an increased risk of acute respiratory distress syndrome (ARDS) and infection, mainly pneumonia probably related to an imbalanced production of adipokines. In ventilated patients, obesity increases ICU length of stay and the duration of mechanical ventilation .

Obesity is relatively common among individuals with COPD, corresponding to 20%-35% of patients with COPD. Increasing evidence suggests that obesity is a risk factor for impaired quality of life, exercise intolerance, and suboptimal disease control in COPD .

Eligibility Criteria:
Inclusion Criteria:

* Adult patients of both genders more than 18 years old admitted at RICU, diagnosed COPD and need mechanical ventilation from August 2023 to August 2024.

Exclusion Criteria:

patients less than 18 years old. patients who refused to participate in the research. patients with missing data.
A Study Evaluating the Efficacy and Safety of Sildenafil in Patients With Erectile Dysfunction Receiving Hemodialysis

The study was done to evaluate the efficacy, safety, and tolerability of orally administered sildenafil taken as needed about one hour before sexual activity after a 10-week period in male outpatients with erectile dysfunction and severe renal failure who were on hemodialysis.


Eligibility Criteria:
Inclusion Criteria:

* Included patients had been in a stable relationship with a female partner for at least 6 months
* A diagnosis of renal failure, with creatinine clearance ≤10 ml/min; been under hemodialysis for at least 6 months prior to the screening period, and a clinical diagnosis of erectile dysfunction (ED) as confirmed by International Index of Erectile Function (IIEF-5) score of \<21 and defined as an "incapacity to obtain and/or maintain an erection sufficient for a satisfactory sexual performance".

Exclusion Criteria:

* Patients in regular use of nitrates or nitric oxide donor drugs, or have received a prescription to use these substances in any formulation
* Patients with genital anatomic malformation that may significantly impair erection (e.g., serious penile fibrosis)
* Patients with other sexual disorders (e.g., hypoactive sexual desire) considered as a primary diagnosis, with a coexisting ED diagnosis, including patients receiving anti-androgenic therapy whose libido has not been preserved; patients receiving hormonal replacement therapy for at least 6 months, or whose dose has not been stabilized within the last 6 months before the study screening period
* Patients with diabetes mellitus presenting poor control of their diabetes and/or proliferate diabetes retinopathy.