cyrilzakka/clinical-trials huggingface dataset:
International Multicenter Prospective Transtar Registry

Obstructed Defecation Syndrome (ODS) describes a condition which is characterized by chronic constipation. The symptoms of ODS include abdominal pain or cramping, irregular bowel frequency and the feeling of not having emptied the rectum. ODS is usually associated with internal rectal prolapse and/or rectocele. For surgical treatment of ODS, a plethora of surgical techniques have been described with no one method having been assessed as a gold standard.

A new surgical procedure - Transtar - has been introduced in Europe recently. The goal of this registry is to assess safety, effectiveness and patient quality of life, associated with Transtar for chronic constipation due to morphological changes, such as internal rectal prolapse and rectocele.

Eligibility Criteria:
Inclusion Criteria:

* Patients with obstructed defecation, fragmented defecation or incomplete evacuation as a presenting symptom documented by a standardized symptom score
* confirmed internal rectal prolapse or rectocele on dynamic defecography
* adequate external sphincter on rectal digital examination.

Exclusion Criteria:

* Subjects with any other surgical procedure than STARR for ODS
* Subjects in whom STARR is not performed with the Contour Transtar stapler
* Subjects with a physical or psychological condition which would impair participation in the registry.
Efficacy and Safety of Propranolol Versus Atenolol on the Proliferative Phase of Infantile Hemangioma

The purpose of this study is to compare the efficacy of orally administered propranolol versus atenolol in the treatment of potentially disfiguring or functionally threatening IHs.

Currently, propranolol is the preferred treatment for problematic proliferating infantile hemangiomas (IHs). Although propranolol is clearly efficacious, rare side effects, such as hypoglycemia, may be life-threatening. The possibility of propranolol resistance and treatment failure is also important, and highlights the need for employing more established techniques in certain cases.

Nonselective β-adrenergic antagonists, such as propranolol and timolol, are competitive antagonists of catecholamines at the β1- and β2-adrenergic receptors (β-ARs). β2-AR blockade may result in hypoglycemia as a result of decreased glycogenolysis, gluconeogenesis, and lipolysis. Moreover, bronchial hyperreactivity is a direct effect of nonselective β-blockers, resulting in bronchospasms due to pulmonic β2-AR blockade. A solution to minimize many of the side effects of nonselective β-blocker therapy may be the use of more selective β1-blockers such as metoprolol or atenolol, which, at low dosages, have little β2 activity. Unfortunately, there is a paucity of clinical data comparing the efficacy of selective and non-selective β-blocker. Furthermore, because of the broad heterogeneity of IH (e.g., proliferating versus involuting), confounding with other pharmacologic exposures (e.g., corticosteroids), associated complications (e.g., ulceration) and comorbid medical anomalies (e.g., PHACE) that can influence efficiency after IH treatment, observational studies are unable to definitively establish the clinical utility of β-blockers in IH. Thus, questions regarding the efficacy of the subtypes of β-blockers must be answered in randomized controlled trials, which may provide the only way to overcome the selection and ascertainment bias.

The purpose of this study is to compare the efficacy of orally administered propranolol versus atenolol in the treatment of potentially disfiguring or functionally threatening IHs.

Eligibility Criteria:
Inclusion Criteria:

* Patients younger than 24 weeks.
* Presenting a hemangioma with the following characteristics:
* Subcutaneous and/or cutaneous
* Minimum diameter of 1.5 cm on face, 3 cm outside face and 1.5 cm if it is ulcerated.
* Consent of both parents (or the person having parental authority in families)

Exclusion Criteria:

* Infant presenting contraindications for the administration of propranolol or atenolol.
* Hemangioma has been previous treated with corticosteroids, laser, cryotherapy, or only other treatments.
* Patients with an inability to participate or to follow the study treatment and assessment plan.
Intraoperative Ketamine Versus Saline in Depressed Patients Undergoing Anesthesia for Non-cardiac Surgery

This study evaluates whether ketamine, given as part of an anesthetic, improves depression symptoms in depressed patients undergoing non-cardiac surgery. Half of participants will receive a ketamine infusion during surgery, while the other half will receive a placebo (normal saline) during surgery.

Major Depressive Disorder (MDD) is widely prevalent among patients preparing to have surgery, and is a known risk factor for complications after surgery, including wound infection, myocardial infarction and opioid use disorder. Ketamine has emerged as an effective, rapid-acting antidepressant therapy for patients with MDD, and may be a useful tool to prevent MDD-related morbidity in the perioperative period. Ketamine has been well studied for MDD in outpatient clinics where it is given as an infusion (0.5 mg/kg over 40 minutes) in awake patients. Ketamine is often used as part of an anesthetic cocktail in sedated or anesthetized patients, but it is unknown whether ketamine has an antidepressant effect in this context. The investigators will determine whether a ketamine infusion, compared to placebo (normal saline infusion), has an antidepressant effect when given during surgical anesthesia. If ketamine is an effective antidepressant in this population under anesthesia, its use could be incorporated into a set of interventions to minimize the perioperative complications associated with MDD.

Eligibility Criteria:
Inclusion Criteria:

* Patient presenting for non-cardiac, non-intracranial surgery
* Major Depressive Disorder

Exclusion Criteria:

* Pregnant of breastfeeding women
Phenotypes, Biomarkers and Pathophysiology in Hereditary Spastic Paraplegias and Related Disorders

The aim of this study is to determine the clinical spectrum and natural progression of Hereditary Spastic Paraplegias (HSP) and related disorders in a prospective multicenter natural history study, identify digital, imaging and molecular biomarkers that can assist in diagnosis and therapy development and study the genetic etiology and molecular mechanisms of these diseases.

The investigators will perform a registry-based standardized prospective Natural History Study (NHS) in HSPs and related disorders. Participants will be seen annually. At study visits a standardized clinical examination will be performed including application of clinical rating scales (selection of rating scales may vary depending on the individual phenotype and specific genotype); data will be entered into a clinical database (HSP Registry; https://www.hsp-registry.net). At all study visits, patients will be asked to donate biosamples; biomaterial collection is optional and participants can elect to participate in sampling of blood, urine, CSF, and/or a skin biopsy.

Optionally, additional examinations may be performed including imaging, quantitative movement analysis, neuropsychological examinations, analysis of patient or observer reported outcomes and OMICS analysis to characterize molecular biomarkers.

In participants without a genetic diagnosis, next generation sequencing may be performed.

Eligibility Criteria:
Inclusion criteria:

* One of the following:

  1. Primary participant: Clinical or genetic diagnosis of HSP or a related disorder
  2. Secondary participant: Unaffected family member (1st or 2nd degree relative) of primary participant (with the above-mentioned restrictions for special populations) able to give informed consent
  3. Unrelated healthy control able to give informed consent

     AND
* Written informed consent

AND

- Participants are willing and able to comply with study procedures

Exclusion criteria:

* Missing informed consent of primary or secondary participant/ healthy control/ legal representatives
* For controls: evidence of a neurodegenerative disease or movement disorders; inability to give informed consent
Follow up of IFN Vs DAAs HCV SVR (IFDACS Study)

The study is designed to provide long term clinical and virologic follow up in subjects infected with hepatitis C virus (HCV) who received interferon-based therapy or direct-acting antiviral agents (DAAs)-based therapy. This long term follow up study is observational and no treatment is provided for HCV infection.


Eligibility Criteria:
Inclusion Criteria:

* Patients with chronic hepatitis C treated with interferon-based therapy or direct-acting agents (DAAs)-based regimen;
* Provide written, informed consent;
* Be willing and able to comply with the visit schedule and protocol-mandated procedures.

Exclusion Criteria:

* Individuals planning to start a new course of hepatitis C therapy including any investigational drug or device during the course of the follow-up time frame;
* History of clinically significant illness or any other major medical disorder that may interfere with follow up, assessments, or compliance with the protocol.
* Inability to provide written informed consent.
The Effect of Daily Dietary Intake of Dried Juice Concentrates of Fruit, Vegetables and Berries Upon Outcomes of Chronic Periodontitis

The objective of this study is to determine whether enhanced micronutrient intake in the form of fruit, vegetable and berry juice powder (FVB) concentrate, improves clinical outcomes in chronic periodontitis patients prior to standard non-surgical treatment.

The objective of this study is to determine whether enhanced micronutrient intake in the form of fruit, vegetable and berry juice powder (FVB) concentrate, improves clinical outcomes in chronic periodontitis patients prior to non-surgical treatment. In addition, the effects of supplementation prior to and following standard non-surgical management will be assessed, relative to a placebo supplemented group.

The investigators hypothesize that 3-months of nutritional support using this FVB will result in additional reductions in marginal gingival inflammation (bleeding) and additional reductions in probing pocket depth (mean \& cumulative), over and above any placebo-related or behavioral effect. In addition, the investigators hypothesize that 3-months of nutritional support prior to a standard non-surgical therapy in conjunction with a continuation of the nutritional support for 3 months will result in further additional reductions in marginal gingival inflammation and probing pocket depth, over and above any placebo-related or behavioral effect following standard non-surgical therapy.

Eligibility Criteria:
Inclusion Criteria:

* be aged 18 years old and over
* have a minimum of 20 teeth
* have chronic periodontitis
* be capable of giving informed consent themselves

Exclusion Criteria:

* Patients with aggressive disease
* Patients with physical or mental disability
* Pregnant women or those breastfeeding
* Patients whose medical history may place them at risk of complications from periodontal therapy (e.g. warfarinised Volunteers)
* Patients taking long term anti-microbial or anti-inflammatory drugs
* Patients unable to swallow the study capsules, or take 6 of these capsules a day
* Patients unable to provide informed consent
* Taking dietary supplements (e.g. multivitamins, antioxidants, fish oils) or have taken them within 1-month of the study
* Shows unwillingness, inability or lack of motivation to carry out the study procedures or is not prepared to give written consent or to refrain from using other oral hygiene products (mouthwashes, chewing gum, water piks etc.) or to undergo professional dental cleaning for the duration of the study (other than as part of this protocol)
* Antibiotic or anti-inflammatory therapy currently or in previous two weeks
* Current orthodontic treatment
* Currently participating in another Dental Trial
* Diabetics
Behavioral Intervention for Low Income Depressed Smokers in Drug Treatment

The objective of the proposed project is to develop a novel, behavioral approach to smoking cessation that can be integrated with residential drug use treatment for low income substance using smokers with elevated depressive symptoms. The approach utilizes behavioral activation strategies which have been shown to reduce smoking among community samples and which can be easily targeted for the particular needs of low income substance users.

This project will take place in two phases. In the first phase, the investigators will utilize pilot testing with 10 participants (two groups of 5 individuals) to integrate two existing behavioral activation manuals to develop the Behavioral Activation for Drug Abusing Smokers (BA-DAS). In Phase II, the investigators will randomize 80 patients to either: 1) standard smoking cessation treatment (ST) and nicotine replacement therapy (NRT) or 2) BA-DAS (which includes ST and NRT). Based on the outcome of this preliminary trial, the BA-DAS protocol will be further refined and readied for larger-scale clinical trials to develop a comprehensive approach to treating smoking among low income, largely minority, depressed smokers in residential drug use treatment, which may be instrumental in reducing smoking among this especially at risk group.

Eligibility Criteria:
Inclusion Criteria:

* between 18 and 65 years of age
* regular smoker for at least one year
* currently smoking an average ≥ 10 cigarettes (also cigarellos, bidis, or Black and Milds included) per day
* report motivation to quit smoking in the next month
* report elevated depressive symptoms

Exclusion Criteria:

* physical concerns contraindicating the nicotine patch
* limited mental competency and/or the inability to give informed, voluntary, written consent to participate
* current use of pharmacotherapy for smoking cessation not provided by the researchers during the quit attempt
* use of psychotropic medication for \< 3 months
* primary use of other tobacco products (specifically: chewing tobacco, cigars, and pipes)
* psychotic symptoms
* current pregnancy or plans to become pregnant within the following three months
Kinesiotaping Along with Mulligan's Mobilization with Movement in Adhesive Capsulitis

The study aimed to evaluate the effectiveness of combining Kinesiotaping with Mulligan's mobilization with movement in treating shoulder adhesive capsulitis. Thirty patients participated in a randomized control trial, divided equally into an experimental group and a control group. The experimental group received Kinesiotaping, Mulligan's mobilization with movement, and conventional physiotherapy, while the control group received only Mulligan's mobilization with movement and conventional physiotherapy. Pain, range of motion, and functional outcomes were measured using a visual analogue scale, goniometer, and the Shoulder Pain and Disability Index (SPADI) questionnaire.


Eligibility Criteria:
Inclusion Criteria:

* Primary adhesive capsulitis,
* Controlled diabetes mellitus,
* Restriction of movements in capsular pattern,
* Shoulder pain for more than one month.

Exclusion Criteria:

* Secondary adhesive capsulitis,
* Cancer,
* Bilateral adhesive capsulitis,
* Skin infections in the shoulder region,
* Shoulder joint infections,
* Wounds or ulcers in the shoulder region,
* Hypersensitivity to tape,
* Recent shoulder dislocation,
* Recent shoulder fractures.
The Safety and Efficacy of Intralymphatic Immunotherapy in Pollen Allergic Adolescents and Young Adults With Asthma

The study evaluates the safety and efficacy of intralymphatic allergen-specific immunotherapy given to adolescents and young adults who are allergic to grass or birch pollen and have mild or moderate asthma. Patients will be treated with three intralymphatic injections; 1000 SQ-U x3 with 4-5 weeks interval, or placebo with 4-5 weeks interval. The patients receiving treatment will be given a fourth injection one year after the initial injections. The study is conducted in collaboration between Professor Lars Olof Cardell (ENT), prof Gunilla Hedlin (Pediatrics) and prof Marianne van Hage (Immunology)".

30 patients with seasonal allergic rhinitis due to birch or grass pollen are included. Study subjects are randomized to intralymphatic injections with placebo or ALK Alutard 5-grasses / birch or placebo. The patients receiving treatment will be given a fourth injection one year after the initial injections.

Eligibility Criteria:
Inclusion Criteria:

* Allergic rhinitis due to grass or birch pollen
* Mild to moderate asthma with a positive methacholine challenge
* Accepted and signed informed consent.

Exclusion Criteria:

* Previously subcutaneous immunotherapy (SCIT) with total symptom relief.
* Previously SCIT but no symptom improvement at all.
* Sensitizations to house dust mite or furry animals, with ongoing exposure and symptoms.
* Severe atopic dermatitis.
* Patients with significant diseases other than allergic rhinitis. A significant disease is defined as a disease which in the opinion of the investigator may either put the patient at risk because of participation in the study or a disease which may influence the results of the study or the patient's ability to participate in the study.
* Patients with a respiratory tract infection in the past 4 weeks prior to Visit 2.
* Pregnant or nursing women or women of childbearing potential not using a medically approved means of contraception (i.e., oral contraceptives, intrauterine devices, diaphragm, or subdermal implants).
* Known autoimmune or collagen disease
* Cardiovascular disease
* Hepatic disease
* Known renal insufficiency
* Cancer
* Hematologic disease
* Chronic infectious disease
* Any medication with a possible side-effect of interfering with the immune response
* Previous immuno- or chemotherapy
* Disease or conditions rendering the treatment of anaphylactic reactions difficult (symptomatic coronary heart diseases, severe arterial hypertension and treatment with β-blockers)
* Major metabolic disease
* Known or suspected allergy to the study product
* Obesity with BMI \> 30 since subcutaneous fat makes ultrasound imaging of lymph nodes harder which may risk the correct placement of injection.
* Patients who, in the opinion of the investigator, abuse alcohol or drugs within 2 years prior to Visit 1.
* Patients who have taken an investigational drug within 1 month or six half lives, whichever is greater, prior to Visit 1.
* Mental incapability of coping with the study
* Withdrawal of informed consent
Acceptance and Commitment Based Group Therapy for Cancer Patients

This study evaluates the preliminary effects of an Acceptance and Commitment (ACT)-based group therapy compared to individual ACT-therapy for adult cancer patients suffering from psychological distress. Half of the participants will receive ACT in a group setting, while the other half will receive individual ACT.

This study evaluates the preliminary effects of an Acceptance and Commitment (ACT)-based group therapy compared to individual ACT-therapy for adult cancer patients suffering from psychological distress. Participants will be recruited from referrals to the Cancer Rehabilitation Unit at Helsingborg Hospital, Sweden. A total number of 12-20 participants will be assigned to either the experimental group, receiving ACT group therapy, or the Active Control group, receiving individual ACT therapy. Both therapy interventions aim at increasing psychological flexibility. Sociodemographic as well as Medical information regarding their somatic disease will be collected at baseline assessment.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Able to speak and understand the Swedish language
* Cancer patients at hospitals in Skånevård Sund (geographical area)
* Experience of psychological distress related to cancer diagnosis or cancer treatment
* Stable and planned cancer treatment or no ongoing treatment

Exclusion Criteria:

* Severe cognitive problems
* Severe psychiatric disorder
* Ongoing substance abuse
Feasibility Study of Stereotactic Body Radiotherapy (SBRT) for Localized Prostate Cancer: Cyberknife vs. VMAT

Recent studies support the use of Stereotactic Body Radiation Therapy (SBRT) for the treatment of localized prostate cancer (PrCa). SBRT is a way to deliver radiation very precisely allowing higher doses to be delivered with fewer treatments, potentially improving patient outcomes. Cyberknife and Volume Modulated Arc Therapy (VMAT) are accepted SBRT techniques. However, the effects of the specific SBRT treatment technique on patient outcomes have not been evaluated in randomized trials.

Although such a trial would be of great interest, patients' willingness to participate is unclear. Multiple patient and clinician factors contribute to the decision to enter a randomized trial. This feasibility study will evaluate patients' willingness to participate in a trial comparing Cyberknife and VMAT SBRT for the treatment of early stage PrCa. Patients accepting enrolment will be randomized to one of the two types of SBRT delivery. Up to 66 patients will be approached, and up to 40 randomized. A questionnaire will help to identify the factors influencing the patient's decision to participate or not. This study will gather information on feasibility, PSA control, patient outcomes and side effects, and will inform the design of a future randomized phase II/III study.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed diagnosis of adenocarcinoma of the prostate
* Histological evaluation of prostate biopsy with assignment of a Gleason score to the biopsy material; Gleason scores ≤ 7
* Clinical stage T1-2b (AJCC 7th edition)
* PSA ≤ 10 ng/mL. PSA should not be obtained within 10 days after prostate biopsy.
* ECOG Performance Status 0-1

Exclusion Criteria:

* Prior or concurrent invasive malignancy (except non-melanomatous skin cancer) or lymphomatous/hematogenous malignancy unless continually disease free for a minimum of 5 years.
* Evidence of distant metastases
* Regional lymph node involvement
* Previous radical surgery (prostatectomy), cryosurgery, or HIFU for prostate cancer. Previous pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy
* Previous hormonal therapy, such as LHRH agonists or LHRH antagonists, anti-androgens, estrogens, or surgical castration
* Use of finasteride or dutasteride within 30 days prior to registration. PSA should not be obtained prior to 30 days after stopping finasteride or dutasteride.
* Previous or concurrent cytotoxic chemotherapy for prostate cancer
* Age \< 18
* Patient unable to provide study-specific informed consent
* Inability to complete the Expanded Prostate Cancer Index Composite (EPIC) questionnaire