cyrilzakka/clinical-trials huggingface dataset:
Evaluating the Implementation of a Family Therapy Intervention ("Tuko Pamoja") Delivered Through Sexual and Reproductive Healthcare Settings

This study aims to contribute to the evidence base related to effective interventions for families in low-resource settings who are experiencing conflict and difficulties in relationships that affect child and caregiver well being alike. Results of this study will (a) inform whether a family therapy approach is feasible and promising in communities in and surrounding Kisumu, Kenya and (b) inform how family wellbeing and mental health can be integrated within the sexual reproductive health service points through culturally-valid ways in this context.

Main Objective: To pilot test the implementation of a family therapy intervention (Tuko Pamoja) in collaboration with two sexual and reproductive healthcare settings in Kisumu, Kenya. Specific Objective: To pilot test the Tuko Pamoja family therapy intervention to assess feasibility, acceptability, and preliminary effectiveness.


Eligibility Criteria:
Inclusion Criteria:

* Family with self-reported elevated distress (e.g., high levels of conflict) that also has a child/adolescent (ages 8-17) with caregiver-reported emotional or behavioral concerns

Exclusion Criteria:

* Families without reported distress and/or without reported adolescent distress.
* Families with children older than 17 or younger than 8 years of age.
* Families in which primary caregivers or children are living too far outside of the community to participate in treatment.
A Single Oral Ascending Dose Study of BIA 9-1067 in Healthy Male Subjects

The purpose of this study was to investigate the safety, tolerability, pharmacokinetics and catechol-O-methyltransferase (COMT) activity of BIA 9-1067 in healthy male subjects after single oral ascending doses.

Single centre, randomised, double-blind, placebo-controlled study of single ascending doses in up to 8 sequential groups of 8 healthy young male subjects.

Eligibility Criteria:
Inclusion Criteria:

* A signed and dated informed consent form before any study-specific screening procedure was performed.
* Aged between 18 and 45 years, inclusive.
* Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs and digital 12-lead ECG.
* Non-smoker or smoker of fewer than 10 cigarettes per day as determined by history. Must be able to abstain from smoking during the inpatient stay.

Exclusion Criteria:

* Any significant cardiovascular (e.g. hypertension), hepatic, renal, respiratory (e.g. childhood asthma), gastrointestinal, endocrine (e.g. diabetes, dyslipidemia), immunologic, dermatological, haematological, neurologic, or psychiatric disease.
* Acute disease state (e.g., nausea, vomiting, fever, diarrhoea) within 7 days before study day 1.
* History of drug abuse within 1 year before study day 1.
* History of alcoholism within 1 year before day 1. Consumption of more than 50 g of ethanol per day (12.5 cL glass of 10° \[10%\] wine = 12 g; 4 cL of aperitif, 42° \[42%\] whiskey = 17 g; 25 cL glass of 3° \[3%\] beer = 7.5 g; 25 cL glass of 6° \[6%\] beer = 15 g
* Positive serologic findings for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), and/or hepatitis C virus (HCV) antibodies.
* Positive findings of urine drug screen (eg, amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, methadone, opiates, MDMA \[3,4-methylenedioxy-methamphetamine; ecstasy\]).
* History of any clinically important drug allergy.
* Prohibited Treatments: use of any investigational drug within 90 days or prescription drug within 30 days before investigational medical product (IMP) administration.
* Consumption of any caffeine-containing products (e.g., coffee, tea, chocolate, or soda) in excess of 6 cups per day (or equivalent), of grapefruit, grapefruit-containing products, or alcoholic beverages within 24 hours before study day 1.
* Use of any over-the-counter drugs including herbal supplements (except for the occasional use of acetaminophen \[paracetamol\], aspirin and vitamins ≤100% recommended daily allowance) within 7 days before IMP administration.
* Donation of blood (i.e. 450 mL) within 60 days before study day 1
Evaluation of an Oral Nutritional Supplement Containing AN777

To evaluate the effect of an experimental oral nutritional supplement containing AN777 compared to another oral nutritional supplement in a malnourished, elderly population.


Eligibility Criteria:
Inclusion Criteria:

Subject (male or female) is \> or equal to 65 and \< or equal to 90 years of age

Subject is ambulatory

Subject has a Subjective Global Assessment of B or C

Subject has gait speed \<0.8 m/s AND/OR low hand-grip strength

Subject has Class 1 or Class 2 sarcopenia

Subject agrees to refrain from starting a resistance exercise program

Exclusion Criteria:

Subject has type 1 or type 2 diabetes

Subject has inflammatory disease with elevated high sensitivity C-reactive protein

Subject has renal function impairment

Subject reports gastrointestinal disorder (severe chronic diarrhea, nausea, vomiting) that would preclude ingestion of the study product; an obstruction of the gastrointestinal tract, inflammatory bowel disease; short bowel syndrome or other major gastrointestinal disease

Subject reports of current active malignant disease or other significant medical diagnoses.

Subject reports a history of allergy to any of the ingredients in the study products

Subject reports currently taking medications/dietary supplements/substances that could profoundly modulate metabolism or weight.
A Study to Assess the Disease Control of Moderate to Severe Atopic Dermatitis in Male and Female Participants of Atleast 12 Years Old Receiving Dupilumab Injections in Gulf Countries

Primary objective:

To assess the disease control of moderate to severe atopic dermatitis in patients aged 12 years and above treated with dupilumab therapy using Atopic Dermatitis Control Tool (ADCT) after 24 weeks of treatment.

Secondary objectives:

* To figure the proportion of patients with reduction of ADCT score by 5 points after 4, 12, and 24 weeks of treatment.
* To figure the proportion of patients with ADCT score less than 7 at weeks 4, 12, and 24.
* Assess the effectiveness of dupilumab in moderate to severe atopic dermatitis (AD) patients, using the severity score as routine practice SCORing Atopic Dermatitis (SCORAD).
* To describe comorbidities related to type 2 inflammation.
* To characterize the safety profile of dupilumab in the local Gulf population.
* To evaluate treatment satisfaction in the local Gulf population.

24 weeks

Eligibility Criteria:
Inclusion Criteria:

* Having moderate to severe atopic dermatitis:

  * Moderate atopic dermatitis is defined at screening and baseline as i) Atopic dermatitis body surface area (BSA) involvement ≥10%; and ii) Pruritus numerical rating scale (NRS) ≥3, Eczema Area and Severity Index (EASI) score ≥16 at screening and baseline, Investigator's Global Assessment (IGA)=3, or SCORing Atopic Dermatitis (SCORAD) is between 25 and 50.
  * Severe atopic dermatitis is defined at screening and baseline as i) Atopic dermatitis BSA involvement ≥10%; ii) Eczema Area and Severity Index (EASI) score ≥20; iii) Investigator's Global Assessment (IGA) score = 4, or SCORAD ≥50.
* Initiating dupilumab therapy within 30 days of enrollment, according to the treating physician's decision independently of study participation.
* Participants and/or his legally approved representatives (LAR, in case of minor subject) agrees to sign an informed consent or an assent.
* Age of 12 years or above.

Exclusion Criteria:

* Participation in another trial.
* Pregnancy or lactating or planning/intending to be pregnant in the next 6 months.
* Presence of active chronic or acute infection requiring systemic treatment
* Diagnosed active endoparasites infection, or suspected high risk of infection.
* Human immunodeficiency virus (HIV), hepatitis B or C, malignancy, or other concomitant illnesses.

The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
Effect of Neuromuscular Training Versus Traditional Exercise on Balance and Fall in Geriatric Population With Fall Risk

To determine the effect of neuromuscular training versus traditional exercise on balance and fall in geriatric population with fall risk

neuromuscular training versus traditional exercise for the balance messurement of fall population with geriatric

Eligibility Criteria:
Inclusion Criteria:

* Patients with balance and fall problem doing physical therapy with an age over 60 years old and willing to participate will be included in the study.

Exclusion Criteria:

* Patient with other serious comorbidities and suffering from heart or kidney disease will not be include or unwilling to participate and those who will aged under 60 years will be excluded from the study
Endoscopic Submucosal Dissection Versus Transanal Endoscopic Microsurgery For Early Rectal Neoplasms And Large Rectal Adenomas: Сomparison Of Treatment Efficacy And Safety.

Transanal endoscopic microsurgery is the main treatment option for rectal tumors such as large adenoma, early cancer because of lower complications and mortality rates and shorter hospital stays rather than conventional surgery. Particularly, However, transanal endoscopic microsurgerymust be performed under either general or spinal anesthesia, and expensive surgical instruments are required. Colorectal endoscopic submucosal dissection is a novel endoscopic procedure that enables en bloc resection of benign colorectal lesions and early colorectal cancer. Endoscopic submucosal dissectioncan be performed under conscious sedation without anesthesia, and there are fewer hospital days than those for transanal endoscopic microsurgery. In the present study, we compared the treatment efficacy and safety between endoscopic submucosal dissectionand transanal endoscopic microsurgery for the treatment of early rectal neoplasms and large rectal adenomas.


Eligibility Criteria:
Inclusion Criteria:

* The lower and upper borders of the adenoma or early rectal cancer are located at ≥2 cm and ≤15 cm from the anal verge, respectively.
* Have signed approved informed consent form for the study
* preoperative stage uT0 and/or uT1, mrT0 and/or mrT1

Exclusion Criteria:

* non-epithelial tumors
* tumors \</= 3 cm in size
* recurrent tumors
* suspicion of lymph node metastasis (N + disease)
* preoperative stage uT2 and/or mrT2
* mucous or low-grade adenocarcinoma
* preoperative stage rM1 and/or uM1
Role of Innate Immunity in Non-Cystic Fibrosis Bronchiectasis

The purpose of this study is to demonstrate that 1) the secretion of mucins, antimicrobial peptides and Toll-like receptors is altered in certain patients with non-CF bronchiectasis, which makes them more susceptible to be infected by potentially pathogenic bacteria (PPB); and 2) the electronic nose is able to detect patterns of specific Volatile Organic Compounds (VOC) for patients with non-CF bronchiectasis colonized by PPB.

Prospective, observational study, which will include 50 patients with non-CF bronchiectasis who will be followed for a period of 12 months. A follow up control will be performed every three months to all patients, consisting in medical record, lung function tests, blood and serum collection, sputum analysis and culture, and collection of exhaled air for analysis using an electronic nose. These tests will also be repeated whenever the patient has an exacerbation. At the beginning and end of the study, a high resolution chest CT will be performed.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of non- CF bronchiectasis based on at least 1 lobe with bronchial dilatation and compatible clinical symptoms such as cough, sputum production and respiratory infections.
* Signed informed consent.

Exclusion Criteria:

* Presence of exacerbation in the last 4 weeks.
* Antibiotic treatment in the last 4 weeks
* Use of oral corticosteroids in the last 4 weeks
* Concomitant terminal illness.
* Current cigarette smoking
* Active allergic bronchopulmonary aspergillosis
* Diagnosis of tuberculosis or active non-tuberculous Mycobacterial infection
Effects of Massage in Different Moments of Application on Autonomic Cardiac Modulation and Cardiorespiratory Parameters

Performing physical exercise alters the body's homeostasis, and recuperative techniques seek to anticipate and potentiate the body's recovery. One of the ways to demonstrate a recovery of the organism is the resumption of autonomic cardiac modulation analyzed through heart rate variability (HRV), a method of global assessment of the behavior of the autonomic nervous system. Among the recovery techniques, massage is the most widely used technique in sports. Therefore, the objective of the study will be to measure the effects of massage as a recuperative technique on autonomic cardiac modulation at different moments of application. It will be a randomized clinical trial where there will be five stages of evaluation. In the first stage, the behavior of the baseline HRV will be evaluated, in the second stage the behavior of the HRV in front of the massage, in the third stage the behavior of the HRV in front of the stress protocol, in the fourth stage the HRV behavior after the stress protocol and immediately after Execution of the massage and finally in the 5th stage where the HRV behavior will be evaluated after the stress protocol and the massage application will be performed at the moment of HRV recovery. The stress protocol will be composed of squats followed by jumps and wingate test, and massage by slides in the anterior thighs and posterior trunk. The HRC indexes in the time domain, frequency domain and Poincaré plot, as well as cardiorespiratory parameters and a questionnaire on individual touch perception will be analyzed. The descriptive statistical method will be used and comparisons of cardiorespiratory parameters and HRV indices will be performed using the analysis of variance technique for repeated measures model in the two factor scheme. The level of significance will be p \<0.05 for all tests.


Eligibility Criteria:
Inclusion Criteria:

* Healthy Volunteers
* Appropriate age limit
* Male

Exclusion Criteria:

* Smokers
* Use of drugs that influence the autonomic modulation of the heart.
* Ethicalists
* Carriers of known metabolic and / or endocrine disorders
* Sedentary individuals, insufficiently active and very active according to IPAQ
* Individuals outside the BMI range
Pelvis Displacement and Gait Indicators in Patient With Lumbar Disc Herniation

The purpose of this study is to investigate the correlation between pattern of gait and pelvic displacement in patients with lumbar disc herniation.

Walking is a repetitive movement that moves your body while keeping your posture stable. The pelvis is located between the hip and lumbar region, where many muscles are attached to regulate the movement of the hip and lumbar spine. Asymmetrical pelvic alignment affects stability of the lower extremities and trunk, making normal walking difficult. The purpose of this study is to investigate the pattern of gait according to pelvic displacement in patients with lumbar disc herniation.

Eligibility Criteria:
Inclusion Criteria:

* Lumbar intervertebral disc herniation as confirmed by a doctor of medicine or a doctor of Korean medicine through an MRI
* Patient who got gait analysis

Exclusion Criteria:

* Patients without MRI and X-ray
* Patient diagnosed with ankle disease
EXCimEr Laser for Long lENgTh Lesions in Below-The-Knee Arteries Study

This investigation is designed to assess the immediate and long-term angiographic patency outcomes of excimer laser recanalisation followed by PTA in the treatment of long (\>50 mm) infrapopliteal lesions in patients with critical limb ischemia (CLI)

The Spectranetics Turbo elite™ excimer laser catheters are percutaneous intravascular devices constructed of multiple optical fibers around a guidewire lumen. The laser catheters transmit ultraviolet energy from the Spectranetics CVX-300® Excimer Laser System to the obstruction in the artery. The ultraviolet energy is delivered to the tip of the laser catheter to photo-ablate fibrous, calcific and atheromatous lesions, thus recanalizing diseased vessels.


Eligibility Criteria:
Inclusion Criteria:

* The treatment vessel is DeNovo
* Stenotic (\>50%) or occlusive atherosclerotic disease of infrapopliteal artery(s)
* Length of target lesion is \> 50 mm
* Reference target vessel diameter between 2-4.0 mm by visual assessment
* Documented Rutherford Class 4 or 5 symptomatic critical limb ischemia
* The patient must be \>18 years of age
* Life-expectancy of more than 12 months
* The patient has no child bearing potential or negative serum pregnancy test within 7 days of the index procedure
* The patient must be willing and able to return to the appropriate follow-up times for the duration of the study
* The patient must provide written patient informed consent that is approved by the ethics committee
* Anatomic Inclusion Criteria

  * All inflow lesions successfully (\<30 residual stenosis) treated prior to target lesion treatment during same procedure or according standard of care without unresolved complications
  * At least one angiographically visible target at the ankle for establishment of straight line flow.

Exclusion Criteria:

* Patient refusing treatment
* The target vessel segment diameter is not suitable for available catheter design.
* Unsuccessfully treated endovascular or bypass( \>30% residual stenosis) proximal ( iliac, SFA, popliteal) inflow limiting arterial/graft stenosis
* Lesion lies within or adjacent to an aneurysm
* The patient has a known allergy to heparin, Aspirin or other antiaggregant therapies or a bleeding diatheses or is unable, or unwilling, to tolerate such therapies.
* The patient has a history of prior life-threatening contrast media reaction.
* The patient is currently enrolled in another investigational device or drug trial.
* The patient is currently breast-feeding, pregnant or intends to become pregnant.
* The patient is unable to provide informed consent
* The patient has end stage renal disease (currently on any form of dialysis)
* Known Left Ventricular Ejection Fraction \< 35%
* The patient has had an MI within 30 days prior to enrollment
* The patient has had a CVA within 90 days prior to enrollment
* Serum Creatinine \> 150 µmol
* The patient has a previous bypass in the target limb
* The patient has a current systemic infection
To Compare the Effectiveness of Suvorexant vs Placebo on Sleep Pressure in Hypertensives With Insomnia

The purpose of this study is to compare the effectiveness and safety of suvorexant versus placebo on sleep pressure and circadian rhythm in hypertensives with insomnia.

The study consists of a 4-week run-in period and a 2-week treatment period.

Eligibility Criteria:
Inclusion Criteria:

\[At interim registration\]

Patients who meet the following criteria are eligible for the study:

1. Patients who give written consent of agreement to voluntarily participation in the clinical study
2. Age 20 years or older
3. Sex: Male or female
4. Treatment classification: Outpatient
5. Hypertensive patient who meet at least one of the following:

   * Under antihypertensive medications
   * Clinic systolic blood pressure (SBP) less than 160 mmHg
6. Patients with insomnia who meet at least one of the following:

   * Patients with any one of the following symptoms twice a week or more and at least 1 month-continuation: difficulty initiating sleep (time to sleep onset 2 hours or more longer than usual), difficulty maintaining sleep (awakening twice or more in the night), early morning awakening (awakening 2 hours or more earlier in the morning than usual), difficulty sleeping deeply (no soundly asleep feeling at the time of awakening in the morning).

     b. Patients with interference with social or occupational function due to the above insomnia symptoms

\[At official registration\]

Patients who meet the following criteria at the end of run-in period are eligible for the study:

1. Stable unchanged antihypertensive medication for run-in period.
2. Average morning home SBP more than 135 mmHg during 5 days before the end of run-in period.

Exclusion Criteria:

1. Patients with serious liver disease.
2. Patients with serious respiratory disease.
3. Patients with secondary hypertension
4. Patients with sleep apnea syndrome
5. Patients with history of narcolepsy or cataplexy
6. Patients with history of organic cerebral disorders
7. Patients with history of hypersensitivity to suvorexant
8. Patients received CYP3A strongly-inhibitors including itraconazole, clarithromycin and ritonavir, saquinavir, nelfinavir, indinavir, telaprevir and voriconazole at the start of the run-in period
9. Patients with average clinic SBP of 160 mmHg or more at the start of the run-in period
10. Patients received suvorexant and other hypnotic at the start of the run-in period on a regular basis
11. Patients who are breast-feeding, pregnant, possibly pregnant, or plan to become pregnant
12. Patients who are considered not to be eligible for this study by their investigator or sub-investigator
Efficacy and Safety of RX-10045 Ophthalmic Solution for Ocular Inflammation and Pain in Cataract Surgery

The primary objective of this study is to assess the efficacy and safety of 2 concentrations of RX-10045 ophthalmic solution, 0.05% and 0.1%, compared to placebo for the treatment of ocular inflammation and pain in subjects undergoing cataract surgery.


Eligibility Criteria:
Inclusion Criteria:

* Unilateral cataract surgery (phacoemulsification or extracapsular extraction) with posterior chamber intraocular lens implantation in the capsular bag.

Exclusion Criteria:

* Any additional surgical procedures at the time of the cataract surgery
* Refractive surgery in the study eye within the past 2 years
* History or presence of noninfectious inflammatory ocular disease (e.g., episcleritis, scleritis, uveitis) in either eye
* Intraocular pressure of \> 21 mm Hg in either eye
* Proliferative or severe nonproliferative diabetic retinopathy in either eye
* Neovascular/wet age-related macular degeneration in either eye