cyrilzakka/clinical-trials huggingface dataset:
Study of Grazoprevir (MK-5172) + Elbasvir (MK-8742) + Ribavirin in Participants With Chronic Hepatitis C Who Failed Prior Direct-Acting Antiviral Therapy (MK-5172-048)

In this study, participants with hepatitis C virus (HCV) genotype 1 (GT1) who failed prior direct-acting antiviral (DAA) therapy will receive Grazoprevir (MK-5172) + Elbasvir (MK-8742) + Ribavirin (RBV) to evaluate sustained virologic response (SVR) using this drug combination.


Eligibility Criteria:
Inclusion criteria:

* Documented chronic HCV GT1 infection (with no evidence of non-typable or mixed genotype)
* Absence of cirrhosis, or cirrhosis with these criteria: METAVIR F4, or Fibroscan with result \>12.5 kPa, or FibroSure® (Fibrotest®) score of \>0.75 + aspartate aminotransferase (AST): platelet ratio index (APRI) of \>2- Prior regimen containing an approved DAA (boceprevir, telaprevir, simeprevir, or sofosbuvir), pegylated interferon, and/or RBV
* Participants of reproductive potential must agree to remain truly abstinent or use (or have their partner use) 2 acceptable methods of birth control from at least 2 weeks prior to Day 1 and continue until at least 6 months after last dose of study drug, or longer if dictated by local regulations

Exclusion criteria:

* Received any HCV regimen containing a DAA with the exception of boceprevir, telaprevir, simeprevir, or sofosbuvir in combination with pegylated interferon and/or RBV
* Evidence of decompensated liver disease or cirrhosis
* Co-infected with hepatitis B virus or human immunodeficiency virus (HIV)
* History of malignancy \<=5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer or carcinoma in situ; or under evaluation for other active or suspected malignancy
* Evidence of hepatocellular carcinoma (HCC) or under evaluation for HCC
* Currently participating or has participated in a study with an investigational compound within 30 days of signing informed consent and is not willing to refrain from participating in another such study during the course of this study
* Clinically-relevant drug or alcohol abuse within 12 months of screening
* Pregnant, breast-feeding, or expecting to conceive or donate eggs or sperm from at least 2 weeks prior to Day 1 and continue throughout treatment and follow up, or longer if dictated by local regulations
* Male participant whose female partner (s) is/are pregnant
* Organ transplants (including hematopoietic stem cell transplants) other than cornea and hair
* Poor venous access
* History of gastric surgery (e.g., stapling, bypass) or history of malabsorption disorders (e.g., celiac sprue disease)
* Hemoglobinopathy, including, but not limited to, thalassemia major
* Any medical condition requiring, or likely to require, chronic systemic administration of corticosteroids during the course of the trial
* Evidence or history of chronic hepatitis not caused by HCV, including but not limited to nonalcoholic steatohepatitis (NASH), drug-induced hepatitis, and autoimmune hepatitis
A Pilot Investigation of Clinician-guided Internet-Delivered Cognitive Behavioural Therapy for Depressed Patients

This study aims to explore the efficacy and acceptability of a clinician-guided internet-based Cognitive Behavioural Therapy (iCBT) programme for patients with depression, in Singapore.

All outpatients, from the Institute of Mental Health, Singapore, who are diagnosed with a primary diagosis of mild to moderate depression and were referred to the Psychology Department for therapy were invited to take part in this research. Participants were randomised into two groups: iCBT Intervention Group and Delayed Waitlist-Control Group. The four-week iCBT programme comprised of three face to face 30-minute sessions with a clinician and six online modules).The treatment group is hypothesised to exhibit pre-post improvements in depressive symptoms, compared to the control group.

Eligibility Criteria:
Inclusion Criteria:

* 21 to 65 years old
* Not currently seeing a therapist for any form of invidual or group therapy
* Diagnosed with a primary diagnosis of depression by IMH psychiatrist
* A total score of above 9 on the Patient Health Questionnaire (PHQ-9; Kroenke et al., 2001), indicating at least mild symptoms
* If using medication for depression then on a stable dose for at least 1 month,
* Provides informed consent
* Able to read and speak at least Primary 6 level English
* Adequate IT skills to operate iCBT programme

Exclusion Criteria:

* Severe depression (i.e. score = 23 on PHQ-9)
* Strong suicidal ideation (i.e. score \> 2 on Question 9 of the PHQ-9)
* Current active suicidal intention or plan
* Presenting problem is not depression
* Does not meet the minimum English language requirements stated above
* Participants who are concurrently attending other forms of group/individual psychotherapy
Fullscale_Intervention Study: Genetic Risk Communication in Coronary Heart Disease and Wearables

Background: This study aims to determine the effects of communicating genetic risk for Coronary Heart Disease (CHD) alone or in combination with goal setting and prompts from a wearable device on objectively measured sedentary time (ST) in East Asians. It is hypothesized that this combination will lead to significant favorable changes in objectively ST, and that such changes will be more likely to be sustained over 6-month follow-up.

Methods: In a parallel group, randomized controlled trial, a total 414 individuals of East Asians aged over 60years will be allocated into one of three groups: 1 control and 2 intervention groups. Blood samples will be used for estimation of CHD genetic and analysis of metabolic risk markers. Genetic risk for CHD will be estimated based on recently identified 79 SNPs (associated with CHD for East Asians) using an established methodology. Questionnaires and physical measurement will be administered at Before and after the 12-month intervention and at 6-month follow-up. Each group will receive a Fitbit device. Both intervention groups will be given CHD genetic risk estimates along with lifestyle advice but one of them will additionally use Fitbit's step-goal setting and prompt functions. The primary outcome is objectively measured sedentary time. Secondary outcomes include objectively measured MVPA, calories burned, and five intermediate metabolic risk markers (total cholesterol/HDL-C/LDL-C/triglycerides).


Eligibility Criteria:
Inclusion Criteria:

* East Asian ancestry
* Do not meet the WHO-recommended levels of PA (i.e., ≥150 minutes/week of moderate-intensity PA, ≥75 minutes/week of vigorous-intensity PA, or an equivalent combination of the two; determined through the IPAQ-Short Form).

Exclusion Criteria:

* Previously diagnosed with CHD, and/or participation in another exercise-intervention study.
Impact of Prophylactic Octreotide to Pancreatic Exocrine Secretion

This study aims to examine whether octreotide has an effect on inhibition of the exocrine secretion fo the pancreas, which might lower the rate of postoperative pancreatic fistula after pancreatoduodenectomy. Patients who will undergo pancreatoduodenectomy for periampullary tumors were enrolled. The patients were randomly assigned to intervention (use of octreotide) or placebo groups. Octreotide was injected subcutaneously every 8 hours for 7 days. Every patients will undergo pancreaticojejunostomy with external stent for remnant pancreas management. The pancreatic juice is drained through the external stent by negative pressure and amounted.

Primary endpoint was the amount of pancreatic juice for each postoperative day. Secondary endpoint was the rate of pancreatic fistula.

This study aims to examine whether octreotide has an effect on inhibition of the exocrine secretion fo the pancreas, which might lower the rate of postoperative pancreatic fistula after pancreatoduodenectomy. Patients who will undergo pancreatoduodenectomy for periampullary tumors were enrolled. The patients were randomly assigned to intervention (use of octreotide) or placebo groups. Octreotide of 100ug(1mL) was injected subcutaneously just before operation and every 8 hours for 7 days postoperatively. The placebo group was managed with normal saline (1mL) for same period. Every patients will undergo pancreaticojejunostomy with external stent for remnant pancreas management. The pancreatic juice is drained through the external stent by negative pressure (Barovac) and amounted.

Postoperative care of patients was same between groups such as pain control and supportive care. The amount of drained pancreatic juice via external stent was recorded everyday.

Primary endpoint was the amount of pancreatic juice for each postoperative day. Secondary endpoint was the rate of pancreatic fistula.

Eligibility Criteria:
Inclusion Criteria:

* Patients who will undergo pancreatoduodenectomy for periampullary tumors

Exclusion Criteria:

* Patients with preoperative pancreatitis
* Patients who did not undergo pancreatoduodenectomy
* Patients who underwent bypass surgery or total pancreatectomy
* Patients who injection of octreotide less than 5 days
Effectiveness of Extracorporeal Shockwave Therapy and Nutraceutical Supplementation in the Treatment of Epicondylitis: a Clinical Trial

Lateral epicondylitis is a pathologic condition of the musculotendinous system, characterized by the presence of pain at the lateral epicondyle of the humerus; it is a tendinopathy of the extensor muscles of the forearm, often caused by overuse or repetitive use of the arm, forced extension of the elbow, or direct trauma to the humeral epicondyle. This study evaluated the efficacy of Extracorporeal ShockWave Treatment (ESWT) combined with a supplemental nutraceutical treatment of Hyaluronic Acid, Collagen, Vitamin C, and Manganese, compared with single treatment in patients with lateral epicondylitis in term of improvement in pain, functional capacity, muscle strength, and reduction of inflammation on ultrasound images. A clinical trial was conducted at the U.O.C. of "Recovery and Functional Rehabilitation" of A.O.U.P. "P. Giaccone" of Palermo from Marc 2024 to July 2024. Patients were randomized into 3 groups: in group "A", n° 5 sessions of focal ESWT were given every six days; in group "B", patients took daily for 30 days, supplemental nutraceutical treatment of Hyaluronic Acid, Collagen, Vitamin C, and Manganese; and group "C", patients had combined treatment of ESWT (one session every six days for a total of five sessions) and nutraceutical supplementation (one administration per day for one month). All patients were evaluated at enrollment (T0), after one month, at the end of rehabilitation treatment (T1), and at a follow up 30 days after the end of treatment (T2). Researched will compare patients treated with ESWT or with nutraceutical treatment, and patients who had combined treatment to see if there are real differences in term of pain reduction and improved short- and long-term quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of lateral epicondylitis;
* Ultrasound evidence of inflammatory status of the tendon of the wrist common extensor muscle;
* Numerical Rating Scale (NRS) at T0 ≥ 4;
* Pharmacological wash out starting seven days before treatment;
* Written informed consent.

Exclusion Criteria:

* Pregnancy;
* Already diagnosed or diagnostically defined neoplasms;
* Pacemaker wearers;
* Coagulation disorders and/or anticoagulant therapy;
* Skin lesions and/or local infections;
* Tendon injury and/or previous surgery on the wrist extensor tendons;
* Cervical myelopathy;
* Epilepsy;
* Patients with contraindications and/or allergies to the active ingredients of nutracetical supplementation;
* Obesity with BMI\&amp;gt;30 (kg/m2).
Clinical Trail of Repetitive Transcranial Magnetic Stimulation (rTMS) in the Treatment of Upper Limb Bradykinesia in Parkinson' Disease' Patients

A randomized, double-blind, sham-controlled unicenter clinical trial was used to investigate the effectiveness and neural mechanism of high-frequency repetitive transcranial magnetic stimulation in the treatment of upper limb bradykinesia in patients with Parkinson's disease.


Eligibility Criteria:
Inclusion Criteria:

* Hoehn and Yahr (HY) stage 1-2
* Able to understand and cooperate with the study
* Predominantly characterized by bradykinesia
* Onset on the left side

Exclusion Criteria:

* Contraindications for TMS including DBS surgery, Ventriculoperitoneal shunt, etc
* Other neurological disorders
* Significant resting tremor, with MDS-UPDRS-III tremor score ≥3
* Resting threshold cannot be measured
* Received other TMS treatments within the last 3 months
POC-MD MRI-based Trial in Relapsing-remitting Multiple Scler

A randomized, multi-center, double-blind, proof-of-concept study to assess the effect of multiple infusions of AIN457 (10 mg/kg) versus placebo on disease activity as measured by MRI scans over a 24 week period in patients with relapsing-remitting multiple sclerosis


Eligibility Criteria:
Inclusion Criteria:

-

Exclusion Criteria:

-
Study of Value of Dexamethasone Used in Ovulation Induction

This study intends to solve the following problems: whether use dexamethasone can obviously decrease transplant cancelling probability in fresh embryo transplant cycle or not, reduce time and frequency going to hospital repeatedly for patients need frozen embryo transplant or not, and reduce the economic burden for patients or not; By comparing pregnancy rate of single transplant, hope to make clear in IVF-ET treatment for patients progesterone increases to a certain level whether it is a good choice to transfer fresh embryo after dexamethasone treatment, or frozen embryo transplant is better.


Eligibility Criteria:
Inclusion Criteria:

- female, 18 years old≤age≤35 years old, 18≤BMI≤25, standard patient, menstrual regularity

Exclusion Criteria:

Hyperprolactinemia, Thyroid dysfunction, uterine malformation ( inadequacy mediastinal uterus ≥1.0cm, Unicornate uterus, double uterus, T Angle of uterus, etc.), uterus adhesion, untreated hydrosalpinx , hysteromyoma（ hysteromyoma≥1.0 cm, and/or endometrial hysteromyoma≤1 cm), endometriosis, diabetes, hypertension, adrenal cortex hyperplasia, Cushing's syndrome, a pituitary amenorrhea
Comparing the Effect of Adding Dexmedetomidine to Bupivacaine in Classical and Modified Thoracolumbar Interfascial Plane Block on Postoperative Pain in Patients Undergoing Lumbar Disc Surgeries

Spinal surgeries are frequently conducted to stabilize the vertebrae and discs of the spine. These surgeries typically require substantial manipulation of subcutaneous tissues, bones, and ligaments . Postoperative pain relates to mechanical irritation, compression, and postoperative inflammation. The uncontrolled pain could promote the development of chronic persistent pain and worsen independence, mood, and quality of life. Effective pain management facilitates early mobilisation and accelerates hospital discharge. this study aim to investigate the effectiveness of a mixture of dexmedetomidine and bupivacaine in classical thoracolumbar interfascial plane block compare to modified thoracolumbar interfascial plane block on postoperative pain in patients undergoing lumbar disc surgeries.

Postoperative pain control after spinal surgeries has been a topic of interest for researchers in the past decade. Indeed, poor pain control can not only impact patient satisfaction but also delay rehabilitation and increase healthcare costs.

The thoracolumbar interfascial plane (TLIP) block was defined by Hand et al. for reducing pain following spinal surgery. In this block, the anesthetic drug is administered between the multifidus and longissimus muscles to target the dorsal ramus of the thoracolumbar nerves. The TLIP block was later modified by Ahiskalioglu et al., with the involvement of the administration of a local anesthetic between the longissimus and iliocostalis, which was observed to demonstrate a dermatomal dispersion similar to that by the TLIP block.

Dexmedetomidine is highly specific and highly selective a2-adrenoceptive agonist and it's action is selective to the CNS without the unwanted effect on the CVS that would result from a activation . It has been found that, in many experimental and clinical regional block practices, the addition of dexmedetomidine to the local anesthetic reduces tissue and nerve damage, increases duration of sensory and motor block, and reduces postoperative pain.

Eligibility Criteria:
Inclusion Criteria:

* • Age \>18 years old

  * Both sex
  * Patients who were in risk-scoring groups I-II of the American Society of Anesthesiologists (ASA)

Exclusion Criteria:

* • Patient refusal.

  * coagulation disorders that affect the blood's clotting activities e.g.: Hemophilia.
  * skin lesions or infection at site of proposed needle.
  * known allergy to local anesthetics or dexmedetomidine.
  * patients suffering from mental disease as cannot Assess the Visual Analogue Scale (VAS) that measures pain intensity as, mental retardation \& psychosis
Investigation of the Efficacy of Internal and External Perturbation Exercises on Functional Parameters in Stroke Rehabilitation

Stroke is a serious medical condition that causes the death of brain cells as a result of blockage of a blood vessel that feeds the brain (ischemic stroke) or bleeding in or around the brain (hemorrhagic stroke). People who have had a stroke have a higher risk of falling than people who have not had a stroke at the same age. Lack of balance control not only increases the risk of falling, but also leads to fear of falling and reduces the integration of people with stroke into society.

The central nervous system uses two main postural strategies to maintain and restore balance when perturbed. These; are anticipatory and compensatory postural adjustments. Anticipatory postural adjustments control the position of the body's center of mass by activating the trunk and leg muscles prior to a forthcoming body perturbation, thus minimizing the risk of loosing equilibrium. Compensatory postural adjustment are initiated by sensory feedback signals and serve as a mechanism of restoration of the position of the center of mass after a perturbation has already occurred.

In this study, the investigators aimed to determine which one is more effective, unlike previous studies that showed that internal and external perturbation exercises were effective when applied together. For this purpose, the researchers the planned to investigate and compare the effects on balance, performance, activity and participation in individuals to whom only internal perturbations were applied and only external perturbations were applied.

The participants will be divided into 2 groups, as Group A and Group B, with 10 participants in each group, in a randomized controlled manner.

Treatment Protocol:

Conventional treatment was applied to participants included in both groups for 4 weeks, 5 days a week, 40-minute sessions. In addition to conventional treatment, 30 minutes of perturbation-based balance training was given to the participant in the study. Participants in Group A received internal perturbation training, and participants in Group B received external perturbation training.


Eligibility Criteria:
Inclusion Criteria:

* Unilateral stroke history
* Adults with chronic stroke (\>6 months poststroke)
* Ability to stand for at least 30 seconds without support

Exclusion Criteria:

* Those with Parkinson's disease, amputation, severe osteoporosis
* Those with uncontrolled diabetes, hypertension
* In addition to stroke, the presence of any problem that may adversely affect balance
* Areas below 24 in the mini mental state test
Epidemiological Study on the Management of Out-of-hospital Cardiac Arrest Survivors in Champagne ArDEnnes

Out-of-hospital cardiac arrest (OHCA) is a public health problem, affecting 50,000 people per year in France. Intervention time (initiation of cardiopulmonary resuscitation (CPR) and advanced CPR) are associated with a better prognosis. Despite this, the latest published data show a very low overall survival (5%). Our territory has only three centers distributed hospitals with both a 24-hour coronary angiography platform and an intensive care unit. Finally, although 60% of ACEHs receive coronary angiography in the Île de France region, it is performed on only 15% of patients in the Reims University Hospital.

Therefore, it seems essential to conduct a study on the reality of the support of ACEH and to study the clinical and biological factors as well as the influence of the geographical distribution of specialized technical platforms on the prognosis of patients.


Eligibility Criteria:
Inclusion Criteria:

* Patient victim of ACEH in the Champagne-Ardenne region admitted living in hospital.

Exclusion Criteria:

* patient under the age of 18
Effectiveness of Experiential Fibrowalk Therapy

The present project will evaluate through a randomised controlled clinical trial with 4-month follow-up, the efficacy in clinical symptoms and quality of life (3-month time horizon) of the multicomponent EXPERIENTIAL FIBROWALK programme in treating individuals diagnosed with fibromyalgia, in compare with original Fibrowalk and virtual Fibrowalk. Pre-post changes will be evaluated in various variables under investigation, will include kinesiophobia, physical function, anxiety, depression, physical dysfunction, overall impact, and symptom intensity.

The design of the present study with 3 treatment branches:

Condition or disease Fibromyalgia Intervention/treatment Behavioral: TAU + Experiential Fibrowalk Behavioral: TAU + Fibrowalk Behavioral: TAU + virtual

The objective of the Experiential Fibrolwalk study is to determine the clinical effectiveness of a new treatment protocol for individuals with fibromyalgia. This protocol was developed by identifying predictors of poor response and through collaboration between physiotherapists, clinical psychologists, and patients. The objectives of this 4-month controlled clinical trial are twofold. Firstly, it aims to assess the impact of a protocol developed collaboratively by clinical therapists and users on the quality of life of individuals with fibromyalgia. Secondly, it aims to determine the pre-post changes in kinesiophobia, physical function, anxiety, depression, physical dysfunction, overall impact, and symptom intensity. Methods and analysis: The study will involve 120 fibromyalgia patients recruited from the Central Sensitivity Syndromes Specialized Unit at Vall d'Hebron Hospital's Rheumatology Service, who will be randomly assigned to one of three study groups: TAU + Experiential Fibrowalk, TAU + Fibrowalk, TAU + virtual. A comprehensive assessment to collect functional impact, depressive-anxiety symptoms, physical function, fatigue, kinesiophobia, pain catastrophism, impression of change,quality of life variables will be conducted pre-intervention, at half of the intervention (6 weeks), post-intervention (12 weeks), and at 3-month follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Adults from 18 to 75 years-old.
* 1990 American College of Rheumatology (ACR) classification criteria + the 2011 modified ACR diagnostic criteria for fibromyalgia
* Able to understand Spanish and accept to participate in the study.

Exclusion Criteria:

* Participating in concurrent or past RCTs (previous year).
* Comorbidity with severe mental disorders (i.e. psychosis) or neurodegenerative diseases (i.e. Alzheimer) that that would limit the ability of the patient to participate in the RCT.