bioihbjkbjnl/mcl2 huggingface dataset:
Feasibility Study: Safety and Efficacy of the Ulthera® System for Treatment of Axillary Hyperhidrosis
Condition: Hyperhidrosis
MeSH terms: Hyperhidrosis
Study type: Interventional

Summary: 
      Up to 20 subjects will be treated. Subjects will receive two (2) bilateral Ultherapy™ or Sham
      treatments of the axilla. The study hypothesis is that subjects who receive Ultherapy™
      treatment will have a greater reduction in axillary sweating compared to subjects receiving
      Sham treatments. Follow-up visits will occur at 7 and 14 days following treatment #1, and at
      7, 14, 30, 60 and 90 days following treatment #2. At each follow-up visit, assessments will
      be completed to compare the amount of axillary sweating compared to baseline.
    

Detailed description: 
      This study is a prospective, single-center, randomized, sham-controlled, blinded pilot
      clinical trial. Subjects will be randomly assigned to one of two treatment groups in a 2:1
      randomization scheme, two (2) subjects assigned to receive Ultherapy™ treatment to every one
      subject assigned to receive Sham treatment.

      Gravimetric measurement of sweat production and starch iodine tests will be performed, and
      Hyperhidrosis Disease Severity Scale (HDSS) scores will be obtained, prior to treatment and
      at each follow-up visit. Patient satisfaction will also be assessed. Sham treated subjects
      will have the option of continuing to Stage II and receive active treatment after completion
      of their Stage I 90 day study visit.

      In a protocol amendment, the initial Stage I study cohort, excluding Sham treated subjects
      who opt to continue to Stage II, will be recruited to complete one long-term follow-up visit
      at 365 days following subjects' second study treatment. The same follow-up assessments will
      be completed to compare the amount of axillary sweating compared to baseline.
    

Intervention name(s): Ulthera System Treatment; Sham treatment
Intervention type(s): Drug; Drug
Intervention description(s): Focused ultrasound energy delivered below the surface of the skin; Study treatment using the Ulthera System, but delivering no ultrasound energy.
Other intervention name(s): Ultherapy™
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Hyperhidrosis; Axillary sweating; Ulthera® System; Ultherapy™ Treatment; Ulthera, Inc.
Postendodontic Pain on Using Max-i-Probe vs NaviTip as Irrigation Needles
Condition: Symptomatic Irreversible Pulpitis
MeSH terms: Pulpitis
Study type: Interventional

Summary: 
      The aim of this prospective, randomized, clinical trial was to evaluate the effect of the
      side-vented Max-i-Probe versus the end-vented NaviTip as endodontic needles during syringe
      irrigation on post-operative pain in adult patients with symptomatic irreversible pulpitis in
      posterior mandibular teeth.
    

Detailed description: 
      The aim of this prospective, randomized, clinical trial was to evaluate the effect of the
      side-vented Max-i-Probe versus the end-vented NaviTip as endodontic needles during syringe
      irrigation on post-operative pain in adult patients with symptomatic irreversible pulpitis in
      posterior mandibular teeth. Medical and dental history was obtained from all participants in
      this trial and clinical examination for teeth was performed. Participants with symptomatic
      irreversible pulpitis were included. After access cavity preparation, participants were
      randomly assigned to one of the following groups: experimental group (Max-i-Probe) or control
      group (NaviTip). One-visit root canal treatment was performed . Each patient received a 48-h
      diary to record postoperative pain. Post-operative pain was measured at the following time
      points: 4, 12, 24 and 48 hours after root canal treatment.
    

Intervention name(s): Max-i-Probe; NaviTip
Intervention type(s): Device; Device
Intervention description(s): Using Max-i-Probe as endodontic needle during syringe irrigation; Using NaviTip as endodontic needle during syringe irrigation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Early Recognition of Pulmonary Arterial Hypertension in Myelodysplastic and Myeloproliferative Diseases
Condition: Myeloproliferative Disorder; Myelodysplastic Syndromes; Pulmonary Hypertension
MeSH terms: Hypertension, Pulmonary; Pulmonary Arterial Hypertension; Hypertension; Myelodysplastic Syndromes; Myeloproliferative Disorders
Study type: Observational

Summary: 
      Myelodysplastic and myeloproliferative Disease represent conditions with increased risk for
      pulmonary hypertension. However, the exact prevalence of pulmonary hypertension in these
      conditions is not known. The effects of pulmonary hypertension on the clinical picture and
      the symptoms of patients in these conditions needs also further exploration. This exploratory
      study is designed to describe the prevalence of pulmonary hypertension in the population with
      such hematologic diseases, and the stages of pulmonary hypertension as well its effect on
      exercise capacity at time of diagnosis.
    

Detailed description: 
      For early recognition of pulmonary hypertension exercise doppler echocardiography will be
      used in all patients. Patients with elevated pulmonary arterial pressure at rest or during
      exercise (estimated by echocardiography), or with decreased exercise capacity (as a potential
      sign of pulmonary hypertension) are advised to undergo right heart catheterisation.
      Cardiopulmonary exercise testing and six-minute walk distance measurement are performed to
      measure exercise capacity. The described work-up of patients allows precise and objective
      hemodynamic and clinical evaluation.
    

Intervention name(s): echocardiography, right heart catheterisation
Intervention type(s): Other
Intervention description(s): at each patient an echocardiography will be performed at rest and during exercise. For the evaluation of exercise capacity, cardiopulmonary exercise testing and six-minute walk is performed. Right heart catheterisation is recommended to those with suspected pulmonary hypertension.
Other intervention name(s): EDE, RHC
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        patients with known myeloproliferative or myelodysplastic disease as a risk factor for
        pulmonary hypertension
      
Biospecimen description: 
      Samples with DNA will be retained for later examinations at the Department for Genetics, if
      the patient agrees with it (specific question at the patient information).
Effect of Food on the Pharmacokinetics of ORIC-114
Condition: Food Effect in Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      A randomized, 2-part, 2-sequence, 2-period, open-label, crossover study evaluating the effect
      of food on the pharmacokinetics (PK) of ORIC-114 tablet formulation in healthy adult
      subjects.
    

Detailed description: 
      The study will be performed in two parts. Part 1 will assess the effect of food at a lower
      dose of ORIC-114 to first ascertain the degree of food effect (if any) on ORIC-114 exposure
      as a way to ensure the safety of the participating subjects. Part 2 will further assess the
      food effect at a higher dose of ORIC-114.

      If the preliminary Part 1 results clearly show no food effect, Part 2 may not need to be
      conducted upon assessment by the Sponsor.

      If Part 2 is conducted, the dose of ORIC-114 will be selected within the anticipated
      efficacious clinical dose range based on results from Part 1.
    

Intervention name(s): ORIC-114
Intervention type(s): Drug
Intervention description(s): Food effect healthy subjects
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomized, 2-part, 2-sequence, 2-period, open-label, crossover
Masking: None (Open Label)
Primary purpose: Other
Keywords: Food effect; ORIC-114
Topical Salve for Skin Oxygenation and Blood Flow
Condition: Skin Oxygenation; Peripheral Perfusion
Study type: Interventional
Phase: Phase 2

Summary: 
      Delayed wound healing leads to increased risk for infection, and thus increased risk for
      morbidity and mortality. Skin oxygen delivery and peripheral blood flow predict wound
      healing. The investigators will conduct a double-masked, placebo-controlled cross-over
      clinical pilot trial in order to evaluate the effects of a topical, homeopathic/herbal salve
      (Original Healing Salve, Puremedy, Inc.) on skin oxygenation and peripheral blood flow.
    

Detailed description: 
      Delayed wound healing leads to increased risk for infection, and thus increased risk for
      morbidity and mortality. Skin oxygen delivery and peripheral blood flow predict wound
      healing. In order to evaluate the effects of a topical, homeopathic/herbal salve (Original
      Healing Salve, Puremedy, Inc.) on skin oxygenation and peripheral blood flow, the
      investigators will conduct a double-masked, placebo-controlled cross-over clinical pilot
      trial with randomized testing order to evaluate the effects of the salve on cutaneous oxygen
      saturation (TcPO2) and ankle-to-brachial pressure index (ABPI). The investigators will
      recruit thirty-two participants in two cohorts to participate, one with and one without type
      2 diabetes, who are otherwise generally healthy without active wounds, ulcers or skin rashes.
      Both TcPO2 and ABPI will be measured before and after the application of both the
      homeopathic/herbal salve ("active"), and before and after the application of the inert salve
      base ("placebo"). Analyses will compare pre/post changes in TcPO2 and ABPI before and after
      application of the active salve within the same visit, and also compare the changes from the
      active salve to the before and after changes in TcPO2 and ABPI measured from the placebo
      salve. If the Original Healing Salve improves cutaneous oxygenation and/or ABPI, future
      research may evaluate the formula specifically for wound healing and antimicrobial effects.
      Thus the proposed research is a pilot study targeting mechanistic outcomes, which predict
      potential clinical efficacy. The proposed research is significant, as lower cost, more
      effective treatments are needed to improve wound healing and reduce the morbidity associated
      with the complications of delayed wound healing.
    

Intervention name(s): Original Healing Salve (OHS); OHS base only
Intervention type(s): Other; Other
Intervention description(s): Topical salve (Puremedy, Inc.); Olive and beeswax salve base
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Skin oxygenation; peripheral perfusion
Second-Line Treatments for Anovulatory Infertility in PCOS Patients
Condition: Polycystic Ovary Syndrome; Infertility; Anovulation
MeSH terms: Polycystic Ovary Syndrome; Infertility; Anovulation; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      To date, it is still unclear the potential role of laparoscopic ovarian diathermy (LOD) in
      the management of polycystic ovary syndrome (PCOS)-related anovulatory infertility. Metformin
      administration, alone or combined with clomiphene citrate (CC), has shown to be an effective
      and attractive second-line treatment for ovulation induction in women with polycystic ovary
      syndrome (PCOS) after failure of CC treatment. The aim of the present study will be to
      compare in a randomized controlled fashion the efficacy of LOD with metformin plus CC
      administration in the treatment of the CC-resistant PCOS patients.
    

Detailed description: 
      A total of 50 primary infertile anovulatory PCOS patients with documented CC-resistance will
      be enrolled and randomized into two groups of treatment of 25 subjects each. Group A will
      undergo diagnostic laparoscopy followed by metformin plus CC, whereas group B will undergo
      LOD followed by observation. Anovulatory patients will receive IM progesterone. The treatment
      will be of six months followed by nine-month of observation for pregnant patients. The
      incidence of spontaneous menses, and the pregnancy, abortion, and live-birth rates will be
      recorded.
    

Intervention name(s): Metformin plus clomiphene citrate; Laparoscopic ovarian drilling
Intervention type(s): Drug; Procedure
Intervention description(s): Metformin administration will start from 3rd day of a P-induced withdrawal bleeding with a dose of 850 mg (1 tablet daily) and increasing the dosage after one week up to 1700 mg/day (two tablets daily). Clomiphene citrate CC will be administered for five days beginning on cycle day 3rd of a P-induced withdrawal bleeding using a starting dose of 50 mg daily. If ovulation will not occur, the dose will be increased by 50 mg in successive cycles until the ovulation will be achieved or up to a maximal dose of 150 mg daily.; Laparoscopic ovarian drilling will be performed as follows: according to ovary size three to six punctures will be performed at each ovary inserting an insulated needle cautery of 36 mm perpendicularly as possible to the ovarian surface with a cutting current of 100 watt power. Then, the needle will be activated for 2-3 seconds at each point using a coagulating current of 40 watt power. At completion of the procedure, the ovarian surface will be washed with a crystalloid solution and all injured areas will be completely covered with hyaluronic acid gel.
Intervention MeSH terms: Metformin; Clomiphene; Enclomiphene; Zuclomiphene
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Anovulation; Clomiphene citrate; Fertility; Metformin; Ovulation induction; PCOS; Sterility; Treatment; Clomiphene citrate-resistance
Assessment of Effect of Rapastinel on Driving Performance
Condition: Driving Performance
Study type: Interventional
Phase: Phase 1

Summary: 
      Based on the pharmacological class of rapastinel, this study will be conducted to evaluate
      the participant's driving performance after single IV doses of rapastinel as compared with
      single oral doses of alprazolam, a benzodiazepine that demonstrates driving impairment, and
      placebo in healthy participants.
    


Intervention name(s): Rapastinel; Alprazolam; Ketamine; Rapastinel Matched Placebo; Alprazolam Matched Placebo; Ketamine Matched Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Participants will be administered single IV doses of rapastinel, ketamine, rapastinel matched placebo, and ketamine matched placebo, and single oral doses of alprazolam and alprazolam matched placebo in a randomized crossover manner.; Participants will be administered single IV doses of rapastinel, ketamine, rapastinel matched placebo, and ketamine matched placebo, and single oral doses of alprazolam and alprazolam matched placebo in a randomized crossover manner.; Participants will be administered single IV doses of rapastinel, ketamine, rapastinel matched placebo, and ketamine matched placebo, and single oral doses of alprazolam and alprazolam matched placebo in a randomized crossover manner.; Participants will be administered single IV doses of rapastinel, ketamine, rapastinel matched placebo, and ketamine matched placebo, and single oral doses of alprazolam and alprazolam matched placebo in a randomized crossover manner.; Participants will be administered single IV doses of rapastinel, ketamine, rapastinel matched placebo, and ketamine matched placebo, and single oral doses of alprazolam and alprazolam matched placebo in a randomized crossover manner.; Participants will be administered single IV doses of rapastinel, ketamine, rapastinel matched placebo, and ketamine matched placebo, and single oral doses of alprazolam and alprazolam matched placebo in a randomized crossover manner.
Intervention MeSH terms: Ketamine; Alprazolam
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
A Study to Investigate the Safety, Tolerability and Pharmacokinetics of Inhaled CHF6001
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1

Summary: 
      A phase I randomised, double-blind, placebo-controlled study of single and repeated ascending
      doses in healthy volunteers to investigate the safety, tolerability and pharmacokinetics of
      inhaled chf 6001.
    

Detailed description: 
      To assess the safety and tolerability of single and repeated ascending doses of CHF 6001 in
      healthy volunteers and to investigate the pharmacokinetic (PK) profile of CHF 6001 and its
      metabolites CHF 5956 and CHF 6095.
    

Intervention name(s): Single Ascending Dose (SAD); Multiple Ascending Dose (MAD)
Intervention type(s): Drug; Drug
Other intervention name(s): CHF6001; CHF6001
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Intravascular Injection Incidences During Lumbar Medial Branch Block
Condition: Intravascular Injection
Study type: Interventional

Summary: 
      The purpose of this study is to compare using oblique fluoroscopic angle has any advantage in
      reducing the incidence of vascular punture and technical easiness during lumbar medial branch
      block
    

Detailed description: 
      In previous report, the use of oblique fluoroscopic angle during S1 transforaminal injection
      demonstrated technical easiness and reduced intravascular injection incidences. For the
      procedure lumbar medial branch block, both anteroposterior and oblique fluoroscopic angle are
      possible. Usually, which approach method to use is determined according to the physician's
      preferences.

      The final target for lumbar medial branch block is the junction betweeen superior articular
      process and transverse process. This target can be easily confirmed under the scotty dog
      appearance. If we use oblique fluoroscopic angle, this approach (30 degree) can make scotty
      dog appearance more visible so that physician can identify bony landmark more easily for
      lumbar medial branch block. For beginners, oblique fluoroscopic approach seems to provide
      more advantages in identifying bony landmark. However, it is uncertain whether this approach
      can provide technicaL easiness and reduce the intravascualr injection incidences.
    

Intervention name(s): lumbar medial branch block
Intervention type(s): Procedure
Intervention description(s): lumbar medial branch block
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: intravascular injection
DIabetic Retinopathy Candesartan Trials.
Condition: Type 1 Diabetes
MeSH terms: Retinal Diseases; Diabetic Retinopathy
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective is to determine whether candesartan, compared to placebo reduces the
      progression of diabetic retinopathy in normotensive, normoalbuminuric type 1 diabetic
      patients with retinopathy.

      The secondary objective is to determine whether candesartan, compared to placebo, reduces the
      incidence of clinically significant macular oedema (CSME) and/or proliferative diabetic
      retinopathy (PDR) and beneficially influences the rate of change in urinary albumin excretion
      rate (UAER).

      This study is part of the DIRECT Programme also including a primary prevention study of
      diabetic retinopathy in type 1 diabetes and a secondary prevention study in type 2 diabetes.
      The primary objective for all three pooled studies is to determine whether candesartan,
      compared to placebo, reduces the incidence of microalbuminuria in type 1 and type 2 diabetic
      patients.
    


Intervention name(s): candesartan
Intervention type(s): Drug
Intervention description(s): 32 mg oral tablet
Other intervention name(s): ATACAND
Intervention MeSH terms: Candesartan; Candesartan cilexetil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Diabetes mellitus type 1
Ayurvedic Nutritional Counseling for Patients With IBS in Comparison to Conventional Nutritional Counseling
Condition: IBS - Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome
Study type: Interventional

Summary: 
      The main goal of this randomized controlled clinical study is to evaluate the efficacy of an
      individual Ayurvedic nutritional counseling (according to tradition) compared to an
      individual conventional dietary advice (according to the German Nutrition Society - DGE) in
      patients with irritable bowel syndrome. It is to be investigated whether nutritional therapy
      elements, which patients can self-implement independently in the home environment, can
      achieve sustainable therapy effects.
    


Intervention name(s): Ayurvedic nutritional counseling; Conventional nutritional counseling
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Ayurveda; IBS; Complementary medicine; nutritional counseling
Rituximab Treatment in Sjogren's Syndrome
Condition: Sjogren's Syndrome
MeSH terms: Sjogren's Syndrome; Syndrome
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study is an evaluation of the effect of rituximab compared to placebo in combination
      with steroids on salivary flow and serological and clinical parameters in patients with
      primary SS.
    

Detailed description: 
      Study design:

      phase II trial

      Study objective:

      evaluation of the effect of rituximab compared to placebo in combination with steroids on
      salivary flow and serological and clinical parameters in patients with primary SS

      Number of participating centres:

      1

      Duration:

      follow-up 48 weeks

      Study medication:

      2 infusions on day 1 and day 15 rituximab infusions (1000 mg) or placebo infusions
      intravenous infusion of 100 mg of methylprednisolone before infusion of rituximab (or the
      placebo for rituximab), together with 60 mg per day of oral prednisone on days 2, 3, 16 and
      17, 30 mg per day on days 4, 5, 18 and 19 and 15 mg per day on days 6 and 20

      Primary objective/endpoint:

      stimulated salivary gland function (stimulated submandibular/sublingual and parotid saliva)

      Secondary objectives/endpoint:

      Functional parameters Laboratory parameters Subjective parameters Histological/Molecular
      parameters

      Number of subjects:

      30 patients with primary SS (20 patients rituximab treatment, 10 patients placebo)
    

Intervention name(s): rituximab (anti-CD20)
Intervention type(s): Drug
Intervention description(s): 2 infusions of 1000 mg
Other intervention name(s): Mabthera
Intervention MeSH terms: Rituximab
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment