cyrilzakka/clinical-trials huggingface dataset:
Arthroscopic Debridement Versus Autologous Cytokine Rich Serum for the Treatment of Lateral Epicondylitis

This study aims to compare arthroscopic resection (surgical intervention) versus infiltration of cytokine rich serum (CRS) (proteins derived from the patient's own blood) for the treatment of lateral epicondylitis (LE).

Lateral epicondylitis (LE) is a common debilitating condition that affects the extensor muscles of the forearm at its junction with the lateral humeral epicondyle. This pathology is commonly treated by a surgical intervention. However, advances in research have allowed the discovery of new and less invasive techniques for its treatment, for example the infiltration of cytokine rich serum.

The aim of the study is to compare the common treatment of this pathology, arthroscopic resection (surgical intervention) with a new technique, infiltration of cytokine rich serum (CRS) (proteins derived from the patient's own blood) with respect to medium and long-term pain reduction.

The study will include a total of 86 patients. Patients will be included by randomization into two groups:

* GROUP 1: 43 patients will be treated with 2 infiltrations of cytokine rich serum.
* GROUP 2: 43 patients will be treated by a regular surgical treatment consisting of arthroscopic resection.

The main objective of this study is to evaluate the efficacy of CRS as compared to arthroscopic resection in reducing pain in the medium term (6 months) in patients with chronic lateral epicondylitis.

Eligibility Criteria:
Inclusion Criteria:

* Over 18 years of age
* Patients with persistent pain (EVA \> 5) at lateral epicondyle level of at least 3 months duration.
* Patients with a diagnosis of chronic lateral epicondylitis confirmed with a complementary diagnostic test such as Echo or MRI.
* Availability to follow the study protocol for up to 24 months.
* Patients with the ability to understand study information and give informed consent.
* Patients who sign informed consent.
* Normal hematologic parameters.

Exclusion Criteria:

* Local infection present.
* Patients who have been treated with corticosteroid infiltrations in the same area in the past 4 months.
* Patients who have received treatment with growth factors, PRP, cytokines, or new drug treatments in the same area in the last 12 months.
* Pregnancy or breast-feeding.
* Neoplastic disease.
* Patients being treated with immunosuppressants (medical evaluation).
* Patients undergoing arthroscopic surgery of the same elbow.
* Active liver disease.
* Immunosuppressive or immunodeficiency states.
* Coagulation deficit or abnormalities.
* Thrombocytopenia.
* Treatment with anticoagulants.
* Difficulty understanding and following study procedures.
* Participation in a clinical trial with medications.
Safety, Effectiveness and Manipulability Evaluation of a Domestic PD Machine

This study is a randomized, multi-center，crossover study of a domestic FM peritoneal dialysis machine and Baxter HOMECHOICE.It aims to verify safety, effectiveness and manipulability of a domestic peritoneal dialysis machine.

Our study is a randomized, multi-center，crossover study. It compares a domestic FM peritoneal dialysis machine with Baxter HOMECHOICE.It aims to verify safety, effectiveness and manipulability of a domestic peritoneal dialysis machine.

Eligibility Criteria:
Inclusion Criteria:

Age ≥18, male or female Dialysis duration:≥30 days Sign the written informed consent

Exclusion Criteria:

Hemodialysis Exit site infection or tunnel infection Peritonitis ≤30 days before screening Catheter mechanical failure Anti-HIV positive Allergic to components of dialysate Comorbidity:Active, residual malignant tumor, or systemic infection, liver cirrhosis, severe congestive heart failure,hypertension Poor compliance Pregnant or lactating, women of childbearing age do not agree to use effective contraceptive measures during the trial Has a history of alcoholism and drug abuse (defined as illegal drugs) Any circumstances when patients are believed unsuitable for this trial
Guided Self-Help for Parents of Children With Attention-Deficit/Hyperactivity Disorder (ADHD)

Cognitive-behavioral based guided self-help for parents of children with Attention-Deficit/Hyperactivity Disorder (ADHD) is investigated in a feasibility and effectiveness study. The treatment is offered under routine-care conditions of the health-care system in Germany. Practicability, treatment participation and effectiveness is documented and tested in a one-group pre-test/post-test design.

Self-directed interventions may overcome many of the barriers associated with accessing face-to-face services, as there is lowered stigma and significantly reduced or eliminated cost, transport, and timing difficulties. Families can complete self-directed programs at home, in their own time and at their own pace. Furthermore self-administered programs are often very cost-effective and their use can ease the financial burden of mental health of the community. These parenting programs can be particularly effective by reaching the populace. Moreover in primary care settings where financial resources, time and expertise might be lacking to provide behavioral interventions, self-directed programs might be a promising tool for disseminating effective parenting interventions more widely.

Bibliotherapy is one form of self-directed therapy. In bibliotherapy a selected book is thought to meet the specific need of the person to be treated and reading is used as the therapeutic technique. In opposition to pure self-help programs, bibliotherapy in terms of guided self-help provides patients (or parents) with written instructions as well as therapeutic contacts at regular intervals. During these contacts, problems and questions can be discussed to give further support. Self-help interventions have already proven to be effective for adults with anxiety or affective disorders as well as for depressive adolescents. However there has only been little research concerning the reduction of children's behaviour problems through parental self-help programs under minimal contact conditions.

Eligibility Criteria:
Inclusion Criteria:

* Child diagnosis of ADHD

Exclusion Criteria:

* Language or reading difficulties of participating parent
Treatment of Patients With Relapsed or Primary Refractory Aggressive B- Cell NHL

Phase II study for treatment of patients with relapsed or primary refractory aggressive B- cell NHL and anthracycline chemotherapy pretreatment, who received or did not qualify for autologous stem cell transplantation.

Phase II study for treatment of patients with relapsed or primary refractory aggressive B- cell NHL and anthracycline chemotherapy pretreatment, who received or did not qualify for autologous stem cell transplantation. Aim is to find response rates and duration of combination chemotherapy (bendamustine/rituximab) in patients with relapsed or refractory CD 20 positive B cell NHL.

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven high grade B-NHL (CD 20 \>= 20 % positive)
* Age \>= 18 years
* At least one pretreatment with anthracycline polychemotherapy +/- radiatio:
* first relapse nad contraindication for aggressive salvage therapy e.g. high dose therapy with autologous stem cell transplantation
* second relapse (after aggressive salvage therapy)
* patient's refusal of aggressive salvage therapy in first relapse
* informed consent

Exclusion Criteria:

* untreated patients
* pretreatment with bendamustine
* primary CNS- lymphoma
* Karnofsky index \< 50 (except caused by lymphoma)
* HIV positive, hepatitis B or C
* serious concurrent disease
* non-compensated heart failure (\>=NYHA 3)
* non-compensated hypertension
* renal insufficiency (creatinine \> 2.0 mg/dl), not related to lymphoma
* hepatic insufficiency with transaminase values greater than 3-fold of normal values and/or bilirubin levels \> 200 µmol/l, not related to lymphoma
* missing compliance respective incapability to comply (e.g.cerebral dysfunction
* pregnancy
* hematopoetic insufficiency not lymphoma related (leucocyte count \<= 2500/µl, granulocyte count \<= 1000/µl, platelet count \<= 80000/µl)
A Prospective, Observational Study of Patients With Cervical Dystonia (Dystonie) Treated With OnabotulinumtoxinA

This is an observational study to assess health-related quality of life in patients with cervical dystonia (dystonie) treated with OnabotulinumtoxinA per routine clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of cervical dystonia (dystonie) and able to receive botulinum toxin Type A as deemed medically necessary by the physician

Exclusion Criteria:

* Participation in a clinical trial for any botulinum toxin indication
* Planning elective surgery during the observational study period
* Treatment with any botulinum toxin product for cervical dystonia (dystonie)
* Treatment with any botulinum toxin product for a non-cervical dystonia (dystonie) condition within 2 months of study start
Hemodynamic Testing Strategies to Assess Pulmonary Hypertension in Heart Failure

The goal of this observational study is to learn about heart function and high lung blood pressure in patients with heart failure. The main question\[s\] it aims to answer are whether we can improve the ability to predict patients who will have complications after they receive treatment including heart transplant and left ventricular assist devices.

Prospective cohort study of patients with heart failure with reduced ejection fraction that are referred for diagnostic right heart catheterization as part of their evaluation for candidacy for advanced heart failure therapies.

Eligibility Criteria:
Inclusion Criteria:

* Adults age 18 years or older
* Heart failure with reduced ejection fraction (\<40%)
* referred for RHC at our centre for evaluation of candidacy for advanced HF therapies.

Exclusion Criteria:

Severe valvular or complex congenital heart disease Short-term mechanical circulatory support for progressive cardiogenic shock (e.g. extracorporeal membrane oxygenation) Acute coronary syndrome or revascularization occurred within 7 days prior to the RHC.

Pregnant or breast-feeding Known hypersensitivity to sodium nitroprusside Advanced liver dysfunction Reduced capacity or inability to provide informed consent
Randomized Trial of Early Versus Standard Drainage Removal After Pancreatic Resections

Despite a substantial decrease in postoperative mortality, morbidity after pancreatic resections is still high, even at high-volume centers. It has been recently suggested that early removal of postoperative drainages is associated to a decreased rate of intra-abdominal complications, with particular regard to pancreatic fistula. Furthermore, our research group demonstrated that measuring amylase value in drainages (AVD) on postoperative day 1 plays a cardinal role in predicting the developement of abdominal complications, including pancreatic fistula. In particular, patients with an AVD lower than 5000 IU/L in postoperative day 1 were considered at low risk of fistula. Therefore, the investigators designed a randomized prospective trial on early (postoperative day 3) versus standard (postoperative day 5) drainages removal after pancreatic resections in patients at low risk of developing pancreatic fistula (AVD \< 5000 IU/L in postoperative day 1) to test whether drainages "per se" influence postoperative complication rates and to eventually validate a fast-track policy in pancreatic resections.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergone either pancreaticoduodenectomy (reconstruction by pancreaticojejunostomy) or distal pancreatectomy with an amylase value in drains on postoperative day 1 less than 5000 IU/L

Exclusion Criteria:

* Pancreaticoduodenectomy reconstructed with pancreaticogastrostomy
* Clinical suspect of postoperative haemorrhage within 72hours after the operation
* Clinical suspect of biliary fistula
* Fluid collection greater than 3cm at an ultrasound carried out on postoperative day 3
A Study to Test the Effect of CDP870 in the Treatment of Crohn's Disease Over 26 Weeks, Comparing CDP870 to a Dummy Drug (Placebo)

A 26 week study to examine the efficacy, safety and pharmacokinetics of CDP870 in Crohn's disease

Receiving immunosuppressants (azathioprine/6-MP/methotrexate) at Week 0 or not.

604 patients will be enrolled with 1006 patients screened (to allow for 25% screen failures between screening and Week 0 and expected presentation at Screening of 60% of patients with CRP \< 10 mg/L and 40% of patients with CRP ≥ 10 mg/L).

Eligibility Criteria:
Inclusion Criteria:

* Definitive diagnosis of Crohn's disease confirmed (at least 3 months prior to study entry) either by radiological, endoscopic or histological evidence, affecting the terminal ileum (L1), colon (L2) or ileocolon (L3\*. \*Vienna Classification (1998)
* Active Crohn's disease (≥ 220 and ≤ 450) scored over the 7 days prior to the first dose of study drug.
* Male and female aged 18 years or above at screening.
* Patients who meet all concomitant medication criteria in the protocol specified table. For all drugs being taken at screening, the patient should be able to remain on a stable dose throughout the duration of the study, although steroids may be tapered starting at Weeks 8 to 12.

Exclusion Criteria:

* Crohn's Disease Related
* Fistula abscess present at screening.
* Stricturing type disease with symptoms or signs of non-inflammatory mechanical obstruction or bowel perforation in last 3 months.
* Short bowel syndrome.
* Functional colostomy or ileostomy (note: patients who have had a temporary stoma in the past, which has been reversed, are eligible to enter the study).
* Positive stool laboratory results for enteric pathogens.
Induction Study #1 of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn's Disease

This is a study to explore the effect of oral ozanimod as an induction treatment for participants with moderately to severely active Crohn's Disease.


Eligibility Criteria:
Inclusion Criteria:

* Crohn's disease for ≥ 3 months on endoscopy and on histological exam
* Inadequate response or loss of response to corticosteroids, immunomodulators, and/or biologic therapies
* Crohn's Disease Activity Index (CDAI) score ≥ 220 and ≤ 450
* An average daily stool frequency ≥ 4 points and/or an abdominal pain of ≥ 2 points
* Has Simple Endoscopic Score for Crohn's Disease (SES-CD) score of ≥ 6 (or SES-CD ≥ 4 in participants with isolated ileal disease)

Exclusion Criteria:

* Has a diagnosis of ulcerative colitis, indeterminate colitis, radiation colitis, or ischemic colitis, or has strictures with prestenotic dilatation requiring procedural intervention
* Has extensive small bowel resection (\>100cm) or known diagnosis of short bowel syndrome, or requires total parenteral nutrition
* Current stoma, ileal-anal pouch anastomosis, or fistula

Other protocol-defined inclusion/exclusion criteria apply
Effectiveness of Airrosti and TheraBand Exercises on Double-Crossed Syndrome in Smart Phone User's Shoulder

Double-crossed syndrome" refers to a specific alignment of overactive and underactive muscles in the neck, chest, and shoulders. AIRROSTI stands for Applied Integration for the Rapid Recovery of Soft Tissue Injuries. This study aims to evaluate the effectiveness of Airrosti exercises combined with TheraBand exercises in reducing pain and disability in the neck and shoulders. TheraBand exercise programs are commonly used to improve muscle activation. However, research on the effectiveness of AIRROSTI combined with TheraBand exercises for treating Double-Crossed Syndrome among smartphone users is limited, and more evidence is needed to support their effectiveness.

Research objective is to evaluate the effectiveness of Airrosti and Theraband exercises in reducing pain and disability among smartphone users with Double-Crossed Syndrome. To evaluate the combined effect of Airrosti and Theraband exercises in reducing pain and disability among smartphone users with Double-Crossed Syndrome. To compare the effect of Airrosti and Theraband exercises in reducing pain and disability among smartphone users with Double-Crossed Syndrome.

Eligibility Criteria:
Inclusion Criteria:

young female participants with rounded shoulder postures. Participants aged between 18 and 25 years. No history of shoulder trauma, current shoulder pathology, thoracic scoliosis, and kyphosis deformity.

Exclusion Criteria:

Participants excluded if they received any other form of medical treatment or have thoracic scoliosis or kyphosis deformity.
Influence of Implant Crown Transmucosal Contour Design on Soft and Hard Tissue Clinical Outcomes

This study will evaluate how the crown's shape under the gums will influence the gum tissue around dental implants.

This research is studying the transmucosal contour, or shape of crowns (white-colored tooth structure that sits above the gum) under the gums on dental implants. Participants will be randomly selected for the dental implant crown to be designed with either a straight or concave transmucosal contour, and followed up on for 1 year after crown delivery.

Eligibility Criteria:
Inclusion criteria

* Be a current participant of HUM00208140 main study
* Have a dental implant that is ready to be restored (placed at least 3 months ago and healing is adequate)

Exclusion Criteria:

• The dental implant crown was already delivered.
Do Bonding Disruptions Occur More Often in Children With Asthma Than in Non-asthmatic Populations?

Six studies have preceded this project. Three studies suggested that there is a significant connection between pediatric asthma and disruptions in maternal-infant bonding (Feinberg, 1988; Schwartz, 1988; Pennington, 1991). Three studies suggested that children with asthma benefit from a type of therapy that improves bonding with their mothers (Madrid, Ames, Skolek, \& Brown, 2000; Madrid, Ames, Horner, Brown, \& Navarrette, 2004; Madrid, Pennington, Brown \& Wolfe, 2011).

This study proposes to study in a more thorough fashion the question of the incidence of bonding disruptions with between mothers and their children with asthma. This time there will be a larger sample, and more stringent criteria will used in assigning children to the asthma cohort. Through questions answered by mothers whose children have been said to have asthma, we will be able to decide if the children's respiratory conditions are likely to be attributable to asthma or more likely reflective of another respiratory condition such as vocal cord dysfunction or anxiety related hyperventilation (Anbar, 2014).


Eligibility Criteria:
Inclusion Criteria:

* Biological mothers of male and female children between 2 and 12 years of age who live with or have contact with their children
* English is the primary language of the biological mother

Exclusion Criteria:

* Mothers of children only below 2 or above 12 years of age
* Mothers of children thought to have a chronic health condition other than asthma
* Mothers who have already completed a questionnaire with another child
Safety and Feasibility of St. Mark's Electrode for the Hypoglossal Nerve and Cortico-lingual Pathway Study

The possibility of registering the M-response and the motor evoked potential (MEP) from the muscles of the tongue by using the St. Mark's electrode will be evaluated. The safety of method will be confirmed. Registered parameters will be compared with other known methods and comparative effectiveness of proposed method will be determined.

The study will involve healthy volunteers without clinical symptoms of hypoglossal nerve and cortico-lingual pathway lesions and without surgical interventions in the tongue .The volunteers will be examined once for the parameters of the amplitude and latency of the M-response and MEP, as well as the difference between these indicators at different sides of the examination during nerve conduction study (NCS) and transcranial magnetic stimulation (TMS) of the hypoglossal nerve and the cortico-lingual pathway.


Eligibility Criteria:
Inclusion criteria:

* Absence of clinical symptoms of impaired hypoglossal nerve and cortico-lingual pathways;
* Absence of history of surgical interventions in the tongue area;
* The subject has read the information sheet and signed the informed consent.

Exclusion Criteria:

* Clinical symptoms of hypoglossal nerve or cortico-lingual pathway (dysarthria, dysphagia (pseudobulbar palsy) lesions, flaccid paralysis of the tongue muscles, atrophy and fasciculations of the tongue muscles);
* Tumors, metastatic lesions and cysts in the region of the brain stem, posterior cranial fossa, base of the skull, in the region of the carotid segment, salivary glands;
* Vascular pathologies in the carotid sinus area: vascular malformations, dissection of the internal carotid artery aneurysm, venous thrombosis;
* Recent dental procedures with one of the following complications: development of an abscess, direct injury to the nerve by medical equipment, development of hematoma;
* History of carotid endarterectomy;
* Motor neuron disease and other neurodegenerative or demyelinating diseases;
* History of cancer and courses of radiation therapy;
* The presence of implantable programmable devices.
A Study to Compare the Efficacy of GNS561 Versus Standard of Care in Patients With SARS-CoV-2 (COVID-19) Infection

This is a multicenter, open-label, controlled, randomized phase 2 study designed to evaluate the safety and efficacy profile of GNS561 in patients with COVID-19.

Patients will be treated either with oral GNS561 plus standard of care or only standard of care. All patients in experimental arm will be treated for ten days. Study drug will be provided as oral capsules containing 200 mg of GNS561. Patients will be followed-up during hospitalization and after discharge.

Eligibility Criteria:
Inclusion Criteria:

* Documented diagnosis of COVID-19 (diagnostic test performed in a certified laboratory).
* Clinical status: Hospitalized for moderate COVID-19 with News2 score between 5 and 6

Exclusion Criteria:

* Patient known to have intolerance or hypersensitivity to chloroquine or any quinoline derivates (quinine, tafenoquine, hydroxychloroquine, mefloquine).
* History of QT prolongation (QTc ≥ 500 ms) or QTc ≥ 500msec at screening or bradycardia \< 50/mn
* Current use of loop diuretics and potassium supplementation or documented history of hypokalemia or hypokalemia \< 3.5mmol/l at screening
* Prior allogeneic bone marrow transplantation or solid organ transplant in the past.
* Pregnant or breastfeeding patient, or expecting to conceive children within the projected duration of the trial, starting with the screening visit through 6 months after the last dose of study drugs.