bioihbjkbjnl/mcl2 huggingface dataset:
The Importance of Patient Education - A Randomised Controlled Trial
Condition: Osteoporosis; Quality of Life; Level of Adherence; Behavior
MeSH terms: Osteoporosis
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Modification of individual life style factors and fall prevention programmes may have
      significant positive effects on fracture incidence. Also, a large number of studies have
      demonstrated that pharmacological therapy of osteoporosis is effective; however non-adherence
      to such therapy is a well recognized problem. Few studies, however, have examined the effect
      of particular patient education programmes on knowledge and adherence to therapy.

      We hypothesised that a group-based, multi-disciplinary, education programme increases the
      total quality of treatment for patients with osteoporosis, Patients' knowledge on
      osteoporosis and adherence with pharmacological therapy ect.

      A total of 300 patients, recently diagnosed with osteoporosis and started on specific
      treatment, were randomised to either the "school" or "control" group. In the school-group,
      patients attended four classes with 8-12 participants during four weeks (a total of 12
      hours). Teaching was performed by nurses, physiotherapists, dieticians, and doctors and was
      based on dialogs and situated learning. The classes covered "facts on osteoporosis",
      "fractures and pain", "diet", "preventive measures", "balance and exercise", and "medical
      treatment". Teaching was designed to increase empowerment. The control group were offered the
      department's standard treatment including follow-up visits.

      All 300 patients received questionnaires regarding "Knowledge about Osteoporosis", "Level of
      Adherence", "Quality of life", "Dietary calcium intake", "Level of physical activity", "Falls
      events" registered every month by postcard, at inclusion and after 3, 12, and 24 month. BMD
      was examined by DXA-scan at inclusion and after 12 and 24 month. The last patient will answer
      the questionnaires first of May 2007.
    


Intervention name(s): Group based multidisciplinary patient education programme
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Group based patient education,; multidisciplinary,; physical activity,; adherence to treatment,; quality of life
Exercise Training in Chronic Obstructive Pulmonary Disease (COPD)
Condition: COPD
Study type: Interventional

Summary: 
      Exercise training is the key component of respiratory rehabilitation.The success of long-term
      program resides in the integration between exercise prescription and patients'compliance with
      home training. This can be difficult for patients, especially in terms of understanding the
      exercise intensity.

      This study is designed to evaluate different methods of exercise training at home, to help
      understanding and maintaining the walking intensity in COPD patients. Outcome: exercise
      performance, daily physical activity and respiratory function.
    


Intervention name(s): Home exercise training; NO Exercise Training
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 20-30 min/day for at least 4 days/week; No intervention
Other intervention name(s): Pulmonary Rehabilitation; No intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: COPD; home exercise training
Efficacy of Proton Pump Inhibitor for Chronic Cough Caused by Gastroesophageal Reflux; Double-blind, Placebo-controlled, Randomized Clinical Trial
Condition: Chronic Cough Caused by Gastroesophageal Reflux
MeSH terms: Gastroesophageal Reflux; Esophagitis, Peptic; Cough
Study type: Interventional

Summary: 
      Efficacy of proton pump inhibitor for chronic cough caused by gastroesophageal reflux;
      double-blind, placebo-controlled, randomized clinical trial
    


Intervention name(s): High-dose PPI; standard PPI; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): :40mg, po(per oral) 2times.day, 8weeks; : 40mg, po(per oral) 1times.day, 8weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Chronic cough, proton pump inhibitor, GERD, nonacid reflux,
A Phase 2 Durability of Response Study of CTP-543 in Adult Patients With Moderate to Severe Alopecia Areata
Condition: Alopecia Areata
MeSH terms: Alopecia; Alopecia Areata
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a two part, double-blind, randomized, multicenter study to evaluate the regrowth of
      hair with CTP-543 and subsequent durability of that regrowth following dose reduction in
      adult patients with moderate to severe alopecia areata.
    


Intervention name(s): CTP-543; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral dosing; Oral dosing
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: CTP-543
Tamoxifen to Prevent Bone Loss and Heart Disease in Premenopausal Women Receiving Chemotherapy for Stage I or Stage II Breast Cancer
Condition: Breast Cancer; Osteoporosis
MeSH terms: Breast Neoplasms; Osteoporosis
Study type: Observational

Summary: 
      RATIONALE: Tamoxifen may be able to increase bone density and decrease cholesterol in women
      who are undergoing chemotherapy for breast cancer.

      PURPOSE: Clinical trial to study the effectiveness of tamoxifen in preventing bone loss and
      heart disease caused by chemotherapy treatment in premenopausal women who have stage I or
      stage II breast cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Compare the bone density in the femoral neck and lumbar spine and cholesterol levels in
           premenopausal women with stage I or II breast cancer treated with adjuvant chemotherapy
           with or without tamoxifen.

        -  Collect information regarding breast cancer risk factors, treatment, pathology, diet,
           activity levels, weight, and smoking in these patients.

      OUTLINE: Patients are stratified according to type of treatment (adjuvant chemotherapy plus
      tamoxifen vs adjuvant chemotherapy alone).

      Patients receive adjuvant chemotherapy with or without oral tamoxifen at the discretion of
      the treating physician.

      Prior to starting chemotherapy, patients undergo blood draw to measure baseline levels of
      follicle-stimulating hormone, estradiol, total cholesterol, high-density lipoproteins, and
      low-density lipoproteins. Patients undergo baseline bone densitometry of the femoral neck and
      lumbar spine to assess bone density prior to starting chemotherapy or within 30 days of the
      first drug treatment. Laboratory studies and bone densitometry are repeated at years 1 and 2.
      A comparison is made between the study findings at baseline and at years 1 and 2.

      PROJECTED ACCRUAL: A total of 80 patients (40 per stratum) will be accrued for this study.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with stage I or II breast cancer currently undergoing treatment with either
        chemotherapy or tamoxifen.
      
Keywords: osteoporosis; stage I breast cancer; stage II breast cancer
Impact of Increased Protein Density Diet to Muscle Mass and Strength Among Mid-aged and Older Adults
Condition: Muscle Loss; Muscle Weakness; Fragility
MeSH terms: Muscle Weakness
Study type: Interventional

Summary: 
      The subjects of this intervention program are mainly based on community-dwelling mid-aged and
      older adults. The investigator's program will provide meals containing different
      proportionated protein.As this project is a double blind test, only the investigators will
      know which subject corresponding to specific group of diets.

      Besides, the investigators use the valued-based healthcare standard set as well as the Center
      for Epidemiological Studies-Depression, Charlson's comorbidity index Montreal Cognitive
      Assesment ,and Mini Nutritional Assessment as outcome measures and to use the randomized
      controlled trial design to validate if increased protein density diet could improve the
      vitality and health of mid-aged and old adults .
    

Detailed description: 
      With aging, functions of every organs become to decline. Muscle mass, is one of the decline.
      According to previous research, adults would lose 40% among from aged 20 to 70. If muscle
      mass decline combining with the decline of muscle strength is so called Sarcopenia.When
      muscle mass decline, infectious risk gets higher, and resilience after illness gets lower. In
      addition, activity and life quality are also responsible for falling, cognitive difficulty,
      disability and mortality among seniors. We hope to find out the etiologies of Sarcopenia
      through this program and develop prevention strategy and model to mollify the the negative
      effect of rapid aging society.
    

Intervention name(s): 25% protein; 15% protein
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Compared to usual group of 15% protein in meals, intervention group will receive 25% protein contents under same estimated calorie menus. Protein may come from either egg, meat, fish, soy, or milk product.; Designed as comparator , compared to empirical arm of 25% protein in meals, intervention group will receive 15% protein contents under same estimated calorie menus. Protein may come from either egg, meat, fish, soy, or milk product.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This program is designed as a double blind parallel randomized intervention. The primary purpose of this program is Prevention.
Masking: Single (Participant)
Primary purpose: Prevention
Clinical Trial to Evaluate UV-light-induced Allergic Skin Reactions After Application of Delgocitinib Cream
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      Participants will have study medicine applied by site staff- delgocitinib cream or vehicle,
      and then exposed to UV light. The trial is designed to find out if delgocitinib cream can
      cause skin photoallergy after UV-light exposure in people with healthy skin.
    

Detailed description: 
      This is a single-centre, randomised, double-blind, vehicle-controlled, within-subject
      comparison phase 1 trial in Germany.

      The trial consists of a screening phase, an induction phase, a rest phase, and a challenge
      phase. There will be 2 columns of test fields on each participant's back with the 3
      treatments in either column for a total of 6 treatments. One column of test fields will be
      irradiated and the other will not be irradiated. All participants will be exposed to UV-light
      on skin treated delgocitinib cream or vehicle and on untreated skin on test fields to be
      irradiated.
    

Intervention name(s): Delgocitinib cream; Delgocitinib cream vehicle
Intervention type(s): Drug; Drug
Intervention description(s): Cream for topical application; The cream vehicle is similar to the delgocitinib cream except that it does not contain any active ingredient.
Other intervention name(s): LEO 124249 cream
Allocation: Randomized
Intervention model: Single Group Assignment
Intervention model description: All subjects will receive all treatments with treatments randomised over test fields.
Masking: Double (Participant, Investigator)
Primary purpose: Other
Study on Energy Cost Prediction of Cycle Ergometer
Condition: Healthy; Obesity
Study type: Observational

Summary: 
      This study purpose is (1) to develop the new energy expenditure equation; (2) to increase
      accuracy of energy cost prediction of cycle ergometer; (3) to find out some dependent
      factors.
    

Detailed description: 
      Oxygen consumption (ml/min) was measured while subjects were at rest and exercised at four
      submaximal workloads in steady state on cycle ergometer. Bioelectrical impedance analysis was
      used to estimate the body fats and skeletal muscle mass.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        healthy female
      
Keywords: healthy female
Pharmacokinetic, Safety, and Tolerability Study of Risperidone ISM® at Different Dose Strengths
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      This clinical trial is designed to evaluate different dosages of risperidone ISM, a new
      long-acting injectable form.
    

Detailed description: 
      This clinical trial will try to characterize and document the pharmacokinetics of risperidone
      ISM in schizophrenic or schizoaffective patients after one intramuscular injection at
      different dose strengths.Likewise, the safety and tolerability of risperidone ISM will be
      evaluated in the above mentioned population.

      Following confirmation of eligibility and a washout period for study-prohibited drugs, a
      total of 33 subjects will be randomized in a 1:1:1 ratio to receive a single intramuscular
      (IM) injection of one of the following dosages of study drug:

      Group 1: 50 mg risperidone ISM Group 2: 75 mg risperidone ISM Group 3: 100 mg risperidone ISM
      Several blood samples for plasma pharmacokinetic (PK) assessments will be obtained pre-dose
      and post-dose. Safety assessments will be conducted at each pre-specified time points.
    

Intervention name(s): Risperidone ISM 50 mg; Risperidone ISM 75 mg; Risperidone ISM 100 mg
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Risperidone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pharmacokinetics; Safety; Risperidone ISM®; Intramuscular; Schizophrenia
Efficacy of the Transversus Abdominus Plane (TAP) Block for Post-Cesarean Delivery Analgesia
Condition: Pain
Study type: Interventional

Summary: 
      The purpose of this study is to determine if patients having the transversus abdominal place
      (TAP) block at the end of a cesarean delivery have less pain in the post-delivery period than
      those who do not. Freezing medication is injected between the layers of muscle on either side
      of the belly, to freeze the nerves that carry pain stimuli from an abdominal wound. This
      technique has been useful for many abdominal operations, and has recently been studied in
      cesarean sections, however more information is needed.
    

Detailed description: 
      A cesarean section is a surgical procedure and, like all surgeries, there is pain after the
      operation. The purpose of this study is to find out if patients have less pain after a
      cesarean delivery when they receive an injection of local anesthetic on either side of their
      abdomen, into the plane of the transversus abdominis muscle. We are also interested in
      whether or not this injection decreases the need for other pain-killing medication during
      this time.

      Patients will randomly be assigned to receive either local anesthetic or a placebo. In
      addition, all patients will receive the usual standard of care and medication for pain. At 6,
      12, 24 and 48 hours after the operation, patients will be asked about their pain and
      satisfaction with pain management. The risk of side effects is very low, as the block is done
      in an area with low blood supply. We propose that the addition of the TAP block to the
      current multi-modal regimen of post-cesarean pain management will reduce pain scores and
      requests for additional analgesia post-operatively, as well as increase patient satisfaction
      with their pain control.
    

Intervention name(s): ropivacaine; saline solution
Intervention type(s): Drug; Drug
Intervention description(s): 2 injections of 20mL 0.375% ropivacaine - one given on each side.; 2 injections of 20mL plain saline solution - one on each side.
Other intervention name(s): Naropin
Intervention MeSH terms: Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cesarean section
Image Guided Radiotherapy (IGRT) for Prone Partial Breast Irradiation
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      Partial breast irradiation (PBI) is becoming a new paradigm for breast cancer radiation.[1]
      No type I or II evidence is currently available to demonstrate equivalence to standard whole
      breast radiotherapy, and a prospective randomized trial jointly sponsored by NSABP and RTOG
      (NSABP B-39 and RTOG 0413) is currently accruing patients, comparing whole breast
      radiotherapy to PBI, either by brachytherapy or external beam techniques (EB). Until the
      results of this or similar trials are available, PBI remains a research domain, and it should
      be offered to patients only in the context of a clinical experimental protocol.
    

Detailed description: 
      Despite the fact that less extensive experience than that of brachytherapy is available, PBI
      delivery through an external-beam has many advantages. First of all, it is likely to be more
      acceptable to the patient since it is non-invasive and it does not require a surgical
      procedure or anesthesia. Moreover, since it is delivered after surgery, the pathological
      analysis of the segmental mastectomy specimen is available to inform the selection of the
      best candidates. In addition, EB-PBI is likely to become more widely reproducible, since it
      does not rely on the experience and skills of the radiation oncologist performing the
      brachytherapy implant. Besides, once the technique is established, it can be widely applied
      at any facility provided with a linear accelerator, without the risk presented by some
      brachytherapy approaches that can not be completed because of the unfavorable interplay of
      patient's anatomy with the technical limitations of the applicator. Finally, in terms of
      health care economics, an external beam approach spares the costs of an extra surgical
      procedure and that of several days of hospitalization (in the case of LDR brachytherapy).
    

Intervention name(s): IGRT for prone partial breast irradiation (PBI)
Intervention type(s): Other
Intervention description(s): IGRT for prone partial breast irradiation (PBI): All patients will be treated prone with 6 Gy/fraction delivered in 5 fractions over a 1-week period for a total dose of 30 Gy. Simulation and treatment will be started within 50 days from surgery in order to maximize the chances of optimal lumpectomy cavity visualization on the planning and cone beam CT scans. All patients will be followed monthly for the first 90 days then q3 months for the first year, then yearly for the next 10 years.
Other intervention name(s): IGRT; PBI
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: image guided radiation therapy; partial breast irradiation; breast cancer; breast; cancer; breast preservation; IGRT; PBI
Domperidone in Secondary Progressive Multiple Sclerosis (SPMS)
Condition: Multiple Sclerosis, Secondary Progressive
MeSH terms: Neoplasm Metastasis; Multiple Sclerosis; Multiple Sclerosis, Chronic Progressive; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this clinical trial is to determine if Domperidone in a dose of 40 mg daily
      can prevent worsening of walking ability in people secondary progressive MS. The number of
      participants in this study will be 62. A maximum of 75 people with secondary progressive MS
      will be included. Each patient will be followed for 12 months from inclusion. Domperidone is
      a medication which has been shown to increase levels of the hormone prolactin. The best
      understood function of prolactin is the stimulation of milk production in women after
      delivery. However, the increase in prolactin levels seen in patients treated with standard
      doses of Domperidone (in doses of up to 80mg per day) usually does not lead to clinical
      symptoms. Prolactin has been shown to improve myelin repair in mice. Domperidone therefore
      may also improve myelin repair in people with MS. Domperidone is currently approved in Canada
      to treat slow moving bowels and nausea, for instance in patients with Parkinson's Disease or
      Diabetes Mellitus, where too slowly moving bowels can cause constipation. Domperidone is
      available as a tablet that is usually taken four times per day. Doses up to 80mg per day may
      be used but we estimate that a dose of only 40mg daily will be needed to stimulate myelin
      repair. Domperidone is usually well tolerated.
    

Detailed description: 
      Primary objective

      To demonstrate non-futility of domperidone for reducing progression of disability, as
      measured with the timed 25 foot walk (T25FW), in secondary progressive Multiple Sclerosis
      (SPMS).

      Secondary objectives

        -  To assess the safety of domperidone in the study population for the duration of the
           study.

        -  To assess the effect of domperidone on hand dexterity as measured with the 9HPT

        -  To assess the effect of domperidone on cognition, as measured with the SDMT

        -  To assess the effect of domperidone on health related quality of life, as measured with
           the MSQOL-54

        -  To assess the effect of domperidone on fatigue, as measured with the MFIS

        -  To establish the Simon-2-stage model as a study model in MS research. The application of
           this methodology to studies in progressive MS will have important consequences for the
           design and conduct of clinical and translational research in progressive MS, in
           particular for phase II trials in progressive MS
    

Intervention name(s): Domperidone
Intervention type(s): Drug
Intervention description(s): Simon-2-stage design for domperidone futility
Other intervention name(s): domperidone maleate
Intervention MeSH terms: Domperidone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment