cyrilzakka/clinical-trials huggingface dataset:
Identifying Prognostic Variables for Persistent Upper Limb Dysfunctions After Breast Cancer Treatment

Breast cancer is the most frequently occurring cancer, assuming that it accounts for 29% of all new cancers in women (European Cancer Information System). The number of long-term survivors is increasing rapidly due to improving accuracy of the detecting methods, the early diagnosis and advances in cancer treatment.

The International Consortium for Health Outcomes Measurement Initiative described upper limb (UL) function as the health outcome that matters most for breast cancer survivors (BCS). 50% of BCS at 6 months post-radiotherapy suffer from of decreased UL function, i.e. difficulties in performing activities of daily living with the upper limb. Patients experiencing UL dysfunctions and other problems are less likely to be physically active. Given that physical inactivity is associated with an increased risk of mortality after breast cancer, taking away the barriers to physical activity (e.g. UL dysfunctions) is very important. Identifying these factors contributing to chronic UL dysfunction is important in terms of identifying targets for prospective evaluation and specific treatment approaches at specific time points during breast cancer treatment.

There is a need to rethink the follow-up strategy (besides the treatment of the cancer itself) and develop a clinical care pathway consisting of multifactorial screening instruments to identify women and men who are in need of extra rehabilitation efforts and specific rehabilitation goals to alleviate symptoms and side effects experienced by breast cancer survivors. This clinical care pathway should cover all aspects of the International Classification of Function, Disease and Health (ICF), a biopsychosocial framework that conceptualizes a person's level of functioning and bodily structures, activity and participation and contextual factors (including personal and environmental factors).

The present study aims to identify the factors, during and after breast cancer treatment, contributing to persistent Upper Limb (UL) dysfunctions.


Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for surgery (mastectomy or breast conserving surgery; in combination with axillary lymph node dissection or sentinel node biopsy) for unilateral primary breast cancer or patients with oligometastatic breast cancer.
* Patients with a cognitive and language functioning enabling coherent Dutch communication between the examiner and the participant
* Patients who can comply with the protocol at baseline assessment and willing to provide written informed consent

Exclusion Criteria:

* BCS with widespread distance metastases, previous breast surgery, or planned bilateral surgery
* And/or with a diagnosis of a neurological or rheumatological condition,
* And/or BCS who are not available the entire duration of the study
Uncontrolled Postviral Asthma and Persistent Symptoms After COVID-19

Patients with long covid referred for physical rehabilitation at the Norwegian Sports Medicine Centre - Football Association in Oslo, Norway, were assessed for postviral asthma.

All patients performed methacholin bronchial provocation test, and those with a negative bronchial provocation were eqipped with an app-based spirometer to detect excessive lung variability. Eventual detection of postviral asthma will be treated according to GINA guidelines and eventual effect will be assessed by lung function variability and symptoms.

Eligibility Criteria:
Inclusion Criteria:

° Patients with long covid for more than 6 months referred for physical rehabilitation

Exclusion Criteria:

° None
Maintenance Gabapentin to Prolong Pregnancy.

This is a pilot study to evaluate the tolerability and effects of maintenance gabapentin therapy on the rate of premature birth in women who have had preterm labor.


Eligibility Criteria:
Eligibility Criteria:

1. Healthy 18-45 year old female with singleton pregnancy, 20-34 weeks gestation, without ruptured membranes.
2. Preterm labor defined as regular uterine contractions of at least 6/hour for ≥ 1 hour with ≥ 1cm of cervical dilation or ≤ 2.5cm cervical length or any documented cervical change from the initial pelvic exam.
3. Cervical dilation not more than 4cm.
4. Initiation of a tocolytic agent (e.g. magnesium sulfate, nifedipine, indomethacin) within the previous 72 hours.
5. Pregnancy not conceived through in-vitro fertilization (IVF) due to the known higher rates of congenital defects associated with this procedure.30
6. No placenta praevia or abruptio placentae or cervical cerclage.
7. No intra-uterine growth restriction or non-reassuring fetal status.
8. No known serious fetal malformations.
9. No chorioamnionitis or medical/psychiatric/substance abuse comorbidity that may complicate the pregnancy or interfere with the subject's ability to comply with study procedures in the opinion of Dr. Guttuso or the subject's obstetrician.
10. No history of suicide attempt. No suicidal thoughts over past 6 months.
11. Not currently receiving gabapentin, pregabalin, progesterone or a known teratogenic medication and no known allergy to gabapentin therapy.
A Study Comparing Corticosteroids Alone Versus Corticosteroids and Extracorporal Photopheresis (ECP) as First-line Treatment of Standard II Acute Graft-versus-host Disease

Acute graft versus host-disease remains a major cause of morbidity and mortality after allogeneic hematopoietic stem cell transplantation. The incidence of grade II to IV acute GVHD ranges from 30 to 50% of the patients transplanted. Steroids remain the standard first line treatment for acute GVHD.

Prolonged exposure to steroids is associated to increased risk of infections and of osteoporosis, osteonecrosis and alteration of growth in children. Thus, reducing steroid exposure in order to reduce treatment-related morbidity is another important goal in the management of standard risk aGVHD.

Extracoporeal photopheresis (ECP) is active in controlling steroid refractory or dependent acute GVHD.

Hypothesis:

In this study, the team hypothesizes that addition of ECP to first line treatment with 2 mg/kg steroids of standard risk grade II aGVHD can reduce steroid exposure by increasing the probability of 6 month FFTF including absence of systemic steroids for chronic GVHD.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years ;
* Having received an allogeneic stem cell transplantation for any malignant or non-malignant hemopathy and whatever the type of donor and graft.
* with grade II acute GVHD with skin involvement (stage 1-3 skin +/- stage 1 gastro intestinal) in the 3 months following the allogeneic stem cell transplantation
* acute GVHD in the first line treatment
* validation of the presence of peripheral or central venous access allowing to perform 2 ECP per week during 3 months. In the absence of a pre-existing and adpated central catheter at the time of inclusion, peripheral venous access will be preferred
* Leucocytes \> 1.5 G/L
* Platelets \> 30 G/L, Haematocrite \> 27% (allowed transfusions)
* Patient affiliated to a French Social Security regimen
* information consent form signed.

Exclusion Criteria:

* acute GVHD of grade I
* acute GVHD of grade \> II
* progressive hematologic disease at inclusion
* uncontrolled ongoing infection at time of inclusion: bacterial or fungal infections, increasing CMV viral load.
* patient with HIV positivity or replicative HBV or HCV infection
* Contraindications for UVADEX / photopheresis / stéroids / posaconazole / heparin
* Patient with a history of deep venous thrombosis
* Pregnancy
* Women of child bearing potentiel not using contaception
Use of N-Acetylcysteine (NAC) in Fingernail Biting

To conduct a pilot randomized placebo-controlled feasibility trial of N-acetylcysteine (NAC) in onychophagia, preliminarily assessing the tolerability and effects of this pharmacotherapy on young adults who bite their fingernails. It is proposed that NAC will help decrease fingernail biting.

This is a proof-of-concept pilot placebo-controlled trial of N-acetylcysteine (NAC) in young people who bite fingernails. The primary interest is in assessing the feasibility of conducting this line of research, while preliminarily exploring potential effects on nail biting, as measured by nail length.

Eligibility Criteria:
Inclusion Criteria:

* 1. Age 18-30 2. Fingernail biter for ≥5 years

Exclusion Criteria:

* 1. Any unstable major DSM-IV Axis I psychiatric disorder in the past month (e.g., psychotic disorders, bipolar disorder, major depressive disorder) 2. Current substance dependence in the past month 3. Current unstable major medical disorder or medical condition in the past 6 months (e.g., renal impairment) 4. Current pregnancy or breastfeeding 5. Current seizure disorder or asthma, due to possible elevated risk for adverse effects with NAC in individuals with these conditions 6. Known hypersensitivity to NAC 7. Use of carbamazepine or nitroglycerin (or any other medication deemed to be hazardous if taken with NAC) within 14 days of study participation
Combined tDCS and TMS on Subjective Tinnitus and Combined Depression

The investigators combined transcranial direct current stimulation (tDCS) and transcranial magnetic stimulation (TMS) to increase the effective response of a single session of neuromodulation in subjective tinnitus.

To treat motor and psychiatric disorders, transcranial direct current stimulation (tDCS) and transcranial magnetic stimulation (TMS) are world-widely in use in clinics. The investigators combined these two types of neuromodulation techniques to increase the effective response of a single session of neuromodulation in subjective tinnitus. Experimental groups with 80 tinnitus subjects consisted of four different treatment groups which are tDCS, tDCS with sham TMS, tDCS-TMS and TMS group. Subjects were given 1.5milliampere (mA) tDCS on the bi-frontal area and TMS stimulated contralateral single side of the temporoparietal cortex with 200 pulses at 1herz (Hz) stimulation.

Eligibility Criteria:
Inclusion Criteria:

* Research volunteers who agreed to participate in the clinical trial were gathered from the tinnitus clinic of the Department of Otorhinolaryngology Head-and-Neck Surgery, Seoul National University Bundang Hospital

Exclusion Criteria:

* psychoactive drug user
* implanted material
* pacemaker user
ProSat - Effect of Probiotics on Satiety

The aim of the ProSat study is to examine the effects of a probiotic capsule containing one of two doses (low and high dose) of Lb. Casei on subjective appetite sensation, ad libitum energy intake, and appetite hormone response in a single meal test and to determine whether the acute effects persist after daily supplementation of the probiotic capsule.


Eligibility Criteria:
Inclusion Criteria:

* Healthy men and women
* Normal to slight overweight (BMI: 22-28 kg/m2)
* 20-45 years of age

Exclusion Criteria:

* Smoking
* Daily medicine use (oral contraceptives excluded)
* Use of pre- and probiotic supplements and foods
* Blood donation 3 months prior to the study
* Hb\<8mmol/l
* Chronic illnesses such as hyperlipidemia, diabetes inflammatory diseases
* Pregnancy or breastfeeding
* Elite athletes (\>10 hours hard exercise/week)
* Vegetarians
Evaluation of Prophylactic Heated Humidification on Obstructive Sleep Apnea (OSA) Patient Short Term Compliance to CPAP Therapy

To compare two different clinical strategies in order to evaluate the impact of prophylactic heated humidification on OSA patients' compliance to CPAP therapy.

To compare two different clinical strategies in order to evaluate the impact of prophylactic heated humidification on OSA patients' compliance to CPAP therapy.

Eligibility Criteria:
Inclusion Criteria:

* Adult Patient
* Newly diagnosed OSA Patients eligible to CPAP therapy
* Signed informed consent

Exclusion Criteria:

* CPAP therapy contraindications
* Pregnancy
* Patient unable to come to study follow up visits or unable to finish the study.
* Informed consent not signed
* Adults who are subject to a legal protection measure or are unable to express their consent (such as patients under guardianship and patients deprived of judicial or administrative freedom)
A Study to Investigate the Safety and Efficacy of KQB198 as Monotherapy and in Combination in Participants With Advanced Hematologic Malignancies

The goal of this clinical trial is to learn if KQB198 works to treat advanced hematologic malignancies in adults. It will also learn about the safety of KQB198. The main questions it aims to answer are:

* What is the safe dose of KQB198 by itself or in combination with other anti-cancer drugs?
* Does KQB198 alone or in combination with other anti-cancer drugs decrease the size of the tumor?
* What happens to KQB198 in the body?

Participants will:

* Take KQB198 daily, alone or in combination with another anti-cancer drug
* Visit the clinic about 8 times in the first 8 weeks, and then once every 4 weeks after that


Eligibility Criteria:
Inclusion Criteria:

* Adequate organ function

Part 1 and Part 2, Cohort B Participants Only:

• Ph+ CML in chronic phase who have been previously treated with at least 2 different tyrosine kinase inhibitors (TKIs) and are relapsed from or intolerant to those TKIs and ineligible for alternative therapeutic options likely to produce clinical benefit as determined by the investigator.

Part 2, Cohort A Participants Only:

• Participants with Ph+ CML in chronic phase who are on dasatinib prior to study entry and have a warning or failure to dasatinib as determined by the investigator per ELN 2020 guidelines

Exclusion Criteria:

* CML in accelerated or blast phase
* Prior therapy with a similar mechanism of action to KQB198
* History of intestinal disease, inflammatory bowel disease, major gastric surgery, or other gastrointestinal conditions likely to alter absorption of study treatment or result in inability to swallow
* History of interstitial lung disease
* Cardiac abnormalities
Post Thrombotic Syndrome Prevention Study

This is a two arm, prospective, single center, randomized clinical trial. Subjects will be randomly assigned into one of two groups using block randomization technique in a 1:1 ratio. The control group will receive care using elastic compression stocking and the intervention group will use the ACTitouch device. Stratified randomization will occur based on whether the Deep Vein Thrombosis (DVT) has iliac or non-iliac involvement. Subjects will be followed for 2 years with clinic visits occurring at 1, 3, 6, 12, and 24 months.

The purpose of this study is to determine if use of a pneumatic compression device (ACTitouch, Tactile Medical) is beneficial in improving or preventing the development of Post Thrombotic Syndrome (PTS). 84 patients who have a history of an acute proximal unilateral leg DVT diagnosed one or more months prior to enrollment, or diagnosed with a chronic proximal unilateral leg DVT at time of enrollment, on duplex or other imaging study will be randomized into two groups: the control group receiving the standard of care compression stockings and the intervention group receiving ACTitouch device.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age or older
* History of an acute proximal unilateral leg DVT diagnosed one or more months prior to enrollment, or diagnosed with a chronic proximal unilateral leg DVT at time of enrollment, on duplex or other imaging study (i.e MRV, CTV, venogram)
* Current anticoagulation therapy
* Physical ability to independently don ACTitouch or availability of help to place device

Exclusion Criteria:

* Current diagnosis of PTS or PTS symptoms
* Diagnosis of acute DVT less than 30 days prior to enrollment
* History of prior ipsilateral DVT
* Chronic venous insufficiency (CVI) with a CEAP 4 or greater and/or noted changes in the deep system during the diagnosing duplex
* Morbid Obesity (BMI \> 45)
* Congestive heart failure with symptoms not controlled by medical intervention
* Pulmonary edema, active, with symptoms not controlled by medical intervention
* Peripheral artery disease (PAD) unless the patient has an ankle pressure of 60mmHg or more
* Walking disability (immobile)
* Women who are pregnant or trying to become pregnant
* Any other condition in which compression would be contraindicated as determined by the treating physician
The Effect of a Vegan Alginate Product on Athletes Recovery and Performance

The feeding strategies during recovery are essential to optimize a subsequent performance. Carbohydrate is a major fuel source during exercise as it has been shown to maintain high rates of carbohydrate oxidation. Protein intake in combination with carbohydrate have been shown to increase Amino acid bioavailability and may alter physiologic responses during exercise, which may be relevant to endurance performance. The goal of this study is to assess the effect of a new developed vegan product on athletes recovery and subsequent performance.


Eligibility Criteria:
Inclusion Criteria:

* males between 18-50 years of age
* moderate to trained individuals with a VO2max \> 50 ml/min/kg

Exclusion Criteria:

* persons diagnosed with metabolic diseases (i.e. Type 2 Diabetes) which relates to the carbohydrate metabolism.
* persons ingesting prescribed drugs/medicin, supplements or a special diet (i.e. low carbohydrate), which might affect the glykogen synthesis and/or performance.
A Multicenter,2-Arm,Randomized,Controlled Study Evaluate the Effectiveness of the UltraShape® Contour I VER 3.1 System for Non-Invasive Reduction in Abdominal Circumference

The primary objective of this study is to evaluate the effectiveness of the Contour I VER 3.1 System on abdominal midsection circumference reduction relative to no treatment.

The secondary objective of this study is to assess subject satisfaction measured with a self-assessment questionnaire


Eligibility Criteria:
Inclusion Criteria:

1. Female or male subjects, 18 and 65 years of age at the time of enrollment
2. Abdominal fat thickness of at least 1.5 cm (measurement by caliper)
3. For women of child-bearing potential:

   1. negative urine pregnancy test.
   2. Women of child bearing age are required to be using an acceptable form of birth control for the duration of the study.
4. General good health confirmed by medical history and skin examination of the treated area
5. Written informed consent to participate in the study
6. Ability to comply with the requirements of the study
7. BMI ≤ 30

   Intra-procedural Inclusion criteria (prior to starting the treatment phase):

   subjects are eligible to continue the study and participate in the treatment phase if she meets all of the following intra-procedural inclusion criteria:
8. For women of child-bearing potential: negative pregnancy test
9. Abdominal fat thickness of at least 1.5 cm prior to initial treatment (measurement by caliper)

Exclusion Criteria:

1. History of hypertension, ischemic heart disease, valvular heart disease, congestive heart failure, pacemaker/defibrillator, abdominal aortic aneurysm
2. Current hyperlipidemia, diabetes mellitus, hepatitis, liver disease, HIV positive status, blood coagulopathy or excessive bleeding, autoimmune or connective tissue disease or malignancy.
3. Previous liposuction in the treatment area
4. History of skin disease in the treatment area, known tendency to form keloids or poor wound healing
5. Skin lesions in the treatment area other than simple nevi on physical examination (e.g., atypical nevus, tattoo, abrasions) including depressed scars in the treatment area
6. Poor skin quality (i.e., laxity)
7. Abdominal wall diastasis or hernia on physical examination
8. Abnormal kidney, liver or coagulation functions, abnormal lipid profile or blood count within the last 3 months
9. Obesity (BMI \> 30)
10. Childbirth within the last 12 months or breastfeeding women.
11. Any acute or chronic condition which, in the opinion of the Investigator, could interfere with the conduct of the study
12. Unstable weight within the last 6 months (i.e., ± 3% weight change in the prior six months)
13. Inability to comply with circumference measurement procedure (e.g., inability to held breath for the required duration)
14. Participation in another clinical study within the last six months.
15. Previous body contouring treatments in the areas of the abdomen and flanks.
Methotrexate Alone vs Combination With Excimer Light in Nail Psoriasis

The aim of this study is to compare the efficacy of excimer laser in combination with intralesional MTX injection to intralesional MTX injection alone in treating nail psoriasis

Psoriasis is a chronic inflammatory disease affecting the skin, nails, and joints. Approximately 61% of psoriatic patients have nail involvement. This percentage can increase up to 90% in patients with psoriatic arthritis. Clinically, nail disease has many presentations depending on the location of the inflammatory process in either the matrix, the nail bed, or the periungual tissue, which results in distinct injury patterns.

Nail psoriasis can lead to impairment in the quality of life and work function due to pain, discomfort, and poor esthetic aspect. Treating nail involvement is important in improving the health outcomes and quality of life among patients with psoriasis. Nail psoriasis is a clinical diagnosis generally made in the context of existing psoriatic skin lesions. The nail psoriasis severity index (NAPSI) has recently been reported as a possible reproducible, objective, and simple tool for clinical assessment of psoriatic nail disease.

Treatment of nail psoriasis is challenging because of the anatomical properties of the nail unit that act as a barrier to active drug delivery and the naturally slow growth rate of the nail plate, which often delays noticeable clinical responses by months. Treatment options available for nail psoriasis include topical therapy, intralesional injections, and systemic and biologic agents. Poor penetration of topical therapy into the nail and surrounding tissue, adverse effects and monitoring of systemic therapies, and patient adherence to therapy make the treatment of nail psoriasis a challenge.

Few publications have been recently concerned intralesional injection of methotrexate in nail psoriasis. This therapy was documented for the first time in 2011. Intramatricial injection of methotrexate is an interesting intralesional therapy as it provides a higher concentration of the drug at the site of action, while avoiding the complications seen with triamcinolone acetonide (injection site atrophy, disappearance of the phalanx under injection, or tendon rupture) The use of excimer laser for the treatment of psoriasis was first documented in 1997. The excimer laser induces T-cell apoptosis characterized by breaks in DNA strands as well as expression of mitochondrial proteins associated with cell death.

Eligibility Criteria:
Inclusion Criteria:

* patients with bilateral fingernail psoriasis will be recruited. The diagnosis will be based upon the clinical characteristics of nail psoriasis.
* Patients will be included after they have stopped any systemic therapy for at least 8 weeks.

Exclusion Criteria:

* Pregnant or lactating woman
* Patients with history of photosensitivity or keloid formation.
Optimizing the Effect of COPD Rehabilitation

Patients with Chronic Obstructive Pulmonary Disease (COPD) may benefit from an 8-week pulmonary rehabilitation programme. However, the effect of the programme tends to attenuate with time. Patients who complete the programme are randomized to continued rehabilitation follow-up and control follow-up.

Patients with Chronic Obstructive Pulmonary Disease (COPD) may benefit from an 8-week pulmonary rehabilitation programme according to guidelines of the Danish Society of Pulmonary Medicine. However, the effect of programme tends to attenuate with time. Patients who complete the programme are randomized to continued rehabilitation follow-up and control follow-up.

Eligibility Criteria:
Inclusion Criteria:

* FEV1 \< 60% of expected

Exclusion Criteria:

* Other severe chronic conditions