cyrilzakka/clinical-trials huggingface dataset:
Treatment of Fistula in Ano With Autologous Fatty Tissue Cells Transplantation

This is a prospective interventional study on the treatment of transsphincteric fistula in ano. After abdominal or thigh liposuction, fat was injected around the fistula tract that was then transected percutaneously with a sharp cannula and fat injected between and around the cut parts. The internal opening was closed with a suture. Minimum follow up of 12 months is planed

The study is intended to be carried out at the Department of Surgery of Uppsala University Hospital, as a single-center study. All (consecutive) otherwise healthy patients between the ages of 18-70 who have been diagnosed with perianal fistula where attempts to close the fistula is considered appropriate are asked to participate. This is done by the examining physician at their visit at the outpatient clinic. These are either patients who already have a relieving seton or those who need to be revised and treated with a seton before final closure.

They receive written information about the study plan and have time to think about it. If they choose to participate in the study, they are planed for a visit to one of the surgeons involved in the study and here get another opportunity to ask questions and then also sign an informed consent. This step can be adjusted as telephone contact due to the Covid-19 pandemic. Thereafter, they are included in the study.

The participants are operated on only by the surgeons involved, all of whom have undergone practical training in how fat cell transplantation is carried out according to the standardized Coleman method.

The procedure itself then takes place as a day surgery operation at the Samariter Hemmet ( part of the Surgical Department, Uppsala University Hospital ) operating department and either as a one- or two-step procedure, depending on whether they have a relieving seton or not. The seton has to be placed sometime before the definitive fatty tissue procedure so that there is no sign of inflammation/infection.

A 3- and 12-months follow up visit is then arranged. In these visits, the patients are examined for evaluation of the result, possible residual fistulas, and complications. Wexner score and VAS scale are filed in and saved in their patient files.

Eligibility Criteria:
Inclusion Criteria:

* Verified perianal or rectovaginal fistula
* Healthy individuals that can be accepted for an elective operation with total anesthesia.
* Signed consent

Exclusion Criteria:

* Patients under the age of 18 or over the age of 75 years
* Another disease that can affect the perianal are or the procedure
* Patients that are not able to understand and sign the consent themselves.
Short and Long Term Effects of IASTM and ESWT Therapy in Individuals With Lateral Epicondylitis

Pain, decreased grip strength, and loss of function are observed in individuals with lateral epicondylitis. The aim of this study is to investigate the effects of ESWT and IASTM applications on pain, grip strength and function in individuals with lateral epicondylitis.

The study will be carried out on volunteers after the approval of the ethics committee. Before the research, individuals and / or their relatives will be informed about the purpose and content of the study. Participants will be randomly divided into three groups: IASTM, ESWT and home exercise group. In addition to home exercise, IASTM and ESWT groups will be given 2 sessions per week for 4 weeks. Pain, grip strength and functionality of the participants will be evaluated before the application, after 4 weeks of application and 4 weeks after the end of the application.

Eligibility Criteria:
Inclusion Criteria:

* being diagnosed with chronic LET by a physician
* visual analog scale (VAS) pain score ≥ 3

Exclusion Criteria:

* any accompanying pathology in the wrist and forearm, such as a fracture or dislocation of the elbow;
* treatment with corticosteroid injections in the past 6 months
Enhancing Uptake of Family Planning Services by HIV-Infected Women Attending the PMTCT Program

A specific organized program utilizing peers in the PMTCT clinic who provide family planning information and support to HIV infected mothers was compared to providing standard family planning messages currently used in the clinic.

A planned group education structural intervention utilizing peers in the PMTCT clinic who provide family planning information and support to HIV infected mothers was compared to the standard of care which consisted of providing standard family planning messages to women attending the PMTCT Clinic. The study had two phases.

The Formative Phase consisted of six focus group discussions and six in depth interviews.

In the Implementation Phase, patient attendance and family planning uptake summaries for during implementation were monitored and summarized daily. Weekly average summaries were considered as time points.

Eligibility Criteria:
Inclusion Criteria:

* This being a program based intervention, all HIV positive mothers who utilize the PMTCT and post natal clinic during the study period will be enrolled.

Exclusion Criteria:

* none
Efficacy of Biphasic Insulin Aspart 30 in Subjects With Type 2 Diabetes Failing on OADs

This trial is conducted in North America. The aim of this trial is to investigate the efficacy of biphasic insulin aspart 30 in subjects with type 2 diabetes not achieving glycaemic targets on OADs (oral anti-diabetic drugs).


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes mellitus for at least 12 months
* HbA1c between 7.5-14.5% (inclusive) at screening
* Insulin naïve
* An antidiabetic regimen that has been stable for at least 3 months prior to screening
* An antidiabetic regimen that includes a minimum of 2 OADs

Exclusion Criteria:

* Use of any insulin preparations within the past 6 months
* Active proliferative retinopathy or maculopathy requiring treatment within 6 months prior to screening
Pharmacokinetic Study of Porfiromycin in Head and Neck Cancer and Other Cancer Patients With Solid Tumors

Study to determine the steady-state pharmacokinetics and urinary excretion of porfiromycin and major metabolites in head and neck cancer and other cancer patients with solid tumors who receive radiation therapy.


Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically proven advanced head and neck cancer or other solid tumors undergoing radiation therapy
* Patients with prior chemotherapy will be considered if chemotherapy occurred more than 30 days prior to this study
* Patients must be receiving concomitant radiotherapy (RT)
* Performance status of ≥ 70% on the Karnofsky performance scale (KPS)
* Must be ≥ 18 years of age
* Expected survival of at least three months
* Written informed consent

Exclusion Criteria:

* Patients who meet any of the following clinical laboratory criteria:

  * Granulocyte count of \< 2000/mm\*\*3
  * Platelets \< 75,000/mm\*\*3
  * Serum creatinine \> 1.5 times the upper limit of normal
  * Bilirubin \> 1.5 times the upper limit of normal
  * Prothrombin time and partial thromboplastin time \> 1.5 times the upper limit of normal
* Women who are pregnant
* Men and women of child-bearing potential who are unwilling to utilize a medically acceptable method of contraception
* Patients who have any known bleeding disorder at the discretion of the investigator
* Presence of any other life-threatening illness, such as unstable angina, severe oxygen dependent chronic obstructive pulmonary disease, or unstable liver or renal disease
* Treatment with granulocyte colony-stimulating factor, granulocyte-macrophage colony-stimulating factor or Interleukin-1l within 30 days prior to the start of RT
* Patients who have had prior exposure to mitomycin C or porfiromycin
fMRI of Flight of Ideas in Bipolar Disorder

Bipolar disorder is a mental disease characterized by mood dysregulation and arises from manic, depressive or mixed episodes. The observations of the patient's speech and language behaviour due to flight of ideas or loss of goal probably result from an underlying disturbance in semantic networks dealing with semantic associations. The aim of our study will be to have a better comprehension of thought disorders in bipolar disorder by cognitive exploration of semantic processing.

Bipolar disorder is a mental disease characterized by mood dysregulation and arises from manic, depressive or mixed episodes. During these episodes, formal thought disorders are observed, associated to emotional perturbation, behaviour troubles and some psychotic symptoms. During mania, the type of thought disorders observed are derailment, flight of ideas, with an increase in the amount of spontaneous speech and loss of goal. These observations of the patient's speech and language behaviour probably result from an underlying disturbance in semantic networks dealing with semantic associations. These networks have been studied extensively in schizophrenia but remain unknown in bipolar disorder. In this context, the aim of our study will be to have a better comprehension of formal thought disorders in bipolar disorder by cognitive exploration of semantic activation and inhibition.

Eligibility Criteria:
Inclusion criteria

BD patients :

* Men or women, right-handed
* diagnosis of type 1 bipolar disorder, according to the DSM-IV criteria
* aged from 18 to 65 years-old
* Native French speaker
* Affiliated to the social security

Healthy Controls (HC):

* Men or women, right-handed
* aged from 18 to 65 years-old
* Native French speaker
* Affiliated to the social security

Exclusion criteria

BD patients :

* recent alcohol and/or drug abuse or dependence
* significant general medical illness, including neurological disorders or head trauma
* sensorial impairment (visual and/or hearing)
* Contraindication to the use of MRI

HC:

* first-degree-relative history of bipolar disorder, schizophrenia or schizoaffective disorder according to DSM-IV
* recent alcohol and/or drug abuse or dependence
* significant general medical illness, including neurological disorders or head trauma
* sensorial impairment (visual and/or hearing)
* Contraindication to the use of MRI
Risk for Ketonaemia in Type 1 Diabetes Pregnancies With Sensor-augmented Pump Therapy

The ROKSANA study is an open-label crossover RCT with the aim to evaluate whether sensor-augmented pump therapy (SAP) with predictive low glucose suspend technology is associated with an increased risk for ketonaemia during type 1 diabetes pregnancies.

10 pregnant women with type 1 diabetes will be included . Participants will be randomized 1/1 between 12-30 weeks of pregnancy to SAP with predictive stop before low during two weeks or predictive stop on low. Participants will be cross-over to the other group after two weeks (from stop before low to stop on low or vice versa). During the study, participants will be asked to measure blood ketones three times per day.

Eligibility Criteria:
Inclusion Criteria:

* type 1 diabetes
* age 18-45 years
* a singleton pregnancy with ultrasound-confirmed gestational age between 12- 30 weeks.
* treated with 640 insulin pump and have a baseline HbA1c level ≤10%.

Exclusion Criteria:

* a physical or psychological disease likely to interfere with the conduct of the study
* medications known to interfere with glucose metabolism
Tablet-based Aphasia Therapy in the Chronic Phase

Aphasia is one of the most common and disabling disorders following stroke, in many cases resolving in long-term deficits. There is evidence that intensive aphasia therapy is effective for language recovery, even in the chronic phase post-stroke. However, as many patients are left with residual language disorders and intensive aphasia rehabilitation is difficult to achieve, the investigators are exploring tablet-based therapies to further facilitate language recovery in a cost-effective manner.

This study will investigate the clinical effects of intensive tablet-based aphasia therapy as an add-on to conventional aphasia therapy (= high intensive) compared to conventional aphasia therapy (either alone, or in combination with recreational tablet use (= low intensive) in patients with aphasia following stroke, as measured by specific linguistic tests, within task improvements, functional communication and quality of life.

Furthermore, the investigators want to learn more about the recovery of specific underlying language processes via event-related potentials (ERPs). At last, the investigators aim to explore whether patients with aphasia are satisfied with a tablet-based aphasia therapy, whether the app is user-friendly and which barriers the participants might have encountered.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed with mild-severe aphasia (token test score between 7 and 49) after a left hemispheric ischemic or hemorrhagic stroke
* inclusion starting from 6 months post-stroke
* age 18 - 85 years
* being right-handed (according to the questionnaire for handedness, Van Strien)
* mother tongue: Dutch
* imaging (CT or MRI) prior to inclusion
* signed informed consent

Exclusion Criteria:

* history of a previous stroke with persistent (\> 24 hours) language symptoms
* history of other diseases of the central nervous system, psychological disorders and (developmental) speech and/or language disorders
* serious non-linguistic, cognitive disorders (as documented in the patients' medical history)
* inability to perform tablet-based tasks (based on a short training session)
* excessive use of alcohol or drugs
Safety and Efficacy of AFQ056 in Adolescent Patients With Fragile X Syndrome

This Phase IIb study is designed to assess whether 3 doses of AFQ056 are safe and effective in treating the behavioral symptoms of Fragile X Syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Patients with Fragile X Syndrome, who are at least moderately ill based on a Clinical Global Impression Severity score of at least 4 and have qualifying scores on the ABC-C and IQ test at Visit 1

Exclusion Criteria:

* Advanced, severe or unstable disease that may interfere with the study outcome evaluations
* Cancer within the past 5 years, other than localized skin cancer
* Current treatment with more than two psychoactive medications, excluding anti-epileptics
* History of severe self-injurious behavior
* Weigh less than 32 kg
* Females who are sexually active

Other protocol-defined inclusion/exclusion criteria may apply
Cystic Fibrosis Remote Monitoring System

The objective of this study is to determine if interactive technology (i.e. virtual coaching) that facilitates vest therapy goal setting and provides positive reinforcement will increase adherence to vest therapy for airway clearance in individuals with CF.

Cystic fibrosis (CF) is a life-limiting multi-system disease primarily characterized by chronic lung infections and pulmonary symptoms such as cough, dyspnea, and chest tightness. Those with CF rely on numerous pharmaceutical and treatment-based therapies as part of their routine care to maintain lung health. Airway clearance, one such treatment-based therapy, uses breathing techniques and various vibrating devices to mobilize lung secretions and is considered a cornerstone of CF care. Vest therapy, a "shaking vest" that applies pressure and high frequency vibrations to the chest wall is the most commonly used technique for airway clearance in the U.S., but adherence to recommended goals for airway clearance is low. Barriers to adherence include the time limitations and unclear goal setting for effective treatment. A previous pilot study by this research team showed that CF patients find the use of airway clearance vests equipped with both pre-set and individually determined programing capabilities as well as electronic monitoring and transmitting capabilities to be acceptable and feasible. Information such as vest-use time, vest pressure measures, programming choices and symptom reporting is captured by these devices and transmitted to health care teams for review as well as provided to patients to provide feedback on treatment goals. This study aims to determine if providing patients with clearly stated treatment goals and the means to monitor and receive positive reinforcing feedback on vest use through interactive technology (i.e. virtual coaching) will improve vest therapy adherence in individuals with CF.

Eligibility Criteria:
Inclusion Criteria:

* Have a diagnosis of cystic fibrosis
* Be physically capable of and willing to use the study device
* Access to an internet connection
* Access to a mobile device capable of using applications
* Be familiar with how to utilize a mobile device and/or applications
* Self-reported CF-related therapy adherence between 25%-75% on a screening questionnaire

Exclusion Criteria:

* History of solid-organ transplant
* Inability to speak and read the English language
* Any contraindication to vest use for airway clearance
Healthy Prebiotic and Postbiotic Effects of Peanuts and Peanut Butter: College Intervention Trial

Nuts have a prebiotic effect mainly due to their content of fiber and polyphenols, which provide substrates for the human gut microbiota. It is known that prebiotic substances are metabolized by microbiota generating postbiotics substances (products or metabolic by-products secreted by live bacteria or released after bacterial lysis). These products may improve host health and partly explain the health benefits of nut consumption. However, no study has been performed about the pre- and postbiotic effects of peanut and peanut butter consumption. Therefore, researchers propose a new interventional study to assess the impact of daily peanut and peanut butter intake on the organism, evaluating the pre- and postbiotic effects. The metabolome data generated will be correlated with the beneficial effects and cognitive skills. The final aim of this work is to spread a message of the health benefits of peanut consumption for the general population.

To evaluate the possible changes in microbiota and cognitive skills after consumption of roasted peanuts and peanut butter, a three-arm parallel-group randomized, and controlled study is being carried out. Ninety healthy college students were enrolled, according to the sample size estimated. Blood, urine, feces and saliva are being drawing at baseline, 3 and 6 months. Peripheral blood mononuclear cells are being extracted to evaluate the metabolic changes caused by the proposed nutritional interventions. To assess diet and physical activity a 151-items food frequency questionnaire plus a 7-day dietary record and a validated questionnaire Minnesota are being used. To determinate the effects of the intervention on body composition and vascular risk factors, anthropometric, biochemical and clinical measurements are being collected. Possible changes in cognitive skills will be determined from a validated cognitive questionnaire (WAIS-IV, Wechsler Memory Scale-IV (WMS-IV), COPE and HAD). To evaluate inflammation and metabolic status before and after intervention, levels of hormones and signaling molecules will be analyzed in blood samples. The effect of roasted peanut and peanut butter consumption on microbiota will be assayed through identification and quantification of polyphenols and short-chain fatty acids in biological samples, as well as the gut microbiota characterization from DNA extraction.

Eligibility Criteria:
Inclusion Criteria:

- Healthy college students (aged between 18 and 32 years)

Exclusion Criteria:

* History of pathological conditions (cardiovascular diseases, cancer, diabetes and other chronic diseases)
* Alteration of clinical parameters (cholesterol, triglycerides and other markers)
* Peanut allergy or intolerance
* Use of dietary supplements or drugs
* Unusual dietary habits
* Usual consumption of wine and grapes
* Alcohol intake (\>30 g/day in males and \>20 g/day in females)
* Smokers
* BMI \<18.5 or \>25
A Long-term Follow-up Study to Evaluate the Impact of Lumicitabine on the Incidence of Asthma and/or Wheezing in Infants and Children With a History of Respiratory Syncytial Virus Infection

The purpose of this long-term follow-up (LTFU) study is to evaluate the incidence of the clinical diagnosis of asthma and the frequency of wheezing in infants and children with respiratory syncytial virus (RSV) infection who were treated with (lumicitabine or placebo) and have completed their last planned study-related visit in a feeding Phase 2 study (64041575RSV2004).

RSV is a leading cause of lower respiratory tract disease in infants. The primary hypothesis is that treatment of RSV-infected infants/children with lumicitabine (also known as JNJ-64041575 or ALS-008176) will decrease subsequent wheezing/asthma compared to placebo (looks like lumicitabine). The participants who have completed treatment course (lumicitabine/placebo) and last study visit in a previous study, 64041575RSV2004, for the treatment of RSV infection will be enrolled in this LTFU study. The main purpose of this study is to understand the impact of lumicitabine on the occurrence of asthma/wheezing in infants/children with a history of RSV infection. The participants will be assessed via monthly calls with the parents/caregivers and also at site visits at 3, 6,12 and 24 months.

Eligibility Criteria:
Inclusion Criteria:

* Male or female infants and children who were previously randomized in study 64041575RSV2004 for the treatment of respiratory syncytial virus (RSV) infection and who completed the planned course of the study drug and the last study-related visit of study 64041575RSV2004
* The participant's legally acceptable representative must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing for the participant to participate in the study

Exclusion Criteria:

* The participants legally acceptable representative, i.e, parent/legal guardian/caregiver, is not able to maintain reliable communication with the investigator
* Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
Randomized Trial of Adjuvant Chemotherapy With Cisplatin Followed by UFT in Serosa-positive Gastric Cancer (JCOG9206-2)

To evaluate the survival benefit of adjuvant chemotherapy after curative resection with D2 or greater lymph node dissection in T3-4 gastric cancer patients.

Purpose: To evaluate the survival benefit of adjuvant chemotherapy after curative resection in serosa-positive gastric cancer patients, a multicenter phase III clinical trial was conducted by 13 participating centers in Japan. Methods: From January 1993 to March 1998, 268 patients were randomized to either adjuvant chemotherapy (135 pts) or surgery alone (133 pts). The chemotherapy comprised intraperitoneal cisplatin 70 mg/m2 before closing the abdomen, and after surgery intravenous cisplatin 70 mg/m2 (day 14) and 5-fluorouracil (5-FU) 700 mg/m2 daily (day 14-16), and oral FU (UFT) 267 mg/m2 daily from 4 weeks after surgery for the next 12 months. The primary endpoint was overall survival. Relapse-free survival and the site of recurrence were secondary endpoints.

Comparison: gastrectomy with D2 or greater lymph node dissection versus gastrectomy with adjuvant chemotherapy after curative resection in serosa-positive gastric cancer patients.

Eligibility Criteria:
Inclusion Criteria:

1. Curative operation with D2 or greater lymph node dissection
2. Histologically proven gastric adenocarcinoma
3. Macroscopically serosa-positive (T3-4)
4. No metastases to level 3 - 4 lymph nodes station (N0-2)
5. 75 years or younger
6. Negative peritoneal lavage cytology
7. Adequate organ function WBC \>=4000/mm3,Hb \>=11.0g/dl,Plt \>=100.000/mm3,AST/ALT, T.Bil, BUN, Creatinine \<=2.5 x Normal Upper Limit,Creatinine clearance \<=70 ml/min
8. Written informed consent

Exclusion Criteria:

1. Prior chemotherapy or radiotherapy
2. Synchronous or metachronous malignancy in other organs