cyrilzakka/clinical-trials huggingface dataset:
Randomized Controlled Trial of Endoscopic Dilation: Triamcinolone Injection

The purpose of this pilot study is to find out if adding triamcinolone (steroid) injection at the participant's initial esophagogastroduodenoscopy (EGD) procedure will improve the opening of their esophagus and decrease the need for repeat dilations.

This is a randomized two-arms cross-over trial. In this study there are two groups, the control group and the triamcinolone treatment group. The cross-over design will apply only in the control group when patients are not responding to EGD dilations alone (defined as no sustained improvement in baseline dysphagia) and they will be allowed to cross-over to the triamcinolone group and undergo 3 successive EGDs with triamcinolone injection.

Typically, triamcinolone (steroid) injection is given as a standard of care after several esophageal dilations are performed and failed to improve the condition. Therefore, researchers want to find out if adding triamcinolone (steroid) injection at the participant's initial EGD procedure will improve the opening of their esophagus and decrease the need for repeat dilations.

Eligibility Criteria:
Inclusion Criteria:

* Patients who present for EGD with dilation for dysphagia symptoms thought secondary to either radiation-induced stricture or anastomotic stricture based on history

Exclusion Criteria:

* Inability to consent for the procedure
* Known coagulopathy \[International Normalized Ratio (INR) \>1.5, Platelets \<75 K\]
* Endoscopic finding of a stricture that is not caused by either radiation or anastomotic narrowing
* Nasopharyngeal strictures
A Pilot Study to Assess the Efficacy and Safety of Folic Acid and/or Vitamin B Complex on Hepatitis C Infected Patients Treated With Pegylated Interferon and Ribavirin.

Since success of the combination therapy with PEG-IFN and RBV is contingent on maintaining adequate doses of both drugs throughout the treatment period, the emergence of hematological side effects is expected and requires intervention. The hematological adverse effects lead to a trade-off between continuing the treatment with optimal dosage, to clear the virus, exacerbating thereby the side effects versus decreasing dosage to relieve severe anemia, reducing thereby the chances of achieving sustained virological response (SVR). Therefore, we aimed at giving Folic acid® and Neurobion® to HCV-infected patients during treatment with different types of PEG-IFN plus ribavirin in an attempt to evaluate its efficacy and safety as a prophylactic treatment to prevent hematological adverse effects. Preventing adverse effects without interfering with the therapeutic efficacy of different types of PEG-IFN plus ribavirin in HCV patients will lead to better health outcomes and improvement in their quality of life (HRQOL).


Eligibility Criteria:
Inclusion Criteria:

Chronic hepatitis C patients of both sexes were eligible for inclusion if they were HCV RNA positive, naive to PEG-INF and RBV, and had abnormal serum alanine transaminase levels on two occasions during the preceding six months.

Exclusion Criteria:

Patients with significant hematological abnormalities at baseline, such as neutropenia (ANC \<1200 x 103 cells/µL), thrombocytopenia (\<70 x 103 cells/ µL), and anemia (\<10.5 g/dL), were excluded. Patients were also excluded from study participation if they had serum creatinine ≥1.70 mg/dL (150 µmol), hepatitis B surface antigen positivity, decompensated cirrhosis, or other forms of liver disease not attributable to HCV. Patients with severe depression or psychosis, uncontrolled seizures, poorly controlled cardiovascular disease, diabetes mellitus, or autoimmune disorders were also ineligible. Women were ineligible for study participation if they were pregnant or unwilling to use at least 2 forms of effective contraception during the entire study period.
Effects of Klapp Method Exercises in Breast Feeding Females With Kyphotic Posture

Group A will be given Klapp method exercises to the participant for a period of 1 month twice in a week for 50min. Group B will be given printed information on an at-home exercise program, such, posture correction,corrective exercises and breathing exercises. They will be asked to perform the exercises twice weekly during the study and follow-up period. All these sessions will be of 50 minute for 2 session per week for 4 weeks

The Klapp exercises program, is an active therapeutic exercise that aims to stretch, mobilize, and strengthen the spine, offering both pain reduction and postural improvement. This method is widely applied, for the correction of vertebral deformities such as kyphosis, lordosis and scoliosis, to the treatment of thoracic cage abnormalities and thoracic cage shape changes after thoracoplasty, as well as in the treatment of spinal muscle interference from polio and spinal osteochondrosis.

The aim of this study to investigate the effects of klapp method exercises on pain, posture correction and self-efficacy in breast feeding females with kyphotic posture.

This will be a randomized Controlled trial conducted on (32) participants. Data will be collected from Civil hospital and Al-siddique hospital, Sialkot by using non-probability convenience sampling technique. Breast feeding females between the age of 22 to 30 with kyphotic posture. Participants who had a history orthopedic disorder, orthopedic surgery, history of recent fracture, non-lactating females will be excluded from this study. A sample of (32) will be divided in to two groups with (16) participants in each group. Group A will be given Klapp method exercises to the participant for a period of 1 month twice in a week for 50min. Group B will be given printed information on an at-home exercise program, such, posture correction, corrective exercises and breathing exercises. They will be asked to perform the exercises twice weekly during the study and follow-up period. All these sessions will be of 50 minute for 2 session per week for 4 weeks. Pre and post assessment of pain, pain will be assessed by visual analogue scale, posture will be evaluated by inclinometer, self-efficacy breast feeding will be assessed self-efficacy breastfeeding scale (BSES-SF). Data will be analyzed by using SPSS version 26.0

Eligibility Criteria:
Inclusion Criteria:

* Primiparous females
* Female who had C-Section
* Lactating females (females who have had feed their babies for last 6 months)
* Pain in neck (pain score 4-6 in visual analogue scale)
* Female with kyphotic angle greater than 45 degrees (assess by inclinometer)

Exclusion Criteria:

* history of orthopedic surgery (spinal fusion)
* orthopedic disorder (disk degeneration, osteoporosis)
* history of vertebral fracture
* Female who had given vaginal birth
* Breast feeding issues (lactation failure, nipple failure)
Early Haemodynamic Optimization Using Preload Dependence During Septic Shock = EHOSS-1

Haemodynamic optimization is of paramount importance in septic shock, but is really consensual and standardized during the first 6 hours of treatment. Haemodynamic treatment including fluid loading management, vasoactive treatment and oxygen transport optimization is mainly based on expert recommendations or non-randomized trials. Recently, preload dependence indexes such as pulse pressure variation have been shown to be more accurate to predict fluid responsiveness than static indexes such as filling pressures. However, whether using preload dependence indexes changes septic shock prognostic remains to date unknown. The aim of this non-blinded randomized controlled trial is to assess whether haemodynamic optimization using preload dependence indexes and pulmonary thermodilution 1. reduces septic shock duration assessed by administration duration of vasoactive treatment (primary end point), 2. reduces regional hypoperfusion assessed by arterial lactate, 3. reduces lung hydrostatic oedema linked to excessive fluid loading (assessed by PaO2/FIO2 ratio and extravascular lung water). 4. reduces organ dysfunction (assessed by the SOFA score), ICU stay and 7 and 28 day mortality Control group is managed with an algorithm using filling pressures to drive haemodynamic treatment.


Eligibility Criteria:
Inclusion Criteria:

* age over 18 years
* and fulfilment of two of four criteria for the systemic inflammatory response syndrome
* and systolic blood pressure no higher than 90 mm Hg (after a crystalloid-fluid challenge of 25 ml per kilogram of body weight over a 30-minute period)
* and documented or suspected infection

Exclusion Criteria:

* delay between first observation of hypotension and inclusion above 12 hours
* pregnancy
* acute coronary syndrome
* acute cerebral vascular event (\< 1 month),
* contraindication to central venous catheterization in the superior vena cava territory
* contraindication to femoral arterial catheterization
* active haemorrhage
* burn injury
* trauma
* requirement for immediate surgery (\< 6 hours)
* acute pulmonary oedema of cardiogenic origin
* do-not-resuscitate status, or advanced directives restricting implementation of the protocol.
* Informed consent not obtained from the patient or surrogates
* Patient already included in another therapeutic trial
* patient previously included in the same therapeutic trial
Mindfulness to Improve Functional Outcomes in Patients With Fibromyalgia or Central Sensitization

The primary aim of the study will be to determine the feasibility of utilizing a web-based mindfulness program in adult patients with chronic pain with a diagnosis of fibromyalgia or central sensitization.

Chronic pain has a substantial economic cost and rate of impairment. Patients who suffer from fibromyalgia and other pain conditions leading to central sensitization have limited treatment options. The only medications currently approved by the Food and Drug Administration (FDA) for the treatment of fibromyalgia includes pregabalin, milnacipran and duloxetine. The International Association for the Study of Pain (IASP) also recommends the implementation of an exercise program and cognitive behavioral therapy. A previous meta-analysis found weak evidence to support Mindfulness-Based Stress Reductions (MBSR) in fibromyalgia patients, however more robust clinical studies are needed. In the midst of an opioid crisis, MBSR provides a safer alternative for the treatment of chronic pain. Unfortunately, an instructor lead MBSR program is both costly and largely unavailable in rural areas of the country. This web-based mindfulness program provides a treatment option for patients who would otherwise, not have access to alternative medicine therapies.

Eligibility Criteria:
Inclusion Criteria:

* Age from 30-65
* Patients with a diagnosis of fibromyalgia or central sensitization for greater than 6 months who are referred to the Interventional Pain Clinic

Exclusion Criteria:

* Patients on greater than 120 morphine equivalents per day
* Patients with untreated psychological illness
* Patients already enrolled in ongoing trials involving pain management and treatment interventions
* Patients currently undergoing treatment at the Osher Center for Integrative Health or patients with previous or current training in mindfulness.
TMC207-C202: Study to Evaluate Bactericidal Activity of Multiple Oral Doses of TMC207 in Subjects With Sputum-Smear Positive Tuberculosis

The purpose of this study is to assess the effects of 3 different oral doses of TMC207 administered over a 7 day period on the organism that causes tuberculosis

This is a Phase IIa, open-label, randomized trial in treatment-naïve, sputum smear-positive, subjects with pulmonary TB to assess the extended early bactericidal activity (eEBA) of TMC207. The study population will consist of 60 treatment-naive subjects with M. tuberculosis infection.

Subjects will receive orally 25 mg TMC207 po q.d. (Treatment A), 100 mg TMC207 po q.d. (Treatment B) or 400 mg TMC207 po q.d. (Treatment C) daily for 7 days. Subjects in treatment group D will receive 600 mg rifampin po q.d. daily for 7 days and subjects in treatment group E will receive 300 mg isoniazid po q.d. daily for 7 days. After 7 days, subjects in all treatment groups will receive appropriate anti-TB therapy according to national standards of country TB guidelines and culture and sensitivity results of the sputum specimens until clinical and microbiological cures have been achieved. Three once-daily dose regimens of TMC207, for 7 days, will be studied versus 2 comparator treatments, rifampin and isoniazid in the present trial.TMC207 treatment groups: 25 mg TMC207 po q.d; 100 mg. TMC207 po q.d; 400 mg TMC207 po q.d.; TMC207 will be administered as a 10 or 40 mg/mL oral solution. Comparator groups: 600 mg rifampin po q.d. administered as capsules containing 300 mg rifampin; 300 mg isoniazid po q.d. administered as tablets containing 300 mg isoniazid.

Eligibility Criteria:
Inclusion Criteria:

* Treatment-naive subjects with pulmonary M. tuberculosis infection, willing to start anti-TB therapy
* Positive for acid-fast bacilli on direct smear exam of sputum specimen
* Must consent to HIV testing
* Must agree to hospital admission

Exclusion Criteria:

* History or presence of hepatic or GI disease that may interfere with the absorption of TMC207, isoniazid or rifampin
* Subjects who received previous anti-mycobacterial drugs for the treatment of a mycobacteria infection and subjects who have received more than 2 weeks of treatment with a fluoroquinolone
* Subjects who have received antiretroviral therapy and/or oral or I.V. anti-fungal medication w/in the last 90 days
* Subjects with sputum cultures of M. tuberculosis resistant to rifampin
* Impaired hepatic function
C-Protein in Fatigue and Aging

This study is investigating changes to the proteins in skeletal muscle that contribute to reduced muscle size and muscle function that occurs with aging.

Age-related muscle atrophy and contractile dysfunction have been well described at the cellular level, but the molecular mechanisms that contribute to this dysfunction are poorly understood. Improved understanding of these mechanisms is critically important for the improvement of physical rehabilitation in older adults at risk for mobility impairment and physical disability. Our studies will pursue pre-clinical evidence that post translational modification of specific proteins in skeletal muscle lead to an "aging phenotype" in skeletal muscle that may unlock new strategies for improving physical function in older adults with physical frailty.

Eligibility Criteria:
Inclusion Criteria:

* Adults between the ages 18-35 or 65-80 years
* Healthy by self-report
* Willing to participate in all aspects of the study design including muscle biopsy, unilateral exercise, and physical activity monitoring
* Fluent in English (due to lack of translation services, it is not practical to conduct the study using a language other than English).

Exclusion Criteria:

* Orthopaedic limitation (severe knee osteoarthritis, prior joint replacement, etc.).
* Volunteer has dementia or related mental issues that potentially put the subject at risk as determined by prior diagnosis.
* Volunteer has known untreated endocrine disease (hypo/hyper thyroidism, Addison's Disease or Cushing's syndrome, etc.)
* Volunteer has untreated/poorly-controlled hypertension (stage 2, per American College of Cardiology \[\>140/90 mmHg\]).
* Volunteer has significant heart, liver, kidney or respiratory disease.
* Volunteer has diabetes (insulin dependent or non-insulin dependent).
* Volunteer has known coagulopathies.
* Volunteer has taken anabolic steroids in the prior six months.
* Volunteer has received treatment for cancer (other than effective Mohs Surgery for successful removal of basal cell or squamous cell carcinomas)
* Unexpected weight loss \>5kg is last 12 months
* Volunteer is an active smoker or quit within the last year.
* Volunteer has known current alcohol or drug use disorder (AUD; defined as binge drinking of \>4 days in the last month. Binge drinking is \>5 drinks for men and \>4 drinks for women, per occasion). Or, if a volunteer reports drinking in excess of "low risk" per NIAAA (\>7 drinks/week for men and \>3 drinks/day for women and \>14 drinks/week and \>4 drinks/day).
* Volunteer has a diagnosed neuromuscular disorder.
* Volunteer has allergy to lidocaine.
Efficacy and Safety Evaluation of HCPA-1 Silicone Stent in the Treatment of Central Airway Obstructions

The aim of the study is, primarily, evaluate the safety of the use of the silicone stent HCPA-1 in patients with clinically significant tracheal and/or bronchial stenosis. Secondarily, this study aims to evaluate the efficacy of the use of the silicone stent HCPA-1 who are in the same conditions described above and also estimate the costs the use of these silicone stents involve.

* It is a prospective multicenter clinical study, not controlled, with evaluation of clinical variables before and after the intervention (insertion of one or more silicone stents in the trachea or bronchi and main or intermediate bronchus by rigid bronchoscopy under general anesthesia).
* 110 patients, both genders, will be followed for one year, total of 8 visits, in order to evaluate the safety of the procedure of stent insertion.

It is allowed to include patients for whom it is indicated the combination of treatments (eg, electrocoagulation followed by stent placement) - full anticoagulation or severe disturbance of coagulation. (Includes: use of any anticoagulant, by oral, intravenous or subcutaneous administration with full intention of coagulation / therapy; coagulopathy with INR\> 2.0 or aPTT \[KTTP\]\> 1.5 times control or platelet count \<50000). Note: The use of antiplatelet drugs (aspirin, clopidogrel, ticlopidine) is allowed.

- The HCPA-1 silicone stent is made of biocompatible silicone, medical grade, via injection process in the matrix using different densities of the same material for a set of prostheses with rigid and flexible variables; available in the following dimensions (diameter x length in mm): 9x30, 9x50, 11x30, 11x50, 13x30, 13x50, 14x30, 14x50, 16x50, 16x70, 18x50 and 18x70. Requires specific surgical (applicator) for insertion.

Eligibility Criteria:
Inclusion Criteria:

* Consent to participate in the study by signing (the patient or family member/ legal guardian) of the Informed Consent Form;
* 18 years old or more;
* clinically significant stenosis (symptomatic or about to become symptomatic) for the trachea, main bronchus or intermediate bronchus, which can be treated with the stent implement.

Exclusion Criteria:

* clinical or absolute anesthesic contraindication of the rigid bronchoscopy under general anesthesia;
* constitutional or acquired anatomic limitations that prevent the rigid bronchoscopy;
* another indication of exclusive preferential treatment modality for stenosis (surgery, radiotherapy, chemotherapy, other). Note: It is allowed to include patients for whom it is indicated the combination of treatments (eg, electrocoagulation followed by stent placement);
* full anticoagulation or severe disturbance of coagulation. (Includes: use of any anticoagulant, by oral, intravenous or subcutaneous administration with full intention of coagulation / therapy; coagulopathy with INR\> 2.0 or aPTT \[KTTP\]\> 1.5 times control or platelet count \<50000). Note: The use of antiplatelet drugs (aspirin, clopidogrel, ticlopidine) is permitted.
Engage & Connect: A Psychotherapy for Postpartum Depression

This randomized controlled trial compares a novel psychotherapy, Engage \& Connect, with a Symptom Review and Psychoeducation intervention, tailored to reduce postpartum depression. The study includes 9-weeks interventions, delivered remotely. It will examine changes in social isolation, processing of social rewards and depression severity over 9 weeks of treatment.

Postpartum depression is linked with decreased motivation to seek rewarding activities and enjoyment of pleasurable experiences. Social isolation and low perceived social support predict persistence of postpartum depression. Engagement in rewarding social activities with significant others may increase motivation and enjoyment, motivating utilization of a therapy that addresses social isolation and reward response. The investigators developed Engage \& Connect (E\&C), a 9-week psychotherapy program that focuses on increasing meaningful social activities with significant others. This study will be a pilot Randomized Controlled Trial that will compare the 9-week E\&C course for mothers with postpartum depression with a Symptom Review and Psychoeducation condition (SRP) for mothers with postpartum depression.

Eligibility Criteria:
Inclusion Criteria:

1. Up to 1 year post-delivery
2. Edinburgh Postnatal Depression Scale (EPDS) score ≥ 10.
3. Off antidepressants or on a stable dose of an antidepressant for 8 weeks and do not intend to change the dose in the next 10 weeks.
4. Capacity to provide consent for research assessment and treatment.
5. Speaks English proficiently

Exclusion Criteria:

1. Intent or plan to attempt suicide in the near future
2. Ongoing psychotherapy (no more than once every 8 weeks or during the duration of the intervention)
3. Active substance abuse or dependence
4. Severe fetal anomalies, stillbirth or infant death at time of enrollment for index pregnancy
5. History or presence of psychiatric diagnoses other than major depressive disorder without psychotic features, generalized anxiety disorder, persistent depressive disorder, or specific phobia.
6. Use of psychotropic drugs or cholinesterase inhibitors other than use of ≤ 0.5 mg of lorazepam daily up to seven times per week.